Core Viewpoint - Yisheng Biotechnology (01061) experienced a stock price increase of over 10%, currently trading at 5.94 HKD with a transaction volume of 9.3261 million HKD, following the announcement of a joint development licensing agreement with Shanghai Junshi Biosciences Co., Ltd. [1] Group 1: Company Developments - Yisheng Biotechnology announced a joint development licensing agreement with its wholly-owned subsidiaries and Shanghai Junshi Biosciences, granting exclusive rights for the licensed product [1] - The licensed product is a recombinant anti-VEGF humanized monoclonal antibody, intended for the treatment of exudative (wet) age-related macular degeneration (wet AMD) [1] - The biological product license application for the anti-VEGF ophthalmic injection (HLX04-O) has recently been accepted by the National Medical Products Administration (NMPA) of China [1] Group 2: Product Details - HLX04-O is developed based on Junshi's independently developed Hanbeitai (Bevacizumab injection), optimized for ophthalmic use while maintaining the active ingredient [1] - The new ophthalmic formulation is designed to meet the specific needs for treating wet AMD [1]

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]

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]

Core Viewpoint - The company Fuhong Hanlin (复宏汉霖) announced that its HLX04-O injection has met the primary endpoint in a Phase III clinical study for wet age-related macular degeneration (wAMD) in Chinese patients [1][2]. Group 1: Clinical Study Details - The study was a multicenter, randomized, double-blind, positive-controlled non-inferiority trial comparing HLX04-O with Ranibizumab (雷珠单抗) in wAMD patients [2]. - Patients were randomly assigned in a 1:1 ratio to receive either HLX04-O (1.25 mg) or Ranibizumab (0.5 mg) via intravitreal injection every four weeks for one year, with the primary endpoint being the change in best-corrected visual acuity (BCVA) from baseline at week 48 [2]. - Results showed that the average letter score improvement in the HLX04-O group at week 48 was non-inferior to that of the Ranibizumab group, achieving the primary endpoint [2]. Group 2: Product Development and Market Potential - HLX04-O is developed based on the company's existing product Hanbeitai (汉贝泰, Bevacizumab injection), optimized for ophthalmic use while maintaining the active ingredient [3]. - In addition to the successful Phase III study, international multicenter Phase III trials for HLX04-O are ongoing in several European countries, Australia, the United States, and mainland China [3]. - As of the announcement date, there are no Bevacizumab products approved for wAMD in mainland China, and the projected sales for wAMD treatments in China for 2024 are approximately RMB 4.18 billion [3].

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]