Sichuan Kelun-Biotech's Fourth NDA for Sac-TMT Accepted for Priority Review by China's CDE for Advanced HR+/HER2- Breast Cancer Treatment

Reuters

2025/05/22

Sichuan Kelun-Biotech's Fourth NDA for Sac-TMT Accepted for Priority Review by China's CDE for Advanced HR+/HER2- Breast Cancer Treatment

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. has announced that the Center for Drug Evaluation $(CDE)$ of the National Medical Products Administration (NMPA) of China has accepted the new indication application for their TROP2-directed antibody-drug conjugate, sacituzumab tirumotecan (sac-TMT), for the treatment of adult patients with unresectable locally advanced, metastatic hormone-receptor positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer. This marks the fourth indication application for sac-TMT accepted by the NMPA, highlighting the drug's clinical value and innovative nature. The application will undergo the priority review and approval process, following positive results from the registrational phase 3 OptiTROP-Breast02 study. This development underscores Kelun-Biotech's commitment to advancing oncology therapeutics to meet unmet clinical needs worldwide.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. published the original content used to generate this news brief via PR Newswire (Ref. ID: CN94038) on May 22, 2025, and is solely responsible for the information contained therein.

免责声明：投资有风险，本文并非投资建议，以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请，作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考，不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证，投资者应自行研究并在投资前寻求专业建议。

