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亿胜生物科技(01061.HK):用以治疗湿性AMD的anti-VEGF眼用注射生物药品(HLX04-O)的生物制品许可申请已获受理

Group 1 - The core point of the article is that Edding Biotechnology (01061.HK) has received acceptance for its biopharmaceutical license application for the anti-VEGF eye injection product HLX04-O, intended for the treatment of wet AMD, from the National Medical Products Administration (NMPA) in China [1] - HLX04-O is developed based on the independently researched Hanbeitai (Bevacizumab injection) by the company, optimized for ophthalmic use in terms of formulation, specifications, and production processes while maintaining the same active ingredient [1] - As of the announcement date, there are no approved Bevacizumab products for the treatment of wet AMD in China, with projected sales for drugs targeting wet AMD in China estimated at approximately RMB 4.9 billion for 2024 according to the latest data from IQVIA CHPA [1]