Rio999 personal page - To The Moon

Rio999

Rio999

Stay foolish

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2024-03-15

$特斯拉(TSLA)$ 120 possible

2024-03-11

Sounds good

GenScript Biotech (01548.HK) Reports Annual Results Revenue Increases 34.2% R&D Expenses Increase to Approximately US$433 Million

2024-02-23

A breakthrough into 2024.

Legend Biotech Receives CHMP Awardship for CARVYKTI ® Positive opinions for frontline treatment

2021-08-25

$Roblox Corporation(RBLX)$OF METAFOR METABY META

2021-07-02

Let me dig data elsewhere.This is my Legend under construction

Sorry, the original content has been removed

2021-06-18

Hodler

Sorry, the original content has been removed

2020-08-21

news

Sorry, the original content has been removed

2020-04-22

$Zoom(ZM)$EXXONMOBILE HAS CONDUCTED GROUNDBREAKING CEREMONY ON CLOUD FOR A CANTONESE PROJECT WORTH 10 BILLION USD. MAYBE NOT VIA ZOOM, HOWEVER, IT IS A TREND. FUTURE IS HERE.

2020-03-16

$Zoom(ZM)$really stable

Go to Tiger App to see more news

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href=\"https://ttm.financial/S/TSLA\">$特斯拉(TSLA)$&nbsp;</a> 120 possible","listText":"<a href=\"https://ttm.financial/S/TSLA\">$特斯拉(TSLA)$&nbsp;</a> 120 possible","text":"$特斯拉(TSLA)$ 120 possible","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":0,"repostSize":0,"link":"https://ttm.financial/post/284608203792656","isVote":1,"tweetType":1,"viewCount":2866,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":283015058595936,"gmtCreate":1710123984796,"gmtModify":1710123988086,"author":{"id":"3486361727758741","authorId":"3486361727758741","name":"Rio999","avatar":"https://static.tigerbbs.com/c1e4178e32cb0fcff4b50f4dce9cc6b4","crmLevel":3,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3486361727758741","authorIdStr":"3486361727758741"},"themes":[],"htmlText":"Sounds good&nbsp;","listText":"Sounds good&nbsp;","text":"Sounds 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Group's revenue continued to grow strongly. For the year ended 31 December 2023, the Group's revenue was approximately US$839.5 million, representing an increase of 34.2% from approximately US$625.7 million in the previous year, of which the external revenue from the non-cell therapy business was approximately US$554.5 million, representing an increase of 8.9% from approximately US$509.0 million in the previous year, and the external revenue from the cell therapy business was approximately US$285.0 million, representing an increase of 144.2% from approximately US$116.7 million in the previous year.</p><p>Strong Revenue Growth Drives Group<span>Gross profit</span>Strong growth. During the Year, the Group's gross profit was approximately US$409.6 million, representing an increase of 34.7% as compared to approximately US$304.1 million in the Previous Year, of which the gross profit (before offsetting) of the non-cell therapy business was approximately US$270.6 million, representing an increase of 5.3% as compared to approximately US$257.1 million in the Previous Year, and the gross profit (before offsetting) of the cell therapy business was approximately US$140.9 million, representing an increase of 173.1% as compared to approximately US$51.6 million in the Previous Year.</p><p>The increase in revenue and gross profit was mainly attributable to (i) the continuous growth in revenue from major strategic customers of the non-cellular therapy business and competitive commercial operations in the European and American markets; and (ii) the rapid growth in sales in the U.S. and European markets following the commercial approval of CARVYKTI.</p><p>In 2023, research and development expenses increased by 10.9% to approximately US$432.8 million from approximately US$390.1 million in 2022. This was primarily due to (i) increased investment in talent, hiring experienced personnel and providing competitive packaging and equity-settled share-based compensation expenses for all business units; (ii) ongoing investment in cilta-cel R&D activities (including increasing the patient enrollment rate of cilta-cel Phase 3 clinical trials) and other R&D pipeline projects; And (iii) continuously invest in new products and services to enhance competitiveness. Adjusted research and development expenses increased by 10.3% compared to the same period in 2022.</p><p>The company said that the group plans to actively build production capacity worldwide to meet strong customer demand in the future. In terms of life science services and products, the Group plans to continue to invest in and enhance the production capacity of the molecular biology and protein businesses, and expand the production capacity of GMP, a key reagent in the CGT supply chain. In terms of biologics development services, the Group plans to expand its antibody, plasmid and viral GMP manufacturing facilities in China.</p><p>For industrial synthetic biological products, the Group plans to further optimize production facilities and increase production. The company also plans to expand the synthetic biology laboratory to enhance the company's R&D capabilities. In terms of cell therapy, the Group plans to actively expand CARVYKTI's production capacity in North America and Europe, with a view to expanding the number of frontline multiple myeloma patients that can be treated. The Group also plans to invest in upgrading the supply chain, IT infrastructure and other supporting functions to enhance operational efficiency and facilitate strong business growth.</p><p></article></body></html></p>","source":"tencent","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>GenScript Biotech (01548.HK) Reports Annual Results Revenue Increases 34.2% R&D Expenses Increase to Approximately US$433 Million</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 12.5px; color: #7E829C; margin: 0;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nGenScript Biotech (01548.HK) Reports Annual Results Revenue Increases 34.2% R&D Expenses Increase to Approximately US$433 Million\n</h2>\n<h4 class=\"meta\">\n<p class=\"head\">\n<strong class=\"h-name small\">格隆汇资讯</strong><span class=\"h-time small\">2024-03-10 18:30</span>\n</p>\n</h4>\n</header>\n<article>\n<p><html><body><article>Gelonghui March 10 |<a href=\"https://laohu8.com/S/01548\">GenScript Biotech</a>(01548.HK) announced that the Group's revenue continued to grow strongly. For the year ended 31 December 2023, the Group's revenue was approximately US$839.5 million, representing an increase of 34.2% from approximately US$625.7 million in the previous year, of which the external revenue from the non-cell therapy business was approximately US$554.5 million, representing an increase of 8.9% from approximately US$509.0 million in the previous year, and the external revenue from the cell therapy business was approximately US$285.0 million, representing an increase of 144.2% from approximately US$116.7 million in the previous year.</p><p>Strong Revenue Growth Drives Group<span>Gross profit</span>Strong growth. During the Year, the Group's gross profit was approximately US$409.6 million, representing an increase of 34.7% as compared to approximately US$304.1 million in the Previous Year, of which the gross profit (before offsetting) of the non-cell therapy business was approximately US$270.6 million, representing an increase of 5.3% as compared to approximately US$257.1 million in the Previous Year, and the gross profit (before offsetting) of the cell therapy business was approximately US$140.9 million, representing an increase of 173.1% as compared to approximately US$51.6 million in the Previous Year.</p><p>The increase in revenue and gross profit was mainly attributable to (i) the continuous growth in revenue from major strategic customers of the non-cellular therapy business and competitive commercial operations in the European and American markets; and (ii) the rapid growth in sales in the U.S. and European markets following the commercial approval of CARVYKTI.</p><p>In 2023, research and development expenses increased by 10.9% to approximately US$432.8 million from approximately US$390.1 million in 2022. This was primarily due to (i) increased investment in talent, hiring experienced personnel and providing competitive packaging and equity-settled share-based compensation expenses for all business units; (ii) ongoing investment in cilta-cel R&D activities (including increasing the patient enrollment rate of cilta-cel Phase 3 clinical trials) and other R&D pipeline projects; And (iii) continuously invest in new products and services to enhance competitiveness. Adjusted research and development expenses increased by 10.3% compared to the same period in 2022.</p><p>The company said that the group plans to actively build production capacity worldwide to meet strong customer demand in the future. In terms of life science services and products, the Group plans to continue to invest in and enhance the production capacity of the molecular biology and protein businesses, and expand the production capacity of GMP, a key reagent in the CGT supply chain. In terms of biologics development services, the Group plans to expand its antibody, plasmid and viral GMP manufacturing facilities in China.</p><p>For industrial synthetic biological products, the Group plans to further optimize production facilities and increase production. The company also plans to expand the synthetic biology laboratory to enhance the company's R&D capabilities. In terms of cell therapy, the Group plans to actively expand CARVYKTI's production capacity in North America and Europe, with a view to expanding the number of frontline multiple myeloma patients that can be treated. The Group also plans to invest in upgrading the supply chain, IT infrastructure and other supporting functions to enhance operational efficiency and facilitate strong business growth.</p><p></article></body></html></p>\n<div class=\"bt-text\">\n\n\n<p> source：<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20240310183021876d5641&s=b\">格隆汇资讯</a></p>\n\n\n</div>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"01548":"金斯瑞生物科技","BK1583":"高瓴概念","BK1141":"生命科学工具和服务","BK1576":"医药外包概念"},"source_url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20240310183021876d5641&s=b","is_english":false,"share_image_url":"https://static.laohu8.com/9a95c1376e76363c1401fee7d3717173","article_id":"2418503896","content_text":"格隆汇3月10日丨 金斯瑞生物科技(01548.HK)发布公告，集团收入持续强劲增长，截至2023年12月31日止年度，集团的收益约为839.5百万美元，较上年度的约625.7百万美元增加34.2%，其中非细胞疗法业务的外部收益约为554.5百万美元，较上年度的约509.0百万美元增加8.9%，细胞疗法业务的外部收益约为285.0百万美元，较上年度的约116.7百万美元增加144.2%。强劲收入增长带动集团毛利强劲增长。该年度，集团的毛利约为409.6百万美元，较上年度的约304.1百万美元增加34.7%，其中非细胞疗法业务的毛利(抵销前)约为270.6百万美元，较上年度的约257.1百万美元增加5.3%，细胞疗法业务的毛利(抵销前)约为140.9百万美元，较上年度的约51.6百万美元增加173.1%。收益及毛利增加主要是由于(i)非细胞疗法业务来自主要战略客户的收益持续增长及欧美市场具有竞争力的商业运营；及(ii)CARVYKTI获商业化批准后，在美国和欧洲市场的销售额快速增长。于2023年，研发开支由2022年的约390.1百万美元，增加10.9%至约432.8百万美元。这主要是由于(i)增加对人才的投资，聘请有经验的人员，并为所有业务部门提供有竞争力的待遇和以股权结算的股份薪酬开支；(ii)持续的cilta-cel研发活动投入(包括提高cilta-cel 3期临床试验患者入组率)及其他研发管线项目投入；及(iii)持续投资新产品及服务，以提高竞争力。经调整研发开支较2022年同期增加10.3%。公司表示，集团计划在全球范围内积极建立生产产能，以满足未来强劲的客户需求。生命科学服务及产品方面，集团计划继续投资及提升分子生物学及蛋白业务产能，并扩建CGT供应链关键试剂GMP生产产能。生物制剂开发服务方面，集团计划在中国扩建抗体、质粒和病毒GMP生产设施。工业合成生物产品方面，集团计划进一步优化生产设施，提高产量。公司亦计划扩建合成生物学实验室，增强公司的研发能力。细胞治疗方面，集团计划积极扩大CARVYKTI在北美和欧洲的产能，以期能够扩大可治疗的前线多发性骨髓瘤患者。集团亦计划投资升级供应链、IT基础设施以及其他支持职能，以提升运营效率，促进业务强劲增长。","news_type":1,"symbols_score_info":{"01548":1}},"isVote":1,"tweetType":1,"viewCount":2905,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":277190357270592,"gmtCreate":1708699436188,"gmtModify":1708699440337,"author":{"id":"3486361727758741","authorId":"3486361727758741","name":"Rio999","avatar":"https://static.tigerbbs.com/c1e4178e32cb0fcff4b50f4dce9cc6b4","crmLevel":3,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3486361727758741","authorIdStr":"3486361727758741"},"themes":[],"htmlText":"A breakthrough into 2024.","listText":"A breakthrough into 2024.","text":"A breakthrough into 2024.","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://ttm.financial/post/277190357270592","repostId":"2413593763","repostType":2,"repost":{"id":"2413593763","kind":"news","pubTimestamp":1708692420,"share":"https://ttm.financial/m/news/2413593763?lang=en_US&edition=fundamental","pubTime":"2024-02-23 20:47","market":"us","language":"zh","title":"Legend Biotech Receives CHMP Awardship for CARVYKTI ® Positive opinions for frontline treatment","url":"https://stock-news.laohu8.com/highlight/detail?id=2413593763","media":"美通社","summary":"传奇生物首席执行官黄颖博士表示：\"这一里程碑表明了我们将CARVYKTI带给全球更多及更前线患者以改变治疗格局的承诺。