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Jiuzhitang Maker Supports the Successful Concluding of the Cell Therapy Drug R&D and Regulatory Submission Seminar
2024-04-29
As the reform of the pharmaceutical regulatory system continues to advance, cell therapy products are increasingly being integrated into the pharmaceutical management framework. This policy direction provides a clear roadmap for the development of China's cell therapy industry.
As of now, China has achieved significant milestones: five immune cell therapy products have been approved for market launch, marking the country's advancement to an internationally leading level in the research, development, production, and regulation of immune cell therapies—and providing patients with innovative, highly effective treatment options.
Additionally, nearly 100 stem-cell-based drugs have already received implicit approval from regulatory authorities and have entered the clinical trial phase, highlighting the robustness and dynamism of China's stem-cell drug development pipeline. This signals that China's stem-cell therapy industry is poised to unlock unprecedented growth opportunities in the near future.
A Feast of Knowledge / Gathering of Industry Leaders
Recently, the Cell Drug R&D and Regulatory Submission Workshop, hosted by the China Association of Medical Biotechnology and co-organized by Jiuzhitang Maker (Beijing) Cell Technology Co., Ltd. (hereafter referred to as "Jiuzhitang Maker"), was successfully held in Beijing from April 25 to 26, 2024. The conference focused on the path to drug development and regulatory strategies for cell therapy products, aiming to enhance industry professionals' capabilities and success rates in drug submissions, thereby effectively advancing the efficient and standardized growth of China's cell therapy sector.
The conference brought together quality leaders, production managers, R&D heads, and drug registration specialists from the biopharmaceutical industry, along with numerous professionals involved in product development, manufacturing, quality control, and other related fields. Together, they engaged in in-depth discussions on cutting-edge cell therapy technologies, regulatory insights, and detailed case studies—sharing invaluable knowledge and collaboratively shaping the future of the industry.
Major Share / Insightful Perspectives
As a key co-organizer of this conference, Jiuzhitang Maker fully demonstrated its deep expertise and significant industry influence in the field of stem cell therapy.
Dr. Gao Yansong, General Manager of Jiuzhitang Maker, delivered a keynote speech titled "Key Considerations in Developing Cell Therapy Products According to Pharmacopoeia Standards," offering an in-depth analysis of Mesoblast, the global biopharmaceutical giant, covering its market launch journey, manufacturing processes, quality control measures, and its flagship product, Remestemcel-L. The presentation aimed to distill valuable lessons and insights, providing meaningful guidance for stem cell companies in China as they advance their own R&D efforts.
Dr. Gao Yansong’s analysis not only focuses on Mesoblast’s practical experiences and reflections in areas such as production process optimization, quality control, pharmacological mechanism research, and potency-testing methodologies, but also underscores the critical importance of key steps like enhancing scalable expansion capabilities, implementing early-stage process improvements, designing scientifically rigorous clinical trials, and developing products rooted in well-defined mechanisms of action. Dr. Gao’s insights provide stem-cell companies with comprehensive, actionable industry perspectives, offering clear and viable pathways for these enterprises to elevate R&D quality, refine manufacturing processes, and ensure product compliance—thereby accelerating the steady progress of China’s stem-cell industry toward a future characterized by scientific rigor, regulatory excellence, and operational efficiency.
Ms. Wang Lin, Deputy General Manager of Jiuzhitang Maker, delivered a presentation titled "Analysis of Common Issues in IND Applications for Cell Product Registration." She shared her extensive experience and insightful perspectives in the field of cell therapy drug registration.
During her speech, General Manager Wang provided an in-depth analysis of various potential issues that may arise during the current stem cell drug registration process. She systematically addressed key aspects such as regulatory interpretation, data preparation, and communication strategies, offering attendees a comprehensive and practical checklist of problem-solving solutions. Her insights not only helped participating companies avoid potential risks in the submission process but also significantly enhanced the industry's overall awareness of compliance and operational excellence in IND applications, laying a solid foundation for promoting standardized and efficient registration of stem cell-based therapeutic products.
Staying true to our original aspirations / Upholding industry responsibility
Jiuzhitang Maker actively participated in and strongly supported this seminar, showcasing its commitment to corporate social responsibility as it strives to advance the cell therapy industry. , further solidifying the company's expert position and brand influence in this field.
Through the expert insights shared by two senior executives, Jiuzhitang Maker not only showcased its strong expertise and impressive achievements in stem-cell drug R&D and regulatory submissions to the industry, but also provided valuable learning resources and practical guidance for attendees, effectively accelerating the industry’s progress toward greater standardization.
The successful convening of this conference comes at a critical juncture as China continues to deepen its pharmaceutical regulatory reforms, cell therapy products have received approval for market launch, clinical trials of 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 robust momentum in the research, development, and regulatory submission 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, working hand-in-hand with industry partners to jointly usher in a new chapter for China’s cell therapy sector.
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