Core Viewpoint - Rongchang Biologics has announced a business development (BD) deal with Santen Pharmaceutical for the exclusive licensing of the ophthalmic innovative drug RC28-E in several Asian markets, marking its second BD announcement this year [1][2]. Group 1: Business Development and Financials - Rongchang Biologics will receive an upfront payment of 250 million yuan, with potential milestone payments totaling up to 520 million yuan for development and regulatory achievements, and up to 525 million yuan for sales milestones [1]. - The company will also earn a tiered sales royalty based on product sales in the licensed regions, ranging from high single-digit to double-digit percentages [1]. Group 2: Product Details and Clinical Trials - RC28-E is a dual-target fusion protein drug aimed at treating neovascular eye diseases, specifically targeting VEGF and FGF pathways to inhibit new blood vessel formation [2]. - The drug is currently undergoing Phase III clinical trials for wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), with an expected submission for market approval in China for DME in the second half of 2025 and for wAMD in mid-2026 [3][5]. Group 3: Market Context and Competition - The domestic ophthalmic drug market is transitioning from generics to innovative products, with increasing competition as patents for existing drugs expire [6][9]. - Other companies, such as Qilu Pharmaceutical and Innovent Biologics, are also advancing in the development of biosimilars and innovative drugs in the ophthalmic space, indicating a shift towards more competitive innovation in the sector [9].

本次HLX04-O的首次上市注册申请(NDA)主要基于一项比较玻璃体内注射(IVT)HLX04-O与雷珠单抗治 疗湿性年龄相关性黄斑变性(wAMD)的多中心、随机、双盲、阳性对照的非劣效3期研究。研究结果显 示，HLX04-O组第48周最佳矫正视力(BCVA)较基线改善的平均字母数变化非劣于雷珠单抗组，达到主 要研究终点。HLX04-O安全性良好，未观察到新的安全信号。 复宏汉霖(02696)发布公告，近日，HLX04-O用于治疗湿性年龄相关性黄斑变性(wAMD)的上市注册申请 (NDA)获国家药品监督管理局(NMPA)药品审评中心受理。 ...

本次HLX04-O的首次上市注册申请(NDA)主要基于一项比较玻璃体内注射(IVT)HLX04-O与雷珠单抗治 疗湿性年龄相关性黄斑变性(wAMD)的多中心、随机、双盲、阳性对照的非劣效3期研究。研究结果显 示，HLX04-O组第48周最佳矫正视力(BCVA)较基线改善的平均字母数变化非劣于雷珠单抗组，达到主 要研究终点。HLX04-O安全性良好，未观察到新的安全信号。 截至本公告日，于中国境内上市的贝伐珠单抗产品均无湿性年龄相关性黄斑变性(wAMD)适应症。根据 IQVIA CHPA的最新数据（IQVIA是全球医药健康产业专业信息和战略咨询服务提供商），2024年，于 中国境内上市的针对湿性年龄相关性黄斑变性(wAMD)适应症的药物的销售额约为人民币49.0亿元。 格隆汇8月13日丨复宏汉霖(02696.HK)公布，近日，HLX04-O用于治疗湿性年龄相关性黄斑变性 (wAMD)的上市注册申请(NDA)获国家药品监督管理局(NMPA)药品审评中心受理。 ...

本次HLX04-O的首次上市注册申请(NDA)主要基于一项比较玻璃体内注射 (IVT)HLX04-O与雷珠单抗治 疗湿性年龄相关性黄斑变性(wAMD)的多中心、随机、双盲、阳性对照的非劣效3期研究。研究结果显 示，HLX04-O组第48 周最佳矫正视力(BCVA)较基线改善的平均字母数变化非劣于雷珠单抗组，达到主 要研究终点。HLX04-O安全性良好，未观察到新的安全信号。 智通财经APP讯，复宏汉霖(02696)发布公告，近日，HLX04-O用于治疗湿性年龄相关性黄斑变性 (wAMD)的上市注册申请(NDA)获国家药品监督管理局(NMPA)药品审评中心受理。 ...

HLX04-O是复宏汉霖利用基因工程技术构建的一款重组抗VEGF人源化单克隆抗体注射液，能够特异性 结合VEGF，阻断VEGF与内皮细胞上的受体Flt1(VEGFR-1)和KDR(VEGFR-2)结合，抑制其酪氨酸激酶 信号通路的激活，进而抑制内皮细胞增生，减少新生血管生成，从而实现对湿性年龄相关性黄斑变性 (wAMD)等血管增生眼部疾病的治疗。 研究结果显示，HLX04-O组第48周BCVA较基线改善的平均字母数变化结果非劣于雷珠单抗组，达到主 要研究终点。此外，HLX04-O和雷珠单抗对wAMD患者人群整体、眼部、非眼部的安全性特征均相 似，且安全性良好。 8月13日，国家药品监督管理局药品审评中心(CDE)官网显示，复宏汉霖(02696.HK)和亿胜生物 (01061.HK)联合递交了贝伐珠单抗眼内注射液(HLX04-O)的上市申请。Insight数据库显示，这是第2个在 国内报上市的贝伐珠单抗眼科制剂。 据了解，亿胜生物已和复宏汉霖达成协议，在全球范围内共同开发HLX04-O用于治疗湿性年龄相关性 黄斑变性等眼科疾病。 此前，2025年4月，复宏汉霖宣布HLX04-O用于wAMD中国患者的III期临床 ...

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]