Core Viewpoint - The announcement highlights a collaboration between the company and Shanghai Junshi Biosciences Co., Ltd. to jointly develop a biopharmaceutical product 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 develop and market a product containing a recombinant anti-VEGF monoclonal antibody [1] - The licensed product is intended for use as a biopharmaceutical for treating wet AMD [1] Group 2: Product Development - The anti-VEGF eye injection biopharmaceutical (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 researched and developed Hanbeitai (Bevacizumab injection), optimized for ophthalmic use while maintaining the active ingredient [1] Group 3: Clinical Trials - In addition to the Phase III clinical study (AURA-1) for HLX04-O in wet AMD patients in China, an international multicenter Phase III clinical study (AURA-2) is being conducted across multiple European countries, Australia, the United States, and China [2] - The final patient visit for the AURA-2 study is expected to be completed by January 2025 [2]
亿胜生物科技：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