[Why&Next] CAR-T Breaks Through the Solid Tumor Barrier... A New Market Emerges

First Global Approval Granted in China
Solid Tumors, Long Considered an Impregnable Fortress
Cell Therapy Market Expected to Expand

Chimeric Antigen Receptor T-cell (CAR-T) therapy has, for the first time in the world, received approval for the treatment of solid tumors in China. Solid tumors have long been considered an “impregnable fortress” in the development of CAR-T therapies, as immune cells often struggle to produce adequate anti-cancer effects in these cases. With a Chinese company having overcome this barrier for the first time, there is growing interest in whether the cell therapy market will expand into the solid tumor sector.

According to the pharmaceutical and biotechnology industry on June 24, China's National Medical Products Administration (NMPA) has approved Carsgen Therapeutics’ claudin 18.2 (CLDN18.2)-targeted CAR-T therapy, Satricell, for patients with advanced gastric cancer and gastroesophageal junction cancer. The approval applies to patients with CLDN18.2-positive, HER2-negative status who have undergone at least two prior treatments. This marks the first time a CAR-T therapy has been approved for a solid tumor indication.

According to the phase 2 clinical trial results that formed the basis for approval, the median progression-free survival (PFS) for the Satricell group was 3.25 months, longer than the 1.77 months observed in the physician’s choice standard therapy group. The risk of disease progression or death was reduced by 63% compared to existing therapies. The median overall survival (OS) was 7.92 months for the Satricell group versus 5.49 months for the control group.

CAR-T is a personalized cell therapy in which a patient's T cells are extracted, genetically modified to recognize cancer cells, and then reinfused. Once inside the patient’s body, CAR-T cells attack cancer cells by recognizing specific proteins on their surfaces. Until now, CAR-T therapies have been commercialized mainly for hematologic cancers such as leukemia, lymphoma, and multiple myeloma. There have been no CAR-T therapies approved for solid tumor indications until this point.

The difficulty in targeting solid tumors with CAR-T therapies is due to several factors. First, solid tumors form masses in organs or tissues and build thick barriers around the tumor, making it difficult for engineered T cells to penetrate the cancer tissue. The immunosuppressive tumor microenvironment (TME), which inhibits T-cell activity, is another major obstacle. While hematologic cancers often present distinctive cell membrane proteins such as CD19 and BCMA that can be targeted, in solid tumors, cancer and normal cells often share some of the same proteins, increasing the risk that healthy tissue will be attacked—more so than in blood cancers.

Nevertheless, developing CAR-T therapies for solid tumors has been viewed as an essential mission within the cell therapy market. About 90% of all cancers are solid tumors, and there is high demand for treatments for major types such as gastric, lung, pancreatic, and colorectal cancers. If CAR-T, which has so far grown based on hematologic cancers, can be expanded to solid tumors, the cell therapy market could significantly broaden its scope.

In this context, the fact that China has secured the first approval is highly significant. China is already considered a leader in the global CAR-T development race. As of August 2025, there were 1,908 CAR-T clinical trials worldwide, with China accounting for 1,006 of them—more than half and far surpassing the United States (549 trials). The combination of a large patient pool, rapid clinical progress, and aggressive development by local biotech firms is boosting China’s presence in the CAR-T field.

The key issue now is commercialization. It remains to be seen whether Satricell will expand beyond China to secure global approvals in the United States, Europe, and elsewhere, and how large the actual prescription volume will grow. Michael Quante, Head of Gastrointestinal Oncology at Freiburg University Hospital in Germany, said through a local research institute, “The CLDN18.2 expression criteria used in this study were lower than the over-75% threshold used in previous zolbetuximab studies,” adding, “Since the study population consisted solely of Chinese patients, there are limitations in generalizing the results to Western patients.” Carsgen plans to announce the price of Satricell soon, with the first patient administration expected in about three to four weeks.

Korean companies are also continuing to develop CAR-T therapies targeting solid tumors. Curecell, which introduced the first domestically developed CAR-T therapy “LIMCARTO,” is actively developing solid tumor CAR-T therapies as a core growth driver. AbClon is developing its solid tumor candidate AT501 based on its CAR-T platform zCAR-T. HLB Innovation is also conducting a phase 1 clinical trial for the solid tumor CAR-T therapy SynKIR-110 through its U.S. subsidiary Verismo Therapeutics.

This content was produced with the assistance of AI translation services.