European Commission Grants Orphan Drug Designation to Nanjing Leads Biolabs’ LBL-024 for EP-NEC

Reuters01-22

European Commission Grants Orphan Drug Designation to Nanjing Leads Biolabs’ LBL-024 for EP-NEC

Nanjing Leads Biolabs Co., Ltd. announced that the European Commission has granted Orphan Drug Designation $(ODD)$ to LBL-024 (Opamtistomig), a PD-L1/4-1BB bispecific antibody, for the treatment of extrapulmonary neuroendocrine carcinoma (EP-NEC). This follows a previous orphan designation for LBL-024 by the U.S. Food and Drug Administration (FDA) for the treatment of neuroendocrine carcinoma (NEC). The company also received approval from the National Medical Products Administration (NMPA) in China to conduct a single-arm registrational trial and was granted Breakthrough Therapy Designation (BTD) by the NMPA for LBL-024 in late-line advanced EP-NEC.

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. Nanjing Leads Biolabs Co. Ltd. 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-20260122-11999008), on January 22, 2026, and is solely responsible for the information contained therein.

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ID: HKEX-EPS-20260122-11999008), on January 22, 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":"HK0000252152.HKD","symbol_name":"易方达 (香港) 中国股票股息基金A 类 (累积) 港元","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260122:nNDL8VSCJv:1","article_id":"2605999504","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2605999504","pubTimestamp":1769086751,"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":"Nanjing Leads Biolabs Co., Ltd. announced that the European Commission has granted Orphan Drug Designation  to LBL-024 , a PD-L1/4-1BB bispecific antibody, for the treatment of extrapulmonary neuroendocrine carcinoma . 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