Hutchmed (NASDAQ:HCM) ADRs traded higher on Friday after regulators in China agreed to review the company’s lymphoma therapy tazemetostat, developed and sold in partnership with Ipsen (OTCPK:IPSEY).
China’s National Medical Products Administration (NMPA) has been granted priority review for the New Drug Application (NDA) targeting adults with relapsed or refractory (“R/R”) follicular lymphoma, the biotechnology company said in a press release Thursday.
The NDA is supported by data from a China-based mid-stage trial and other clinical studies conducted by Ipsen’s (OTCPK:IPSEF) Epizyme unit for tazemetostat in regions outside of China.
China’s Special Administrative Regions (SARs), Hong Kong and Macao, have already approved the methyltransferase inhibitor.
In the US, tazemetostat is available as Tazverik under the FDA’s accelerated approval program for certain cases of R/R FL and advanced epithelioid sarcoma.