热议股票

1
2
3
4
5
6
7
8
9
10

{"basename":"/hans","ssrTDKData":{"titleTemplate":"%s - 老虎证券","title":"老虎证券 | 轻松买卖美股港股A股/美债/ETF/Crypto/期权期货","description":"老虎证券提供多项优惠： 港股&Crypto 0佣0平台费、A股通一年免佣、美股期权0佣、IPO打新0融资利息0手续费。 美股1美元起投，免费实时行情与多种工具，立即开户享更多优惠！","keywords":"老虎证券,老虎证券开户,老虎证券香港,老虎证券登录,老虎证券官网,香港证券开户,证券公司开户,股票开户,香港证券公司,香港证券,证券公司,股票投资,投资app,投资平台,股票买卖,股票交易平台,股票app,证券app,新手投资","social":{"ogDescription":"老虎证券提供多项优惠： 港股&Crypto 0佣0平台费、A股通一年免佣、美股期权0佣、IPO打新0融资利息0手续费。 美股1美元起投，免费实时行情与多种工具，立即开户享更多优惠！","ogImage":"https://c1.itigergrowtha.com/portal5/static/media/og-logo.be62fbe1.png","ogUrl":"https://www.itiger.com/hans/news/2537969482"},"companyName":"老虎证券"},"pageData":{"isMobile":false,"isTiger":false,"isTTM":true,"region":"HKG","license":"TBHK","edition":"fundamental"},"isCrawlerRequest":true,"__swrFallback__":{"@#url:\"https://stock-news.skytigris.cn/v3/news\",params:#id:\"2537969482\",edition:\"fundamental\",auth_exemption:1,,,undefined,":{"share":"https://ttm.financial/m/news/2537969482?lang=zh_CN&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-05-22 09:58","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2537969482","market":"us","top_or_hot":-1,"title":"Sichuan Kelun-Biotech's Fourth NDA for Sac-TMT Accepted for Priority Review by China's CDE for Advanced HR+/HER2- Breast Cancer Treatment","media":"Reuters","content":"<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      Sichuan Kelun-Biotech's Fourth NDA for Sac-TMT Accepted for Priority Review by China's CDE for Advanced HR+/HER2- Breast Cancer Treatment\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. has announced that the Center for Drug Evaluation <a href=\"https://laohu8.com/S/CDE\">$(CDE)$</a> of the National Medical Products Administration (NMPA) of China has accepted the new indication application for their TROP2-directed antibody-drug conjugate, sacituzumab tirumotecan (sac-TMT), for the treatment of adult patients with unresectable locally advanced, metastatic hormone-receptor positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer. This marks the fourth indication application for sac-TMT accepted by the NMPA, highlighting the drug's clinical value and innovative nature. The application will undergo the priority review and approval process, following positive results from the registrational phase 3 OptiTROP-Breast02 study. This development underscores Kelun-Biotech's commitment to advancing oncology therapeutics to meet unmet clinical needs worldwide.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. published the original content used to generate this news brief via PR Newswire (Ref. ID: CN94038) on May 22, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>","source":null,"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>Sichuan Kelun-Biotech's Fourth NDA for Sac-TMT Accepted for Priority Review by China's CDE for Advanced HR+/HER2- Breast Cancer 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: 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\">\nSichuan Kelun-Biotech's Fourth NDA for Sac-TMT Accepted for Priority Review by China's CDE for Advanced HR+/HER2- Breast Cancer Treatment\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1032215980\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Reuters </p>\n<p class=\"h-time\">2025-05-22 09:58</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      Sichuan Kelun-Biotech's Fourth NDA for Sac-TMT Accepted for Priority Review by China's CDE for Advanced HR+/HER2- Breast Cancer Treatment\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. has announced that the Center for Drug Evaluation <a href=\"https://laohu8.com/S/CDE\">$(CDE)$</a> of the National Medical Products Administration (NMPA) of China has accepted the new indication application for their TROP2-directed antibody-drug conjugate, sacituzumab tirumotecan (sac-TMT), for the treatment of adult patients with unresectable locally advanced, metastatic hormone-receptor positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer. This marks the fourth indication application for sac-TMT accepted by the NMPA, highlighting the drug's clinical value and innovative nature. The application will undergo the priority review and approval process, following positive results from the registrational phase 3 OptiTROP-Breast02 study. This development underscores Kelun-Biotech's commitment to advancing oncology therapeutics to meet unmet clinical needs worldwide.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. published the original content used to generate this news brief via PR Newswire (Ref. ID: CN94038) on May 22, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK1161","symbol_name":"生物科技","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250522:nNDL3BHCW3:1","article_id":"2537969482","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2537969482","pubTimestamp":1747879090,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","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,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Sichuan Kelun-Biotech's Fourth NDA for Sac-TMT Accepted for Priority Review by China's CDE for Advanced HR+/HER2- Breast Cancer Treatment. Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. published the original content used to generate this news brief via PR Newswire  on May 22, 2025, and is solely responsible for the information contained therein.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK1161":"生物科技","06990":"科伦博泰生物-B","LU0196878994.USD":"MANULIFE GF CHINA VALUE \"AA\" (USD) INC","LU1934453819.USD":"AB CHINA A SHARES EQUITY PORTFOLIO \"A\" (USD) ACC","LU2148510915.USD":"FULLERTON LUX FUNDS - CHINA A EQUITIES \"R\" (USD) ACC","BK0060":"抗癌","LU1064131003.USD":"FULLERTON LUX FUNDS - CHINA A EQUITIES \"A\" (USD) ACC","LU1064130708.USD":"FULLERTON LUX FUNDS - CHINA A EQUITIES \"I\" (USD) ACC","LU1979443071.USD":"AB CHINA A SHARES EQUITY PORTFOLIO \"AD\" (USDHDG) INC","BK0239":"医药制造","002422":"科伦药业"},"translate_title":"四川科伦生物第四份SAC-TMT NDA获中国CDE优先审评受理，用于晚期HR+/HER2-乳腺癌治疗","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"002422":0.9,"06990":0.9},"content_text":"Sichuan Kelun-Biotech's Fourth NDA for Sac-TMT Accepted for Priority Review by China's CDE for Advanced HR+/HER2- Breast Cancer Treatment\n    \n\n        Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. has announced that the Center for Drug Evaluation $(CDE)$ of the National Medical Products Administration (NMPA) of China has accepted the new indication application for their TROP2-directed antibody-drug conjugate, sacituzumab tirumotecan (sac-TMT), for the treatment of adult patients with unresectable locally advanced, metastatic hormone-receptor positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer. This marks the fourth indication application for sac-TMT accepted by the NMPA, highlighting the drug's clinical value and innovative nature. The application will undergo the priority review and approval process, following positive results from the registrational phase 3 OptiTROP-Breast02 study. This development underscores Kelun-Biotech's commitment to advancing oncology therapeutics to meet unmet clinical needs worldwide.\n      \n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. published the original content used to generate this news brief via PR Newswire (Ref. ID: CN94038) on May 22, 2025, and is solely responsible for the information contained therein.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"}}}