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]

智通财经APP讯，亿胜生物科技(01061)发布公告，有关受许人(均为公司的全资附属公司)与上海复宏汉 霖生物技术股份有限公司(复宏汉霖)订立共同开发许可协议，以根据共同开发许可协议的条款共同开发 许可产品及向受许人授出有关许可产品的独家权利。许可产品为内含重组抗血管内皮生长因子人源化单 克隆抗体(anti-VEGF)作为原料药的生物药品，拟用于治疗渗出性(湿性)老年性黄斑部病变(湿性AMD)。 除了于2025年四月已达到主要研究终点的HLX04-O在湿性AMD中国患者中开展的三期临床研究(AURA- 1)外，HLX04-O在湿性AMD患者中开展的国际多中心三期临床研究正于多个欧洲国家、澳大利亚、美 国及中国有序开展(AURA-2)，并于2025年一月完成最后一名患者的最后一次访视。 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于近期获得中国国 家药品监督管理局(NMPA)药品审评中心(CDE)受理。 HLX04-O是在复宏汉霖自主研发的汉贝泰(贝伐珠单抗注射液)的基础上，根据眼科用药的需求对汉贝泰 (贝伐珠单抗注射液)的处方、规格和生产工艺进行优化，在活性成份 ...

HLX04-O是在复宏汉霖自主研发的汉贝泰(贝伐珠单抗注射液)的基础上，根据眼科用药的需求对汉贝泰 (贝伐珠单抗注射液)的处方、规格和生产工艺进行优化，在活性成份不变的基础上，开发的新的眼科制 剂产品，拟用于湿性AMD的治疗。 除了于2025年四月已达到主要研究终点的HLX04-O在湿性AMD中国患者中开展的三期临床研究(AURA- 1)外，HLX04-O在湿性AMD患者中开展的国际多中心三期临床研究正于多个欧洲国家、澳大利亚、美 国及中国有序开展(AURA-2)，并于2025年一月完成最后一名患者的最后一次访视。 亿胜生物科技(01061)发布公告，有关受许人(均为公司的全资附属公司)与上海复宏汉霖生物技术股份有 限公司(复宏汉霖)订立共同开发许可协议，以根据共同开发许可协议的条款共同开发许可产品及向受许 人授出有关许可产品的独家权利。许可产品为内含重组抗血管内皮生长因子人源化单克隆抗体(anti- VEGF)作为原料药的生物药品，拟用于治疗渗出性(湿性)老年性黄斑部病变(湿性AMD)。 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于近期获得中国国 家药品监督 ...

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]