/The first stem cell therapy drug is approved, experts in the industry discuss the future of the cell therapy industry

NEWS

The first stem cell therapy drug is approved, experts in the industry discuss the future of the cell therapy industry

NanHua Bio-medicine CO.,Ltd

2025/02/27

Category: Industry Information
Author:
Source:
Release time: 2025-02-27 09:50
Number of visits:

Category: Industry Information
Author:
Source:
Release time: 2025-02-27 09:50
Number of visits:

Details

On January 2, 2025, the National Medical Products Administration (NMPA) officially approved the listing of my country's first stem cell therapy drug - Amymetose injection for the treatment of acute graft-versus-host disease (aGVHD) that fails hormone therapy in patients over 14 years old with mainly gastrointestinal involvement. This marks a historic breakthrough in the field of stem cell therapy in China. In order to gain a deeper understanding of the impact of this incident on the industry and future development trends, Sina.com reporters comprehensively interviewed a number of key industry figures, including experts, entrepreneurs and policymakers in the field of stem cells.

Analysis by industry experts

Zhuang Fengfeng, vice president of the Biotechnology Branch of the China Association for the Promotion of Anti-Aging, said: "The launch of Amymetose Injection is a historic event in the field of stem cell therapy. It not only provides patients with new treatment options, but also sets a new benchmark for the entire industry. The unification of stem cell technology evaluation standards is crucial. The approval of the first stem cell therapy drug not only proves that its preparation and production process strictly follows established standards, but also sets an example and provides valuable reference for subsequent similar products on the market."

Zhuang Fengfeng also pointed out that stem cell technology has broad application prospects in the medical field. It has not only made breakthroughs in the treatment of acute graft-versus-host disease, but also shown great potential in many fields such as cancer, cardiovascular diseases, and neurological diseases. In the next few years, with the continuous advancement of technology and the gradual standardization of policies, it is expected that more stem cell drugs will be approved for marketing.

Viewpoints from representatives of the business community

Chen Xiaoying, chairman of Platinum Biotech (Beijing) Co., Ltd., said in an interview: "The launch of Amymetose Injection is the result of the company's years of research and development efforts. We are very proud to bring new treatment hope to patients. During the development of this drug, we overcame many technical difficulties and deeply realized the huge potential and challenges of stem cell technology. In the future, we will continue to increase investment in research and development and promote the development and launch of more stem cell drugs."

You Changqiao, director and general manager of NanHua Bio-medicine CO., Ltd (000504), the only state-owned company listed on the main board of the stem cell, immune cell and tissue engineering industry in China, also shared his views: "The launch of Amymetose injection is a huge encouragement to the entire stem cell industry. NanHua Bio-medicine CO.,Ltd has been committed to the research and application of stem cells and regenerative medicine, and we are pleased to see breakthroughs in this field. The successful launch of Amymetose injection not only provides new treatment options for patients, but also points the way for the future development of the stem cell industry. NanHua Bio-medicine CO.,Ltd will continue to increase investment in scientific research, strengthen cooperation with domestic and foreign research institutions, and promote the innovation and application of stem cell technology." You Changqiao also mentioned that NanHua Bio-medicine CO., Ltd. not only has a complete stem cell storage and research and development platform, but in the field of stem cell exosome technology, it has taken the lead in undertaking scientific research projects at or above the provincial level such as the 2020 Provincial Science and Technology Plan Project, the 2024 Provincial Doctoral Innovation Station Construction Project, and the 2024 Provincial Key R&D Plan Project. It has achieved a series of scientific research results and technological breakthroughs in application fields such as the treatment of lung injury and neonatal acute respiratory distress syndrome with stem cell exosomes, and the treatment of encephalopathy with engineered exosomes targeting neuroinflammation.

policy maker voice

Wang Tao, deputy director of the Drug Evaluation Center of the State Food and Drug Administration, said in an interview: "The launch of Amimetose injection is an important milestone in the field of stem cell therapy. The State Food and Drug Administration has always been committed to promoting the innovation and development of the biomedical industry, and we are very happy to see breakthroughs in this field. In the future, we will continue to improve relevant policies and regulations, increase supervision, and ensure the safety and effectiveness of stem cell drugs. At the same time, we will also actively support the innovation and application of stem cell technology and promote the sustainable and healthy development of the biomedical industry."

Conclusion

The launch of Amytocer injection marks a historic breakthrough in the field of stem cell therapy in China. This event not only brought new treatment hope to patients, but also set a new benchmark for the entire industry. In the future, with the continuous advancement of technology and the gradual standardization of policies, it is expected that more stem cell drugs will be approved for marketing and make greater contributions to human health.

Previous: Hunan Daily丨Seize the "window period" and trigger a "new hot spot"! In the cell industry, Hunan is accelerating its efforts! Next: China’s “Nobel Prize” awarded to Deng Hongkui, director of Peking University Stem Cell Research Center