On 27 February 2022, JW Therapeutics (2126.HK), an innovative biotechnology company, announced that the National Medical Products Administration (NMPA) had accepted its application for marketing (sNDA) of its autologous chimeric antigen receptor T (CAR-T) cellular immunotherapy product targeted at CD19, Carteyva® (relmacabtagene autoleucel injection), for the treatment of a new indication - relapsed or refractory follicular lymphoma (r/r FL). This is the second application filed by JW Therapeutics for marketing of Carteyva®, which is expected to be the first cellular therapy product approved for the treatment of r/r FL in China. Previously, Carteyva® was certified in September 2020 by NMPA as a breakthrough therapy drug for the treatment of r/r FL.
At the 63rd Annual Meeting of the American Society of Hematology (ASH), Professor Song Yuqin, Chief Physician of the Department of Lymphoma at Beijing Cancer Hospital and Director of Chinese Society of Clinical Oncology (CSCO), said, “Data from RELIANCE showed that Carteyva® has demonstrated excellent clinical efficacy and safety in patients with relapsed or refractory follicular lymphoma, and we look forward to Carteyva® obtaining the approval for marketing for a new indication.”
Aug 02, 2023
