SHANGHAI, CHINA, Dec 7, 2025- JW Therapeutics (HKEx: 2126), an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, announced that its first CAR-T product independently developed in China and approved as a Category 1 new drug, Carteyva® (Relmacabtagene Autoleucel Injection), has been successfully included in the first edition of the National Healthcare Security Administration (NHSA)'s Commercial Health Insurance Innovative Drug Directory.
In 2025, the NHSA initiated the exploration and formulation of the Commercial Health Insurance Innovative Drug Directory for the first time. Since the policy's launch, a total of 141 products submitted applications. After rigorous rounds of formal review, comprehensive panel evaluation, calculation, and price negotiations, only less than 20% of the drugs, characterized by high innovation and significant clinical value, were successfully included in the first edition. According to the NHSA's arrangement, the new edition of the National Reimbursement Drug List (NRDL) and the first edition of the Commercial Health Insurance Innovative Drug Directory will officially take effect on January 1, 2026.
The successful inclusion of Carteyva® in the NHSA's Commercial Health Insurance Innovative Drug Directory signifies that the clinical value and innovativeness of this cutting-edge cell immunotherapy product have received high-level national recognition. With the guidance and demonstration effect of the first national directory, it is expected to be incorporated into more diverse and extensive commercial health insurance products in the future.
As the only CAR-T product currently approved in China for three non-Hodgkin lymphoma indications (including the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy, the treatment of adult patients with follicular lymphoma that is refractory or that relapses within 24 months of second-line or above systemic treatment (r/r FL), and the treatment of adult patients with relapsed or refractory mantle cell lymphoma (r/r MCL) after two or more lines of systemic therapy including bruton tyrosine kinase inhibitors (BTKi)), Carteyva® had already been included in over 100 Inclusive Supplementary Health Insurance ("Puhuibao") plans and nearly 100 Major Medical Insurance plans prior to the establishment of this national directory, thanks to its significant clinical value. It has been fully validated through extensive clinical practice and real-world studies among Chinese patients. This important milestone inclusion will significantly enhance the accessibility and affordability of Carteyva®, effectively alleviating the financial burden for eligible patients, and enabling more Chinese lymphoma patients to access the hope of a cure from this breakthrough CAR-T cell therapy and return to normal life.
Min Liu, Chairman and CEO of JW Therapeutics, said, "The successful inclusion of Carteyva® in the first edition of the Commercial Health Insurance Innovative Drug Directory marks a significant milestone in JW Therapeutics' development journey. JW Therapeutics will actively support the nation's multi-tiered medical security system construction, continuously explore diverse payment methods, and improve patient accessibility. The company remains committed to its 'Patient First' philosophy, contributing to enhanced treatment hope and quality of life for Chinese lymphoma patients, and supporting the realization of the 'Healthy China 2030' vision."
About JW Therapeutics
JW Therapeutics (HKEx:2126) is an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products. Since its founding in 2016, JW Therapeutics has built an integrated platform for product development in cell immunotherapy, as well as a product pipeline covering hematologic malignancies, solid tumors and autoimmune diseases. JW Therapeutics is committed to bringing breakthrough and quality cell immunotherapy products and the hope of a cure to patients in China and beyond, and to leading the healthy and standardized development of China’s cell immunotherapy industry. For more information, please visit www.jwtherapeutics.com.
About Relmacabtagene Autoleucel Injection
Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name for oncology indications: Carteyva®) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). Being the first product of JW Therapeutics, Carteyva® has been approved by NMPA for three indications, including the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy, the treatment of adult patients with follicular lymphoma that is refractory or that relapses within 24 months of second-line or above systemic treatment (r/r FL), and the treatment of adult patients with relapsed or refractory mantle cell lymphoma (r/r MCL) after two or more lines of systemic therapy including bruton tyrosine kinase inhibitors (BTKi), making it the first CAR-T product approved as a Category 1 biologics product in China. Currently, it is the CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, priority review and breakthrough therapy designations.
Forward-Looking Statements
The forward-looking statements are based on the management's expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described. Significant risks and uncertainties, include those discussed below and more fully described in Hong Kong Exchanges and Clearing Limited (HKEx) reports filed by the Company. Unless otherwise noted, the Company is providing this information as of the date it publicized, and expressly disclaims any duty to update information contained in the issues and relevant information, or provide any explanation. For detailed information, please visit the company website: www.jwtherapeutics.com/en/forward-looking-statements/.