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

Reuters

2025/09/10

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.

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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":"BK1161","symbol_name":"生物科技","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. 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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. 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