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]

Group 1 - The core viewpoint of the news is that the phase III clinical trial (AURA-1) for HLX04-O, a treatment for wet AMD in Chinese patients, has met its primary endpoint [1] - AURA-1 is a multicenter, randomized, double-blind, positive-controlled non-inferiority trial comparing the efficacy and safety of HLX04-O with ranibizumab in newly diagnosed wet AMD patients [1] - The primary endpoint of the study was the change in best-corrected visual acuity (BCVA) from baseline at week 48, and the results showed that HLX04-O was non-inferior to ranibizumab [1] Group 2 - HLX04-O is developed based on Hanbio's independently developed Hanbeitai (Bevacizumab injection), optimized for ophthalmic use while maintaining the active ingredient [2] - In addition to AURA-1, an international multicenter phase III clinical study (AURA-2) for HLX04-O is ongoing in multiple European countries, Australia, the United States, and China, expected to complete in January 2025 [2]