China’s National Medical Products Administration (NMPA) has approved CARsgen Therapeutics’ satricabtagene autoleucel, known as satri-cel, marking the first regulatory approval of a CAR-T therapy for a solid tumor.
The therapy is approved in China for patients with Claudin18.2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma whose disease has progressed after at least two prior lines of treatment.
The decision represents a major milestone for cellular therapy. While CAR-T therapies have transformed treatment for several blood cancers, solid tumors have remained a far more difficult setting because of tumor heterogeneity, limited T-cell persistence, an immunosuppressive tumor microenvironment, and concerns surrounding treatment-related toxicity.
A New Option for Heavily Pretreated Gastric Cancer
Satri-cel is directed against Claudin18.2, a target expressed in gastric cancer and several other solid tumor types. According to CARsgen, Claudin18.2 has limited expression in healthy tissues while being highly expressed in selected gastric cancers, making it a promising target for CAR-T cell therapy.
CARsgen has stated that it is the first company to successfully identify, validate, and report Claudin18.2 as a target for CAR-T therapy in solid tumors.
The approval addresses an important unmet need in advanced gastric and gastroesophageal junction cancer, where treatment options become increasingly limited after progression on multiple systemic therapies.
Phase 2 Data Supported the Approval
The NMPA decision follows results from a phase 2 study that compared satri-cel with physician’s choice of chemotherapy in patients with advanced gastric cancer.
At the 2025 American Society of Clinical Oncology Annual Meeting, CARsgen reported that satri-cel was associated with a median progression-free survival of 3.25 months, compared with 1.77 months in the physician’s choice arm.
Median overall survival was 7.92 months with satri-cel, compared with 5.49 months with standard treatment options.
CARsgen said the therapy demonstrated a significant efficacy benefit with a manageable safety profile compared with existing treatment approaches.
Breaking Through the Solid Tumor Barrier
CAR-T therapy has achieved substantial success in hematologic malignancies, including certain leukemias, lymphomas, and multiple myeloma. However, translating this approach into solid tumors has been more challenging.
Tumor antigen selection remains one of the key barriers. An ideal target must be sufficiently expressed on cancer cells while having limited presence in normal tissues. Claudin18.2 has emerged as one of the most closely watched targets in gastric cancer, especially as multiple therapeutic approaches—including monoclonal antibodies, antibody-drug conjugates, bispecific antibodies, and cellular therapies—continue to enter clinical development.
CARsgen also developed a preconditioning regimen for satri-cel that includes low-dose nab-paclitaxel alongside conventional lymphodepleting chemotherapy. The approach is designed to support CAR-T cell activity before infusion.
Gastric Cancer Burden Remains High in China
Gastric cancer continues to represent a major public health challenge across Asia. More than 70% of new gastric cancer cases and deaths occur in the region.
CARsgen noted that patients in China account for approximately 47% of the global gastric cancer burden, underlining the importance of new treatment options for advanced disease.
Professor Lin Shen, M.D., of Peking University Cancer Hospital, whose team led the clinical studies of satri-cel, described the approval as a turning point for cellular therapy in solid tumors. He noted that the therapy could help fill a treatment gap for later-line advanced gastric cancer and provide a foundation for future studies in earlier disease settings and combination strategies.
Expansion Into Earlier Treatment Settings
CARsgen is now working to expand the development of satri-cel beyond later-line gastric cancer.
The company is investigating the therapy in earlier treatment lines and perioperative settings. A phase 1 study in pancreatic cancer is also ongoing in China.
Zonghai Li, M.D., Ph.D., Founder, Chief Executive Officer, and Chief Scientific Officer of CARsgen, said the company plans to advance clinical access to satri-cel in China while pursuing broader international development.
Three Additional World-First Approvals in China
Satri-cel was among several notable approvals announced by the NMPA on June 22.
The agency also granted conditional approval to Sichuan Biokin Pharmaceutical’s izalontamab brengitecan, also known as iza-bren, described as the world’s first bispecific antibody-drug conjugate.
Iza-bren targets EGFR and HER3 and is approved in China for patients with nasopharyngeal carcinoma who have received at least two prior systemic therapies, including chemotherapy and a PD-1 or PD-L1 inhibitor.
Bristol Myers Squibb holds rights to iza-bren outside China through a deal with Biokin subsidiary SystImmune that included an $800 million upfront payment and potential value of up to $8.4 billion. Outside China, the therapy is being evaluated in global phase 2 and phase 3 studies in previously treated triple-negative breast cancer, bladder cancer, and EGFR-mutated non-small cell lung cancer.
A Novel Antibacterial Spray for Wound Infections
The NMPA also approved Pulai Pharmaceutical’s antibacterial spray containing peceleganan, a novel non-antibiotic antimicrobial peptide.
The spray is indicated for wound infections or superficial burns caused by Staphylococcus epidermidis, Staphylococcus haemolyticus, and Acinetobacter baumannii.
Peceleganan works through electrostatic interactions and hydrophobic insertion into bacterial cell membranes. This mechanism enables treatment of wound infections without relying on conventional antibiotic pathways.
The product is commercially partnered with Chia Tai Tianqing Pharmaceutical, a subsidiary of Sino Biopharm.
A First Bispecific Antibody for Rabies Prevention
China’s Genrix Bio also received approval for silevimig, described as the world’s first bispecific antibody for post-exposure prophylaxis against rabies.
The therapy targets two distinct epitopes of the rabies virus and is intended to provide passive immunization after suspected rabies exposure.
China Medical System, which holds commercialization rights to silevimig, said the product uses a small dose that can be manufactured at scale and may allow for easier administration.
Lilly’s Inluriyo Also Receives Chinese Approval
Eli Lilly’s oral selective estrogen receptor degrader, Inluriyo, was also approved in China for patients with ER-positive, HER2-negative, ESR1-mutant locally advanced or metastatic breast cancer previously treated with endocrine therapy.
Inluriyo first received FDA approval after reducing the risk of progression or death by 38% compared with standard endocrine therapy in eligible patients.
In the United States, the treatment is approved as monotherapy. In China, regulators approved both Inluriyo monotherapy and its combination with Lilly’s CDK4/6 inhibitor Verzenio, following later data showing a favorable overall survival trend for the combination.
Written by Nare Hovhannisyan, MD
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