“30日通道”后首例获批！长春高新“尝鲜”，创新药临床试验审评审批提速

Core Viewpoint - Changchun Gaoxin's subsidiary, Jinsai Pharmaceutical, has received approval from the National Medical Products Administration for the clinical trial of GenSci142 capsules, a first-class innovative biological product aimed at treating bacterial vaginosis, addressing a significant unmet clinical need among women of childbearing age [1][4]. Group 1: Product Development - GenSci142 capsules are designed to selectively and rapidly kill the main pathogens of bacterial vaginosis while preserving protective lactobacilli, and they can penetrate and disrupt biofilms, reducing recurrence [4]. - The approval of the clinical trial for GenSci142 capsules marks the first new drug clinical trial application approved under the newly introduced "30-day channel" for innovative drug clinical trial reviews [5]. Group 2: Regulatory Environment - The National Medical Products Administration has optimized the clinical trial management system, significantly improving the efficiency of drug clinical trial reviews, with average review times reduced to about 50 working days [5]. - The new 30-day channel is designed for innovative drugs that meet specific criteria, including those with significant clinical value and those developed in sync with global research [6]. Group 3: Industry Impact - The policy changes are seen as a key measure for adapting pharmaceutical regulation to industry innovation, benefiting both large pharmaceutical companies and smaller innovative firms by enhancing the speed of clinical trial approvals [7]. - The encouragement of global synchronized research and international multi-center clinical trials is expected to attract multinational pharmaceutical companies to conduct early-stage research in China, integrating Chinese innovations into the global research framework [7].