JW Therapeutics has received China’s National Medical Products Administration (NMPA) approval for Carteyva (relmacabtagene autoleucel injection) to treat adult patients with relapsed or refractory Mantle Cell Lymphoma (r/r MCL).

Carteyva is an anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product. It was developed using a CAR-T cell process platform of Juno Therapeutics, a Bristol Myers Squibb company.

This is the third marketing authorisation for Carteyva by JW Therapeutics and marks the first cell therapy product in China approved specifically for r/r MCL.

The medication is already approved for r/r large B-cell lymphoma (LBCL) and r/r follicular lymphoma (FL).

Previously, relmacabtagene received breakthrough therapy designation from the NMPA in March 2022 and priority review in December 2023.

JW Therapeutics senior vice president and regulatory, research and development and head Sophia Yang said: “We are delighted to have a product that can deliver meaningful efficacy in this disease, nearly 70% of patients with r/r MCL have achieved complete remission after treatment with Carteyva, and the overall safety data demonstrated that the treatment was generally well-tolerated.

“Carteyva becomes the first commercial CAR-T cell product for the treatment of r/r MCL in China.”

The supplemental biological license application (sBLA) for Carteyva, accepted by NMPA in January, was supported by clinical results from a single-arm, multi-centre study conducted in China.

The study involved adult patients with r/r MCL, who had previously undergone treatment with a CD20-targeting antibody, anthracycline, bendamustine, or Bruton’s tyrosine kinase inhibitors (BTKis).

Among the 59 patients evaluable for efficacy, Carteyva showed significant clinical responses, with the objective response rate (ORR) reaching 81.36% and the complete response rate (CRR) at 67.8%.

Additionally, the incidence of severe cytokine release syndrome (CRS) was 6.8%, and the incidence of severe neurotoxicity (NT) was also 6.8%.

Relmacabtagene is also being developed for acute lymphoblastic leukaemia (ALL) and chronic lymphocytic leukaemia (CLL).

Other assets in JW Therapeutics’ pipeline include JWCAR129 for multiple myeloma and JWCAR029 for systemic lupus erythematosus.

Additionally, the Chinese firm’s solid tumour pipeline includes assets for hepatocellular carcinoma, and non-small cell lung cancer among others.