China's Cell and Gene Therapy Market Rapidly Expands with Clinical Trial Registrations Surging Nearly 30% in 2025

　　【Pharmaceutical Network Market Analysis] In recent years, the market for cell and gene therapy drugs in China has been expanding rapidly. According to the "Annual Report on the Progress of Clinical Trials for New Drug Registration in China (2025)" released by the Center for Drug Evaluation of the National Medical Products Administration, a total of 149 clinical trials for cell and gene therapy drugs were registered in 2025, representing a 29.6% increase compared to 2024. These trials involved 131 drug products, including 81 cell therapy products (61.8%) and 50 gene therapy products (38.2%). In terms of the number of clinical trials, the 81 cell therapy products accounted for 97 registered trials (65.1%), while the 50 gene therapy products accounted for 52 registered trials (34.9%).
 

From the perspective of indications, cell and gene therapy drugs are predominantly focused on oncology, with a total of 57 registrations (38.3%), followed by drugs for neurological disorders and those for dermatological and ENT (ear, nose, and throat) conditions. By category, the top three indications for cell therapies are oncology, neurological disorders, and hematological disorders; whereas for gene therapies, the top three indications are oncology, dermatological and ENT conditions, and gynecological and neurological disorders.
 

With the rapid rise of cell and gene therapy drugs, a number of outstanding companies have emerged in China. For example, CARsgen Therapeutics focuses on developing innovative CAR-T cell therapies for indications including, but not limited to, hematologic malignancies, solid tumors, and autoimmune diseases. In February 2024, its CAR-T cell product, Saikaze® (zelvorabtagene autoleucel injection), was approved for marketing in China.
 

On June 22, the National Medical Products Administration (NMPA) announced that it had approved, through the priority review and approval pathway, the market launch of Suripucel Injection (brand name: Kailimei), submitted by Kaixing Life Sciences (Shanghai) Co., Ltd., a subsidiary of CARsgen Therapeutics. This is the first CAR-T cell therapy product approved for the treatment of solid tumors, specifically indicated for advanced gastric or gastroesophageal junction adenocarcinoma that is CLDN18.2-positive, HER2-negative, and has progressed after at least two prior lines of therapy. Industry experts note that more than a decade after the advent of CAR-T therapy, the over ten globally marketed products have remained confined to the field of hematologic malignancies, leaving solid tumors—which account for approximately 90% of all malignant cancers—as an untouched “forbidden zone” for CAR-T therapies. The breakthrough achieved by CARsgen Therapeutics marks a leapfrog advancement for China in the frontier field of cell and gene therapy (CGT).
 

HuaDao CAR-Tcell has continued to achieve breakthroughs in the CAR-T field. On April 30, the Center for Drug Evaluation of the National Medical Products Administration announced that the marketing application for HuaDao’s first Class 1 innovative drug—Wanjioluncai Injection, a CAR-T cell therapy for refractory and relapsed non-Hodgkin’s lymphoma—had been formally accepted for review. This therapy is indicated for the treatment of refractory and relapsed non-Hodgkin’s lymphoma. Industry observers noted that what truly stirred the market was its previously announced pricing: just over RMB 200,000. This price represents a near “cliff-like” drop compared to the current domestic list prices of approved CAR-T products, which range from RMB 999,000 to RMB 1.29 million per dose. In addition, the company has four other CAR-T drug candidates targeting different cancer types that have entered Phase I–II clinical trials.
 

Furthermore, Legend Biotech is a global biopharmaceutical company in the commercialization stage, with its core business focused on the research and development of CAR-T and related cell therapy products. In February 2022, ciltacabtagene autoleucel injection (English brand name: Carvykti; Chinese brand name: Ka Weidi®), a CAR-T cell therapy product jointly developed by Legend Biotech and Janssen Pharmaceuticals, received FDA approval for market launch. It subsequently received approval from the National Medical Products Administration (NMPA) in August 2024. Data indicates that the product’s global sales in 2025 approached US$1.9 billion, nearly doubling year-on-year. Belief BioMed is an enterprise integrating the research and development, manufacturing, and clinical application of gene therapy products. In April 2025, its gene therapy drug for hemophilia B, Xinjiuning® (generic name: pepdatocogene autotemcel injection), received NMPA approval for market launch.
 

On a global scale, the CAR-T market is experiencing rapid growth. Institutional data shows that in 2025, the total sales of seven CAR-T therapies worldwide rose from $4.5 billion in 2024 to $5.967 billion, representing a year-on-year increase of nearly 32%. Industry agencies predict that by 2032, the global CAR-T cell therapy market will reach RMB 263.86 billion, with a compound annual growth rate (CAGR) of 29.4%. In 2025, China’s CAR-T market size was approximately RMB 3.82 billion; although its growth rate is impressive, there remains a significant order-of-magnitude gap compared to the global market.
 

Overall, China’s cell and gene therapy (CGT) industry is undergoing rapid transformation. The convergence of three favorable factors—technological breakthroughs in solid tumors, the potential market entry of locally developed low-cost novel drugs, and successful international expansion of products—will unlock long-term growth potential for the sector. In the future, with the launch of more domestically produced innovative drugs, continuous optimization of production costs, and gradual inclusion in national medical insurance coverage, Chinese-made CGT therapies are poised to achieve new breakthroughs.
 

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