Shanghai marks milestone with first locally developed CAR-T product approval

Kaixing Life Technology (Shanghai) Co Ltd, a subsidiary of CARsgen and a key player in the bonded area of the China (Shanghai) Pilot Free Trade Zone, has reached a significant milestone.

Their CAR-T product, Zevor-cel (CT053), designed for treating relapsed or refractory multiple myeloma in adults, has received market approval from the National Medical Products Administration.

This marks the first CAR-T product approved for the market from the bonded area and the first independently developed CAR-T product in Shanghai, the fifth nationwide.

Established in 2018, Kaixing Life Technology is a pioneering enterprise in the biopharmaceutical field. The company primarily engages in technical services, development, consulting, and technology transfer.

Zevor-cel (CT053) is an autologous BCMA-targeted CAR-T cell product with a fully human BCMA-specific single-chain variable fragment. Its approval is based on promising efficacy and safety demonstrated in a Phase II clinical trial.

This achievement is significant for the development of the biopharmaceutical industry in the bonded area, emphasizing the region's role in promoting innovation and commercialization in cell and gene therapy.