CARSGEN-B(02171.HK): Kailimei® Secures NMPA Marketing Approval, the World’s First CAR-T Cell Therapy for Solid Tumors
NewTimeSpace News: Carsgen Therapeutics Holdings Limited (02171.HK) announced that the New Drug Application for Kailimei® (Satricabtagene Autoleucel Injection), an in-house developed Claudin18.2-targeted CAR-T cell therapy product, has been granted marketing approval by the National Medical Products Administration (NMPA). It is indicated for the treatment of advanced gastric/gastroesophageal junction adenocarcinoma that is Claudin18.2-positive, HER2-negative and has failed at least two lines of prior therapy. Kailimei® is the world’s first CAR-T cell therapy product approved for solid tumor treatment.
NewTimeSpace News: On 22 June 2026, Carsgen Therapeutics Holdings Limited (02171.HK) issued an inside information announcement disclosing that Kailimei® has obtained marketing approval from the NMPA.
Kailimei® is an autologous CAR-T cell therapy targeting Claudin18.2. Claudin18.2 is a highly selective marker protein, which is only expressed in differentiated gastric mucosal epithelial cells, with extremely limited expression in normal healthy tissues and high expression in gastric cancer cells. The approval of this product is supported by CT041-ST-01, an open-label, multicenter, confirmatory randomized controlled Phase II clinical trial conducted in China. Per research data published inThe Lancetand presented at the 2025 ASCO Annual Meeting, Kailimei® demonstrated encouraging efficacy and a favorable safety profile.
Carsgen Therapeutics is the global pioneer that successfully identified, validated and reported the solid tumor-associated antigen Claudin18.2 as an effective target for CAR-T cell therapy. The Company has built a global patent portfolio covering Kailimei®, encompassing target, indications, dosage regimens and lymphodepletion preconditioning protocols.
There were approximately 358,700 new gastric cancer cases in China in 2022, and the number of new domestic gastric cancer cases is projected to reach 607,000 by 2050.
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