CARsgen的实体肿瘤CAR-T疗法接近中国批准，成为全球首例   2026-06-22

 

CARsgen Therapeutics Holdings has entered the final stage of China’s marketing approval process and could become the world’s first approved CAR-T treatment for solid tumors before the end of this year, Yicai learned from multiple sources.

The product is being reviewed for patients with Claudin18.2-positive advanced gastric or gastroesophageal junction adenocarcinoma who have failed at least two prior lines of treatment. If approved, it would mark a major milestone for the CAR-T industry, as no CAR-T therapy for solid tumors has yet received marketing approval anywhere in the world.

Shanghai regulators have pledged support to accelerate the review process. During a recent visit to the Shanghai manufacturing base of CARsgen, Guo Shuting, deputy director of the Shanghai Municipal Drug Administration, said the agency would fully support the company in speeding up the launch of its innovative product, according to a June 18 notice released by the regulator.

The municipal drug authority will strengthen pre-approval support services, coordinate review and inspection procedures, and prioritize good manufacturing practice (GMP) compliance inspections for innovative products under its principle of “early intervention and full-process guidance,” Guo said. The regulator will also help establish communication channels with the Yangtze River Delta branch of the Center for Drug Evaluation under China’s National Medical Products Administration to facilitate the registration process.

Hong Kong-listed CARsgen submitted its New Drug Application (NDA) for satri-cel to the Center for Drug Evaluation in June last year, and the application was accepted for review.

According to the company's NDA filing, satri-cel is an autologous CAR-T product designed to target Claudin18.2-expressing tumors in patients with advanced gastric and gastroesophageal junction adenocarcinoma, referring to an advanced cancer of the stomach or the area where the esophagus meets the stomach, which has spread or cannot be cured with surgery.

Solid-Tumor Breakthrough Could Expand CAR-T Market

Over the past decade, CAR-T therapies have been used primarily to treat hematological malignancies -- cancers that affect the blood, bone marrow, or lymphatic system -- and certain rare diseases, while their effectiveness against solid tumors has remained under evaluation. To date, no CAR-T therapy for solid tumors has received marketing approval anywhere in the world. Industry participants estimate that successful commercialization in solid tumors could expand the addressable market for CAR-T therapies by nearly 10 times.

“The approval of the first CAR-T therapy for solid tumors would be positive for the entire industry and could accelerate the clinical application of CAR-T therapies across a broader range of cancers,” an executive at another CAR-T developer told Yicai.

“We are very optimistic about CAR-T therapies as a preventive treatment to reduce postoperative metastasis and recurrence,” Yu Xuejun, founder and chairman of immunotherapy company Huadao Biotech, told Yicai. “When a therapy can reduce, prevent and control metastasis and recurrence after surgery, solid tumors may eventually become curable.”

“CAR-T is a cell therapy approach that may provide long-term benefits after a single administration,” Yu said. “As long as tumor cells express specific antigens on their surface, CAR-T cells can actively target those antigens. This is why CAR-T is also viewed as a broad-spectrum anti-cancer therapy.”

The marketing application for Wanji Aolunsai Injection, a CAR-T therapy developed by Huadao Biotech for relapsed or refractory non-Hodgkin lymphoma, was accepted by Chinese regulators last month. The company expects the product to reduce the cost of CAR-T treatment from around CNY1 million per dose to about CNY200,000 (USD147,720 to USD29,540).

According to Research and Markets, the global cell and gene therapy market is expected to reach USD26.2 billion in 2026 and grow to USD60.6 billion by 2030, representing a compound annual growth rate of 23.3 percent.

 

来源：Yicai Global

 

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