Zhaoke Ophthalmology Ltd. Announces NMPA Acceptance of Biologics License Application for TAB014 for wAMD Treatment

Reuters

06-12

Zhaoke Ophthalmology Ltd. Announces NMPA Acceptance of Biologics License Application for TAB014 for wAMD Treatment

Zhaoke Ophthalmology Ltd. has announced that the National Medical Products Administration (NMPA) of China has accepted its Biologics License Application $(BLA.AU)$ for TAB014, a treatment for wet age-related macular degeneration (wAMD). This marks the first submission of a bevacizumab-based antibody for wAMD in China. The application is supported by successful Phase III clinical trial results, which demonstrated the efficacy of TAB014 in improving best corrected visual acuity compared to Lucentis®. The trial was a randomized, double-blind, non-inferiority study. Zhaoke Ophthalmology Ltd. has exclusive rights over the development and commercialization of TAB014 in China, Hong Kong, and Macau, while TOT BIOPHARM Co., Ltd. will handle manufacturing. The approval process underscores Zhaoke's commitment to advancing ophthalmic treatments in the region.

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. Zhaoke Ophthalmology Ltd. published the original content used to generate this news brief on June 12, 2025, and is solely responsible for the information contained therein.

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Announces NMPA Acceptance of Biologics License Application for TAB014 for wAMD Treatment\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        Zhaoke Ophthalmology Ltd. has announced that the National Medical Products Administration (NMPA) of China has accepted its Biologics License Application <a href=\"https://laohu8.com/S/BLA.AU\">$(BLA.AU)$</a> for TAB014, a treatment for wet age-related macular degeneration (wAMD). This marks the first submission of a bevacizumab-based antibody for wAMD in China. The application is supported by successful Phase III clinical trial results, which demonstrated the efficacy of TAB014 in improving best corrected visual acuity compared to Lucentis®. The trial was a randomized, double-blind, non-inferiority study. 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Zhaoke Ophthalmology Ltd. published the original content used to generate this news brief on June 12, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\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:20250612:nNDL1YwNrn:1","article_id":"2542596399","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2542596399","pubTimestamp":1749717691,"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":"Zhaoke Ophthalmology Ltd. has announced that the National Medical Products Administration  of China has accepted its Biologics License Application  for TAB014, a treatment for wet age-related macular degeneration . 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