Shanghai Henlius Biotech Secures NMPA Approval for Phase 2/3 Trials of HLX22 and HLX87 in HER2-Positive Breast Cancer

Reuters

1 hour ago

<a href="https://laohu8.com/S/SGBCF">Shanghai Henlius Biotech</a> Secures NMPA Approval for Phase 2/3 Trials of HLX22 and HLX87 in HER2-Positive Breast Cancer

Shanghai Henlius Biotech Inc. announced that the National Medical Products Administration has approved applications for Phase 2/3 clinical trials of HLX22 (recombinant humanised anti-HER2 monoclonal antibody injection) in combination with HLX87 (antibody-drug conjugate targeting HER2) for the first-line treatment and neoadjuvant treatment of HER2-positive breast cancer. As of the announcement date, no similar combination has been approved for marketing globally. The approval marks a significant step forward in the company's oncology pipeline, but Henlius cautioned that successful development and commercialization of HLX22 and HLX87 cannot be guaranteed.

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. Shanghai Henlius Biotech Inc. 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-20251209-11949301), on December 09, 2025, and is solely responsible for the information contained therein.

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As of the announcement date, no similar combination has been approved for marketing globally. The approval marks a significant step forward in the company's oncology pipeline, but Henlius cautioned that successful development and commercialization of HLX22 and HLX87 cannot be guaranteed.\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. Shanghai Henlius Biotech Inc. 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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As of the announcement date, no similar combination has been approved for marketing globally. The approval marks a significant step forward in the company's oncology pipeline, but Henlius cautioned that successful development and commercialization of HLX22 and HLX87 cannot be guaranteed.\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. Shanghai Henlius Biotech Inc. 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-20251209-11949301), on December 09, 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:20251209:nNDL1L7tPm:1","article_id":"2590311384","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2590311384","pubTimestamp":1765271717,"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":"Shanghai Henlius Biotech Inc. announced that the National Medical Products Administration has approved applications for Phase 2/3 clinical trials of HLX22  in combination with HLX87  for the first-line treatment and neoadjuvant treatment of HER2-positive breast cancer. As of the announcement date, no similar combination has been approved for marketing globally. The approval marks a significant step forward in the company's oncology pipeline, but Henlius cautioned that successful development and commercialization of HLX22 and HLX87 cannot be guaranteed.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. Shanghai Henlius Biotech Inc. published the original content used to generate this news brief via IIS, the Issuer Information Service opera","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK1161":"生物科技","HK0000165453.HKD":"华夏精选大中华科技基金 A类港币","BK1230":"工业集团企业","02696":"复宏汉霖","00656":"复星国际"},"translate_title":"复宏汉霖生物获得NMPA批准HLX22和HLX87治疗HER2阳性乳腺癌的2/3期试验","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"02696":0.9,"00656":0.9},"content_text":"Shanghai Henlius Biotech Secures NMPA Approval for Phase 2/3 Trials of HLX22 and HLX87 in HER2-Positive Breast Cancer\n    \n\n        Shanghai Henlius Biotech Inc. announced that the National Medical Products Administration has approved applications for Phase 2/3 clinical trials of HLX22 (recombinant humanised anti-HER2 monoclonal antibody injection) in combination with HLX87 (antibody-drug conjugate targeting HER2) for the first-line treatment and neoadjuvant treatment of HER2-positive breast cancer. As of the announcement date, no similar combination has been approved for marketing globally. The approval marks a significant step forward in the company's oncology pipeline, but Henlius cautioned that successful development and commercialization of HLX22 and HLX87 cannot be guaranteed.\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. Shanghai Henlius Biotech Inc. 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-20251209-11949301), on December 09, 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"}}}