en.Wedoany.com Reported - The National Medical Products Administration (NMPA) has approved, through a priority review and approval process, the Claudin18.2 autologous humanized CAR-T cell therapy product, Kailimei (Satri-cel injection), independently developed by CARsgen Therapeutics Holdings Co., Ltd., for the treatment of Claudin18.2-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced gastric or gastroesophageal junction adenocarcinoma that has failed at least second-line therapy. This is the world's first approved solid tumor CAR-T cell therapy product.
CAR-T therapy has demonstrated efficacy in hematologic malignancies, but in the field of solid tumors, challenges such as an immunosuppressive tumor microenvironment, insufficient target recognition accuracy, and poor cell infiltration have kept a large number of global investigational products in early clinical stages for an extended period. Solid tumors account for approximately 90% of all malignant tumors. Gastric cancer is one of the most common malignancies in China, with new cases annually accounting for about 40% of the global total. Patients with advanced gastric or gastroesophageal junction adenocarcinoma who have failed standard therapy have a very poor prognosis and limited treatment options. Satri-cel is precisely targeting this area of high clinical need.
CARsgen initiated clinical research on Claudin18.2 CAR-T in 2017, focusing on common challenges such as immunosuppression in the solid tumor microenvironment and precise target identification. Through gradual technological breakthroughs, the company has transformed original innovation into a viable treatment option for patients. Although many global institutions have shifted to other technological approaches, CARsgen has consistently adhered to the Claudin18.2 target, continuously advancing clinical translation and completing the marketing application.
The confirmatory clinical study of Satri-cel was led by Professor Shen Lin from Peking University Cancer Hospital and conducted in collaboration with over twenty medical institutions nationwide. The results of this randomized controlled study were published in the internationally renowned medical journal The Lancet, with data quality recognized by international peers. While most solid tumor CAR-T products remain in early clinical trial stages, CARsgen has taken the lead in presenting confirmatory data and completing the application.
Data from an investigator-initiated trial (IIT) published in Nature Medicine in 2024 showed that Satri-cel, used as sequential therapy after first-line treatment for gastric cancer, achieved an objective response rate (ORR) of 100% in 4 patients with target lesions. Among them, 2 patients underwent surgical resection after infusion and achieved long-term survival of nearly 5 years. Preliminary results from an IIT on adjuvant therapy for pancreatic cancer, presented at the 2025 European Society for Medical Oncology (ESMO) Annual Congress, showed that among 6 subjects, 5 (83.3%) experienced a significant decrease in CA19-9 levels after infusion, with reductions ranging from 51.3% to 96.1%. One of these patients completed 52 weeks of follow-up without disease recurrence. CARsgen has initiated two exploratory studies: sequential CAR-T therapy after first-line treatment for advanced gastric cancer and CAR-T consolidation therapy after postoperative adjuvant chemotherapy, aiming to help more patients gain the opportunity for surgery.
According to Dr. Li Zonghai, Founder, Chairman, CEO, and CSO of CARsgen, the company has established a fully self-controlled, end-to-end CAR-T production system covering the three core stages of plasmid, lentiviral vector, and cell manufacturing. The production base located in Jinshan, Shanghai, built to GMP standards, holds the first drug manufacturing license in the domestic CAR-T field, ensuring stable product supply for market launch. The company will also build a new commercial production base to further increase capacity. CARsgen is simultaneously developing a companion diagnostic kit for Claudin18.2, which has entered the registration review process for Class III medical devices. The relevant testing protocol has been incorporated into the "Expert Consensus on Clinical Testing of Claudin18.2 in Gastric Cancer." Data indicate that approximately 68% of gastric cancer patients have moderate to high Claudin18.2 expression, allowing for precise patient selection using this tool.
The approval process for Satri-cel was relatively fast. The drug was included as a breakthrough therapy variety in March 2025, granted priority review in May, and rapidly approved after formal acceptance in June. This speed was facilitated by policies implemented by the NMPA's Center for Drug Evaluation, including early intervention, integrated research and review, priority review and approval, and breakthrough therapy designation. The drug regulatory authorities adopted a service model of "early intervention, tailored policies for each enterprise, dedicated personnel and teams, and full-process tracking." The Yangtze River Delta sub-center's proactive acceptance shortened processing times. City-district coordination supported the company in expanding its production base, with a total investment of approximately 370 million yuan. In the commercialization phase, initiatives such as "Shanghai Huimin Insurance" and "Face-to-Face between Medical and Enterprise" have facilitated faster clinical adoption of innovative drugs.
Currently, the cost of autologous CAR-T is as high as several hundred thousand yuan. Following the drug's approval, CARsgen stated that it will continue to research next-generation CAR-T products to reduce costs. CARsgen has been deeply involved in the cell therapy field for over a decade and has more than ten CAR-T research pipelines covering autologous, allogeneic, and in vivo CAR-T approaches, targeting areas including hematologic malignancies, solid tumors, and autoimmune diseases.
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