CHMP 的积极意见是将CARVYKTI用于欧洲更多患者以使其得益于该一次性输注疗法的重要一步。2022年2月，西达基奥仑赛获得美国FDA批准上市，5月获得欧盟EC授予的附条件上市许可，9月获得日本MHLW批准上市，用于治疗复发或难治性多发性骨髓瘤成人患者，商品名为CARVYKTI。","content":"<p><html><body><table border=\"0\" cellpadding=\"5\" cellspacing=\"10\"><tbody><tr><td><img border=\"0\" hspace=\"0\" src=\"https://mma.prnasia.com/media2/2346145/LEGEND_CMYK_Logo.jpg?p=medium600\" title=\"logo\" vspace=\"0\" width=\"118\"/></td></tr></tbody></table><i>CARVYKTI<sup>®</sup></i><i>（</i><i>Cilla-cel,</i><i>Cedarchiolensai) is the first to receive the European Medicines Agency's Committee on Medicinal Products for Human Use (</i><i>CHMP</i><i>) Positive opinion</i><i>CAR-T</i><i>Therapy</i></p><p><span>NANJING</span><span>February 23, 2024</span>/PRNewswire/ - -Feb. 23, 2024 local time,<a href=\"https://laohu8.com/S/LEGN\">Legendary creatures</a>(NASDAQ: LEGN) announced in Somerset, New Jersey, USA that the European Medicines Agency (EMA) Committee on Medicinal Products for Human Use (CHMP) recommended approval to expand CARVYKTI<sup>®</sup>(cilta-cel, CIDACIOLENSEL) to include relapsed and refractory multiple myeloma who have received at least first-line prior therapy including one immunomodulator and one proteasome inhibitor Adult patients with disease progression and resistance to lenalidomide in the last-line therapy. This item I<span>Class I</span>The application for variation was submitted to the EMA by Janssen-Cilag International N.V., an affiliate of partner Janssen, and the positive opinion of the CHMP will be reviewed by the European Commission with a final approval decision.</p><p><div></div>Dr. Ying Huang, CEO of Legend Biotech, said: \"This milestone demonstrates that we will CARVYKTI<sup>®</sup>The commitment to bring more and more frontline patients around the world to change the treatment landscape. The positive opinion from the CHMP demonstrates our tireless efforts in partnering with Janssen to provide patients with new treatment options and bring hope to them and their families. \"</p><p>CHMP on CARVYKTI<sup>®</sup>The recommendations are supported by data from the CARTITUDE-4 study (NCT04181827), the first randomized Phase 3 study to evaluate CARVYKTI<sup>®</sup>Efficacy and safety compared to pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd) in patients with multiple myeloma who have relapsed and are resistant to lenalidomide after prior 1-3 lines of therapy<sup><span>[1]</span></sup>。</p><p>Dr. Jesús San Miguel, Senior Consultant, Professor of Medical Hematology, Clinical and Clinical Lead, Clinical Cancer Center, University of Navarra, Spain, said: \"The results of the CARTITUDE-4 study indicate that patients with early relapse can gain significant clinical benefits from this therapy. The positive opinion of the CHMP is to put CARVYKTI<sup>®</sup>This is an important step for more patients in Europe to benefit from this one-time infusion therapy. \"</p><p><b>about</b><b>CARVYKTI<sup>®</sup></b><b>（</b><b>cilta-cel</b><b>, Cedarchiorunsay)</b></p><p>Cedarchiorensai is a chimeric antigen receptor T cell (CAR-T) therapy that targets B cell maturation antigen (BCMA), using the transgene of the chimeric antigen receptor (CAR) to modify the patient's own T cells to recognize and eliminate BCMA-expressing cells. BCMA is mainly expressed on the surface of malignant multiple myeloma B cell lineage, advanced B cells and plasma cells. The CAR protein of Cidagiolensai has two single-domain antibodies targeting BCMA and has high affinity for BCMA-expressing cells. After binding to BCMA-expressing cells, CAR can promote T cell activation and expansion, and then eliminate target cells<sup>[2]</sup>。</p><p>In December 2017, Janssen entered into a global exclusive licensing and collaboration agreement with Legendary Biotech to develop and commercialize Cedarchiolensai. In February 2022, Chidagiolensai was approved for marketing by the US FDA, conditional marketing authorization granted by the European Union EC in May, and approved for marketing by MHLW in Japan in September for the treatment of relapsed or refractory multiple myeloma in adults Patients, under the trade name CARVYKTI<sup>®</sup>。 Cedarchiolensai received breakthrough therapy designation in the United States in December 2019 and in China in August 2020. Additionally, Cedarchiolense was recognized as a priority drug by the European Commission in April 2019. The US FDA, the European EMA and the Japanese PMDA granted orphan drug designation to Chidagiolensai in February 2019, February 2020 and June 2020, respectively. In March 2022, the European Medicines Agency's Orphan Medicines Committee unanimously recommended maintaining the orphan drug designation of Cedarchiolensex based on clinical data (improved and persistent complete response rate after treatment).</p><p><b>about</b><b>CARTITUDE-4</b></p><p>CARTITUDE-4 (NCT04181827) is an international, randomized, open-label phase 3 study evaluating the efficacy and safety of chidagiolensex versus pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd) in adult patients with relapsed and lenalidomide-resistant multiple myeloma who have received previous line 1-3 therapy, with progression-free survival (PFS) as the primary endpoint of the study<sup>[3]</sup>。</p><p><b>About multiple myeloma</b></p><p>Multiple myeloma is considered an incurable hematological tumor and is a malignant disease caused by the hyperproliferation of plasma cells in the bone marrow<sup>[4]</sup>。 More than 35,000 people are expected to be diagnosed with multiple myeloma in the U.S. in 2024, and more than 12,000 people will die from the disease<sup>[5]</sup>。 Although some patients with multiple myeloma are asymptomatic and are diagnosed due to symptoms, these symptoms may include bone disease, low abnormal blood cell count, elevated blood calcium, kidney problems, or infection<sup>[6]</sup>。</p><p><b>About Legendary Creatures</b></p><p>Legend Biotech (NASDAQ: LEGN), founded in 2014, is a multinational biopharmaceutical company integrating research and development, clinical, production and commercial development of tumor immune cell therapy. It ranks first in the field of immune cell therapy in the world, with global employees. The total number exceeds 1,800 people. Currently through the cooperation with Janssen, the first product CARVYKTI<sup>®</sup>(cilta-cel, Cidagiolensai) was approved for marketing by the U.S. Food and Drug Administration (FDA), Japan's Ministry of Health, Labor and Welfare (MHLW) in 2022, and obtained conditional marketing authorization from the European Commission (EC), which is expected to solve the world-class problem of multiple myeloma treatment. At the end of 2022, the National Medical Products Administration officially accepted the New Drug Marketing Application (NDA) for Chidagiolensai, and it was included in the priority review process in January 2023. In addition, the company also has a number of cell therapies under development for the treatment of hematological tumors, solid tumors and other difficult diseases.</p><p>More information is available at:</p><p><b><i>CAUTIONS REGARDING FORWARD-LOOKING</i></b></p><p><i>Statements in this press release regarding future expectations, plans and prospects, and any other statements regarding matters other than historical fact, constitute</i><i>1995</i><i>\"forward-looking statements\" within the meaning of the Private Securities Litigation Reform Act. These statements include, but are not limited to, statements relating to the strategy and goals of the Legendary Creature; Right</i><i>CARVYKTI<sup>®</sup></i><i>Related expressions, including legendary creature pairs</i><i>CARVYKTI<sup>®</sup></i><i>Expectations of; With</i><i>CARVYKTI<sup>®</sup></i><i>patient-related expressions, including expectations of an expanded patient population; With</i><i>CARVYKTI<sup>®</sup></i><i>Declaration of relevant statements, and to the United States</i><i>FDA</i><i>And the progress of filings by other regulatory agencies, and the potential benefits of Legendary Biologics product candidates. The expressions \"anticipate,\"\"believe,\"\"continue,\"\"may,\"\"estimate,\"\"expect,\"\"intend,\"\"may,\"\"plan,\"\"potential,\"\"predict,\"\"anticipate,\"\"should,\"\"target,\"\"will,\"\"would\" and similar expressions are intended to identify forward-looking statements, but not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements due to various important factors. Legendary Biologic's expectations may be affected by, among other factors: uncertainties in the development of new drugs, unexpected clinical trial results, including additional analysis of existing clinical data or unexpected results of new clinical data; Unexpected regulatory actions or delays, including requirements to provide additional security and</i><i>/</i><i>Or validity information or analysis of information, or government regulation in general; Unexpected delays due to actions taken or failure to take action by our third-party partners; uncertainties arising from challenges to Legendary Biotech's patent or other proprietary intellectual property protection, including uncertainties involved in the course of U.S. litigation; General competition; Government, industry and general product pricing and other political pressures;</i><i>COVID-19</i><i>the duration and severity of the pandemic, and the governmental and regulatory measures taken in response to the changing landscape; And legendary creatures in</i><i>2023</i><i>Year</i><i>3</i><i>Monthly</i><i>30</i><i>Filed with the U.S. Securities and Exchange Commission</i><i>20-F</i><i>Other factors discussed in the \"Risk Factors\" section of the Annual Report of Form. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, actual results may differ materially from those expected, believed, estimated or expected described in this press release. Any forward-looking statements contained in this press release speak solely as of the date of this press release. Legend Biotech expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.</i></p><p><span>†</span>Dr. Jesús San Miguel, Senior Consultant, Professor of Medical Hematology, Clinical and Clinical Lead, Clinical Cancer Center, University of Navarre, Spain, provides consulting and consulting services to Legendary Bio and is not paid for any media work.</p><p><b>Reference Source:</b></p><p><div><table border=\"0\" cellpadding=\"1\" cellspacing=\"0\"><tbody><tr><td colspan=\"1\" rowspan=\"1\"><span>[1] ClinicalTrials.gov. BCMA-targeted CAR-T therapy JNJ-68284528 compared with pomalidomide, bortezomib and dexamethasone (PVd) or dalazumab, pomalidomide and dexamethasone (DPd) in patients with relapsed and lenalidomide-resistant multiple myeloma (CARTITUDE-4).. November 2023.</span></p><p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><span>[2] CARVYKTI ™ Prescribing information. Horsham, PA: Janssen Biotech, Inc.</span></p><p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><span>[3] ClinicalTrials.gov. BCMA-targeted CAR-T therapy JNJ-68284528 compared with pomalidomide, bortezomib and dexamethasone (PVd) or dalazumab, pomalidomide and dexamethasone (DPd) in patients with relapsed and lenalidomide-resistant multiple myeloma (CARTITUDE-4).. November 2023.</span></p><p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><span>[4] American Society of Clinical Oncology, Introduction to Multiple Myeloma. types/multiple-myeloma/introduction. March 2023.</span></p><p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><span>[5] American Cancer Society, Key Statistics on Multiple Myeloma.. February 2024.