CARsgen's CAR-T Therapy Zevor-Cel Gains Coverage Under China's New Commercial Health Insurance Catalogue
核心洞察
CARsgen's BCMA (搜索)-targeted CAR-T therapy zevor-cel has been included in China's inaugural Commercial Health Insurance Innovative Drug Catalogue for treating relapsed/refractory multiple myeloma (搜索).
Five-year clinical trial data showed 100% overall response rate with 78.6% achieving complete response, median progression-free survival of 44.1 months, and 76.9% survival at 60 months.
The inclusion in this new insurance catalogue aims to reduce patient financial burden and improve accessibility to advanced cell therapies across China.
CARsgen Therapeutics announced that its BCMA (搜索)-targeted CAR-T cell therapy zevorcabtagene autoleucel (zevor-cel) has been included in China's first Commercial Health Insurance Innovative Drug Catalogue for treating relapsed/refractory multiple myeloma (搜索). The National Healthcare Security Administration (搜索) (NHSA) released this landmark catalogue at a press conference in Guangzhou on December 7, 2025.
Regulatory Milestone and Market Access
The NHSA established the Innovative Drug Catalogue as a companion to the Basic Medical Insurance Catalogue, specifically targeting drugs that demonstrate high innovation, significant clinical value, and substantial patient benefits. This new framework is designed to provide unprecedented support for the innovative drug industry chain while enhancing drug accessibility across China.
Zevor-cel received marketing approval from the National Medical Products Administration (搜索) (NMPA) on February 23, 2024, for treating adult patients with relapsed or refractory multiple myeloma who have progressed after at least three prior lines of therapy, including a proteasome inhibitor (搜索) and an immunomodulatory agent (搜索).
Commercial Performance and Distribution
CARsgen has granted exclusive commercialization rights for zevor-cel in mainland China to Huadong Medicine Co., Ltd. The commercial partner has established comprehensive distribution networks, completing certification and regulatory filings in more than 20 provinces and municipalities across China. From January to September 2025, CARsgen received 170 confirmed orders from Huadong Medicine, surpassing the total orders for the entire year of 2024.
Long-Term Clinical Efficacy Data
Five-year follow-up results from the Phase I clinical trial, presented at the 2025 IMS Annual Meeting, demonstrated exceptional efficacy and safety outcomes. The study achieved a 100% overall response rate (95% CI: 76.8, 100.0), with 11 patients (78.6%) achieving complete response (CR) or stringent complete response (sCR). All patients who achieved CR or better were minimal residual disease (MRD) negative at the 10⁻⁵ threshold.
The median progression-free survival (mPFS) and median duration of response (mDoR) were 44.1 months and 43.2 months in CR/sCR patients, respectively. Median overall survival was not reached, and the patient survival rate at 60 months post-infusion was 76.9%.
Safety Profile
The long-term safety data showed no grade 3 or higher cytokine release syndrome (CRS). Additionally, no immune effector cell-associated neurotoxicity syndrome (ICANS), delayed neurotoxicities, second primary malignancy, or other delayed adverse events were observed throughout the five-year follow-up period.
Industry Impact and Future Outlook
Dr. Huamao Wang, Co-founder and Chief Operating Officer of CARsgen, emphasized the significance of this inclusion: "We are very pleased to see zevor-cel included in the first batch of the Innovative Drug Catalogue. This reflects the nation's high recognition of and policy support for innovative drugs. This inclusion will help further alleviate the financial burden on patients and enhance the accessibility of advanced cell therapies."
The inclusion in China's Commercial Health Insurance Innovative Drug Catalogue represents a significant step toward improving patient access to advanced CAR-T cell therapies, potentially setting a precedent for other innovative cellular therapies seeking coverage under China's evolving healthcare reimbursement system.