The world's first CAR-T cell therapy targeting solid tumors, developed by a Shanghai-based biopharmaceutical company, has been approved in China, marking a major step forward for the country in the field of cell and gene therapy.

The approval was announced by the National Medical Products Administration on Monday.

The new treatment, designed for advanced gastric cancer and adenocarcinoma of the esophagogastric junction, offers a breakthrough option for patients with these gastrointestinal tumors and provides a new Chinese solution to a long-standing clinical challenge, medical experts said.

Doctors noted that patients with these cancers who have not experienced positive outcomes from standard treatments face poor prognoses and extremely limited therapeutic options. The newly approved drug helps fill a critical gap in meeting this urgent clinical need.

Tumors are generally classified into hematologic and solid tumors. Solid tumors, which grow in organ tissues and have fixed shapes, are particularly difficult to treat because of their complex microenvironments, making them more challenging to manage than hematologic malignancies, or blood cancers.

The indications for CAR-T therapy, or chimeric antigen receptor T-cell therapy, have expanded in recent years, driven by advances in the treatment of hematologic cancers, such as leukemia, lymphoma and myeloma. CAR-T therapy involves collecting T cells from a patient's blood and genetically modifying them before reinfusing them into the body to attack cancer cells. The treatment enhances the ability of T cells — described as the body's "health guardians" — to precisely identify and destroy tumor cells, according to medical experts.

"About 90 percent of human tumors are solid tumors, while previously approved CAR-T products were used only for hematologic malignancies. Therefore, the approval of this injection marks a new milestone and suggests that more CAR-T products could be developed for other solid tumors in the future," said Li Zonghai, founder and chief executive officer of CARsgen Therapeutics Holdings. The therapy was developed by a subsidiary of the company.

Li said the company has benefited from strong support from both the central government and the Shanghai municipal government across the entire biopharmaceutical industrial chain. Over the past three years, Shanghai has rolled out a series of action plans to promote technological innovation and industrial development in cell and gene therapy, yielding notable results.

As one of the earliest regions in China to develop the cell and gene therapy industry, Shanghai's Pudong New Area has achieved significant milestones. It is home to the country's first gene therapy product. With the approval of the new drug, Pudong now has five domestically developed CAR-T products on the market, accounting for about a quarter of the global total.

Also on Monday, the world's first approved bispecific antibody-drug conjugate, developed by domestic company Biokin Pharmaceutical, received approval in China for the treatment of nasopharyngeal carcinoma — a rare type of throat cancer.

The company announced plans to establish its global innovation, research and development center in Shanghai's Pudong district, focusing on cutting-edge oncology drugs.

The new therapy offers precise treatment with low toxicity. Its innovative mechanism overcomes the limitations of traditional chemotherapy and single-target drugs, opening a new path for precision cancer treatment.