</span></p><p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><span>[6] American Cancer Society, Multiple Myeloma: Early Detection, Diagnosis, and Staging. March 2023.</span></p><p></td></tr></tbody></table></div>Media Contact:</p><p></body></html></p>","source":"prnasia","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Legend Biotech Receives CHMP Awardship for CARVYKTI ® Positive opinions for frontline treatment</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 12.5px; color: #7E829C; margin: 0;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nLegend Biotech Receives CHMP Awardship for CARVYKTI ® Positive opinions for frontline treatment\n</h2>\n<h4 class=\"meta\">\n<p class=\"head\">\n<strong class=\"h-name small\">美通社</strong><span class=\"h-time small\">2024-02-23 20:47</span>\n</p>\n</h4>\n</header>\n<article>\n<p><html><body><table border=\"0\" cellpadding=\"5\" cellspacing=\"10\"><tbody><tr><td><img border=\"0\" hspace=\"0\" src=\"https://mma.prnasia.com/media2/2346145/LEGEND_CMYK_Logo.jpg?p=medium600\" title=\"logo\" vspace=\"0\" width=\"118\"/></td></tr></tbody></table><i>CARVYKTI<sup>®</sup></i><i>（</i><i>Cilla-cel,</i><i>Cedarchiolensai) is the first to receive the European Medicines Agency's Committee on Medicinal Products for Human Use (</i><i>CHMP</i><i>) Positive opinion</i><i>CAR-T</i><i>Therapy</i></p><p><span>NANJING</span><span>February 23, 2024</span>/PRNewswire/ - -Feb. 23, 2024 local time,<a href=\"https://laohu8.com/S/LEGN\">Legendary creatures</a>(NASDAQ: LEGN) announced in Somerset, New Jersey, USA that the European Medicines Agency (EMA) Committee on Medicinal Products for Human Use (CHMP) recommended approval to expand CARVYKTI<sup>®</sup>(cilta-cel, CIDACIOLENSEL) to include relapsed and refractory multiple myeloma who have received at least first-line prior therapy including one immunomodulator and one proteasome inhibitor Adult patients with disease progression and resistance to lenalidomide in the last-line therapy. This item I<span>Class I</span>The application for variation was submitted to the EMA by Janssen-Cilag International N.V., an affiliate of partner Janssen, and the positive opinion of the CHMP will be reviewed by the European Commission with a final approval decision.</p><p><div></div>Dr. Ying Huang, CEO of Legend Biotech, said: \"This milestone demonstrates that we will CARVYKTI<sup>®</sup>The commitment to bring more and more frontline patients around the world to change the treatment landscape. The positive opinion from the CHMP demonstrates our tireless efforts in partnering with Janssen to provide patients with new treatment options and bring hope to them and their families. \"</p><p>CHMP on CARVYKTI<sup>®</sup>The recommendations are supported by data from the CARTITUDE-4 study (NCT04181827), the first randomized Phase 3 study to evaluate CARVYKTI<sup>®</sup>Efficacy and safety compared to pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd) in patients with multiple myeloma who have relapsed and are resistant to lenalidomide after prior 1-3 lines of therapy<sup><span>[1]</span></sup>。</p><p>Dr. Jesús San Miguel, Senior Consultant, Professor of Medical Hematology, Clinical and Clinical Lead, Clinical Cancer Center, University of Navarra, Spain, said: \"The results of the CARTITUDE-4 study indicate that patients with early relapse can gain significant clinical benefits from this therapy. The positive opinion of the CHMP is to put CARVYKTI<sup>®</sup>This is an important step for more patients in Europe to benefit from this one-time infusion therapy. \"</p><p><b>about</b><b>CARVYKTI<sup>®</sup></b><b>（</b><b>cilta-cel</b><b>, Cedarchiorunsay)</b></p><p>Cedarchiorensai is a chimeric antigen receptor T cell (CAR-T) therapy that targets B cell maturation antigen (BCMA), using the transgene of the chimeric antigen receptor (CAR) to modify the patient's own T cells to recognize and eliminate BCMA-expressing cells. BCMA is mainly expressed on the surface of malignant multiple myeloma B cell lineage, advanced B cells and plasma cells. The CAR protein of Cidagiolensai has two single-domain antibodies targeting BCMA and has high affinity for BCMA-expressing cells. After binding to BCMA-expressing cells, CAR can promote T cell activation and expansion, and then eliminate target cells<sup>[2]</sup>。</p><p>In December 2017, Janssen entered into a global exclusive licensing and collaboration agreement with Legendary Biotech to develop and commercialize Cedarchiolensai. In February 2022, Chidagiolensai was approved for marketing by the US FDA, conditional marketing authorization granted by the European Union EC in May, and approved for marketing by MHLW in Japan in September for the treatment of relapsed or refractory multiple myeloma in adults Patients, under the trade name CARVYKTI<sup>®</sup>。 Cedarchiolensai received breakthrough therapy designation in the United States in December 2019 and in China in August 2020. Additionally, Cedarchiolense was recognized as a priority drug by the European Commission in April 2019. The US FDA, the European EMA and the Japanese PMDA granted orphan drug designation to Chidagiolensai in February 2019, February 2020 and June 2020, respectively. In March 2022, the European Medicines Agency's Orphan Medicines Committee unanimously recommended maintaining the orphan drug designation of Cedarchiolensex based on clinical data (improved and persistent complete response rate after treatment).</p><p><b>about</b><b>CARTITUDE-4</b></p><p>CARTITUDE-4 (NCT04181827) is an international, randomized, open-label phase 3 study evaluating the efficacy and safety of chidagiolensex versus pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd) in adult patients with relapsed and lenalidomide-resistant multiple myeloma who have received previous line 1-3 therapy, with progression-free survival (PFS) as the primary endpoint of the study<sup>[3]</sup>。</p><p><b>About multiple myeloma</b></p><p>Multiple myeloma is considered an incurable hematological tumor and is a malignant disease caused by the hyperproliferation of plasma cells in the bone marrow<sup>[4]</sup>。 More than 35,000 people are expected to be diagnosed with multiple myeloma in the U.S. in 2024, and more than 12,000 people will die from the disease<sup>[5]</sup>。 Although some patients with multiple myeloma are asymptomatic and are diagnosed due to symptoms, these symptoms may include bone disease, low abnormal blood cell count, elevated blood calcium, kidney problems, or infection<sup>[6]</sup>。</p><p><b>About Legendary Creatures</b></p><p>Legend Biotech (NASDAQ: LEGN), founded in 2014, is a multinational biopharmaceutical company integrating research and development, clinical, production and commercial development of tumor immune cell therapy. It ranks first in the field of immune cell therapy in the world, with global employees. The total number exceeds 1,800 people. Currently through the cooperation with Janssen, the first product CARVYKTI<sup>®</sup>(cilta-cel, Cidagiolensai) was approved for marketing by the U.S. Food and Drug Administration (FDA), Japan's Ministry of Health, Labor and Welfare (MHLW) in 2022, and obtained conditional marketing authorization from the European Commission (EC), which is expected to solve the world-class problem of multiple myeloma treatment. At the end of 2022, the National Medical Products Administration officially accepted the New Drug Marketing Application (NDA) for Chidagiolensai, and it was included in the priority review process in January 2023. In addition, the company also has a number of cell therapies under development for the treatment of hematological tumors, solid tumors and other difficult diseases.</p><p>More information is available at:</p><p><b><i>CAUTIONS REGARDING FORWARD-LOOKING</i></b></p><p><i>Statements in this press release regarding future expectations, plans and prospects, and any other statements regarding matters other than historical fact, constitute</i><i>1995</i><i>\"forward-looking statements\" within the meaning of the Private Securities Litigation Reform Act. These statements include, but are not limited to, statements relating to the strategy and goals of the Legendary Creature; Right</i><i>CARVYKTI<sup>®</sup></i><i>Related expressions, including legendary creature pairs</i><i>CARVYKTI<sup>®</sup></i><i>Expectations of; With</i><i>CARVYKTI<sup>®</sup></i><i>patient-related expressions, including expectations of an expanded patient population; With</i><i>CARVYKTI<sup>®</sup></i><i>Declaration of relevant statements, and to the United States</i><i>FDA</i><i>And the progress of filings by other regulatory agencies, and the potential benefits of Legendary Biologics product candidates. The expressions \"anticipate,\"\"believe,\"\"continue,\"\"may,\"\"estimate,\"\"expect,\"\"intend,\"\"may,\"\"plan,\"\"potential,\"\"predict,\"\"anticipate,\"\"should,\"\"target,\"\"will,\"\"would\" and similar expressions are intended to identify forward-looking statements, but not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements due to various important factors. Legendary Biologic's expectations may be affected by, among other factors: uncertainties in the development of new drugs, unexpected clinical trial results, including additional analysis of existing clinical data or unexpected results of new clinical data; Unexpected regulatory actions or delays, including requirements to provide additional security and</i><i>/</i><i>Or validity information or analysis of information, or government regulation in general; Unexpected delays due to actions taken or failure to take action by our third-party partners; uncertainties arising from challenges to Legendary Biotech's patent or other proprietary intellectual property protection, including uncertainties involved in the course of U.S. litigation; General competition; Government, industry and general product pricing and other political pressures;</i><i>COVID-19</i><i>the duration and severity of the pandemic, and the governmental and regulatory measures taken in response to the changing landscape; And legendary creatures in</i><i>2023</i><i>Year</i><i>3</i><i>Monthly</i><i>30</i><i>Filed with the U.S. Securities and Exchange Commission</i><i>20-F</i><i>Other factors discussed in the \"Risk Factors\" section of the Annual Report of Form. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, actual results may differ materially from those expected, believed, estimated or expected described in this press release. Any forward-looking statements contained in this press release speak solely as of the date of this press release. Legend Biotech expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.</i></p><p><span>†</span>Dr. Jesús San Miguel, Senior Consultant, Professor of Medical Hematology, Clinical and Clinical Lead, Clinical Cancer Center, University of Navarre, Spain, provides consulting and consulting services to Legendary Bio and is not paid for any media work.</p><p><b>Reference Source:</b></p><p><div><table border=\"0\" cellpadding=\"1\" cellspacing=\"0\"><tbody><tr><td colspan=\"1\" rowspan=\"1\"><span>[1] ClinicalTrials.gov. BCMA-targeted CAR-T therapy JNJ-68284528 compared with pomalidomide, bortezomib and dexamethasone (PVd) or dalazumab, pomalidomide and dexamethasone (DPd) in patients with relapsed and lenalidomide-resistant multiple myeloma (CARTITUDE-4).. November 2023.</span></p><p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><span>[2] CARVYKTI ™ Prescribing information. Horsham, PA: Janssen Biotech, Inc.</span></p><p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><span>[3] ClinicalTrials.gov. BCMA-targeted CAR-T therapy JNJ-68284528 compared with pomalidomide, bortezomib and dexamethasone (PVd) or dalazumab, pomalidomide and dexamethasone (DPd) in patients with relapsed and lenalidomide-resistant multiple myeloma (CARTITUDE-4).. November 2023.</span></p><p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><span>[4] American Society of Clinical Oncology, Introduction to Multiple Myeloma. types/multiple-myeloma/introduction. March 2023.