EMA CHMP issues positive opinion on Shanghai Henlius pertuzumab biosimilar HLX11

Reuters

Feb 27

EMA CHMP issues positive opinion on Shanghai Henlius pertuzumab biosimilar HLX11

Shanghai Henlius Biotech Inc. said the European Medicines Agency’s Committee for Medicinal Products for Human Use $(CHMP)$ has issued a positive opinion recommending approval of the company’s pertuzumab biosimilar candidate HLX11, referencing Perjeta (pertuzumab). The CHMP opinion will be forwarded to the European Commission, which is expected to issue a final decision within two to three months; if approved, the centralized marketing authorization would apply across EU member states and EEA countries Iceland, Liechtenstein and Norway.

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-20260227-12032908), on February 27, 2026, and is solely responsible for the information contained therein.

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The CHMP opinion will be forwarded to the European Commission, which is expected to issue a final decision within two to three months; if approved, the centralized marketing authorization would apply across EU member states and EEA countries Iceland, Liechtenstein and Norway.\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. 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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ID: HKEX-EPS-20260227-12032908), on February 27, 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":"HK0000306685.HKD","symbol_name":"TAIKANG KAITAI CHINA NEW OPPORTUNITIES FUND \"A\" (HKD) INC","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260227:nNDLbWtqVF:1","article_id":"2614699854","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2614699854","pubTimestamp":1772202196,"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. said the European Medicines Agency’s Committee for Medicinal Products for Human Use  has issued a positive opinion recommending approval of the company’s pertuzumab biosimilar candidate HLX11, referencing Perjeta . 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The CHMP opinion will be forwarded to the European Commission, which is expected to issue a final decision within two to three months; if approved, the centralized marketing authorization would apply across EU member states and EEA countries Iceland, Liechtenstein and Norway.\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. 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-20260227-12032908), on February 27, 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":true,"code":"91000000","status":"200"}}}