FDA Approves IND Application for Shanghai Henlius Biotech HLX15-SC in Multiple Myeloma

Reuters

Feb 16

FDA Approves IND Application for <a href="https://laohu8.com/S/SGBCF">Shanghai Henlius Biotech</a> HLX15-SC in Multiple Myeloma

Shanghai Henlius Biotech Inc. announced that its investigational new drug $(IND)$ application for HLX15-SC, a recombinant anti-CD38 fully human monoclonal antibody injection (subcutaneous injection) for the treatment of multiple myeloma, has been approved by the United States Food and Drug Administration (FDA) for a phase 1 clinical trial. The company independently developed HLX15-SC and has also entered into an agreement to commercialize HLX15 in both subcutaneous and intravenous forms in the United States and agreed European countries.

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-20260216-12025812), on February 16, 2026, and is solely responsible for the information contained therein.

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ID: HKEX-EPS-20260216-12025812), on February 16, 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:20260216:nNDL6rwJtS:1","article_id":"2611080481","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2611080481","pubTimestamp":1771216272,"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 its investigational new drug  application for HLX15-SC, a recombinant anti-CD38 fully human monoclonal antibody injection  for the treatment of multiple myeloma, has been approved by the United States Food and Drug Administration  for a phase 1 clinical trial. The company independently developed HLX15-SC and has also entered into an agreement to commercialize HLX15 in both subcutaneous and intravenous forms in the United States and agreed European countries.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. 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The company independently developed HLX15-SC and has also entered into an agreement to commercialize HLX15 in both subcutaneous and intravenous forms in the United States and agreed European countries.\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. 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