“30日通道”首单落地 长春高新用时36天抢跑创新药赛道

Core Viewpoint - Changchun High-tech's subsidiary, Jinsai Pharmaceutical, received approval for the clinical trial of GenSci142 capsules, marking the first new drug clinical trial application approved under the newly introduced "30-day channel" for innovative drug clinical trials in China [1][2] Group 1: Regulatory Changes - The National Medical Products Administration (NMPA) implemented a 60-day implied approval system in 2019, reducing the review cycle to approximately 50 working days, which accelerated the development of innovative drugs in China [2] - The introduction of the "30-day channel" aims to meet clinical needs and enhance the international competitiveness of China's innovative drugs, allowing eligible clinical trial applications to be reviewed within 30 working days [2] Group 2: Product Details - GenSci142 capsules are a first-class innovative biological product developed by Jinsai Pharmaceutical, intended for the treatment of bacterial vaginosis (BV), a common vaginal infection among women of childbearing age [3] - The existing treatments for BV rely on antibiotics like metronidazole, which have high resistance rates (up to 90%) and high recurrence rates, highlighting the need for new solutions [3] Group 3: R&D Investment and Strategy - Changchun High-tech has significantly increased its R&D investment, with R&D expenses reaching 1.733 billion yuan in the first three quarters of 2025, supporting a rich pipeline of innovative products [3] - The company is leveraging AI technology throughout its R&D process, enhancing efficiency from target discovery to clinical trial design, which provides a competitive edge in the innovative drug development race [4] - The company aims to build a diversified product matrix and focuses on developing innovative drugs in areas such as endocrine metabolism, immunity, oncology, and women's health [4]