</span></p><p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><span>[5] American Cancer Society, Key Statistics on Multiple Myeloma.. February 2024.</span></p><p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><span>[6] American Cancer Society, Multiple Myeloma: Early Detection, Diagnosis, and Staging. March 2023.</span></p><p></td></tr></tbody></table></div>Media Contact:</p><p></body></html></p>\n<div class=\"bt-text\">\n\n\n<p> source：<a href=\"https://wwwold.prnasia.com/story/archive/4344094_ZH44094_1\">美通社</a></p>\n\n\n</div>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"LEGN":"传奇生物","BK4588":"碎股","CHMP":"冠军工业","BK4585":"ETF&股票定投概念","BK4505":"高瓴资本持仓","BK4139":"生物科技","BK4087":"商业印刷"},"source_url":"https://wwwold.prnasia.com/story/archive/4344094_ZH44094_1","is_english":false,"share_image_url":"https://static.laohu8.com/7d5258e5fa9d58069a293859983c0a71","article_id":"2413593763","content_text":"CARVYKTI®（cilta-cel, 西达基奥仑赛）是首个在复发或难治性多发性骨髓瘤患者二线治疗中获得欧洲药品管理局人用药品委员会（CHMP）积极意见的CAR-T 疗法 南京2024年2月23日 /美通社/ -- 当地时间2024年2月23日，传奇生物（NASDAQ: LEGN）在美国新泽西州萨默塞特宣布，欧洲药品管理局（EMA）人用药品委员会（CHMP）建议批准扩大CARVYKTI®（cilta-cel，西达基奥仑赛）的适应症范围，以纳入既往至少接受过一线治疗（包括一种免疫调节剂和一种蛋白酶体抑制剂）的复发和难治性多发性骨髓瘤成人患者，这些患者在最后一线治疗中出现疾病进展且对来那度胺耐药。此项II类变更申请由合作伙伴杨森的附属公司Janssen-Cilag International N.V.提交至EMA，CHMP的积极意见将由欧盟委员会进行审查并做出最终批准决定。   传奇生物首席执行官黄颖博士表示：\"这一里程碑表明了我们将CARVYKTI®带给全球更多及更前线患者以改变治疗格局的承诺。CHMP的积极意见展现了我们与杨森公司合作为患者提供新的治疗选择，并为他们及其家人带来希望的不懈努力。\" CHMP对CARVYKTI®的建议是基于CARTITUDE-4 研究 (NCT04181827) 数据的支持，该研究是首个随机 3 期研究，评估CARVYKTI®与泊马度胺、硼替佐米和地塞米松（PVd）或达雷妥尤单抗、泊马度胺和地塞米松（DPd）相比，在既往接受过1-3线治疗后复发且来那度胺耐药的多发性骨髓瘤患者中的疗效和安全性[1]。 西班牙纳瓦拉大学临床癌症中心高级顾问、医学血液学教授、临床和临床负责人 Jesús San Miguel 博士表示：\"CARTITUDE-4 研究结果表明，早期复发的患者能从该疗法中获得显著的临床受益。CHMP 的积极意见是将CARVYKTI®用于欧洲更多患者以使其得益于该一次性输注疗法的重要一步。\" 关于CARVYKTI®（cilta-cel，西达基奥仑赛） 西达基奥仑赛是一种靶向B细胞成熟抗原（BCMA）的嵌合抗原受体T细胞（CAR-T）疗法，使用嵌合抗原受体（CAR）的转基因对患者自身的T细胞进行修饰，以识别和消除表达BCMA的细胞。BCMA主要表达于恶性多发性骨髓瘤B细胞谱系、晚期B细胞和浆细胞的表面。西达基奥仑赛的CAR蛋白具有两种靶向BCMA单域抗体，对表达BCMA的细胞具有高亲和力，在与表达BCMA的细胞结合后，CAR可促进T细胞活化、扩增，继而清除靶细胞[2]。 2017年12月，杨森与传奇生物签订了全球独家许可和合作协议，以开发和商业化西达基奥仑赛。 2022年2月，西达基奥仑赛获得美国FDA批准上市，5月获得欧盟EC授予的附条件上市许可，9月获得日本MHLW批准上市，用于治疗复发或难治性多发性骨髓瘤成人患者，商品名为CARVYKTI®。西达基奥仑赛于2019年12月在美国和2020年8月在中国获得突破性疗法认定。此外，西达基奥仑赛于2019年4月获得欧盟委员会优先药物资格认定。美国FDA、欧洲EMA和日本PMDA分别于2019年2月、2020年2月及2020年6月授予西达基奥仑赛孤儿药资格认定。2022年3月，欧洲药品管理局的孤儿药品委员会一致建议，根据临床数据（治疗后完全缓解率有所改善且持续存在）维持西达基奥仑赛的孤儿药认定。 关于CARTITUDE-4 CARTITUDE-4 (NCT04181827) 是一项国际、随机、开放标签的3期研究，评估西达基奥仑赛与泊马度胺、硼替佐米和地塞米松（PVd）或达雷妥尤单抗、泊马度胺和地塞米松（DPd）在既往接受过1-3线治疗的复发且来那度胺耐药的多发性骨髓瘤成人患者中的疗效和安全性，以无进展生存期（PFS）为该研究主要终点[3]。 关于多发性骨髓瘤 多发性骨髓瘤被认为是不可治愈的血液肿瘤，是由于骨髓中的浆细胞过度增殖导致的恶性疾病[4]。预计2024年美国将有超过35000人被诊断为多发性骨髓瘤，超过12000人死于该疾病[5]。虽然一些多发性骨髓瘤患者无明显症状，是由于出现症状而被确诊，这些症状可能包括骨病、低血细胞计数异常、血钙升高、肾脏问题或感染等[6]。 关于传奇生物 传奇生物（NASDAQ:LEGN）成立于2014年，是一家集肿瘤免疫细胞疗法研发、临床、生产及商业化开发于一体的跨国生物制药公司，位列全球免疫细胞疗法领域第一方阵，全球员工总数逾1800人。目前通过与杨森的合作，首款产品CARVYKTI®（cilta-cel，西达基奥仑赛）于2022年获得美国食品药品监督管理局（FDA）、日本厚生劳动省（MHLW）批准上市，并获得欧盟委员会（EC）附条件上市许可，有望解决多发性骨髓瘤治疗的世界级难题。2022年底，国家药品监督管理局正式受理西达基奥仑赛的新药上市申请（NDA），并于2023年1月纳入优先审评程序。此外，公司还有多款在研细胞疗法，用于血液瘤、实体瘤及其它疑难疾病的治疗。 更多信息请访问：  关于前瞻性陈述的注意事项 本新闻稿中关于未来预期、计划和前景的陈述，以及关于非历史事实事项的任何其他陈述，均构成1995年《私人证券诉讼改革法案》所指的“前瞻性陈述”。这些陈述包括但不限于与传奇生物的战略和目标有关的表述；对CARVYKTI®相关的表述，包括传奇生物对CARVYKTI®的预期；与CARVYKTI®患者有关的表述，包括对扩大患者群体的预期；与CARVYKTI®申报有关的表述，以及向美国FDA和其他监管机构申报的进展情况，以及传奇生物候选产品的潜在益处。“预期”、“相信”、“继续”、“可能”、“估计”、“期望”、“打算”、“可能”、“计划”、“潜在”、“预测”、“预计”、“应该”、“目标”、“将”、“会”和类似表达旨在识别前瞻性陈述，但并非所有前瞻性陈述都包含这些识别词。由于各种重要因素，实际结果可能与此类前瞻性陈述所指示的结果存在实质性差异。传奇生物的预期可能会受到（其中包括）以下因素影响：新药开发过程中的不确定性，意外的临床试验结果，包括对现有临床资料的额外分析或意外的新临床资料的结果；意外的监管行动或延误，包括要求提供额外的安全性和/或有效性资料或资料分析，或一般的政府监管；由于我们的第三方合作伙伴采取的行动或未能采取行动而导致的意外延误；传奇生物的专利或其他专有知识产权保护受到挑战而产生的不确定性，包括美国诉讼过程中涉及的不确定性；一般竞争；政府、行业和一般产品定价和其他政治压力；COVID-19大流行的持续时间和严重程度，以及为应对不断变化的形势而采取的政府和监管措施；以及传奇生物于 2023 年 3 月 30 日向美国证券交易委员会递交的 20-F 表格年度报告的“风险因素”部分中讨论的其他因素。如果这些风险或不确定性中的一个或多个成为现实，或者如果基本假设被证明不正确，则实际结果可能与本新闻稿中描述的预期、相信、估计或预期的结果存在重大差异。本新闻稿中包含的任何前瞻性陈述仅代表截至本新闻稿发布之日的情况。传奇生物明确声明，无论是由于新信息、未来事件还是其他原因，均不承担更新任何前瞻性陈述的义务。 † 西班牙纳瓦拉大学临床癌症中心高级顾问、医学血液学教授、临床和临床负责人 Jesús San Miguel 博士为传奇生物提供咨询和顾问服务，未因任何媒体工作而获得报酬。 参考来源：     [1] ClinicalTrials.gov.  靶向BCMA的CAR-T疗法JNJ-68284528与泊马度胺、硼替佐米和地塞米松（PVd）或达拉单抗、泊马度胺和地塞米松（DPd）在复发和来那度胺耐药的多发性骨髓瘤患者中的比较研究（CARTITUDE-4）。。2023 年 11 月。    [2] CARVYKTI™ 处方信息。Horsham, PA: Janssen Biotech, Inc.    [3] ClinicalTrials.gov.  靶向BCMA的CAR-T疗法JNJ-68284528与泊马度胺、硼替佐米和地塞米松（PVd）或达拉单抗、泊马度胺和地塞米松（DPd）在复发和来那度胺耐药的多发性骨髓瘤患者中的比较研究（CARTITUDE-4）。。2023 年 11 月。    [4] 美国临床肿瘤学会，多发性骨髓瘤简介。 types/multiple-myeloma/introduction。2023 年 3 月。    [5] 美国癌症协会，关于多发性骨髓瘤的关键统计数据。.2024 年 2 月。    [6] 美国癌症协会，多发性骨髓瘤：早期检测、诊断和分期。2023 年 3 月。      媒体联络：","news_type":1,"symbols_score_info":{"CHMP":1,"LEGN":1}},"isVote":1,"tweetType":1,"viewCount":2578,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":837583594,"gmtCreate":1629899826318,"gmtModify":1676530166766,"author":{"id":"3486361727758741","authorId":"3486361727758741","name":"Rio999","avatar":"https://static.tigerbbs.com/c1e4178e32cb0fcff4b50f4dce9cc6b4","crmLevel":3,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3486361727758741","authorIdStr":"3486361727758741"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/RBLX\">$Roblox Corporation(RBLX)$</a>OF METAFOR METABY META","listText":"<a href=\"https://laohu8.com/S/RBLX\">$Roblox Corporation(RBLX)$</a>OF METAFOR METABY META","text":"$Roblox Corporation(RBLX)$OF METAFOR METABY META","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://ttm.financial/post/837583594","isVote":1,"tweetType":1,"viewCount":2834,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":156880229,"gmtCreate":1625210426761,"gmtModify":1703738423066,"author":{"id":"3486361727758741","authorId":"3486361727758741","name":"Rio999","avatar":"https://static.tigerbbs.com/c1e4178e32cb0fcff4b50f4dce9cc6b4","crmLevel":3,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3486361727758741","authorIdStr":"3486361727758741"},"themes":[],"htmlText":"Let me dig data elsewhere.This is my Legend under construction","listText":"Let me dig data elsewhere.This is my Legend under construction","text":"Let me dig data elsewhere.This is my Legend under construction","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://ttm.financial/post/156880229","repostId":"2148527822","repostType":2,"isVote":1,"tweetType":1,"viewCount":3105,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":166441385,"gmtCreate":1624023758547,"gmtModify":1703826849217,"author":{"id":"3486361727758741","authorId":"3486361727758741","name":"Rio999","avatar":"https://static.tigerbbs.com/c1e4178e32cb0fcff4b50f4dce9cc6b4","crmLevel":3,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3486361727758741","authorIdStr":"3486361727758741"},"themes":[],"htmlText":"Hodler","listText":"Hodler","text":"Hodler","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://ttm.financial/post/166441385","repostId":"2144727877","repostType":2,"isVote":1,"tweetType":1,"viewCount":2809,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":979981366,"gmtCreate":1597971873655,"gmtModify":1705056696582,"author":{"id":"3486361727758741","authorId":"3486361727758741","name":"Rio999","avatar":"https://static.tigerbbs.com/c1e4178e32cb0fcff4b50f4dce9cc6b4","crmLevel":3,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3486361727758741","authorIdStr":"3486361727758741"},"themes":[],"htmlText":"news","listText":"news","text":"news","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://ttm.financial/post/979981366","repostId":"1143118873","repostType":2,"isVote":1,"tweetType":1,"viewCount":3376,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":922216352,"gmtCreate":1587563323176,"gmtModify":1705304500143,"author":{"id":"3486361727758741","authorId":"3486361727758741","name":"Rio999","avatar":"https://static.tigerbbs.com/c1e4178e32cb0fcff4b50f4dce9cc6b4","crmLevel":3,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3486361727758741","authorIdStr":"3486361727758741"},"themes":[],"htmlText":"<a target=\"_blank\" href=\"https://laohu8.com/S/ZM\">$Zoom(ZM)$</a>EXXONMOBILE HAS CONDUCTED GROUNDBREAKING CEREMONY ON CLOUD FOR A CANTONESE PROJECT WORTH 10 BILLION USD. 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FUTURE IS HERE.","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":2,"commentSize":1,"repostSize":0,"link":"https://ttm.financial/post/922216352","isVote":1,"tweetType":1,"viewCount":4024,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":284608203792656,"gmtCreate":1710490604949,"gmtModify":1710490609107,"author":{"id":"3486361727758741","authorId":"3486361727758741","name":"Rio999","avatar":"https://static.tigerbbs.com/c1e4178e32cb0fcff4b50f4dce9cc6b4","crmLevel":3,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"3486361727758741","idStr":"3486361727758741"},"themes":[],"htmlText":"<a href=\"https://ttm.financial/S/TSLA\">$特斯拉(TSLA)$&nbsp;</a> 120 possible","listText":"<a href=\"https://ttm.financial/S/TSLA\">$特斯拉(TSLA)$&nbsp;</a> 120 possible","text":"$特斯拉(TSLA)$ 120 possible","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":0,"repostSize":0,"link":"https://ttm.financial/post/284608203792656","isVote":1,"tweetType":1,"viewCount":2866,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":964621258,"gmtCreate":1584367161974,"gmtModify":1705293899531,"author":{"id":"3486361727758741","authorId":"3486361727758741","name":"Rio999","avatar":"https://static.tigerbbs.com/c1e4178e32cb0fcff4b50f4dce9cc6b4","crmLevel":3,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"3486361727758741","idStr":"3486361727758741"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/ZM\">$Zoom(ZM)$</a>really stable","listText":"<a href=\"https://laohu8.com/S/ZM\">$Zoom(ZM)$</a>really stable","text":"$Zoom(ZM)$really stable","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":0,"repostSize":0,"link":"https://ttm.financial/post/964621258","isVote":1,"tweetType":1,"viewCount":2517,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":283015058595936,"gmtCreate":1710123984796,"gmtModify":1710123988086,"author":{"id":"3486361727758741","authorId":"3486361727758741","name":"Rio999","avatar":"https://static.tigerbbs.com/c1e4178e32cb0fcff4b50f4dce9cc6b4","crmLevel":3,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"3486361727758741","idStr":"3486361727758741"},"themes":[],"htmlText":"Sounds good&nbsp;","listText":"Sounds good&nbsp;","text":"Sounds good","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://ttm.financial/post/283015058595936","repostId":"2418503896","repostType":2,"repost":{"id":"2418503896","kind":"news","pubTimestamp":1710066610,"share":"https://ttm.financial/m/news/2418503896?lang=en_US&edition=fundamental","pubTime":"2024-03-10 18:30","market":"hk","language":"zh","title":"GenScript Biotech (01548.HK) Reports Annual Results Revenue Increases 34.2% R&D Expenses Increase to Approximately US$433 Million","url":"https://stock-news.laohu8.com/highlight/detail?id=2418503896","media":"格隆汇资讯","summary":"格隆汇3月10日丨 金斯瑞生物科技发布公告，集团收入持续强劲增长，截至2023年12月31日止年度，集团的收益约为839.5百万美元，较上年度的约625.7百万美元增加34.2%，其中非细胞疗法业务的外部收益约为554.5百万美元，较上年度的约509.0百万美元增加8.9%，细胞疗法业务的外部收益约为285.0百万美元，较上年度的约116.7百万美元增加144.2%。经调整研发开支较2022年同期增加10.3%。","content":"<p><html><body><article>Gelonghui March 10 |<a href=\"https://laohu8.com/S/01548\">GenScript Biotech</a>(01548.HK) announced that the Group's revenue continued to grow strongly. For the year ended 31 December 2023, the Group's revenue was approximately US$839.5 million, representing an increase of 34.2% from approximately US$625.7 million in the previous year, of which the external revenue from the non-cell therapy business was approximately US$554.5 million, representing an increase of 8.9% from approximately US$509.0 million in the previous year, and the external revenue from the cell therapy business was approximately US$285.0 million, representing an increase of 144.2% from approximately US$116.7 million in the previous year.