Core Viewpoint - The approval of the clinical trial application for GenSci142 capsules marks the first successful application under the newly launched "30-day channel" for innovative drug clinical trial review and approval in China, indicating a significant step in enhancing the efficiency of drug development processes [2][5]. Company Summary - Changchun High-tech's subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (Jinsai Pharmaceutical), received approval from the National Medical Products Administration (NMPA) for the clinical trial of GenSci142 capsules, a first-class innovative biological product aimed at treating bacterial vaginosis, a common infection among women of childbearing age [2][4]. - GenSci142 capsules utilize bioinformatics and AI to optimize molecular structure, effectively targeting and destroying the main pathogens of bacterial vaginosis while preserving beneficial lactobacilli, thus addressing a significant unmet clinical need [4]. Industry Summary - The introduction of the "30-day channel" is part of a broader reform in China's drug review and approval system, which aims to enhance the efficiency of clinical trial management and promote drug innovation. The average review time for drug clinical trials has been reduced to approximately 50 working days since the implementation of the 60-day implied approval in 2019 [5][6]. - The new policy encourages global synchronized research and international multi-center clinical trials, which may attract multinational pharmaceutical companies to conduct early-stage research in China and support local researchers in leading international projects [7]. - The policy also emphasizes the development of pediatric and rare disease drugs, incentivizing companies to address gaps in these therapeutic areas and expedite access to urgently needed new medications for patients [7].

创新药临床试验审评审批"30日通道"正式推出后，首个获批的新药临床试验申请出炉。 11月27日晚间，长春高新发布公告称，近日，公司子公司长春金赛药业有限责任公司（以下简称"金赛药业"）收到国家药品监督管理局核准签发的《药物临 床试验批准通知书》，金赛药业GenSci142胶囊注册临床试验申请获得批准。 根据公告，纳入30日通道的药物临床试验申请，应当为中药、化学药品、生物制品1类创新药临床试验，能够按要求提交申报资料，并需满足以下条件之 一：一是获国家全链条支持创新药发展政策体系支持的具有明显临床价值的重点创新药品种。二是国家药监局药品审评中心公布的符合条件的儿童创新药、 罕见病创新药，以及中药创新药品种。三是全球同步研发品种。具体指全球同步研发品种的Ⅰ期、Ⅱ期临床试验，我国药物临床试验机构的主要研究者牵头 或者共同牵头开展的Ⅲ期国际多中心临床试验。 公告显示，GenSci142胶囊是金赛药业开发的一款1类创新生物制品，拟用于细菌性阴道病的治疗。细菌性阴道病是育龄期女性中最常见的阴道感染性疾病之 一，存在巨大的临床未满足需求。目前，临床推荐药物主要为抗厌氧菌类抗生素，如硝基咪唑类（如甲硝唑、替硝唑）和克林霉素 ...

Core Viewpoint - The National Medical Products Administration (NMPA) has officially launched a 30-day review and approval channel for innovative drug clinical trials, aimed at accelerating the drug development process in China [1][3]. Group 1: Overview of the 30-Day Channel - The 30-day channel for clinical trial applications is designed for innovative drugs that meet specific criteria, including traditional Chinese medicine, chemical drugs, and biological products [3][4]. - The introduction of the 30-day channel follows the implementation of a 60-day implied approval system in 2019, which significantly improved the efficiency of clinical trial reviews [3][8]. - The NMPA aims to enhance the speed of clinical trials while maintaining high safety standards, ensuring that the review process does not compromise the quality of drug safety assessments [9][10]. Group 2: Conditions for Eligibility - To qualify for the 30-day channel, drug applications must demonstrate significant clinical value and can include pediatric drugs, rare disease drugs, and traditional Chinese medicine [4][5]. - The channel encourages global synchronized research, requiring that Phase III international multi-center clinical trials be primarily led by Chinese clinical trial institutions [4][5]. - Applicants must commit to initiating clinical trials within 12 weeks of approval, which emphasizes the need for efficient clinical operations [6][8]. Group 3: Impact on the Industry - China's innovative drug development is rapidly advancing, with over 20% of the global pipeline of new drugs currently under research [8]. - In the first half of 2025, the total amount of innovative drug licensing reached nearly $66 billion, reflecting growing international recognition of Chinese innovative drugs [8]. - The NMPA's ongoing reforms in the review and approval system have led to a significant increase in the number of approved innovative drugs, with 43 approvals in the first half of the year, marking a 59% year-on-year increase [8][9].