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人骨髓间充质干细胞注射液
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九芝堂:控股子公司启动孤独症干细胞新药临床试验
Zhong Zheng Wang· 2025-08-27 07:37
中证报中证网讯(王珞)九芝堂(000989)8月26日晚间公告,公司控股子公司九芝堂美科(北京)细胞技术 有限公司(简称:北京美科)研发的新药人骨髓间充质干细胞注射液项目在临床试验牵头单位首都医科大 学附属北京安定医院通过伦理委员会审查。北京美科与北京安定医院认为已经具备启动临床试验的条 件,于2025年8月26日召开临床试验启动会。这标志着该产品正式进入临床试验阶段。 启动孤独症干细胞新药临床试验 此前,九芝堂公告,人骨髓间充质干细胞注射液获得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》,同意开展治疗孤独症的临床试验。 公告显示,人骨髓间充质干细胞(hBMMSC)注射液,其按照1类新药注册,药品注册分类属于治疗用生 物制品。药品申请适应症为孤独症谱系障碍(ASD)。本次临床试验所用干细胞产品为人骨髓间充质干细 胞(hBMMSC)注射液,由北京美科独立开发生产。 据介绍,孤独症谱系障碍(Autism Spectrum Disorder,简称ASD),又称自闭症,是一种复杂的神经发育 障碍,通常在儿童早期显现,特征为社交沟通困难、重复性行为及兴趣狭窄。目前,国内尚无批准的以 ASD为适应症的药物。 ...
“中国药谷”领航生命健康“兴”力量
Core Viewpoint - The Daxing Biomedical Industry Base, known as "China Pharmaceutical Valley," is accelerating its development in the life and health industry, aiming for high-quality growth and international influence by 2025 [1][3][13]. Group 1: Industry Development - The life and health industry is a strategic emerging industry crucial for national security and public welfare, with Daxing District being a key area for its development in Beijing [3][4]. - The Daxing Biomedical Industry Base has expanded by 9.1 square kilometers, enhancing its capacity for industrial research and production, as well as supporting services [4]. - The base is set to strengthen its core industries, including vaccines, traditional Chinese medicine, and high-end medical devices, while also exploring new sectors like medical aesthetics and animal pharmaceuticals [7][13]. Group 2: Project Initiatives - Several high-impact biomedical projects are set to be established in the Daxing Biomedical Industry Base, including innovative drug development and antibody production [6]. - The second phase of the China Food and Drug Inspection Institute's project has commenced, significantly boosting the region's research and testing capabilities [5]. - The base is actively promoting the construction of a new campus for Capital Medical University, which will enhance research innovation and industry integration [4]. Group 3: Technological Integration - The Daxing Biomedical Industry Base is leveraging big data and artificial intelligence to enhance its service and digital capabilities across various sectors [8][10]. - The base is transitioning from a product-oriented approach to a service-oriented model, exemplified by the establishment of a new retail consumption model by Tongrentang Health [8]. - Advanced AI technologies are being integrated into drug research and development, marking a significant shift towards innovative pharmaceutical solutions [10]. Group 4: Policy and Support - The Daxing Biomedical Industry Base is implementing a "one-stop service platform" to optimize the business environment and support enterprises in accessing various policy benefits [12]. - The base has facilitated the application of over 50 projects for national and municipal policy support, enhancing the operational capabilities of more than 30 enterprises [12]. - The base is committed to fostering a collaborative ecosystem by establishing shared platforms for high-value instruments and equipment among research institutions [11].
九芝堂完成“摘帽” 积极打造业绩增长点
Zhong Zheng Wang· 2025-05-07 02:36
Group 1: Company Performance and Financials - In 2024, the company achieved operating revenue of 2.371 billion yuan and a net profit attributable to shareholders of 216 million yuan, with cash flow from operating activities increasing by 83.14% to 199 million yuan [2] - The company aims to maintain high-quality development despite challenges from rising raw material prices, focusing on product-centric strategies and diversifying its product portfolio [2][3] Group 2: Innovation and R&D - The company is actively developing its stem cell research, with ongoing clinical trials for treatments related to ischemic stroke and autoimmune diseases, having enrolled 31 and 8 participants respectively [3] - A GMP-compliant stem cell R&D production base has been established, meeting both Chinese and U.S. drug application standards, and the company has received CNAS certification [3] Group 3: Shareholder Returns - The company announced a cash dividend of 3 yuan per 10 shares for the 2024 fiscal year, with the dividend record date on May 7 and payment on May 8 [4] - Cumulatively, the company has distributed over 4 billion yuan in dividends since its listing [5] Group 4: Corporate Governance - In January, the company underwent a change in control, with the Heilongjiang Provincial State-owned Assets Supervision and Administration Commission becoming the new actual controller, which is expected to enhance operational efficiency and market competitiveness [6]