美适亚是由保盛药业股份有限公司开发，金赛药业于2024年获得该产品在中国及新加坡独家经销和产品 上市许可持有人授权，目前已获批的适应症包括：用于治疗获得性免疫缺陷综合征患者的厌食症、用于 获得性免疫缺陷综合征患者及癌症患者恶病质引起的体重明显减轻。 长春高新(000661)12月8日晚公告，根据国家医保局及人社部发布的《国家基本医疗保险、生育保险和 工伤保险药品目录（2025年）》（下称"国家医保目录"），公司控股子公司长春金赛药业有限责任公司 （下称"金赛药业"）自主研发的金赛增（现通用名为"金培生长激素注射液"）、合作引进的美适亚（通 用名为"醋酸甲地孕酮口服混悬液"）被新纳入国家医保目录。 据介绍，金赛增是金赛药业于2014年1月获批上市的全球首创长效生长激素，目前获批的适应症包括： 用于内源性生长激素缺乏所引起的儿童生长缓慢（PGHD）、用于性腺发育不全（Turner）所致女孩的 生长障碍、用于特发性身材矮小（ISS）所致的生长迟缓，是国内唯一在PGHD之外有其他适应症的长 效生长激素产品，也是中国唯一具有超15万例真实世界数据验证具备长期疗效及安全性的长效生长激素 产品。目前，金赛增用于治疗成人生长 ...

Core Viewpoint - Changchun High-tech's subsidiary, Gensci Pharmaceutical, has two products, Jinsai Zeng and Meishiya, newly included in the National Medical Insurance Directory for 2025, indicating recognition of their clinical value and innovation by the National Healthcare Security Administration [1][2] Group 1: Product Information - Jinsai Zeng, a long-acting growth hormone, is the only product in China with multiple approved indications beyond pediatric growth hormone deficiency, supported by over 150,000 real-world data cases demonstrating long-term efficacy and safety [1] - Meishiya, developed by Bosheng Pharmaceutical, addresses clinical issues for patients with cachexia and has received direct recommendations in clinical guidelines, showcasing its innovative nano-technology [2] Group 2: Financial and Operational Impact - The inclusion of these products in the National Medical Insurance Directory is expected to enhance market promotion and sales scale, although the exact impact on the company's financial performance is currently unquantifiable [2] - Changchun High-tech's R&D expenses increased by 22.96% year-on-year to 1.733 billion yuan, reflecting the company's commitment to innovation and its transition towards becoming a global pharmaceutical leader [3]

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]

Group 1 - Baidu's Biotech Company, Bai'ao Saitou, is set to launch its IPO on the Sci-Tech Innovation Board, aiming to raise 1.185 billion yuan for early drug development services, antibody drug research, and working capital [1] - Changchun High-tech's subsidiary received approval for its clinical trial application for GenSci142 capsules, marking the first approval under the new 30-day review channel for innovative drugs [2] - Antu Bio announced it received 18 medical device registration certificates, enhancing its product offerings and competitiveness in the market [3] Group 2 - Yidu Tech reported a revenue of 358 million yuan for the six months ending September 30, 2025, reflecting an 8.7% year-on-year growth, with a narrowed loss of 15.76 million yuan [4] - Baiyunshan's subsidiary, Guanghua Pharmaceutical, will receive a total compensation of approximately 449 million yuan for land and fixed assets included in a land reserve program, which aligns with the company's long-term development goals [5]

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 ...

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。 值得一提的是，本次获批是《国家药监局关于优化创新药临床试验审评审批有关事项的公告》发布，即 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。 北京商报讯（记者丁宁）11月27日晚间，长春高新（000661）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。 （文章来源：北京商报） ...

长春高新(000661.SZ)公告，公司子公司长春金赛药业有限责任公司(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。据悉，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。 ...

长春高新公告称，子公司金赛药业收到国家药监局核准签发的《药物临床试验批准通知书》，其 GenSci142胶囊注册临床试验申请获批，适应症为细菌性阴道病。该胶囊是1类创新生物制品，是创新药 临床试验审评审批"30日通道"推出后首个获批的新药临床试验申请。它具有快速起效等优势，对甲硝唑 耐药感染依然有效。若临床试验进展顺利，将利于公司优化业务与产品结构。不过，临床试验进程存在 不确定性。 ...

长春高新11月27日公告， 子公司金赛药业的GenSci142胶囊注册临床试验申请获得国家药品监督管理局 批准。GenSci142胶囊是金赛药业开发的1类创新生物制品，拟用于治疗细菌性阴道病。此次获批是创新 药临床试验审评审批"30日通道"推出后的首个获批新药临床试验申请。 ...