On September 6, 2021 JW Therapeutics (HKEx: 2126), an innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, reported that the National Medical Products Administration (NMPA) of China has approved the New Drug Application (NDA) for its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product relmacabtagene autoleucel injection (hereafter abbreviated as relma-cel, R&D code JWCAR029) 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, and has released the drug registration certificate (Press release, JW Therapeutics, SEP 6, 2021, View Source [SID1234587276]). Relma-cel is the first CAR-T product approved as a Category 1 biologics product in China, and sixth approved CAR-T product globally.
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Relma-cel, JW Therapeutics’ first CAR-T product, was independently developed based on a CAR T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company) to meet the needs of the Chinese market. Currently, it is the only approved CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, granted priority review (in r/r LBCL) and breakthrough therapy designations (in follicular lymphoma). To date, over 100 patients have been dosed with relma-cel in clinical studies, marking relma-cel a most studied anti-CD19 CAR-T product in China.
This approval is based on the results of a single-arm, multi-center, pivotal study (RELIANCE study) to evaluate the efficacy and safety of relma-cel in patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) in China. RELIANCE study results show that relma-cel demonstrated high rates of durable disease response and low rates of CAR-T associated toxicities, and may provide a best-in-class CAR-T therapy profile.
Professor Zhu Jun, the lead investigator of RELIANCE study, Chief of Internal Medicine Department and Lymphoma Department at Peking University Cancer Hospital, said, "The RELIANCE study is a registrational clinical study completed with high quality, and I’m very proud of that. Based on the outstanding efficacy and safety profiles it demonstrated in RELIANCE study, I believe that relma-cel will provide healthcare professionals in China with an additional treatment option and bring hope for long-term remission and even cure for lymphoma patients."
Edward Hu, Vice Chairman and Global Chief Investment Officer at WuXi AppTec, said, "Congratulations to JW Therapeutics for the approval of its first product. WuXi AppTec will continue to enable more companies to deliver advanced therapies for patients globally. Cell and gene therapy is on