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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) granted priority review for the new drug application (NDA) targeting adults with relapsed or refractory (“R/R”) follicular lymphoma, the biotech said in a press release on Thursday.
The NDA is backed by data from a China-based mid-stage trial and other clinical studies conducted by Ipsen (OTCPK:IPSEF) unit Epizyme for tazemetostat in regions outside China.
China’s Special Administrative Regions (SARs), Hong Kong and Macau, have already approved the methyltransferase inhibitor.
In the U.S., tazemetostat is available as Tazverik under the FDA’s accelerated approval program for certain cases of R/R FL and advanced epithelioid sarcoma.