</p><p>Strong Revenue Growth Drives Group<span>Gross profit</span>Strong growth. During the Year, the Group's gross profit was approximately US$409.6 million, representing an increase of 34.7% as compared to approximately US$304.1 million in the Previous Year, of which the gross profit (before offsetting) of the non-cell therapy business was approximately US$270.6 million, representing an increase of 5.3% as compared to approximately US$257.1 million in the Previous Year, and the gross profit (before offsetting) of the cell therapy business was approximately US$140.9 million, representing an increase of 173.1% as compared to approximately US$51.6 million in the Previous Year.</p><p>The increase in revenue and gross profit was mainly attributable to (i) the continuous growth in revenue from major strategic customers of the non-cellular therapy business and competitive commercial operations in the European and American markets; and (ii) the rapid growth in sales in the U.S. and European markets following the commercial approval of CARVYKTI.</p><p>In 2023, research and development expenses increased by 10.9% to approximately US$432.8 million from approximately US$390.1 million in 2022. This was primarily due to (i) increased investment in talent, hiring experienced personnel and providing competitive packaging and equity-settled share-based compensation expenses for all business units; (ii) ongoing investment in cilta-cel R&D activities (including increasing the patient enrollment rate of cilta-cel Phase 3 clinical trials) and other R&D pipeline projects; And (iii) continuously invest in new products and services to enhance competitiveness. Adjusted research and development expenses increased by 10.3% compared to the same period in 2022.</p><p>The company said that the group plans to actively build production capacity worldwide to meet strong customer demand in the future. In terms of life science services and products, the Group plans to continue to invest in and enhance the production capacity of the molecular biology and protein businesses, and expand the production capacity of GMP, a key reagent in the CGT supply chain. In terms of biologics development services, the Group plans to expand its antibody, plasmid and viral GMP manufacturing facilities in China.</p><p>For industrial synthetic biological products, the Group plans to further optimize production facilities and increase production. The company also plans to expand the synthetic biology laboratory to enhance the company's R&D capabilities. In terms of cell therapy, the Group plans to actively expand CARVYKTI's production capacity in North America and Europe, with a view to expanding the number of frontline multiple myeloma patients that can be treated. The Group also plans to invest in upgrading the supply chain, IT infrastructure and other supporting functions to enhance operational efficiency and facilitate strong business growth.</p><p></article></body></html></p>","source":"tencent","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>GenScript Biotech (01548.HK) Reports Annual Results Revenue Increases 34.2% R&D Expenses Increase to Approximately US$433 Million</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 12.5px; color: #7E829C; margin: 0;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nGenScript Biotech (01548.HK) Reports Annual Results Revenue Increases 34.2% R&D Expenses Increase to Approximately US$433 Million\n</h2>\n<h4 class=\"meta\">\n<p class=\"head\">\n<strong class=\"h-name small\">格隆汇资讯</strong><span class=\"h-time small\">2024-03-10 18:30</span>\n</p>\n</h4>\n</header>\n<article>\n<p><html><body><article>Gelonghui March 10 |<a href=\"https://laohu8.com/S/01548\">GenScript Biotech</a>(01548.HK) announced that the Group's revenue continued to grow strongly. For the year ended 31 December 2023, the Group's revenue was approximately US$839.5 million, representing an increase of 34.2% from approximately US$625.7 million in the previous year, of which the external revenue from the non-cell therapy business was approximately US$554.5 million, representing an increase of 8.9% from approximately US$509.0 million in the previous year, and the external revenue from the cell therapy business was approximately US$285.0 million, representing an increase of 144.2% from approximately US$116.7 million in the previous year.</p><p>Strong Revenue Growth Drives Group<span>Gross profit</span>Strong growth. During the Year, the Group's gross profit was approximately US$409.6 million, representing an increase of 34.7% as compared to approximately US$304.1 million in the Previous Year, of which the gross profit (before offsetting) of the non-cell therapy business was approximately US$270.6 million, representing an increase of 5.3% as compared to approximately US$257.1 million in the Previous Year, and the gross profit (before offsetting) of the cell therapy business was approximately US$140.9 million, representing an increase of 173.1% as compared to approximately US$51.6 million in the Previous Year.</p><p>The increase in revenue and gross profit was mainly attributable to (i) the continuous growth in revenue from major strategic customers of the non-cellular therapy business and competitive commercial operations in the European and American markets; and (ii) the rapid growth in sales in the U.S. and European markets following the commercial approval of CARVYKTI.</p><p>In 2023, research and development expenses increased by 10.9% to approximately US$432.8 million from approximately US$390.1 million in 2022. This was primarily due to (i) increased investment in talent, hiring experienced personnel and providing competitive packaging and equity-settled share-based compensation expenses for all business units; (ii) ongoing investment in cilta-cel R&D activities (including increasing the patient enrollment rate of cilta-cel Phase 3 clinical trials) and other R&D pipeline projects; And (iii) continuously invest in new products and services to enhance competitiveness. Adjusted research and development expenses increased by 10.3% compared to the same period in 2022.</p><p>The company said that the group plans to actively build production capacity worldwide to meet strong customer demand in the future. In terms of life science services and products, the Group plans to continue to invest in and enhance the production capacity of the molecular biology and protein businesses, and expand the production capacity of GMP, a key reagent in the CGT supply chain. In terms of biologics development services, the Group plans to expand its antibody, plasmid and viral GMP manufacturing facilities in China.</p><p>For industrial synthetic biological products, the Group plans to further optimize production facilities and increase production. The company also plans to expand the synthetic biology laboratory to enhance the company's R&D capabilities. In terms of cell therapy, the Group plans to actively expand CARVYKTI's production capacity in North America and Europe, with a view to expanding the number of frontline multiple myeloma patients that can be treated. The Group also plans to invest in upgrading the supply chain, IT infrastructure and other supporting functions to enhance operational efficiency and facilitate strong business growth.</p><p></article></body></html></p>\n<div class=\"bt-text\">\n\n\n<p> source：<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20240310183021876d5641&s=b\">格隆汇资讯</a></p>\n\n\n</div>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"01548":"金斯瑞生物科技","BK1583":"高瓴概念","BK1141":"生命科学工具和服务","BK1576":"医药外包概念"},"source_url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20240310183021876d5641&s=b","is_english":false,"share_image_url":"https://static.laohu8.com/9a95c1376e76363c1401fee7d3717173","article_id":"2418503896","content_text":"格隆汇3月10日丨 金斯瑞生物科技(01548.HK)发布公告，集团收入持续强劲增长，截至2023年12月31日止年度，集团的收益约为839.5百万美元，较上年度的约625.7百万美元增加34.2%，其中非细胞疗法业务的外部收益约为554.5百万美元，较上年度的约509.0百万美元增加8.9%，细胞疗法业务的外部收益约为285.0百万美元，较上年度的约116.7百万美元增加144.2%。强劲收入增长带动集团毛利强劲增长。该年度，集团的毛利约为409.6百万美元，较上年度的约304.1百万美元增加34.7%，其中非细胞疗法业务的毛利(抵销前)约为270.6百万美元，较上年度的约257.1百万美元增加5.3%，细胞疗法业务的毛利(抵销前)约为140.9百万美元，较上年度的约51.6百万美元增加173.1%。收益及毛利增加主要是由于(i)非细胞疗法业务来自主要战略客户的收益持续增长及欧美市场具有竞争力的商业运营；及(ii)CARVYKTI获商业化批准后，在美国和欧洲市场的销售额快速增长。于2023年，研发开支由2022年的约390.1百万美元，增加10.9%至约432.8百万美元。这主要是由于(i)增加对人才的投资，聘请有经验的人员，并为所有业务部门提供有竞争力的待遇和以股权结算的股份薪酬开支；(ii)持续的cilta-cel研发活动投入(包括提高cilta-cel 3期临床试验患者入组率)及其他研发管线项目投入；及(iii)持续投资新产品及服务，以提高竞争力。经调整研发开支较2022年同期增加10.3%。公司表示，集团计划在全球范围内积极建立生产产能，以满足未来强劲的客户需求。生命科学服务及产品方面，集团计划继续投资及提升分子生物学及蛋白业务产能，并扩建CGT供应链关键试剂GMP生产产能。生物制剂开发服务方面，集团计划在中国扩建抗体、质粒和病毒GMP生产设施。工业合成生物产品方面，集团计划进一步优化生产设施，提高产量。公司亦计划扩建合成生物学实验室，增强公司的研发能力。细胞治疗方面，集团计划积极扩大CARVYKTI在北美和欧洲的产能，以期能够扩大可治疗的前线多发性骨髓瘤患者。集团亦计划投资升级供应链、IT基础设施以及其他支持职能，以提升运营效率，促进业务强劲增长。","news_type":1,"symbols_score_info":{"01548":1}},"isVote":1,"tweetType":1,"viewCount":2905,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":277190357270592,"gmtCreate":1708699436188,"gmtModify":1708699440337,"author":{"id":"3486361727758741","authorId":"3486361727758741","name":"Rio999","avatar":"https://static.tigerbbs.com/c1e4178e32cb0fcff4b50f4dce9cc6b4","crmLevel":3,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"3486361727758741","idStr":"3486361727758741"},"themes":[],"htmlText":"A breakthrough into 2024.","listText":"A breakthrough into 2024.","text":"A breakthrough into 2024.","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://ttm.financial/post/277190357270592","repostId":"2413593763","repostType":2,"repost":{"id":"2413593763","kind":"news","pubTimestamp":1708692420,"share":"https://ttm.financial/m/news/2413593763?lang=en_US&edition=fundamental","pubTime":"2024-02-23 20:47","market":"us","language":"zh","title":"Legend Biotech Receives CHMP Awardship for CARVYKTI ® Positive opinions for frontline treatment","url":"https://stock-news.laohu8.com/highlight/detail?id=2413593763","media":"美通社","summary":"传奇生物首席执行官黄颖博士表示：\"这一里程碑表明了我们将CARVYKTI带给全球更多及更前线患者以改变治疗格局的承诺。CHMP 的积极意见是将CARVYKTI用于欧洲更多患者以使其得益于该一次性输注疗法的重要一步。2022年2月，西达基奥仑赛获得美国FDA批准上市，5月获得欧盟EC授予的附条件上市许可，9月获得日本MHLW批准上市，用于治疗复发或难治性多发性骨髓瘤成人患者，商品名为CARVYKTI。","content":"<p><html><body><table border=\"0\" cellpadding=\"5\" cellspacing=\"10\"><tbody><tr><td><img border=\"0\" hspace=\"0\" src=\"https://mma.prnasia.com/media2/2346145/LEGEND_CMYK_Logo.jpg?p=medium600\" title=\"logo\" vspace=\"0\" width=\"118\"/></td></tr></tbody></table><i>CARVYKTI<sup>®</sup></i><i>（</i><i>Cilla-cel,</i><i>Cedarchiolensai) is the first to receive the European Medicines Agency's Committee on Medicinal Products for Human Use (</i><i>CHMP</i><i>) Positive opinion</i><i>CAR-T</i><i>Therapy</i></p><p><span>NANJING</span><span>February 23, 2024</span>/PRNewswire/ - -Feb. 23, 2024 local time,<a href=\"https://laohu8.com/S/LEGN\">Legendary creatures</a>(NASDAQ: LEGN) announced in Somerset, New Jersey, USA that the European Medicines Agency (EMA) Committee on Medicinal Products for Human Use (CHMP) recommended approval to expand CARVYKTI<sup>®</sup>(cilta-cel, CIDACIOLENSEL) to include relapsed and refractory multiple myeloma who have received at least first-line prior therapy including one immunomodulator and one proteasome inhibitor Adult patients with disease progression and resistance to lenalidomide in the last-line therapy. This item I<span>Class I</span>The application for variation was submitted to the EMA by Janssen-Cilag International N.V., an affiliate of partner Janssen, and the positive opinion of the CHMP will be reviewed by the European Commission with a final approval decision.</p><p><div></div>Dr. Ying Huang, CEO of Legend Biotech, said: \"This milestone demonstrates that we will CARVYKTI<sup>®</sup>The commitment to bring more and more frontline patients around the world to change the treatment landscape. The positive opinion from the CHMP demonstrates our tireless efforts in partnering with Janssen to provide patients with new treatment options and bring hope to them and their families. \"</p><p>CHMP on CARVYKTI<sup>®</sup>The recommendations are supported by data from the CARTITUDE-4 study (NCT04181827), the first randomized Phase 3 study to evaluate CARVYKTI<sup>®</sup>Efficacy and safety compared to pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd) in patients with multiple myeloma who have relapsed and are resistant to lenalidomide after prior 1-3 lines of therapy<sup><span>[1]</span></sup>。