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2025-01-03
Big news! China's first stem-cell therapy drug approved for market.
The approval of "Amy Maitosai" marks a significant milestone in China’s stem-cell therapy field. This breakthrough not only offers hope to patients who urgently need effective treatment options but also represents an important step forward for China’s stem-cell therapies in both clinical application and commercialization.
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2025-01-02
Mesoblast's Lesson: Can Chinese Stem-Cell Companies Rise to the Challenge?
Jiuzhitang Maker aims to leverage its CQDMO service platform to provide stem cell companies not only with GMP-compliant facilities, a dedicated team of experts, and a robust quality management system that meets both Chinese and U.S. regulatory requirements, but also with expert guidance rooted in its own extensive experience—ranging from developing tailored production strategies and refining quality-control methodologies to preparing comprehensive registration dossiers. Together with industry peers, Jiuzhitang Maker is committed to advancing collaboration, fostering mutual success, and collectively driving the growth and innovation of China’s stem cell sector.
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2024-12-20
Milestone Event: Mesoblast’s stem-cell drug receives FDA approval for market launch
This is not only a victory for Mesoblast—but a milestone for the entire stem cell industry. It inspires Jiuzhitang Maker and stem cell R&D companies around the globe to keep pushing forward, collectively advancing the development of stem cell therapies and contributing even more to the cause of human health.
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2024-11-27
The kickoff meeting for the Jiuzhitang MakerWMS system project was successfully held.
In his concluding remarks, Zhang Quancheng, Chairman of Jiuzhitang Maker, emphasized that this project is of great significance, set to profoundly impact Meike's digital transformation, quality management system, and overall enterprise governance, while also accelerating the digitalization process across the entire Jiuzhitang ecosystem. He urged both teams to adhere rigorously to the planned timeline, ensure meticulous implementation, enhance operational efficiency, and guarantee the project’s practicality—while simultaneously laying a solid foundation for future initiatives, such as the construction of Phase II facilities.
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2024-11-19
Support eligible medical and healthcare institutions in strengthening innovation in cutting-edge technologies, and in conducting clinical research involving stem cells, somatic cells, and more. Strive to pilot the use of internationally approved drugs and medical devices—available abroad but not yet in China—at leading medical centers. Additionally, work toward officially incorporating cell and gene therapies that meet medical technology access criteria into standardized healthcare service pricing frameworks as per regulations.
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2024-10-22
Jiuzhitang Maker’s “Mesenchymal Stem Cell Drug Development Project” advanced through multiple rounds of competition in the regional qualifiers and successfully earned a spot in this year’s global finals. Standing out with its cutting-edge, innovative technology, the project was awarded the Champion Prize in the Angel Growth Category.
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2024-08-01
Recently, the Shanghai Municipal Government released the "Several Opinions on Supporting Innovation and Development Across the Entire Biopharmaceutical Industry Chain," aiming to comprehensively boost innovation and growth in the biopharmaceutical sector through a series of targeted policy measures. The policy covers eight key areas—research and development, clinical trials, regulatory review and approval, application promotion, industrialization implementation, investment and financing, data resources, and internationalization—and includes 37 specific initiatives.
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2024-07-18
The "Notice" clearly states: Foreign-invested enterprises are encouraged to conduct clinical trials in Shenzhen, in accordance with the law, for cell and gene therapy drugs already approved for marketing overseas, and to establish an International Clinical Trial Center in the Guangdong-Hong Kong-Macao Greater Bay Area. Qualified foreign-invested enterprises will also be permitted to participate in pilot programs aimed at further opening up sectors such as gene diagnostics and therapeutic technology development and application.
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