格隆汇12月8日丨先声药业(02096.HK)宣布，2025年12月7日，恩泽舒®(注射用苏维西塔单抗)已被正式 纳入由国家医保局及人力资源社会保障部印发的《国家基本医疗保险、工伤保险和生育保险药品目录 (2025年)》，并将自2026年1月1日起生效。此外，恩度®(重组人血管内皮抑制素注射液)亦顺利完成国 家医保药品目录("NRDL")续约。 ...

先声药业（02096）发布公告，于2025年12月7日，恩泽舒®（注射用苏维西塔单抗）已被正式纳入由国 家医保局及人力资源社会保障部印发的《国家基本医疗保险、工伤保险和生育保险药品目录（2025 年）》，并将自2026年1月1日起生效。此外，恩度® （重组人血管内皮抑制素注射液）亦顺利完成国 家医保药品目录（NRDL）续约。 恩泽舒®是新一代重组人源化抗血管内皮生长因子（VEGF）单克隆抗体，于2025年6月30日在中国获批 上市。恩泽舒®联合紫杉醇、多柔比星脂质体或拓扑替康用于铂耐药后接受过不超过1种系统治疗的成 人复发性卵巢癌、输卵管癌或原发性腹膜癌的治疗。 恩度®是中国第一个抗血管生成靶向药及全球唯一获准销售的内皮抑制素，自2017年起被纳入NRDL以 来，已成为晚期非小细胞肺癌治疗的基石用药之一。 恩泽舒®是新一代重组人源化抗血管内皮生长因子（VEGF）单克隆抗体，于2025年6月30日在中国获批 上市。恩泽舒®联合紫杉醇、多柔比星脂质体或拓扑替康用于铂耐药后接受过不超过1种系统治疗的成 人复发性卵巢癌、输卵管癌或原发性腹膜癌的治疗。 恩度®是中国第一个抗血管生成靶向药及全球唯一获准销售的内皮抑制素， ...

Core Insights - The company reported a revenue of 3.585 billion yuan for the first half of 2025, representing a year-on-year growth of 15.1%, with a net profit attributable to shareholders of 604 million yuan, up 32.2% year-on-year [1] - The innovative drug business was a significant growth driver, generating 2.776 billion yuan in revenue, a 26.0% increase, accounting for 77.4% of total revenue [1] Revenue Breakdown - The neuroscience segment generated 1.249 billion yuan, accounting for 34.8% of total revenue, with a year-on-year growth of 37.3% [2] - The oncology segment reported revenue of 874 million yuan, making up 24.4% of total revenue, with a growth of 41.1% [2] - The autoimmune segment achieved revenue of 878 million yuan, representing 24.5% of total revenue, with a modest growth of 3.3% [2] Product Highlights - The strong growth in the neuroscience field is attributed to the continued expansion of the product Xianbixin® in the stroke injection market, which has captured approximately 29% market share [2] - The oncology segment features several key products, including Endu® and Envida®, which are recommended in multiple clinical practice guidelines [3] - The autoimmune segment's leading product, Aidesin®, has benefited over 1 million patients since its launch in 2012 [3] R&D Investment - The company increased its R&D investment to 1.028 billion yuan, a 68.0% increase year-on-year, representing 28.7% of total revenue [4] - Over the past decade, cumulative R&D investment has exceeded 10 billion yuan, supporting ongoing innovation [4] - The company has ten approved innovative drugs and over 60 projects in its pipeline [4] Strategic Collaborations - The company has established strategic partnerships with various international firms, enhancing its R&D pipeline and international presence [6] - Notable collaborations include licensing agreements with AbbVie and NextCure for innovative drug candidates [6] Marketing and Financial Health - The company has a comprehensive marketing network with approximately 4,179 personnel across China, covering over 3,000 tertiary hospitals and 17,000 other medical institutions [7] - As of June 30, 2025, the company reported cash and cash equivalents of 2.671 billion yuan, with a net operating cash flow of 867 million yuan [7] Industry Environment - The Chinese pharmaceutical industry is experiencing favorable policy changes that support innovative drug development, including expedited review processes [8] - The company aims to expand its market share and improve drug accessibility through its strong R&D capabilities and commercial strategies [8]

Core Insights - The approval of Enzeshou® (suvorexant injection) by the National Medical Products Administration (NMPA) in China marks a significant advancement in the treatment of platinum-resistant ovarian cancer, providing a much-needed therapeutic option for patients who have undergone limited prior systemic treatment [1][2] - Enzeshou® is a next-generation recombinant humanized monoclonal antibody targeting vascular endothelial growth factor (VEGF), demonstrating superior efficacy compared to existing treatments like Bevacizumab in preclinical studies [2] Group 1: Drug Approval and Indications - Enzeshou® received approval on June 30, 2025, for use in adult patients with recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who are platinum-resistant and have received no more than one prior systemic therapy [1] - The drug addresses a significant unmet clinical need in China, as there are currently no approved anti-angiogenic therapies for platinum-resistant ovarian cancer, particularly for patients previously treated with anti-angiogenic therapies [1] Group 2: Clinical Efficacy - The Phase III clinical trial (SCORES study) demonstrated significant improvements in progression-free survival (PFS), with median PFS extending from 2.73 months to 5.49 months, and a hazard ratio (HR) of 0.46 (0.35, 0.60), with a p-value of less than 0.0001 [2] - The trial also indicated a 23% reduction in the risk of death for the treatment group compared to the control group, with an overall survival (OS) hazard ratio of 0.77 and a p-value of 0.0304, marking Enzeshou® as the first vascular-targeted drug to show significant OS benefits in the platinum-resistant ovarian cancer population [2]