CARsgen Therapeutics Holdings is nearing the final stages of China’s approval process for market authorization and could become the first in the world to receive approval for a CAR-T therapy targeting solid tumors before the year ends, according to multiple sources.
The therapy is currently under review for patients with Claudin18.2-positive advanced gastric or gastroesophageal junction adenocarcinoma who have not responded to at least two previous treatment regimens. If approved, this would represent a significant breakthrough for the CAR-T industry, as no CAR-T treatment for solid tumors has yet secured regulatory approval anywhere globally.
Regulatory authorities in Shanghai have expressed commitment to speeding up the review process. During a recent visit to the Shanghai manufacturing facility of the company, Guo Shuting, deputy director of the Shanghai Municipal Drug Administration, stated that the agency would fully support efforts to launch this innovative product promptly, as noted in an official notice issued on June 18.
The local drug authority plans to enhance pre-approval services, coordinate review and inspection procedures, and prioritize inspections for manufacturing practices that meet GMP standards, under their “early intervention and full-process guidance” approach. They will also facilitate communication with the Yangtze River Delta branch of China’s Center for Drug Evaluation to streamline registration procedures.
Hong Kong-based CARsgen submitted its New Drug Application (NDA) for satri-cel to China’s Center for Drug Evaluation in June of last year. The application is currently under review.
As per the NDA, satri-cel is an autologous CAR-T therapy designed to target tumors expressing Claudin18.2 in patients with advanced gastric and gastroesophageal junction adenocarcinoma—an aggressive form of stomach or esophageal cancer that has spread or cannot be surgically cured.
Breakthrough in Solid Tumor Treatment Could Broaden CAR-T Market
During the past decade, CAR-T therapies have primarily been used for blood cancers—such as leukemia, lymphoma, and multiple myeloma—and certain rare diseases. Their application for solid tumors has remained under clinical evaluation, with no therapies having gained worldwide marketing approval. Industry analysts estimate that successful commercialization of CAR-T for solid tumors could expand the market size by roughly tenfold.
“The approval of the first CAR-T therapy for a solid tumor would be a major win for the entire industry and could accelerate the clinical adoption of CAR-T treatments across more cancer types,” said an executive at another CAR-T development company.
“We are very optimistic about using CAR-T therapies as a preventive strategy to reduce postoperative metastasis and recurrence,” remarked Yu Xuejun, founder and chairman of Huadao Biotech. “If a therapy can effectively prevent, reduce, and control metastasis and recurrence after surgery, many solid tumors could eventually become curable.”
“CAR-T represents a cell therapy approach that may offer long-term benefits after a single dose,” Yu explained. “As long as tumor cells display specific surface antigens, CAR-T cells can actively seek out and destroy them. This positions CAR-T as a broad-spectrum anti-cancer therapy.”
Earlier last month, Huadao Biotech’s application for Wanji Aolunsai Injection—a CAR-T therapy targeting relapsed or refractory non-Hodgkin lymphoma—was accepted by Chinese regulators. The company anticipates this product could reduce treatment costs from around CNY 1 million (approximately USD 147,720) per dose to about CNY 200,000 (roughly USD 29,540).
Research and Markets projects the global cell and gene therapy market will reach USD 26.2 billion by 2026 and expand to USD 60.6 billion by 2030, growing at a compound annual rate of 23.3 percent.