UK MHRA approves CStone’s sugemalimab for unresectable stage III NSCLC

Reuters

2 hours ago

UK MHRA approves CStone’s sugemalimab for unresectable stage III NSCLC

CStone Pharmaceuticals said the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new indication for sugemalimab as monotherapy for adult patients with unresectable stage III non-small cell lung cancer (NSCLC) with PD-L1 expression on at least 1% of tumor cells, without sensitising EGFR mutations or ALK/ROS1 genomic aberrations, whose disease has not progressed after platinum-based chemoradiotherapy. The company said the approval was based on results from the Phase III GEMSTONE-301 trial.

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. CStone Pharmaceuticals published the original content used to generate this news brief via IIS, the Issuer Information Service operated by the Hong Kong Stock Exchange (HKex) (Ref. ID: HKEX-EPS-20260223-12027205), on February 23, 2026, and is solely responsible for the information contained therein.

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The company said the approval was based on results from the Phase III GEMSTONE-301 trial.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>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. CStone Pharmaceuticals published the original content used to generate this news brief via IIS, the Issuer Information Service operated by the Hong Kong Stock Exchange (HKex) (Ref. 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The company said the approval was based on results from the Phase III GEMSTONE-301 trial.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>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. CStone Pharmaceuticals published the original content used to generate this news brief via IIS, the Issuer Information Service operated by the Hong Kong Stock Exchange (HKex) (Ref. ID: HKEX-EPS-20260223-12027205), on February 23, 2026, and is solely responsible for the information contained therein.</span></i>\n</p>\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:20260223:nNDL7T8KFm:1","article_id":"2613272275","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2613272275","pubTimestamp":1771805215,"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":"CStone Pharmaceuticals said the UK Medicines and Healthcare products Regulatory Agency  has approved a new indication for sugemalimab as monotherapy for adult patients with unresectable stage III non-small cell lung cancer  with PD-L1 expression on at least 1% of tumor cells, without sensitising EGFR mutations or ALK/ROS1 genomic aberrations, whose disease has not progressed after platinum-based chemoradiotherapy. The company said the approval was based on results from the Phase III GEMSTONE-301 trial.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. CStone Pharmaceuticals published the original content used to generate this news brief via IIS, the Issuer Information Service operated by the Hong Kong Stock Exchange  , on February 23, 202","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK1161":"生物科技","02616":"基石药业-B","BK1574":"生物医药B类股"},"translate_title":"英国MHRA批准基石药业舒格利单抗治疗不可切除的III期非小细胞肺癌","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"02616":0.9},"content_text":"UK MHRA approves CStone’s sugemalimab for unresectable stage III NSCLC\n    \n\nCStone Pharmaceuticals said the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new indication for sugemalimab as monotherapy for adult patients with unresectable stage III non-small cell lung cancer (NSCLC) with PD-L1 expression on at least 1% of tumor cells, without sensitising EGFR mutations or ALK/ROS1 genomic aberrations, whose disease has not progressed after platinum-based chemoradiotherapy. The company said the approval was based on results from the Phase III GEMSTONE-301 trial.\n      \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. CStone Pharmaceuticals published the original content used to generate this news brief via IIS, the Issuer Information Service operated by the Hong Kong Stock Exchange (HKex) (Ref. ID: HKEX-EPS-20260223-12027205), on February 23, 2026, 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"}}}