HUTCHMED's Tazverik Withdrawn Globally Within a Year of China Launch Due to Secondary Malignancy Risk; Removed from Commercial Insurance Innovation Drug List

Cailian Press, March 9 (Reporter Lu Afeng)The uncertainty in global innovative drug development has once again come to the fore, with EZH2 inhibitors, once highly anticipated, at the epicenter this time.

Today, HUTCHMED (00013.HK) announced that due to the global strategic decision by the licensor Ipsen, the withdrawal and product recall process for the oncology treatment drug Davigo® (tazemetostat), which it commercializes in mainland China, Hong Kong, and Macao, has officially commenced, and all ongoing related clinical trials have been halted.

On the same day, the National Healthcare Security Administration issued a notice stating that, starting from March 9, 2026, the listing qualification of Tazemetostat Hydrobromide Tablets on all provincial pharmaceutical procurement platforms across China will be revoked. Additionally, based on the company’s application, the drug will be removed from the "Commercial Health Insurance Innovative Drug List (2025)."

This innovative drug, once regarded as one of the pilot models for exploring the connection between basic medical insurance and commercial insurance, withdrew from the market just months after entering the directory due to rare serious safety signals discovered in large-scale clinical trials post-launch. Industry insiders told reporters from Cailian Press that this case might also have a certain impact on the future access mechanism of innovative drugs into the medical insurance system.

SYMPHONY-1 Study Reveals Risk of Secondary Tumors, Withdrawn from Chinese Market Just One Year After Launch

The core trigger of this incident came from the SYMPHONY-1 Ib/III phase clinical study conducted by Ipsen. The study aims to evaluate the efficacy and safety of tazemetostat in combination with lenalidomide and rituximab (R² regimen) compared to the R² regimen alone in the treatment of follicular lymphoma (FL).

According to the latest review comments from the Independent Data Monitoring Committee (IDMC), adverse events related to secondary hematologic malignancies were observed in the combination therapy group. Although this safety signal was not clearly evident in previous studies, it gradually emerged in larger-scale clinical trials and is considered a rare serious risk that may occur during the post-marketing phase.

Following a comprehensive evaluation, the research team concluded that the potential risks of the combination therapy may outweigh the clinical benefits available to patients. Based on this conclusion, Ipsen has decided to immediately withdraw all marketing authorizations for Tazverik® worldwide, including the previously approved indications for follicular lymphoma (FL) and epithelioid sarcoma (ES), and to terminate all related clinical trials and expanded access programs.

Currently, Ipsen is collaborating with the U.S. FDA to advance the withdrawal-related procedures and adjusting the treatment regimen for patients in the SYMPHONY-1 study. According to the study protocol, relevant patients will continue to receive standard treatment, namely the lenalidomide and rituximab regimen, while long-term safety follow-up is being conducted.

Affected by the aforementioned decision, HUTCHMED has implemented a series of disposal measures in the Chinese market. The company stated that after obtaining the relevant information, its Chinese subsidiary has placed Tafluprost® under lockout management, suspending all sales and shipments. It has also notified medical institutions to stop prescribing and pharmacies to halt sales, while requesting clinical trial institutions in China to immediately cease using the drug.

Public information shows that Tazemetostat, initially developed by Epizyme, is the world’s first approved EZH2 methyltransferase inhibitor. In 2020, the drug was granted accelerated approval by the FDA in the United States as a monotherapy for the treatment of specific patient populations with relapsed or refractory follicular lymphoma and epithelioid sarcoma.

In the field of epigenetic targeted therapy, this mechanism was once regarded as a promising innovative pathway. In 2021, HUTCHMED acquired the development and commercialization rights for the drug in Greater China through a licensing-in model and incorporated it into its own oncology product portfolio. In March 2025, based on Chinese bridging study data, the drug received conditional approval from the National Medical Products Administration (NMPA) for marketing in China. It is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma who are positive for EZH2 mutations and have previously received at least two systemic therapies. At that time, clinical data showed that it could provide durable relief with a favorable safety profile.

This "License-in" model has been an important path for Chinese Biotech companies in recent years to quickly enrich their product pipelines and advance commercialization. By paying upfront fees and milestone payments, companies in China have been able to introduce cutting-edge global products, shorten the R&D cycle, and rapidly enter the market.

However, the withdrawal of Daviglurax® also reveals the structural risks of this model: even if regional commercial execution proceeds smoothly, once there are significant changes in clinical data or safety issues with the global licensor, the regional market often needs to make synchronous adjustments, and related businesses will be directly impacted.

Rapid Response from Medical Insurance: Commercial Insurance's Innovative Drug List Faces First Exit

Almost in sync with corporate announcements, the action by the National Healthcare Security Administration demonstrates a "zero tolerance" attitude towards drug safety.

Tonight, the National Healthcare Security Administration (NHSA) announced clearly: Starting from March 9, 2026, the listing qualification of TAVIK® on all provincial pharmaceutical procurement platforms across China will be revoked. This means that the procurement channel for this drug in public medical institutions has been completely closed. More significantly, the drug has been officially removed from the **Commercial Health Insurance Innovative Drug List (2025)**.

During the 2025 National Healthcare Security Administration negotiations, the National Healthcare Security Administration officially launched the "Commercial Health Insurance Innovative Drug List" for the first time, attempting to provide a new market access pathway for some innovative drugs through a collaborative payment model of "basic healthcare security + commercial insurance." TAVNEOS® is one of the first innovative drugs to be included in this list.

At that time, several industry insiders pointed out that this catalog was regarded as an important attempt to reform China's innovative drug payment system — for innovative drugs that do not yet meet the conditions to enter the basic medical insurance but have certain clinical value, commercial insurance is expected to become an important supplementary payment channel.

Within this framework, entering the commercial insurance innovative drug list means that the product can achieve a certain level of market coverage through the commercial insurance payment system and is also considered an important pilot for the future multi-level medical security system. However, with the implementation of this global withdrawal decision, Tazverik® has also become the first drug to exit the list due to safety concerns.

For HUTCHMED, this is not a financially fatal blow. In its financial report, although Tazverik® is a marketed product, the core growth drivers are more from self-developed star products such as fruquintinib (Elunate®). In 2025, the sales of Tazverik® by HUTCHMED were $2.5 million. However, as part of its oncology portfolio, the withdrawal of Tazverik® has undoubtedly disrupted the pace of its layout in the field of hematological tumors.

Industry insiders are also concerned about whether this incident will impact the recently established commercial insurance innovative drug catalog.

Zhao Heng, founder of Latitude Health, a medical strategic consulting firm, told reporters that the root cause of Tazverik's® withdrawal from the market this time still lies in changes to global clinical safety data. "This product itself is an imported variety, and as Ipsen decided to withdraw its marketing authorization globally, it was inevitable for the Chinese market to follow suit with the withdrawal," he pointed out. Tazverik® was previously conditionally approved for marketing in China, and against this backdrop, continuous tracking and enhanced management of post-marketing risks by regulators are particularly crucial.

This case may also have a certain impact on the future access mechanism of the medical insurance system for innovative drugs. "In conjunction with the policy direction proposed by the National Healthcare Security Administration this year to strengthen real-world research, conditionally approved drugs hoping to enter the medical insurance catalog or the commercial insurance innovative drug catalog in the future may require more substantial real-world data support." In Zhao Heng's view, this means that after the launch of an innovative drug, it still needs to continuously accumulate clinical evidence, and "it is not certain that it will be able to enter the medical insurance system in the year of its market approval."