2025 年 9 月 4 日 公司研究 产品矩阵强大丰富，多款后期临床项目取得重要里程碑 ——信达生物（1801.HK）2025 年半年报点评 买入（维持） 当前价：107.00 港元 作者 分析师：王明瑞 执业证书编号：S0930520080004 021-52523867 wangmingrui@ebscn.com 分析师：张瀚予 执业证书编号：S0930523070010 021-52523861 zhanghanyu@ebscn.com 资料来源：Wind 相关研报 替妥尤单抗注射液上市申请获得受理，商业 化前景可期——信达生物（1801.HK）公告 点评（2024-05-23） 要点 事件： 公司发布 2025 年半年报，2025H1 实现营业收入 59.53 亿元，同比+50.6%。其中 产品销售收入为 52.34 亿元，同比+37.3%，授权费收入为 6.66 亿元；净利润为 8.34 亿元，去年同期为净亏损 3.93 亿元，实现转亏为盈。 | 市场数据 | | | --- | --- | | 总股本(亿股) | 17.13 | | 总市值(亿港元)： | 1833 | | 一年最低/最高(港元 ...

Core Viewpoint - The National Medical Products Administration (NMPA) has announced a new policy to expedite the clinical trial approval process for innovative drugs, reducing the review time to 30 working days, which represents a 50% acceleration in the approval process [1][2]. Group 1: Policy Changes and Impacts - The new policy aims to prioritize resources for innovative drugs that have significant clinical value, ensuring that only those meeting specific criteria can access the expedited review process [2][4]. - In 2024, the NMPA approved 48 Class 1 innovative drugs, a 20% increase year-on-year, marking the highest number in five years, with over 70% of these approvals achieved through accelerated pathways [2][3]. - The approval of 39 global new drugs in China from January to May 2024, with 34 being domestic innovations, highlights the vibrant growth of China's pharmaceutical innovation [3]. Group 2: Historical Context and Future Outlook - Prior to 2015, the domestic pharmaceutical market primarily followed a model of imitative innovation, with new drugs typically taking 5-7 years longer to launch in China compared to overseas [4]. - The establishment of rapid review channels and the acceleration of key national research projects are expected to enhance China's competitiveness in global pharmaceutical innovation [4][5]. - The recent establishment of review centers in regions like the Yangtze River Delta and the Greater Bay Area aims to improve regulatory efficiency and support the rapid approval of innovative drugs [5]. Group 3: Global Trends - The FDA has also introduced a new priority review program, reducing its approval timeline from approximately 10-12 months to 1-2 months, indicating a global trend towards faster clinical review processes [5].