JW THERAP-B (02126) announced that China's National Medical Products Administration (NMPA) has formally accepted its post-marketing supplemental application for RELMA® to incorporate the use of domestically-produced viral vectors.
Lentiviral vectors serve as crucial gene delivery tools in cell therapy products, enabling the transduction and integration of chimeric antigen receptor genes. As one of the key raw materials for relmacabtagene autoleucel injection production, the currently used lentiviral vectors are supplied by foreign manufacturers, which are expensive and subject to supply instability, significantly limiting the commercial production and clinical development of relmacabtagene autoleucel.
JW THERAP-B has developed and added its self-produced lentiviral vector (JWLV011), aiming to optimize viral production processes and strengthen quality control while ensuring stable and continuous supply of relmacabtagene autoleucel injection and reducing costs.
This application is based on a Phase II single-arm study designed to evaluate and demonstrate the comparability between relmacabtagene autoleucel injection produced using the new process viral vector (JWLV011) and the product manufactured with existing viral vectors.
The study has currently completed at least 3 months of follow-up: the observed 3-month best objective response rate (ORR) was 66.67%, with a complete response (CR) rate of 41.67%. The most common serious adverse events were cytopenias. CAR-T related toxicities such as cytokine release syndrome (CRS) were mostly grade 1, with no grade ≥3 CRS occurrence and no immune effector cell-associated neurotoxicity syndrome (ICANS) of any grade.
Based on the comprehensive efficacy and safety results, the clinical data from this study demonstrates that relmacabtagene autoleucel injection produced by the domestic lentiviral vector (JWLV011) has clinical comparability with products manufactured using existing lentiviral vectors.
Mr. Liu Min, Chairman and CEO of JW THERAP-B, stated: "Lentiviral vectors are not only one of the most important raw materials for cell therapy products, but also the most expensive production material. The domestic substitution of lentiviral vectors holds significant strategic importance for the company. Upon successful completion of viral vector replacement, our commercial product and clinical development supply will be more stable, and product costs will achieve substantial reduction. Lower costs will enable the company to better respond to commercial competition and insurance negotiations, providing us with opportunities to achieve tremendous enhancement in the commercial value of RELMA®."