China NMPA Accepts Hansoh Pharma's NDA for HS-10365 in RET Fusion-Positive NSCLC

Reuters

10/23

China NMPA Accepts Hansoh Pharma's NDA for HS-10365 in RET Fusion-Positive NSCLC

Hansoh Pharmaceutical Group Co., Ltd. announced that China's National Medical Products Administration (NMPA) has accepted the New Drug Application for HS-10365 capsules. This innovative, highly selective RET inhibitor is intended for the treatment of adult patients with RET fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). HS-10365 has shown promising efficacy and a manageable safety profile in clinical trials. The regulatory review is currently ongoing. No grant or funding from multiple organizations was mentioned.

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. Hansoh Pharmaceutical Group Co. Ltd. published the original content used to generate this news brief on October 23, 2025, and is solely responsible for the information contained therein.

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This innovative, highly selective RET inhibitor is intended for the treatment of adult patients with RET fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). HS-10365 has shown promising efficacy and a manageable safety profile in clinical trials. The regulatory review is currently ongoing. No grant or funding from multiple organizations was mentioned.\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. Hansoh Pharmaceutical Group Co. Ltd. published the original content used to generate this news brief on October 23, 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":"03692","symbol_name":"翰森制药","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20251023:nNDL5mnHcb:1","article_id":"2577317303","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2577317303","pubTimestamp":1761217052,"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":"Hansoh Pharmaceutical Group Co., Ltd. announced that China's National Medical Products Administration  has accepted the New Drug Application for HS-10365 capsules. 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