The National Medical Products Administration (NMPA) has recently approved Innovent Biologics and IASO Bio’s CAR-T therapy equecabtagene autoleucel (Fucaso) for the treatment of relapsed and/or refractory multiple myeloma (R/R MM). It will be the first CAR-T therapy for MM patients and second one by a homegrown company in China. The approval will further boost CAR-T therapies’ development in the country, says GlobalData, a leading data and analytics company.

China approved its first CART-T therapy, relmacabtagene autoleucel of JW Therapeutics, in September 2021 for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy.

According to GlobalData’s Pharma Intelligence Center, considering the Phase I, Phase II, and Phase III candidates based on their highest development stage, 155 CAR-T therapies are in development in China as of 11 July 2023. In China, two CAR-T therapies focused on multiple myeloma–zevorcabtagene autoleucel from CARsgen Therapeutics Ltd and ciltacabtagene autoleucel from Legend Biotech–are in the pre-registration stage.

Globally, there are eight CAR-T therapies approved in oncology, including two indigenous CAR-T therapies by Chinese companies in China. Moreover, all the approved CAR-T therapies are developed by leading players like Novartis, Bristol Myer’s Squibb, and Gilead Sciences.

Prashant Khadayate, Pharma Analyst at GlobalData, comments: “In China, the National Reimbursement Drug List (NRDL) plays a huge role in expanding the market access of drugs and homegrown drugs are preferred to be listed in the NRDL. The inclusion of homegrown CAR-T therapies in the NRDL will further improve access for patients eligible for CAR-T therapies. Moreover, homegrown CAR-T therapies would be affordable compared to CAR-T therapies made available by western companies.”

Legend Biotech, one of the first Chinese companies to make a mark with CAR-T research, entered into a worldwide collaboration and licensing agreement with Janssen in December 2017.  Carvykti (ciltacabtagene autoleucel), which it co-developed with Janssen Biotech in multiple myeloma, received FDA approval in February 2022.

Khadayate concludes: “Research focus on CAR-T therapies is increasing drastically in China. Considering the huge pipeline of CAR-T therapies in development, more western companies would want to partner with Chinese companies. This should be seen as a confidence booster for CAR-T therapies’ development in China.”