Hutchmed gets tazemetostat new drug application approved in China
HUTCHMED (China) Limited
291.00p
16:40 05/07/24
Hutchmed China announced on Thursday that the China National Medical Products Administration (NMPA) has accepted its new drug application (NDA) for tazemetostat, granting it priority review for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL).
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The AIM-traded firm said tazemetostat, developed by Epizyme, an Ipsen company, is a first-in-class methyltransferase inhibitor of EZH2.
It was already approved by the US Food and Drug Administration (FDA) for certain patients with R/R FL and advanced epithelioid sarcoma (ES) under the FDA’s accelerated approval programme.
Additionally, the drug was approved by the Japan Ministry of Health, Labour and Welfare for specific R/R FL patients.
Hutchmed's strategic collaboration with Epizyme was focussed on the research, development, manufacturing, and commercialisation of tazemetostat in China, Hong Kong, Macau, and Taiwan.
The NDA in China was supported by data from a multicentre, open-label, phase two bridging study conducted in China, along with clinical studies by Epizyme outside of China.
Tazemetostat had been available in the Hainan Boao Lecheng International Medical Tourism Pilot Zone since May 2022 under the ‘Clinically Urgently Needed Imported Drugs’ scheme, for certain ES and FL patients consistent with the FDA-approved label.
The drug received approval in Macau in March last year, and in Hong Kong in May this year.
At 1434 BST, shares in Hutchmed China were down 1.13% at 270.9p.
Reporting by Josh White for Sharecast.com.