</p><p>Dr. Jesús San Miguel, Senior Consultant, Professor of Medical Hematology, Clinical and Clinical Lead, Clinical Cancer Center, University of Navarra, Spain, said: \"The results of the CARTITUDE-4 study indicate that patients with early relapse can gain significant clinical benefits from this therapy. The positive opinion of the CHMP is to put CARVYKTI<sup>®</sup>This is an important step for more patients in Europe to benefit from this one-time infusion therapy. \"</p><p><b>about</b><b>CARVYKTI<sup>®</sup></b><b>（</b><b>cilta-cel</b><b>, Cedarchiorunsay)</b></p><p>Cedarchiorensai is a chimeric antigen receptor T cell (CAR-T) therapy that targets B cell maturation antigen (BCMA), using the transgene of the chimeric antigen receptor (CAR) to modify the patient's own T cells to recognize and eliminate BCMA-expressing cells. BCMA is mainly expressed on the surface of malignant multiple myeloma B cell lineage, advanced B cells and plasma cells. The CAR protein of Cidagiolensai has two single-domain antibodies targeting BCMA and has high affinity for BCMA-expressing cells. After binding to BCMA-expressing cells, CAR can promote T cell activation and expansion, and then eliminate target cells<sup>[2]</sup>。</p><p>In December 2017, Janssen entered into a global exclusive licensing and collaboration agreement with Legendary Biotech to develop and commercialize Cedarchiolensai. In February 2022, Chidagiolensai was approved for marketing by the US FDA, conditional marketing authorization granted by the European Union EC in May, and approved for marketing by MHLW in Japan in September for the treatment of relapsed or refractory multiple myeloma in adults Patients, under the trade name CARVYKTI<sup>®</sup>。 Cedarchiolensai received breakthrough therapy designation in the United States in December 2019 and in China in August 2020. Additionally, Cedarchiolense was recognized as a priority drug by the European Commission in April 2019. The US FDA, the European EMA and the Japanese PMDA granted orphan drug designation to Chidagiolensai in February 2019, February 2020 and June 2020, respectively. In March 2022, the European Medicines Agency's Orphan Medicines Committee unanimously recommended maintaining the orphan drug designation of Cedarchiolensex based on clinical data (improved and persistent complete response rate after treatment).</p><p><b>about</b><b>CARTITUDE-4</b></p><p>CARTITUDE-4 (NCT04181827) is an international, randomized, open-label phase 3 study evaluating the efficacy and safety of chidagiolensex versus pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd) in adult patients with relapsed and lenalidomide-resistant multiple myeloma who have received previous line 1-3 therapy, with progression-free survival (PFS) as the primary endpoint of the study<sup>[3]</sup>。</p><p><b>About multiple myeloma</b></p><p>Multiple myeloma is considered an incurable hematological tumor and is a malignant disease caused by the hyperproliferation of plasma cells in the bone marrow<sup>[4]</sup>。 More than 35,000 people are expected to be diagnosed with multiple myeloma in the U.S. in 2024, and more than 12,000 people will die from the disease<sup>[5]</sup>。 Although some patients with multiple myeloma are asymptomatic and are diagnosed due to symptoms, these symptoms may include bone disease, low abnormal blood cell count, elevated blood calcium, kidney problems, or infection<sup>[6]</sup>。</p><p><b>About Legendary Creatures</b></p><p>Legend Biotech (NASDAQ: LEGN), founded in 2014, is a multinational biopharmaceutical company integrating research and development, clinical, production and commercial development of tumor immune cell therapy. It ranks first in the field of immune cell therapy in the world, with global employees. The total number exceeds 1,800 people. Currently through the cooperation with Janssen, the first product CARVYKTI<sup>®</sup>(cilta-cel, Cidagiolensai) was approved for marketing by the U.S. Food and Drug Administration (FDA), Japan's Ministry of Health, Labor and Welfare (MHLW) in 2022, and obtained conditional marketing authorization from the European Commission (EC), which is expected to solve the world-class problem of multiple myeloma treatment. At the end of 2022, the National Medical Products Administration officially accepted the New Drug Marketing Application (NDA) for Chidagiolensai, and it was included in the priority review process in January 2023. In addition, the company also has a number of cell therapies under development for the treatment of hematological tumors, solid tumors and other difficult diseases.</p><p>More information is available at:</p><p><b><i>CAUTIONS REGARDING FORWARD-LOOKING</i></b></p><p><i>Statements in this press release regarding future expectations, plans and prospects, and any other statements regarding matters other than historical fact, constitute</i><i>1995</i><i>\"forward-looking statements\" within the meaning of the Private Securities Litigation Reform Act. These statements include, but are not limited to, statements relating to the strategy and goals of the Legendary Creature; Right</i><i>CARVYKTI<sup>®</sup></i><i>Related expressions, including legendary creature pairs</i><i>CARVYKTI<sup>®</sup></i><i>Expectations of; With</i><i>CARVYKTI<sup>®</sup></i><i>patient-related expressions, including expectations of an expanded patient population; With</i><i>CARVYKTI<sup>®</sup></i><i>Declaration of relevant statements, and to the United States</i><i>FDA</i><i>And the progress of filings by other regulatory agencies, and the potential benefits of Legendary Biologics product candidates. The expressions \"anticipate,\"\"believe,\"\"continue,\"\"may,\"\"estimate,\"\"expect,\"\"intend,\"\"may,\"\"plan,\"\"potential,\"\"predict,\"\"anticipate,\"\"should,\"\"target,\"\"will,\"\"would\" and similar expressions are intended to identify forward-looking statements, but not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements due to various important factors. Legendary Biologic's expectations may be affected by, among other factors: uncertainties in the development of new drugs, unexpected clinical trial results, including additional analysis of existing clinical data or unexpected results of new clinical data; Unexpected regulatory actions or delays, including requirements to provide additional security and</i><i>/</i><i>Or validity information or analysis of information, or government regulation in general; Unexpected delays due to actions taken or failure to take action by our third-party partners; uncertainties arising from challenges to Legendary Biotech's patent or other proprietary intellectual property protection, including uncertainties involved in the course of U.S. litigation; General competition; Government, industry and general product pricing and other political pressures;</i><i>COVID-19</i><i>the duration and severity of the pandemic, and the governmental and regulatory measures taken in response to the changing landscape; And legendary creatures in</i><i>2023</i><i>Year</i><i>3</i><i>Monthly</i><i>30</i><i>Filed with the U.S. Securities and Exchange Commission</i><i>20-F</i><i>Other factors discussed in the \"Risk Factors\" section of the Annual Report of Form. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, actual results may differ materially from those expected, believed, estimated or expected described in this press release. Any forward-looking statements contained in this press release speak solely as of the date of this press release. Legend Biotech expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.</i></p><p><span>†</span>Dr. Jesús San Miguel, Senior Consultant, Professor of Medical Hematology, Clinical and Clinical Lead, Clinical Cancer Center, University of Navarre, Spain, provides consulting and consulting services to Legendary Bio and is not paid for any media work.</p><p><b>Reference Source:</b></p><p><div><table border=\"0\" cellpadding=\"1\" cellspacing=\"0\"><tbody><tr><td colspan=\"1\" rowspan=\"1\"><span>[1] ClinicalTrials.gov. BCMA-targeted CAR-T therapy JNJ-68284528 compared with pomalidomide, bortezomib and dexamethasone (PVd) or dalazumab, pomalidomide and dexamethasone (DPd) in patients with relapsed and lenalidomide-resistant multiple myeloma (CARTITUDE-4).. November 2023.</span></p><p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><span>[2] CARVYKTI ™ Prescribing information. Horsham, PA: Janssen Biotech, Inc.</span></p><p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><span>[3] ClinicalTrials.gov. BCMA-targeted CAR-T therapy JNJ-68284528 compared with pomalidomide, bortezomib and dexamethasone (PVd) or dalazumab, pomalidomide and dexamethasone (DPd) in patients with relapsed and lenalidomide-resistant multiple myeloma (CARTITUDE-4).. November 2023.</span></p><p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><span>[4] American Society of Clinical Oncology, Introduction to Multiple Myeloma. types/multiple-myeloma/introduction. March 2023.</span></p><p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><span>[5] American Cancer Society, Key Statistics on Multiple Myeloma.. February 2024.</span></p><p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><span>[6] American Cancer Society, Multiple Myeloma: Early Detection, Diagnosis, and Staging. March 2023.</span></p><p></td></tr></tbody></table></div>Media Contact:</p><p></body></html></p>","source":"prnasia","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Legend Biotech Receives CHMP Awardship for CARVYKTI ® Positive opinions for frontline treatment</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 12.5px; color: #7E829C; margin: 0;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nLegend Biotech Receives CHMP Awardship for CARVYKTI ® Positive opinions for frontline treatment\n</h2>\n<h4 class=\"meta\">\n<p class=\"head\">\n<strong class=\"h-name small\">美通社</strong><span class=\"h-time small\">2024-02-23 20:47</span>\n</p>\n</h4>\n</header>\n<article>\n<p><html><body><table border=\"0\" cellpadding=\"5\" cellspacing=\"10\"><tbody><tr><td><img border=\"0\" hspace=\"0\" src=\"https://mma.prnasia.com/media2/2346145/LEGEND_CMYK_Logo.jpg?p=medium600\" title=\"logo\" vspace=\"0\" width=\"118\"/></td></tr></tbody></table><i>CARVYKTI<sup>®</sup></i><i>（</i><i>Cilla-cel,</i><i>Cedarchiolensai) is the first to receive the European Medicines Agency's Committee on Medicinal Products for Human Use (</i><i>CHMP</i><i>) Positive opinion</i><i>CAR-T</i><i>Therapy</i></p><p><span>NANJING</span><span>February 23, 2024</span>/PRNewswire/ - -Feb. 23, 2024 local time,<a href=\"https://laohu8.com/S/LEGN\">Legendary creatures</a>(NASDAQ: LEGN) announced in Somerset, New Jersey, USA that the European Medicines Agency (EMA) Committee on Medicinal Products for Human Use (CHMP) recommended approval to expand CARVYKTI<sup>®</sup>(cilta-cel, CIDACIOLENSEL) to include relapsed and refractory multiple myeloma who have received at least first-line prior therapy including one immunomodulator and one proteasome inhibitor Adult patients with disease progression and resistance to lenalidomide in the last-line therapy. This item I<span>Class I</span>The application for variation was submitted to the EMA by Janssen-Cilag International N.V., an affiliate of partner Janssen, and the positive opinion of the CHMP will be reviewed by the European Commission with a final approval decision.</p><p><div></div>Dr. Ying Huang, CEO of Legend Biotech, said: \"This milestone demonstrates that we will CARVYKTI<sup>®</sup>The commitment to bring more and more frontline patients around the world to change the treatment landscape. The positive opinion from the CHMP demonstrates our tireless efforts in partnering with Janssen to provide patients with new treatment options and bring hope to them and their families. \"</p><p>CHMP on CARVYKTI<sup>®</sup>The recommendations are supported by data from the CARTITUDE-4 study (NCT04181827), the first randomized Phase 3 study to evaluate CARVYKTI<sup>®</sup>Efficacy and safety compared to pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd) in patients with multiple myeloma who have relapsed and are resistant to lenalidomide after prior 1-3 lines of therapy<sup><span>[1]</span></sup>。