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.

2024-05-24

Beijing unveils new plan: deploying "nuclear-level" initiatives in cutting-edge technology fields such as cell and gene therapy, and synthetic biology.

On May 23, the General Office of the Beijing Municipal People's Government issued the "Beijing Action Plan for Accelerating Collaborative Innovation in Pharmaceuticals and Health (2024–2026)." The plan highlights the deployment of specialized "nuclear-level initiatives" in cutting-edge technology areas such as cell and gene therapy, brain-computer interfaces, and synthetic biology—aimed at fostering groundbreaking, transformative scientific discoveries and technological breakthroughs.

2024-04-29

Jiuzhitang Maker Supports the Successful Concluding of the Cell Therapy Drug R&D and Regulatory Submission Seminar

The successful convening of this conference comes at a pivotal moment as China continues to deepen its pharmaceutical regulatory reforms, cell therapy products have received approval for market launch, clinical trials for stem-cell-based drugs are in full swing, and numerous companies are actively preparing to submit applications for innovative cell therapies. This milestone underscores Jiuzhitang Maker's position as a leading player in the cell therapy industry, leveraging its exceptional technological expertise, extensive practical experience, and commitment to open collaboration—qualities that are now driving forward the research, development, and regulatory submissions of cell-based medicines in China. In doing so, Jiuzhitang Maker is making significant contributions toward building a healthy, well-organized, and innovation-driven ecosystem for cell therapy. Looking ahead, Jiuzhitang Maker remains steadfast in its mission, partnering closely with industry peers to jointly usher in a new chapter for China’s cell therapy sector.

2024-04-10

Guangzhou Unveils New Policies for the Biopharmaceutical Industry—Offering Up to 100 Million Yuan in Support!

On April 7, 2024, the Guangzhou Development Zone Management Committee and the People's Government of Huangpu District, Guangzhou, jointly issued the "Measures to Promote High-Quality Development of the Biopharmaceutical Industry in Guangzhou Development Zone (Huangpu District)." The measures clearly state that innovative drugs or improved new drugs completing Phase I, II, and III clinical trials will receive subsidies of up to RMB 10 million, RMB 20 million, and RMB 30 million, respectively. Additionally, companies that secure a New Drug Certificate or registration approval will be granted a one-time subsidy of RMB 10 million. Combined with existing municipal policies, this comprehensive support could enable a single company to receive up to approximately RMB 100 million for bringing a new drug to market—a level of assistance that ranks among the highest in China.

2024-04-08

Jiuzhitang Maker's Quality Control Department has been awarded the accreditation certificate by the China National Accreditation Service for Conformity Assessment (CNAS).

Recently, Jiuzhitang Maker (Beijing) Cell Technology Co., Ltd. (hereinafter referred to as "Jiuzhitang Maker") announced exciting news: after a rigorous professional evaluation, the company's Quality Control Department has successfully obtained the accreditation certificate (registration number CNAS L20479) issued by the China National Accreditation Service for Conformity Assessment (CNAS).

2024-03-29

Jiuzhitang Maker's Quality Control Department has been awarded the accreditation certificate by the China National Accreditation Service for Conformity Assessment (CNAS).

Jiuzhitang Maker's Quality Control Department has been awarded the accreditation certificate by the China National Accreditation Service for Conformity Assessment (CNAS).

2024-03-22

You're invited to the Seminar on Cell-Based Drug Development and Regulatory Submission

The Cell Drug R&D and Regulatory Submission Workshop, hosted by the China Association for Medical Biotechnology and co-organized by Jiuzhitang Maker (Beijing) Cell Technology Co., Ltd., will be officially held in Beijing on April 25–26, 2024. The workshop will feature industry experts who will share insights into the development journey and regulatory pathways for bringing cell therapy products to market—providing invaluable guidance to help more cell therapy companies enhance their drug-approval capabilities and boost success rates, ultimately driving the efficient and standardized growth of the cell therapy industry.

2024-02-26

Clinical Recruitment: 45 Patients with Ischemic Stroke

China's first Phase I/IIa clinical trial (ASSIST) for treating ischemic stroke using imported stem cells, led by Jiuzhitang Maker, is now recruiting 45 voluntary participants who have experienced ischemic stroke to join the Phase IIa study.