"临床研究表明，甲磺酸普雷福韦片在降低乙肝表面抗原水平方面表现突出，有助于提升临床治愈 比例，从而切实降低肝硬化、肝癌的长期发生风险。"新通药物副总经理刘世峰介绍，"我国慢性乙肝患 者数量庞大，疾病负担重。甲磺酸普雷福韦片进入国家医保药品目录后，将在市场上迅速放量，极大提 升药物可及性，让更多患者能用得上、用得起最新最前沿的治疗方案。" 12月7日，国家医保局、人力资源社会保障部公布《国家基本医疗保险、生育保险和工伤保险药品 目录（2025年）》，全国共有50种1类创新药进入目录。其中，由陕西省级上市后备企业西安新通药物 研究股份有限公司研发的甲磺酸普雷福韦片（商品名称：新舒沐）是全省唯一一个进入国家医保药品目 录的1类创新药，将于2026年1月1日起执行医保支付标准。 "陕西上市后备企业在资本市场的影响力将进一步扩大。"陕西资本市场服务中心相关负责人表示， 将持续完善对生物医药等战略性新兴产业上市后备企业的培育与服务机制，引导更多"耐心资本"助力本 土创新。（记者：孙丹） 1类创新药指未在国内外上市销售的药品，代表我国药品注册分类中药物创新的最高水平。长期以 来，临床一线乙肝治疗药主要为进口药和仿制药。甲磺 ...

Core Viewpoint - The report from the National Medical Products Administration (NMPA) indicates a significant increase in new drug clinical trial registrations in China, highlighting a growing trend in the pharmaceutical industry towards innovative therapies, particularly in cell and gene therapy, as well as pediatric drug development [1][2]. Summary by Sections Clinical Trial Registration Growth - In 2024, the number of new drug clinical trial registrations reached a record high of 4,900, marking a 13.9% increase from the previous year [1][2]. - The efficiency of initiating clinical trials has improved, with over 60% of trials obtaining the first informed consent within six months, and 70.2% for biological products [1]. Regional Concentration of Trials - The report notes a concentration of clinical trials in specific regions, with six areas having over 2,000 participating units, an increase from three regions the previous year. Guangdong Province led with 2,892 participations [3]. Focus on Metabolic Drugs - The competition in the development of metabolic drugs is intensifying, driven by the rising prevalence of sub-health populations, diabetes, and obesity. In 2024, 86 clinical trials for the top 10 chemical drugs were registered, accounting for 6.1% of the total [4]. Pediatric Drug Development - The number of clinical trials targeting pediatric populations has been increasing, with a focus on respiratory diseases, allergies, and preventive vaccines. The NMPA has established a special group for pediatric drug review to address the shortage of medications for children [9][10]. Rare Disease Drug Trials - Clinical trials for rare disease medications are also on the rise, with a stable focus on blood system diseases, neurological disorders, and anti-tumor drugs. In 2024, trials for blood system disease drugs accounted for nearly 30% of the total rare disease clinical trials [10]. Advances in Cell and Gene Therapy - There has been a notable increase in clinical trials for cell and gene therapy products, with the NMPA moving towards a more open regulatory environment for advanced therapies. This includes the potential inclusion of CAR-T and tumor vaccines as advanced treatment drugs [11].