三生制药(01530)盘中涨超8%，截至发稿，涨8.13%，报29.8港元，成交额5.5亿港元。 另外，在体现黄斑水肿改善的中央视网膜厚度(CRT)较基线变化等疗效指标上，601A在第12、24、52周 的数值上也均与雷珠单抗相当，验证了601A改善黄斑水肿的疗效。安全性方面，601A治疗后总体安全 性和耐受性良好，整体获益风险正向。 消息面上，据三生制药官微消息，10月15日，三生制药宣布，公司自主研发的重组抗VEGF人源化单抗 (通用名：贝伐珠单抗眼内注射溶液，研发代号：601A)用于BRVO所致黄斑水肿病变适应症，已向国家 药监局递交该产品首个上市申请并获受理。 据介绍，目前601A在BRVO中开展的III期临床研究已顺利完成，达到主要终点，即：601A治疗BRVO所 致黄斑水肿病变患者24周后，受试者最佳矫正视力(BCVA)较基线的改善非劣于雷珠单抗。在其他次要 疗效终点上，治疗12、24、52周后，目标眼BCVA较基线增加≥5个字母、≥10个字母和≥15个字母的受试 者比例，601A与雷珠单抗相当，证实了601A治疗对视力改善的明确和持续作用。 ...

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].

Core Viewpoint - The announcement indicates that the National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for HLX04-O, a treatment for wet age-related macular degeneration (wAMD) [1] Group 1: Clinical Study Results - The NDA submission is primarily based on a multicenter, randomized, double-blind, positive-controlled Phase III study comparing intravitreal injection (IVT) of HLX04-O with ranibizumab for treating wAMD [1] - The study results show that the average change in best-corrected visual acuity (BCVA) from baseline at week 48 in the HLX04-O group was non-inferior to that of the ranibizumab group, achieving the primary endpoint of the study [1] - HLX04-O demonstrated good safety, with no new safety signals observed [1]

Core Viewpoint - The National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for HLX04-O, a treatment for wet age-related macular degeneration (wAMD) by the company [1] Company Summary - HLX04-O's NDA is based on a multicenter, randomized, double-blind, positive-controlled Phase III study comparing intravitreal injection of HLX04-O with ranibizumab for treating wAMD [1] - The study results indicate that the average change in best-corrected visual acuity (BCVA) at week 48 for the HLX04-O group was non-inferior to that of the ranibizumab group, achieving the primary endpoint [1] - HLX04-O demonstrated good safety, with no new safety signals observed [1] Industry Summary - As of the announcement date, there are no approved products for wAMD in China that are based on bevacizumab [1] - According to the latest data from IQVIA CHPA, the sales revenue for drugs targeting wAMD in China is projected to be approximately RMB 4.9 billion in 2024 [1]

Core Viewpoint - The company, Fuhong Hanlin (02696), has received acceptance for its New Drug Application (NDA) for HLX04-O, a treatment for wet age-related macular degeneration (wAMD), from the National Medical Products Administration (NMPA) [1] Group 1 - The NDA for HLX04-O is based on a multicenter, randomized, double-blind, positive-controlled Phase III study comparing intravitreal injection (IVT) of HLX04-O with Ranibizumab for treating wAMD [1] - The study results indicate that the average change in Best Corrected Visual Acuity (BCVA) at week 48 for the HLX04-O group was non-inferior to that of the Ranibizumab group, achieving the primary endpoint of the study [1] - The safety profile of HLX04-O is favorable, with no new safety signals observed [1]

Core Viewpoint - The joint application for the market approval of HLX04-O, a recombinant anti-VEGF monoclonal antibody injection for the treatment of wet age-related macular degeneration (wAMD), has been submitted by Fuhong Hanlin and Edding Bio, marking the second such application for a bevacizumab ophthalmic formulation in China [1][2][3] Group 1: Product Development - HLX04-O is developed using genetic engineering technology and specifically binds to VEGF, inhibiting its interaction with receptors on endothelial cells, thereby reducing neovascularization associated with wAMD [1] - The drug has successfully met the primary endpoint in a Phase III clinical trial (NCT05003245) comparing its efficacy and safety against Ranibizumab in wAMD patients, showing non-inferiority in terms of best-corrected visual acuity improvement [2] - An international multi-center Phase III clinical study (NCT04740671) is also being conducted for HLX04-O, with participants recruited from China, Australia, the EU, and the US [2] Group 2: Market Context - Currently, there are no approved bevacizumab formulations for ophthalmic diseases in China, making HLX04-O the second reported application for such a drug after TAB014 [3]

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]