China approval for JW Therapeutics' CAR-T relma-cel

6 September 2021
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Chinese drug developer JW Therapeutics (HK: 2126) saw its shares rocket 28% to HK$22.80 today, as it announced that China’s National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for the company’s anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product relmacabtagene autoleucel injection (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.

This marks China’s second approved CAR-T therapy, with the first being Yescarta (axicabtagene ciloleucel), from the Gilead Sciences (Nasdaq: GILD) subsidiary Kite. That approval was granted to Fosun Kite Biotechnology, a joint venture between Kite and Shanghai Fosun Pharmaceutical in June this year.

However, Relma-cel is the first CAR-T product approved as a Category 1 biologics product in China, and sixth approved CAR-T product globally, JW Therapeutics noted.

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