Transthera Sciences Secures Phase II IND Approval for Tinengotinib and Fulvestrant Combination in Treating HR+/HER2- Metastatic Breast Cancer

Reuters

Sep 10

Transthera Sciences Secures Phase II IND Approval for Tinengotinib and Fulvestrant Combination in Treating HR+/HER2- Metastatic Breast Cancer

TransThera Sciences (Nanjing) Inc. has announced a significant regulatory milestone with the approval of a Phase II Investigational New Drug (IND) by the National Medical Products Administration (NMPA) of the People's Republic of China. This approval pertains to the clinical trial of Tinengotinib in combination with Fulvestrant, aimed at treating previously treated hormone receptor-positive (HR+) and human epidermal growth factor receptor 2 negative or low expression (HER2-) relapsed or metastatic breast cancer. The open-label, multicenter study will be conducted in China, focusing on evaluating the safety, efficacy, and pharmacokinetics of the treatment combination. This development marks a promising advancement in offering a new therapeutic option for patients resistant to conventional endocrine therapies.

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. Transthera Sciences (Nanjing) Inc. published the original content used to generate this news brief on September 10, 2025, and is solely responsible for the information contained therein.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Most Discussed

1
2
3
4
5
6
7
8
9
10

{"basename":"","ssrTDKData":{"titleTemplate":"%s - Tiger Brokers","title":"Tiger Brokers | Global Stocks, Options & Futures Trading App","description":"Tiger Brokers, one-stop investment in US stocks, SGX stocks, HK stocks, A-shares & other global assets. One of the best stock trading platforms in Singapore.","keywords":"tiger brokers,tiger trade,tiger brokers singapore,broker online,stock trading in singapore,share trading singapore,brokerage firm singapore,trading app,stock broker singapore,stock trading platforms,trading account","social":{"ogDescription":"Tiger Brokers, one-stop investment in US stocks, SGX stocks, HK stocks, A-shares & other global assets. One of the best stock trading platforms in Singapore.","ogImage":"https://c1.itigergrowtha.com/portal5/static/media/og-logo.be62fbe1.png","ogUrl":"https://www.itiger.com/news/2566602527"},"companyName":"Tiger Brokers"},"pageData":{"isMobile":false,"isTiger":false,"isTTM":true,"region":"SGP","license":"TBSG","edition":"fundamental"},"isCrawlerRequest":true,"__swrFallback__":{"@#url:\"https://stock-news.skytigris.cn/v3/news\",params:#id:\"2566602527\",edition:\"fundamental\",auth_exemption:1,,,undefined,":{"share":"https://ttm.financial/m/news/2566602527?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-09-10 21:53","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2566602527","market":"fut","top_or_hot":-1,"title":"Transthera Sciences Secures Phase II IND Approval for Tinengotinib and Fulvestrant Combination in Treating HR+/HER2- Metastatic Breast Cancer","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      Transthera Sciences Secures Phase II IND Approval for Tinengotinib and Fulvestrant Combination in Treating HR+/HER2- Metastatic Breast Cancer\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        TransThera Sciences (Nanjing) Inc. has announced a significant regulatory milestone with the approval of a Phase II Investigational New Drug (IND) by the National Medical Products Administration (NMPA) of the People's Republic of China. This approval pertains to the clinical trial of Tinengotinib in combination with Fulvestrant, aimed at treating previously treated hormone receptor-positive (HR+) and human epidermal growth factor receptor 2 negative or low expression (HER2-) relapsed or metastatic breast cancer. The open-label, multicenter study will be conducted in China, focusing on evaluating the safety, efficacy, and pharmacokinetics of the treatment combination. This development marks a promising advancement in offering a new therapeutic option for patients resistant to conventional endocrine therapies.\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. Transthera Sciences (Nanjing) Inc. published the original content used to generate this news brief on September 10, 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>Transthera Sciences Secures Phase II IND Approval for Tinengotinib and Fulvestrant Combination in Treating HR+/HER2- Metastatic Breast Cancer</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\">\nTransthera Sciences Secures Phase II IND Approval for Tinengotinib and Fulvestrant Combination in Treating HR+/HER2- Metastatic Breast Cancer\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\">2025-09-10 21:53</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      Transthera Sciences Secures Phase II IND Approval for Tinengotinib and Fulvestrant Combination in Treating HR+/HER2- Metastatic Breast Cancer\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        TransThera Sciences (Nanjing) Inc. has announced a significant regulatory milestone with the approval of a Phase II Investigational New Drug (IND) by the National Medical Products Administration (NMPA) of the People's Republic of China. This approval pertains to the clinical trial of Tinengotinib in combination with Fulvestrant, aimed at treating previously treated hormone receptor-positive (HR+) and human epidermal growth factor receptor 2 negative or low expression (HER2-) relapsed or metastatic breast cancer. The open-label, multicenter study will be conducted in China, focusing on evaluating the safety, efficacy, and pharmacokinetics of the treatment combination. This development marks a promising advancement in offering a new therapeutic option for patients resistant to conventional endocrine therapies.\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. Transthera Sciences (Nanjing) Inc. published the original content used to generate this news brief on September 10, 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":"02617","symbol_name":"药捷安康-B","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250910:nNDLtmHZv:1","article_id":"2566602527","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2566602527","pubTimestamp":1757512397,"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":"Transthera Sciences Secures Phase II IND Approval for Tinengotinib and Fulvestrant Combination in Treating HR+/HER2- Metastatic Breast Cancer. TransThera Sciences  Inc. has announced a significant regulatory milestone with the approval of a Phase II Investigational New Drug  by the National Medical Products Administration  of the People's Republic of China. This approval pertains to the clinical trial of Tinengotinib in combination with Fulvestrant, aimed at treating previously treated hormone receptor-positive (HR+) and human epidermal growth factor receptor 2 negative or low expression  relapsed or metastatic breast cancer. The open-label, multicenter study will be conducted in China, focusing on evaluating the safety, efficacy, and pharmacokinetics of the treatment combination. This development marks a promising advancement in offering a new therapeutic option for patients resistant to conventional endocrine therapies.Disclaimer: This news brief was created by Public Technologies  u","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"02617":"药捷安康-B","BK1161":"生物科技"},"translate_title":"Transthera Sciences获得替能替尼和氟维司群联合治疗HR+/HER2-转移性乳腺癌的II期IND批准","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"02617":0.9},"content_text":"Transthera Sciences Secures Phase II IND Approval for Tinengotinib and Fulvestrant Combination in Treating HR+/HER2- Metastatic Breast Cancer\n    \n\n        TransThera Sciences (Nanjing) Inc. has announced a significant regulatory milestone with the approval of a Phase II Investigational New Drug (IND) by the National Medical Products Administration (NMPA) of the People's Republic of China. This approval pertains to the clinical trial of Tinengotinib in combination with Fulvestrant, aimed at treating previously treated hormone receptor-positive (HR+) and human epidermal growth factor receptor 2 negative or low expression (HER2-) relapsed or metastatic breast cancer. The open-label, multicenter study will be conducted in China, focusing on evaluating the safety, efficacy, and pharmacokinetics of the treatment combination. This development marks a promising advancement in offering a new therapeutic option for patients resistant to conventional endocrine therapies.\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. Transthera Sciences (Nanjing) Inc. published the original content used to generate this news brief on September 10, 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":"executive","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"}}}