SHANGHAI, CHINA, Oct 9, 2025 - JW Therapeutics (HKEx: 2126), an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, announced that the National Medical Products Administration (NMPA) of China has officially accepted its post-marketing supplementary application for Carteyva® to add the use of in-house produced lentiviral vector.
Lentiviral vector, as target gene delivery vehicle, plays a crucial role in cell therapy products, enabling transduction and integration of chimeric antigen receptor genes. Lentiviral vector is a key raw material for the production of Relma-cel injection. Currently, the lentiviral vectors used in production are supplied by oversea manufacturers, which are expensive and the supply is unstable, significantly limiting the commercial production and clinical development of Relma-cel. JW Therapeutics has developed and added a new, in-house produced lentiviral vector to ensure a stable and continuous supply of Relma-cel injection and reduce costs, while optimizing the viral production process and strengthening quality control.
This application is based on a Phase II single-arm study, the purpose of which is to evaluate and demonstrate that Relma-cel injection produced using a new process lentiviral vector (JWLV011) is comparable to Relma-cel injection products produced using current lentiviral vectors. Currently, this study has completed at least 3 months of follow-up: the 3-month best ORR was 66.67%, and the best CR was 41.67%. The most common serious adverse event was cytopenia， CAR-T related toxicity such as CRS was mostly grade 1, no ≥grade 3 CRS occurred, and no ICANS of any grade occurred. Based on the efficacy and safety results, the clinical data of this study showed that Relma-cel injection produced by the in-house produced lentiviral vector (JWLV011) is clinically comparable to products produced by current lentiviral vectors.
Mr. Min Liu, Chairman and CEO of JW Therapeutics, said: “The lentiviral vector is not only one of the most critical raw materials in the production of cell therapy products, but also the highest-cost component. Localizing the production of lentiviral vectors holds significant strategic importance for us. Upon successful substitution with domestically produced viral vectors, we will achieve a more stable supply both for our commercial products and clinical development, along with a substantial reduction in product costs. Lower costs will enable us to better navigate commercial competition and insurance negotiations, creating an opportunity to significantly enhance the commercial value of Carteyva®.”
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
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