HUTCHMED Announces Withdrawal and Recall of Tazverik (Tazemetostat) in Mainland China, Hong Kong, and Macau

Recently, HUTCHMED announced the withdrawal and recall of its oncology drug tazemetostat (brand name: DAVYK) from the markets in mainland China, Hong Kong, China, and Macao, China.

Davyk is an oncology therapeutic agent licensed from Epizyme, Inc. (“Epizyme”), a subsidiary of Ipsen. Epizyme serves as the Marketing Authorization Holder for Davyk in mainland China, while HUTCHMED (Shanghai) Limited, a subsidiary of HUTCHMED, acts as its designated domestic agent/authorizee.

This market withdrawal and recall action stems from Ipsen’s voluntary decision to withdraw the product from the U.S. market. It is reported that Ipsen has notified HUTCHMED that, based on multiple considerations, it is voluntarily withdrawing Tazverik (tazemetostat) from the U.S. market. In response, HUTCHMED took swift action: Hutchison MediPharma (Shanghai) Co., Ltd. immediately initiated market withdrawal and product recall procedures in mainland China, Hong Kong, and Macau, while simultaneously halting all ongoing clinical trials of tazemetostat.

Not only has Ipsen taken action in the Chinese market, but it has also implemented a series of adjustments globally regarding Tazverik. In addition to the decision to withdraw the product from the market, Ipsen has initiated relevant procedures to discontinue tazemetostat treatment for all patients enrolled in the SYMPHONY-1 study. Under the subsequent arrangements, all subjects will receive standard of care, consisting solely of lenalidomide and rituximab. The study will remain open to conduct long-term safety follow-up for all subjects, but no new patients will be enrolled. Furthermore, Ipsen is halting all ongoing clinical trials and expanded access programs (expanded access programs) for tazemetostat. Currently, Ipsen is working closely with the U.S. Food and Drug Administration (FDA) to discuss the next steps for executing the market withdrawal of Tazverik.

From a financial perspective, HUTCHMED’s sales of Fruquintinib (brand name: Elunate) amounted to $2.5 million in 2025. However, HUTCHMED stated that this market withdrawal is not expected to have a material impact on the company’s financial guidance.

On the evening of March 9, the National Healthcare Security Administration issued an official notice revoking the drug’s listing eligibility on all provincial pharmaceutical procurement platforms across China and removing it from the “Innovative Drug Directory for Commercial Health Insurance (2025).”