The biopharmaceutical company CARSGEN-B (02171) has announced that on June 22, 2026, it received a notification from the China National Medical Products Administration (NMPA) approving the New Drug Application for its self-developed Claudin18.2 autologous humanized CAR-T cell therapy product, Kelimei® (Surajit Orelen Injection).

The approval is for the treatment of Claudin18.2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma in patients who have failed at least two prior lines of therapy. Kelimei® is recognized as the world's first CAR-T cell therapy product approved for treating a solid tumor.

Claudin18.2 is a highly selective marker protein expressed primarily in differentiated gastric mucosal epithelial cells. Its expression is highly limited in normal, healthy tissues but is significantly overexpressed in gastric cancer cells. Kelimei® is an autologous CAR-T cell therapy that targets Claudin18.2. It is genetically modified to express a CAR construct composed of a humanized Claudin18.2-specific single-chain variable fragment (hu8E5-2I), a CD8α hinge region, a CD28 transmembrane domain, a CD28 intracellular signaling domain, and a CD3ζ intracellular signaling domain.

To the company's knowledge, CARSGEN was the first globally to successfully identify, validate, and report Claudin18.2 as a viable target for CAR-T cell therapy in solid tumors. To further address the challenges posed by the solid tumor microenvironment for CAR-T therapies, the company has independently developed a proprietary, innovative lymphodepletion pretreatment regimen for Kelimei®.

This regimen enhances CAR-T cell infiltration and anti-tumor efficacy by adding a low dose of albumin-bound paclitaxel to the traditional lymphodepletion regimen of cyclophosphamide and fludarabine. The company has established a global patent portfolio for Kelimei®, covering aspects such as the target, indications, dosing, and the pretreatment regimen.

The approval of Kelimei® is based on an open-label, multicenter, confirmatory randomized controlled Phase II clinical trial conducted in China. According to research data published in The Lancet journal and presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, Kelimei® demonstrated encouraging efficacy and a favorable safety profile.

Gastric cancer refers to epithelial-origin malignant tumors that originate in the stomach. As a region with a high incidence, data from the China National Cancer Center indicates that gastric cancer is the fifth most common cancer in the country. In 2022, there were approximately 358,700 new cases of gastric cancer in China.

With a rapidly aging population, the burden of gastric cancer among the elderly is particularly pronounced. It is projected that the number of new gastric cancer cases in China will reach 607,000 by the year 2050.