</p><p>Dr. Jesús San Miguel, Senior Consultant, Professor of Medical Hematology, Clinical and Clinical Lead, Clinical Cancer Center, University of Navarra, Spain, said: \"The results of the CARTITUDE-4 study indicate that patients with early relapse can gain significant clinical benefits from this therapy. The positive opinion of the CHMP is to put CARVYKTI<sup>®</sup>This is an important step for more patients in Europe to benefit from this one-time infusion therapy. \"</p><p><b>about</b><b>CARVYKTI<sup>®</sup></b><b>（</b><b>cilta-cel</b><b>, Cedarchiorunsay)</b></p><p>Cedarchiorensai is a chimeric antigen receptor T cell (CAR-T) therapy that targets B cell maturation antigen (BCMA), using the transgene of the chimeric antigen receptor (CAR) to modify the patient's own T cells to recognize and eliminate BCMA-expressing cells. BCMA is mainly expressed on the surface of malignant multiple myeloma B cell lineage, advanced B cells and plasma cells. The CAR protein of Cidagiolensai has two single-domain antibodies targeting BCMA and has high affinity for BCMA-expressing cells. After binding to BCMA-expressing cells, CAR can promote T cell activation and expansion, and then eliminate target cells<sup>[2]</sup>。</p><p>In December 2017, Janssen entered into a global exclusive licensing and collaboration agreement with Legendary Biotech to develop and commercialize Cedarchiolensai. In February 2022, Chidagiolensai was approved for marketing by the US FDA, conditional marketing authorization granted by the European Union EC in May, and approved for marketing by MHLW in Japan in September for the treatment of relapsed or refractory multiple myeloma in adults Patients, under the trade name CARVYKTI<sup>®</sup>。 Cedarchiolensai received breakthrough therapy designation in the United States in December 2019 and in China in August 2020. Additionally, Cedarchiolense was recognized as a priority drug by the European Commission in April 2019. The US FDA, the European EMA and the Japanese PMDA granted orphan drug designation to Chidagiolensai in February 2019, February 2020 and June 2020, respectively. In March 2022, the European Medicines Agency's Orphan Medicines Committee unanimously recommended maintaining the orphan drug designation of Cedarchiolensex based on clinical data (improved and persistent complete response rate after treatment).</p><p><b>about</b><b>CARTITUDE-4</b></p><p>CARTITUDE-4 (NCT04181827) is an international, randomized, open-label phase 3 study evaluating the efficacy and safety of chidagiolensex versus pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd) in adult patients with relapsed and lenalidomide-resistant multiple myeloma who have received previous line 1-3 therapy, with progression-free survival (PFS) as the primary endpoint of the study<sup>[3]</sup>。</p><p><b>About multiple myeloma</b></p><p>Multiple myeloma is considered an incurable hematological tumor and is a malignant disease caused by the hyperproliferation of plasma cells in the bone marrow<sup>[4]</sup>。 More than 35,000 people are expected to be diagnosed with multiple myeloma in the U.S. in 2024, and more than 12,000 people will die from the disease<sup>[5]</sup>。 Although some patients with multiple myeloma are asymptomatic and are diagnosed due to symptoms, these symptoms may include bone disease, low abnormal blood cell count, elevated blood calcium, kidney problems, or infection<sup>[6]</sup>。</p><p><b>About Legendary Creatures</b></p><p>Legend Biotech (NASDAQ: LEGN), founded in 2014, is a multinational biopharmaceutical company integrating research and development, clinical, production and commercial development of tumor immune cell therapy. It ranks first in the field of immune cell therapy in the world, with global employees. The total number exceeds 1,800 people. Currently through the cooperation with Janssen, the first product CARVYKTI<sup>®</sup>(cilta-cel, Cidagiolensai) was approved for marketing by the U.S. Food and Drug Administration (FDA), Japan's Ministry of Health, Labor and Welfare (MHLW) in 2022, and obtained conditional marketing authorization from the European Commission (EC), which is expected to solve the world-class problem of multiple myeloma treatment. At the end of 2022, the National Medical Products Administration officially accepted the New Drug Marketing Application (NDA) for Chidagiolensai, and it was included in the priority review process in January 2023. In addition, the company also has a number of cell therapies under development for the treatment of hematological tumors, solid tumors and other difficult diseases.</p><p>More information is available at:</p><p><b><i>CAUTIONS REGARDING FORWARD-LOOKING</i></b></p><p><i>Statements in this press release regarding future expectations, plans and prospects, and any other statements regarding matters other than historical fact, constitute</i><i>1995</i><i>\"forward-looking statements\" within the meaning of the Private Securities Litigation Reform Act. These statements include, but are not limited to, statements relating to the strategy and goals of the Legendary Creature; Right</i><i>CARVYKTI<sup>®</sup></i><i>Related expressions, including legendary creature pairs</i><i>CARVYKTI<sup>®</sup></i><i>Expectations of; With</i><i>CARVYKTI<sup>®</sup></i><i>patient-related expressions, including expectations of an expanded patient population; With</i><i>CARVYKTI<sup>®</sup></i><i>Declaration of relevant statements, and to the United States</i><i>FDA</i><i>And the progress of filings by other regulatory agencies, and the potential benefits of Legendary Biologics product candidates. The expressions \"anticipate,\"\"believe,\"\"continue,\"\"may,\"\"estimate,\"\"expect,\"\"intend,\"\"may,\"\"plan,\"\"potential,\"\"predict,\"\"anticipate,\"\"should,\"\"target,\"\"will,\"\"would\" and similar expressions are intended to identify forward-looking statements, but not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements due to various important factors. Legendary Biologic's expectations may be affected by, among other factors: uncertainties in the development of new drugs, unexpected clinical trial results, including additional analysis of existing clinical data or unexpected results of new clinical data; Unexpected regulatory actions or delays, including requirements to provide additional security and</i><i>/</i><i>Or validity information or analysis of information, or government regulation in general; Unexpected delays due to actions taken or failure to take action by our third-party partners; uncertainties arising from challenges to Legendary Biotech's patent or other proprietary intellectual property protection, including uncertainties involved in the course of U.S. litigation; General competition; Government, industry and general product pricing and other political pressures;</i><i>COVID-19</i><i>the duration and severity of the pandemic, and the governmental and regulatory measures taken in response to the changing landscape; And legendary creatures in</i><i>2023</i><i>Year</i><i>3</i><i>Monthly</i><i>30</i><i>Filed with the U.S. Securities and Exchange Commission</i><i>20-F</i><i>Other factors discussed in the \"Risk Factors\" section of the Annual Report of Form. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, actual results may differ materially from those expected, believed, estimated or expected described in this press release. Any forward-looking statements contained in this press release speak solely as of the date of this press release. Legend Biotech expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.</i></p><p><span>†</span>Dr. Jesús San Miguel, Senior Consultant, Professor of Medical Hematology, Clinical and Clinical Lead, Clinical Cancer Center, University of Navarre, Spain, provides consulting and consulting services to Legendary Bio and is not paid for any media work.</p><p><b>Reference Source:</b></p><p><div><table border=\"0\" cellpadding=\"1\" cellspacing=\"0\"><tbody><tr><td colspan=\"1\" rowspan=\"1\"><span>[1] ClinicalTrials.gov. BCMA-targeted CAR-T therapy JNJ-68284528 compared with pomalidomide, bortezomib and dexamethasone (PVd) or dalazumab, pomalidomide and dexamethasone (DPd) in patients with relapsed and lenalidomide-resistant multiple myeloma (CARTITUDE-4).. November 2023.</span></p><p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><span>[2] CARVYKTI ™ Prescribing information. Horsham, PA: Janssen Biotech, Inc.</span></p><p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><span>[3] ClinicalTrials.gov. BCMA-targeted CAR-T therapy JNJ-68284528 compared with pomalidomide, bortezomib and dexamethasone (PVd) or dalazumab, pomalidomide and dexamethasone (DPd) in patients with relapsed and lenalidomide-resistant multiple myeloma (CARTITUDE-4).. November 2023.</span></p><p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><span>[4] American Society of Clinical Oncology, Introduction to Multiple Myeloma. types/multiple-myeloma/introduction. March 2023.</span></p><p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><span>[5] American Cancer Society, Key Statistics on Multiple Myeloma.. February 2024.</span></p><p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><span>[6] American Cancer Society, Multiple Myeloma: Early Detection, Diagnosis, and Staging. March 2023.</span></p><p></td></tr></tbody></table></div>Media Contact:</p><p></body></html></p>\n<div class=\"bt-text\">\n\n\n<p> source：<a href=\"https://wwwold.prnasia.com/story/archive/4344094_ZH44094_1\">美通社</a></p>\n\n\n</div>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"LEGN":"传奇生物","BK4588":"碎股","CHMP":"冠军工业","BK4585":"ETF&股票定投概念","BK4505":"高瓴资本持仓","BK4139":"生物科技","BK4087":"商业印刷"},"source_url":"https://wwwold.prnasia.com/story/archive/4344094_ZH44094_1","is_english":false,"share_image_url":"https://static.laohu8.com/7d5258e5fa9d58069a293859983c0a71","article_id":"2413593763","content_text":"CARVYKTI®（cilta-cel, 西达基奥仑赛）是首个在复发或难治性多发性骨髓瘤患者二线治疗中获得欧洲药品管理局人用药品委员会（CHMP）积极意见的CAR-T 疗法 南京2024年2月23日 /美通社/ -- 当地时间2024年2月23日，传奇生物（NASDAQ: LEGN）在美国新泽西州萨默塞特宣布，欧洲药品管理局（EMA）人用药品委员会（CHMP）建议批准扩大CARVYKTI®（cilta-cel，西达基奥仑赛）的适应症范围，以纳入既往至少接受过一线治疗（包括一种免疫调节剂和一种蛋白酶体抑制剂）的复发和难治性多发性骨髓瘤成人患者，这些患者在最后一线治疗中出现疾病进展且对来那度胺耐药。此项II类变更申请由合作伙伴杨森的附属公司Janssen-Cilag International N.V.提交至EMA，CHMP的积极意见将由欧盟委员会进行审查并做出最终批准决定。   传奇生物首席执行官黄颖博士表示：\"这一里程碑表明了我们将CARVYKTI®带给全球更多及更前线患者以改变治疗格局的承诺。CHMP的积极意见展现了我们与杨森公司合作为患者提供新的治疗选择，并为他们及其家人带来希望的不懈努力。\" CHMP对CARVYKTI®的建议是基于CARTITUDE-4 研究 (NCT04181827) 数据的支持，该研究是首个随机 3 期研究，评估CARVYKTI®与泊马度胺、硼替佐米和地塞米松（PVd）或达雷妥尤单抗、泊马度胺和地塞米松（DPd）相比，在既往接受过1-3线治疗后复发且来那度胺耐药的多发性骨髓瘤患者中的疗效和安全性[1]。 西班牙纳瓦拉大学临床癌症中心高级顾问、医学血液学教授、临床和临床负责人 Jesús San Miguel 博士表示：\"CARTITUDE-4 研究结果表明，早期复发的患者能从该疗法中获得显著的临床受益。CHMP 的积极意见是将CARVYKTI®用于欧洲更多患者以使其得益于该一次性输注疗法的重要一步。\" 关于CARVYKTI®（cilta-cel，西达基奥仑赛） 西达基奥仑赛是一种靶向B细胞成熟抗原（BCMA）的嵌合抗原受体T细胞（CAR-T）疗法，使用嵌合抗原受体（CAR）的转基因对患者自身的T细胞进行修饰，以识别和消除表达BCMA的细胞。BCMA主要表达于恶性多发性骨髓瘤B细胞谱系、晚期B细胞和浆细胞的表面。西达基奥仑赛的CAR蛋白具有两种靶向BCMA单域抗体，对表达BCMA的细胞具有高亲和力，在与表达BCMA的细胞结合后，CAR可促进T细胞活化、扩增，继而清除靶细胞[2]。 2017年12月，杨森与传奇生物签订了全球独家许可和合作协议，以开发和商业化西达基奥仑赛。 2022年2月，西达基奥仑赛获得美国FDA批准上市，5月获得欧盟EC授予的附条件上市许可，9月获得日本MHLW批准上市，用于治疗复发或难治性多发性骨髓瘤成人患者，商品名为CARVYKTI®。西达基奥仑赛于2019年12月在美国和2020年8月在中国获得突破性疗法认定。此外，西达基奥仑赛于2019年4月获得欧盟委员会优先药物资格认定。美国FDA、欧洲EMA和日本PMDA分别于2019年2月、2020年2月及2020年6月授予西达基奥仑赛孤儿药资格认定。2022年3月，欧洲药品管理局的孤儿药品委员会一致建议，根据临床数据（治疗后完全缓解率有所改善且持续存在）维持西达基奥仑赛的孤儿药认定。 关于CARTITUDE-4 CARTITUDE-4 (NCT04181827) 是一项国际、随机、开放标签的3期研究，评估西达基奥仑赛与泊马度胺、硼替佐米和地塞米松（PVd）或达雷妥尤单抗、泊马度胺和地塞米松（DPd）在既往接受过1-3线治疗的复发且来那度胺耐药的多发性骨髓瘤成人患者中的疗效和安全性，以无进展生存期（PFS）为该研究主要终点[3]。 关于多发性骨髓瘤 多发性骨髓瘤被认为是不可治愈的血液肿瘤，是由于骨髓中的浆细胞过度增殖导致的恶性疾病[4]。预计2024年美国将有超过35000人被诊断为多发性骨髓瘤，超过12000人死于该疾病[5]。虽然一些多发性骨髓瘤患者无明显症状，是由于出现症状而被确诊，这些症状可能包括骨病、低血细胞计数异常、血钙升高、肾脏问题或感染等[6]。 关于传奇生物 传奇生物（NASDAQ:LEGN）成立于2014年，是一家集肿瘤免疫细胞疗法研发、临床、生产及商业化开发于一体的跨国生物制药公司，位列全球免疫细胞疗法领域第一方阵，全球员工总数逾1800人。目前通过与杨森的合作，首款产品CARVYKTI®（cilta-cel，西达基奥仑赛）于2022年获得美国食品药品监督管理局（FDA）、日本厚生劳动省（MHLW）批准上市，并获得欧盟委员会（EC）附条件上市许可，有望解决多发性骨髓瘤治疗的世界级难题。