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.

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.

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.

2024-11-19

Sichuan Free Trade Zone: Striving to convert cell and gene therapies that meet medical technology access standards into approved healthcare service pricing items as per regulations.

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.

2024-10-22

Warmly celebrating Jiuzhitang Maker for winning the Grand Prize at the Tsinghua Alumni Global Finals in Health and Medical Innovation!

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.

2024-08-01

Shanghai provides comprehensive, end-to-end support for biopharmaceutical development, with each entity eligible to receive cumulative annual funding of up to 100 million yuan.

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.

2024-07-18

Shenzhen expands openness! Foreign companies are encouraged to conduct clinical trials in Shenzhen—on the basis of the law—for cell and gene therapy drugs already approved for marketing overseas.

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.

2024-06-27

People's Daily reports: Cell therapy propels the treatment of complex and critical illnesses into a new era.

Recently, China Economic Weekly, the official and authoritative platform of the People's Daily, published an article titled "Cell Therapy Ushers in a New Era for Treating Complex and Intractable Diseases." The article clearly highlights that, thanks to continuous scientific breakthroughs and innovation, modern medicine is undergoing a historic transformation—from relying on traditional treatment methods toward more advanced, cutting-edge cell therapies—marking a critical step forward in humanity's fight against challenging and complex illnesses.

2024-06-18

Mesoblast's Ups and Downs: Part 1

Stem cell drugs represent a new class of medications that go beyond traditional small-molecule drugs, featuring complex products with multiple active properties. For any stem cell pharmaceutical company aiming to gain approval from regulatory authorities and secure market authorization for its stem cell therapies, it’s crucial to address the specific concerns raised by the FDA regarding Mesoblast—particularly in areas such as quality stability, pharmacodynamic studies, and clinical efficacy—and provide robust, data-driven evidence to support these claims.