In recent years, Cell & Gene Therapy (CGT) has been creating a strong wave worldwide. According to Precedence Research, the global CGT market size reached 16.71 billion US dollars in 2024, with a compound annual growth rate of 18.9%. It is expected to exceed 52 billion US dollars in 2031, demonstrating strong growth potential in the industry.

At present, China is accelerating its entry into core markets. Published in "Nature Reviews Drug Discovery" titled: the article "Trends in the development ofcellular and gene Therapy in China" clearly states that China's CGT research and development vitality continues to lead - as of the second quarter of 2025, CDE has cumulatively received 765 IND applications for CGT products. Among them, the three mainstream technologies of CAR-T cell therapy, stem cell therapy and gene therapy account for more than 70%, and in the past eight years, CAR-T cell therapy has become the main force in research and development with an absolute advantage.

Clinical Trial Application (IND) for CGT products

The distribution of IND applications for CGT products accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration from 2017 to the second quarter of 2025. Applications are classified into five major therapeutic categories: somatic cell therapy (including CAR-T, CAR-NK, TCR-T, other gene-modified immune cells, non-gene-modified immune cells and non-immune cell therapies); Stem cell therapy (including induced pluripotent stem cells [iPSCs], other stem cell sources and drug-device combination products); Oncolytic microorganisms (including oncolytic viruses and oncolytic bacteria) Gene therapy Therapeutic vaccines.

From the perspective of various CGT technology paths, CAR-T products have made the fastest overall progress: a total of 72 products are in the exploratory clinical trial stage, 15 are in the confirmatory clinical trial stage, and 7 are under review for new drug application (NDA).

Clinical transformation and market expansion are accelerating simultaneously: The drug regulatory authority has approved the marketing of 9 CGT drugs, including 7 CAR-T drugs, 1 conditionally approved stem cell therapy, and 1 fully approved gene therapy.

One conditionally approved stem cell therapy is Emmetaxel Injection, which was approved in January 2025 for the treatment of acute graft-versus-host disease (aGVHD, ≥2 lines).

The fully approved gene therapy is Xinjiu Ning for the treatment of hemophilia B (moderate to severe), which was approved in China in April 2025.

Recently, 121 innovative drugs, including 5 CAR-T models, have been included in the initial review list of the commercial insurance directory by the National Healthcare Security Administration, aiming to accelerate the release of CGT therapy vitality by optimizing payment methods. Based on this, China's CGT industry is expected to achieve a leapfrog development of innovative drugs through a full-chain acceleration channel of "research and development - approval - commercialization".