2022年底，国家药品监督管理局正式受理西达基奥仑赛的新药上市申请（NDA），并于2023年1月纳入优先审评程序。此外，公司还有多款在研细胞疗法，用于血液瘤、实体瘤及其它疑难疾病的治疗。 更多信息请访问：  关于前瞻性陈述的注意事项 本新闻稿中关于未来预期、计划和前景的陈述，以及关于非历史事实事项的任何其他陈述，均构成1995年《私人证券诉讼改革法案》所指的“前瞻性陈述”。这些陈述包括但不限于与传奇生物的战略和目标有关的表述；对CARVYKTI®相关的表述，包括传奇生物对CARVYKTI®的预期；与CARVYKTI®患者有关的表述，包括对扩大患者群体的预期；与CARVYKTI®申报有关的表述，以及向美国FDA和其他监管机构申报的进展情况，以及传奇生物候选产品的潜在益处。“预期”、“相信”、“继续”、“可能”、“估计”、“期望”、“打算”、“可能”、“计划”、“潜在”、“预测”、“预计”、“应该”、“目标”、“将”、“会”和类似表达旨在识别前瞻性陈述，但并非所有前瞻性陈述都包含这些识别词。由于各种重要因素，实际结果可能与此类前瞻性陈述所指示的结果存在实质性差异。传奇生物的预期可能会受到（其中包括）以下因素影响：新药开发过程中的不确定性，意外的临床试验结果，包括对现有临床资料的额外分析或意外的新临床资料的结果；意外的监管行动或延误，包括要求提供额外的安全性和/或有效性资料或资料分析，或一般的政府监管；由于我们的第三方合作伙伴采取的行动或未能采取行动而导致的意外延误；传奇生物的专利或其他专有知识产权保护受到挑战而产生的不确定性，包括美国诉讼过程中涉及的不确定性；一般竞争；政府、行业和一般产品定价和其他政治压力；COVID-19大流行的持续时间和严重程度，以及为应对不断变化的形势而采取的政府和监管措施；以及传奇生物于 2023 年 3 月 30 日向美国证券交易委员会递交的 20-F 表格年度报告的“风险因素”部分中讨论的其他因素。如果这些风险或不确定性中的一个或多个成为现实，或者如果基本假设被证明不正确，则实际结果可能与本新闻稿中描述的预期、相信、估计或预期的结果存在重大差异。本新闻稿中包含的任何前瞻性陈述仅代表截至本新闻稿发布之日的情况。传奇生物明确声明，无论是由于新信息、未来事件还是其他原因，均不承担更新任何前瞻性陈述的义务。 † 西班牙纳瓦拉大学临床癌症中心高级顾问、医学血液学教授、临床和临床负责人 Jesús San Miguel 博士为传奇生物提供咨询和顾问服务，未因任何媒体工作而获得报酬。 参考来源：     [1] ClinicalTrials.gov.  靶向BCMA的CAR-T疗法JNJ-68284528与泊马度胺、硼替佐米和地塞米松（PVd）或达拉单抗、泊马度胺和地塞米松（DPd）在复发和来那度胺耐药的多发性骨髓瘤患者中的比较研究（CARTITUDE-4）。。2023 年 11 月。    [2] CARVYKTI™ 处方信息。Horsham, PA: Janssen Biotech, Inc.    [3] ClinicalTrials.gov.  靶向BCMA的CAR-T疗法JNJ-68284528与泊马度胺、硼替佐米和地塞米松（PVd）或达拉单抗、泊马度胺和地塞米松（DPd）在复发和来那度胺耐药的多发性骨髓瘤患者中的比较研究（CARTITUDE-4）。。2023 年 11 月。    [4] 美国临床肿瘤学会，多发性骨髓瘤简介。 types/multiple-myeloma/introduction。2023 年 3 月。    [5] 美国癌症协会，关于多发性骨髓瘤的关键统计数据。.2024 年 2 月。    [6] 美国癌症协会，多发性骨髓瘤：早期检测、诊断和分期。2023 年 3 月。      媒体联络：","news_type":1,"symbols_score_info":{"CHMP":1,"LEGN":1}},"isVote":1,"tweetType":1,"viewCount":2578,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":837583594,"gmtCreate":1629899826318,"gmtModify":1676530166766,"author":{"id":"3486361727758741","authorId":"3486361727758741","name":"Rio999","avatar":"https://static.tigerbbs.com/c1e4178e32cb0fcff4b50f4dce9cc6b4","crmLevel":3,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"3486361727758741","idStr":"3486361727758741"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/RBLX\">$Roblox Corporation(RBLX)$</a>OF METAFOR METABY META","listText":"<a href=\"https://laohu8.com/S/RBLX\">$Roblox Corporation(RBLX)$</a>OF METAFOR METABY META","text":"$Roblox Corporation(RBLX)$OF METAFOR METABY META","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://ttm.financial/post/837583594","isVote":1,"tweetType":1,"viewCount":2834,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":156880229,"gmtCreate":1625210426761,"gmtModify":1703738423066,"author":{"id":"3486361727758741","authorId":"3486361727758741","name":"Rio999","avatar":"https://static.tigerbbs.com/c1e4178e32cb0fcff4b50f4dce9cc6b4","crmLevel":3,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"3486361727758741","idStr":"3486361727758741"},"themes":[],"htmlText":"Let me dig data elsewhere.This is my Legend under construction","listText":"Let me dig data elsewhere.This is my Legend under construction","text":"Let me dig data elsewhere.This is my Legend under construction","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://ttm.financial/post/156880229","repostId":"2148527822","repostType":2,"repost":{"id":"2148527822","kind":"highlight","weMediaInfo":{"introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"media_name":"Reuters","id":"1036604489","head_image":"https://static.tigerbbs.com/443ce19704621c837795676028cec868"},"pubTimestamp":1625173393,"share":"https://ttm.financial/m/news/2148527822?lang=en_US&edition=fundamental","pubTime":"2021-07-02 05:03","market":"us","language":"en","title":"BRIEF-Legend Biotech Corp Files For Potential Mixed Shelf Offering Size Not Disclosed","url":"https://stock-news.laohu8.com/highlight/detail?id=2148527822","media":"Reuters","summary":"July 1 (Reuters) - Legend Biotech Corp   :   * LEGEND BIOTECH CORP FILES FOR POTENTIAL MIXED SHELF O","content":"<html><body><p>July 1 (Reuters) - Legend Biotech Corp   :</p><p>   * LEGEND BIOTECH CORP FILES FOR POTENTIAL MIXED SHELF OFFERING; SIZE NOT DISCLOSED - SEC FILING</p><p>Source text () Further company coverage:   </p><p> ((Reuters.Briefs@thomsonreuters.com;))</p></body></html>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>BRIEF-Legend Biotech Corp Files For Potential Mixed Shelf Offering Size Not Disclosed</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; 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}\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nBRIEF-Legend Biotech Corp Files For Potential Mixed Shelf Offering Size Not Disclosed\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1036604489\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/443ce19704621c837795676028cec868);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Reuters </p>\n<p class=\"h-time\">2021-07-02 05:03</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html><body><p>July 1 (Reuters) - Legend Biotech Corp   :</p><p>   * LEGEND BIOTECH CORP FILES FOR POTENTIAL MIXED SHELF OFFERING; SIZE NOT DISCLOSED - SEC FILING</p><p>Source text () Further company coverage:   </p><p> ((Reuters.Briefs@thomsonreuters.com;))</p></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"LEGN":"传奇生物"},"source_url":"http://api.rkd.refinitiv.com/api/News/News.svc/REST/News_1/RetrieveStoryML_1","is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"2148527822","content_text":"July 1 (Reuters) - Legend Biotech Corp   :   * LEGEND BIOTECH CORP FILES FOR POTENTIAL MIXED SHELF OFFERING; SIZE NOT DISCLOSED - SEC FILINGSource text () Further company coverage:    ((Reuters.Briefs@thomsonreuters.com;))","news_type":1,"symbols_score_info":{"LEGN":1}},"isVote":1,"tweetType":1,"viewCount":3105,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":166441385,"gmtCreate":1624023758547,"gmtModify":1703826849217,"author":{"id":"3486361727758741","authorId":"3486361727758741","name":"Rio999","avatar":"https://static.tigerbbs.com/c1e4178e32cb0fcff4b50f4dce9cc6b4","crmLevel":3,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"3486361727758741","idStr":"3486361727758741"},"themes":[],"htmlText":"Hodler","listText":"Hodler","text":"Hodler","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://ttm.financial/post/166441385","repostId":"2144727877","repostType":2,"repost":{"id":"2144727877","kind":"news","pubTimestamp":1624002121,"share":"https://ttm.financial/m/news/2144727877?lang=en_US&edition=fundamental","pubTime":"2021-06-18 15:42","market":"hk","language":"zh","title":"Changes in Hong Kong stocks | GenScript Biotechnology (01548) rose by more than 5% in late trading. The latest excellent data of Cilta-cel is expected to enhance market potential","url":"https://stock-news.laohu8.com/highlight/detail?id=2144727877","media":"智通财经","summary":"智通财经APP获悉，金斯瑞生物科技尾盘涨幅扩大逾5%，截至发稿，涨5.61%，报32.95港元，成交额4.16亿港元。考虑到Cilta-cel前线治疗数据较好，有望提升该产品的市场潜力，目标价上调至38.5港元，维持“增持”评级。报告提到，Cilta-cel在美国的BLA已获美国FDA受理，预计于2021年11月29日前完成BLA审查;在欧洲已于4月提交BLA，若进展顺利预计2022年获批;计划于今年下半年在中国和日本分别提交BLA。Cilta-cel有望成为全球第二款、中国首款靶向BCMA的CAR-T产品。","content":"<p><html><body>Zhitong Finance APP learned that,<a href=\"https://laohu8.com/S/01548\">GenScript Biotech</a>(01548) increased by more than 5% in late trading. As of press time, it rose by 5.61% to HK$ 32.95, with a turnover of HK$ 416 million.</p><p>On the news side,<a href=\"https://laohu8.com/S/601377\">Industrial Securities</a>published a research report, maintaining GenScript Biotech's 2021-23 forecast revenue of US$472/796/1,514 million, representing a year-on-year increase of 20.83%/68.49%/90.25%, and maintaining the 2021-23 forecast net profit attributable to the parent of US$1.77/ -0.64/167 million. Considering the good frontline treatment data of Cilla-cel, which is expected to enhance the market potential of this product, the target price was raised to HK$38.5, maintaining an \"overweight\" rating.</p><p>The report mentioned that Cilta-cel's BLA in the United States has been accepted by the U.S. FDA, and the BLA review is expected to be completed before November 29, 2021; In Europe, the BLA was submitted in April, and if it goes well, it is expected to be approved in 2022; The BLA is scheduled to be submitted in China and Japan respectively in the second half of this year. Cilta-cel is expected to become the second CAR-T product in the world and the first in China to target BCMA.</p><p></body></html></p>","source":"stock_zhitongcaijing","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Changes in Hong Kong stocks | GenScript Biotechnology (01548) rose by more than 5% in late trading. The latest excellent data of Cilta-cel is expected to enhance market potential</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 12.5px; color: #7E829C; margin: 0;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nChanges in Hong Kong stocks | GenScript Biotechnology (01548) rose by more than 5% in late trading. The latest excellent data of Cilta-cel is expected to enhance market potential\n</h2>\n<h4 class=\"meta\">\n<p class=\"head\">\n<strong class=\"h-name small\">智通财经</strong><span class=\"h-time small\">2021-06-18 15:42</span>\n</p>\n</h4>\n</header>\n<article>\n<p><html><body>Zhitong Finance APP learned that,<a href=\"https://laohu8.com/S/01548\">GenScript Biotech</a>(01548) increased by more than 5% in late trading. As of press time, it rose by 5.61% to HK$ 32.95, with a turnover of HK$ 416 million.</p><p>On the news side,<a href=\"https://laohu8.com/S/601377\">Industrial Securities</a>published a research report, maintaining GenScript Biotech's 2021-23 forecast revenue of US$472/796/1,514 million, representing a year-on-year increase of 20.83%/68.49%/90.25%, and maintaining the 2021-23 forecast net profit attributable to the parent of US$1.77/ -0.64/167 million. Considering the good frontline treatment data of Cilla-cel, which is expected to enhance the market potential of this product, the target price was raised to HK$38.5, maintaining an \"overweight\" rating.</p><p>The report mentioned that Cilta-cel's BLA in the United States has been accepted by the U.S. FDA, and the BLA review is expected to be completed before November 29, 2021; In Europe, the BLA was submitted in April, and if it goes well, it is expected to be approved in 2022; The BLA is scheduled to be submitted in China and Japan respectively in the second half of this year. Cilta-cel is expected to become the second CAR-T product in the world and the first in China to target BCMA.</p><p></body></html></p>\n<div class=\"bt-text\">\n\n\n<p> source：<a href=\"http://www.zhitongcaijing.com/content/detail/496532.html\">智通财经</a></p>\n\n\n</div>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"https://static.tigerbbs.com/3153c88188d79bb8182b93c4fdd43636","relate_stocks":{"01548":"金斯瑞生物科技"},"source_url":"http://www.zhitongcaijing.com/content/detail/496532.html","is_english":false,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"2144727877","content_text":"智通财经APP获悉，金斯瑞生物科技(01548)尾盘涨幅扩大逾5%，截至发稿，涨5.61%，报32.95港元，成交额4.16亿港元。消息面上，兴业证券发布研究报告，维持金斯瑞生物科技2021-23年预测收入4.72/7.96/15.14亿美元，同比增长20.83%/68.49%/90.25%，维持2021-23年预测归母净利-1.77/-0.64/1.67亿美元。考虑到Cilta-cel前线治疗数据较好，有望提升该产品的市场潜力，目标价上调至38.5港元，维持“增持”评级。报告提到，Cilta-cel在美国的BLA已获美国FDA受理，预计于2021年11月29日前完成BLA审查;在欧洲已于4月提交BLA，若进展顺利预计2022年获批;计划于今年下半年在中国和日本分别提交BLA。Cilta-cel有望成为全球第二款、中国首款靶向BCMA的CAR-T产品。","news_type":1,"symbols_score_info":{"01548":1}},"isVote":1,"tweetType":1,"viewCount":2809,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":979981366,"gmtCreate":1597971873655,"gmtModify":1705056696582,"author":{"id":"3486361727758741","authorId":"3486361727758741","name":"Rio999","avatar":"https://static.tigerbbs.com/c1e4178e32cb0fcff4b50f4dce9cc6b4","crmLevel":3,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"3486361727758741","idStr":"3486361727758741"},"themes":[],"htmlText":"news","listText":"news","text":"news","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://ttm.financial/post/979981366","repostId":"1143118873","repostType":2,"isVote":1,"tweetType":1,"viewCount":3376,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0}],"lives":[]}