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亿胜生物科技(01061):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
智通财经网·2025-08-13 12:07

Core Viewpoint - The announcement highlights a collaboration between the company and Shanghai Junshi Biosciences Co., Ltd. to jointly develop a biological drug for the treatment of wet age-related macular degeneration (wet AMD) [1] Group 1: Licensing Agreement - The company has entered into a joint development licensing agreement with Shanghai Junshi Biosciences, granting exclusive rights to the licensed product [1] - The licensed product is a recombinant anti-VEGF humanized monoclonal antibody intended for use as a raw material drug [1] Group 2: Product Development - The anti-VEGF eye injection biological drug (HLX04-O) has recently been accepted for review by the National Medical Products Administration (NMPA) in China [1] - HLX04-O is developed based on Junshi's independently developed Hanbeitai (Bevacizumab injection), optimized for ophthalmic use while maintaining the active ingredient [1] Group 3: Clinical Trials - A Phase III clinical trial (AURA-1) for HLX04-O in Chinese patients with wet AMD is set to reach its primary endpoint by April 2025 [2] - An international multicenter Phase III clinical trial (AURA-2) is ongoing in multiple European countries, Australia, the United States, and China, with the last patient visit scheduled for January 2025 [2]