CARsgen's BCMA-targeted CAR-T Therapy Enters China's Health Insurance Catalogue

CARsgen Therapeutics Holdings Limited has announced that its fully human BCMA-targeted CAR-T therapy, zevorcabtagene autoleucel (zevor-cel), has been included in China's 2025 Commercial Health Insurance Innovative Drug Catalogue. This catalogue, established by the National Healthcare Security Administration (NHSA), aims to enhance accessibility and support for innovative drugs with significant clinical benefits. Zevor-cel, developed for treating relapsed or refractory multiple myeloma in adults after at least three prior lines of therapy, was approved by China's National Medical Products Administration in February 2024. CARsgen has licensed exclusive commercialization rights of zevor-cel in mainland China to Huadong Medicine Co., Ltd., which is actively leveraging China's multi-layered insurance system to improve patient access across more than 20 provinces. From January to September 2025, orders for zevor-cel have surpassed the total for the entire previous year, indicating strong market uptake. The CAR T-cell therapy demonstrated promising five-year follow-up results with a high overall response rate, manageable safety profile, and durable efficacy as presented at the 2025 IMS Annual Meeting. In the clinical trial, no severe cytokine release syndrome or neurotoxicity events were observed. The therapy achieved a 100% overall response rate, with 78.6% of patients attaining complete or stringent complete response, all achieving minimal residual disease negativity. Median progression-free survival and duration of response exceeded 44 months. The 60-month survival rate post-infusion was nearly 77%, indicating sustained patient benefits. The inclusion of zevor-cel in the Innovative Drug Catalogue signals strong regulatory and policy support in China for advanced cell therapies, aiming to reduce patient financial burden and improve treatment accessibility. CARsgen continues to focus on developing innovative CAR T-cell therapies with improved safety and efficacy profiles, targeting hematologic malignancies and beyond. This development may influence global CAR T-cell therapy markets, including regulatory and payer strategy considerations. CARsgen's strategic commercial partnerships and successful integration into health insurance reimbursement frameworks highlight evolving market dynamics for innovative biologics in China. The multi-layered insurance accommodation and growing provincial certifications underscore an expanding commercial infrastructure for advanced therapies. This aligns with broader industry trends emphasizing innovation, regulatory engagement, and reimbursement pathways to enhance patient access to novel treatments.