Listed for just one year! This pharmaceutical company urgently announces: Recall of a major anti-cancer drug! What happened?

Editor | Zhang Jinhe, Dong Xing Sheng, Du Bo Proofreader | Jin Mingyu

A new anti-cancer drug branded as “world’s first” and approved for conditional listing in China for less than a year is now facing an urgent market withdrawal and recall.

After market close on March 9, Hutchison China MediTech (Hutchmed) announced that its partner Ipsen has notified them of a voluntary withdrawal of the drug in the United States. Consequently, measures have been taken to initiate withdrawal and recall procedures in China. Hutchmed has promptly begun the withdrawal and recall in Mainland China, Hong Kong, and Macau, and has halted all ongoing clinical trials of Dauvobet.

The sudden market withdrawal and recall were triggered by an overseas clinical study. The latest data from Ipsen’s SYMPHONY-1 study indicated that, based on adverse events related to secondary hematologic malignancies, the potential risks of Dauvobet combined therapy may now outweigh its benefits for patients. As a result, Ipsen decided to voluntarily withdraw Dauvobet in the U.S., with Hutchmed following suit.

It is noteworthy that Dauvobet received conditional approval from the National Medical Products Administration (NMPA) in March 2025 and was included in the first edition of the “National Commercial Health Insurance Innovative Drug List” in December of the same year. From a highly anticipated innovative drug to an emergency withdrawal due to safety concerns, Dauvobet’s brief journey in the Chinese market highlights the complexities and uncertainties of innovative drug development.

Initiation of Market Withdrawal and Product Recall in China

According to the announcement, Dauvobet was developed by Epizyme, a subsidiary of Ipsen, as a globally first-in-class EZH2 methyltransferase inhibitor. In the U.S., Dauvobet was approved as a monotherapy by the FDA in 2020.

Ipsen is the sponsor of the ongoing Phase Ib/III SYMPHONY-1 study, which aims to compare the efficacy of Dauvobet combined with lenalidomide and rituximab (the R regimen) versus R alone in treating follicular lymphoma. Ipsen’s report states that an independent Data Monitoring Committee reviewed the latest data from the study and recommended that, due to adverse events related to secondary hematologic malignancies, the potential risks of the treatment may now outweigh its benefits. Based on this data, Ipsen decided to withdraw Dauvobet in real time, including for indications of follicular lymphoma and epithelioid sarcoma.

In addition to the withdrawal, Ipsen has stopped all Dauvobet treatments in the SYMPHONY-1 study. The company is also halting all ongoing clinical trials and expanded use programs involving Dauvobet. Ipsen is currently working with the FDA to discuss the next steps for the withdrawal process.

Hutchmed stated that upon learning this information, the company immediately implemented a lock-up of the product, suspended all sales and shipments, and notified medical institutions to cease prescriptions and pharmacies to stop selling. They also promptly informed clinical trial sites in China to stop using Dauvobet. The company is actively cooperating with regulators to determine appropriate follow-up actions for withdrawal and recall in Mainland China, Hong Kong, and Macau.

Removed from the 2025 List of Innovative Drugs for Commercial Health Insurance

Reviewing the product’s history in China, in 2021, Hutchmed and Epizyme reached a strategic cooperation agreement, whereby Hutchmed obtained rights to research, develop, manufacture, and commercialize Dauvobet in China through licensing. Hutchmed paid an upfront of $25 million and milestone payments up to $285 million, totaling approximately $310 million.

On March 21, 2025, Hutchmed announced that Dauvobet’s new drug application had been conditionally approved in China for treating adult patients with relapsed or refractory follicular lymphoma (FL) positive for EZH2 mutations after at least two prior systemic therapies.

After its approval, Dauvobet was highly anticipated. By the end of June 2025, the drug had issued its first prescription in China. In December of the same year, Dauvobet was included in the first edition of the “National Commercial Health Insurance Innovative Drug List (2025).” In their recent annual report, Hutchmed stated that a dedicated team has been established to promote sales of Dauvobet and other hematology drugs under development (such as Soleripinib and HMPL-306), with commercialization expected to be achieved by their own team in the coming years.

Now, with Dauvobet’s announcement of market withdrawal and recall, the National Healthcare Security Administration has issued an official notice, rescinding the drug’s listing on all provincial medical procurement platforms nationwide and removing it from the “2025 List of Innovative Drugs for Commercial Health Insurance.”

From a business perspective, the short-term financial impact of Dauvobet on Hutchmed is limited. According to Hutchmed’s full-year 2025 financial report, sales of Dauvobet in 2025 amounted to only $2.5 million. The company emphasizes that this withdrawal is not expected to affect its financial guidance.

For current Dauvobet patients, Hutchmed’s announcement advises that they should immediately consult their physicians to discuss alternative treatment options.