CARsgen Therapeutics Holdings Ltd (HKG: 2171), a specialist in chimeric antigen receptor (CAR)-T cell therapies based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its product CT053 (zevorcabtagene autoleucel; zevor-cel). This B-cell maturation antigen (BCMA)-targeted CAR-T cell therapy is now approved for the treatment of recurrent or refractory multiple myeloma (MM) that has progressed following at least three lines of treatment, including at least one proteasome inhibitor and immunomodulatory agent.
Zevorcabtagene autoleucel is a fully human, autologous BCMA CAR T-cell therapy produced by lentiviral transduction of T cells. The NMPA’s approval was granted based on positive efficacy and safety results from an open-label, single-arm, multi-center Phase II clinical study conducted in China.
Huadong Medicine Co., Ltd (SHE: 000963) secured exclusive commercialization rights to zevorcabtagene autoleucel in mainland China through a licensing deal valued at RMB1.225 billion last year. However, clinical studies for this drug and two other CAR-T therapies by CARsgen Therapeutics in the United States were placed on hold late last year, pending an inspection by the US FDA of the company’s manufacturing facility in Durham, North Carolina.- Flcube.com
