Or Trigger New Cancer! China Pharma's Lymphoma Drug Withdrawn and Recalled from Market, Generated $2.5 Million in Sales Last Year

This article is sourced from Times Finance. Author: Du Sumin

Due to safety risks, the globally first-in-class new drug, Hydrobromide Tazemetostat Tablets (brand name: Dazverke), was included in the commercial insurance innovative drug list for only three months before its fate changed dramatically.

On March 9, Hutchison China MediTech (00013.HK) announced that it had initiated the withdrawal and recall of Tazverke in Mainland China, Hong Kong, and Macau, and stopped all ongoing clinical trials of Tazverke. On the same day, the official website of the National Healthcare Security Administration showed that, starting March 9, Tazverke was removed from all provincial medical procurement platforms nationwide, and upon company application, it was also removed from the “2025 Commercial Health Insurance Innovative Drug List.”

Tazverke was developed by Epizyme, a subsidiary of Ipsen, as the world’s first-in-class EZH2 methyltransferase inhibitor, and received accelerated approval from the U.S. Food and Drug Administration (FDA) in 2020. In 2021, Hutchison China MediTech acquired research, manufacturing, and commercialization rights for this drug in Greater China for a payment of $25 million upfront and up to $285 million in milestone payments.

The direct cause of the withdrawal and recall was triggered by Ipsen’s Phase I/III SYMPHONY clinical trials. The studies found that when Tazverke was combined with lenalidomide and rituximab for treating follicular lymphoma, there were adverse events related to secondary hematologic malignancies. The Independent Data Monitoring Committee (IDMC) determined that “the potential risks of this treatment regimen outweigh the potential benefits for patients.”

In fact, warnings about the risk of secondary malignancies were present at the drug’s approval stage. Times Finance found that the FDA’s prescribing information explicitly indicated that treatment with Tazverke increased the risk of secondary malignancies. In a clinical trial involving 758 adult patients who received Tazverke twice daily as monotherapy, the incidence of myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), or B-cell acute lymphoblastic leukemia (B-ALL) was 1.7%. Long-term monitoring for secondary malignancies is necessary.

The Chinese drug label also mentions that adverse reactions leading to permanent discontinuation with an incidence of ≥2% include “secondary malignancies.”

Image source: TuChong.com

Tazverke’s lifecycle in the Chinese market was short. In May 2022, it was approved for use through the Boao Lecheng Pilot Zone in Hainan, followed by approvals in Macau and Hong Kong. On March 21, 2025, it received conditional approval from the National Medical Products Administration (NMPA) for marketing, and in December of the same year, it was included in the first edition of the national commercial insurance innovative drug list. In total, Tazverke was on the market for less than a year from official approval to withdrawal and recall.

Notably, after its approval in March 2025, Tazverke experienced a sales growth turning point. Sales in Mainland China continued to rise from July, with an annual increase of 158%. By December of that year, it was included in the commercial insurance innovative drug list, which was seen as a sign of entering a period of accelerated commercialization.

However, this growth was based on a very low baseline. According to sales data disclosed by Hutchison China MediTech, since Tazverke’s launch in Hainan in 2022, total sales amounted to only $4.5 million, far below the initial payment made.

Hutchison China MediTech stated in the previous withdrawal announcement that this withdrawal is not expected to affect the company’s financial guidance, emphasizing that in 2025, Tazverke’s sales were projected to be $2.5 million.

Times Finance notes that Hutchison Pharmaceuticals had also held expectations for the continued commercialization of Tazverke. The 2025 annual report shows that the company has assembled a dedicated team responsible for sales of Tazverke and other hematology drugs in development, with hopes of achieving commercialization through its own team in the coming years. Additionally, the company is collaborating with Epizyme to expand its indications to include third-line follicular lymphoma regardless of EZH2 mutation status.

In terms of performance, Hutchison China MediTech’s 2025 results were not particularly impressive. The total annual revenue was $549 million, a decrease of 13% year-over-year; net profit was $456.9 million, up 483%. The revenue decline was mainly due to the disappearance of a $20 million milestone payment from Takeda and a decline in core product sales; the net profit increase was largely due to a one-time gain of $416 million from selling a 45% stake in Shanghai Hutchison Pharmaceuticals.

Excluding asset sales, the company’s core oncology/immunology business revenue was $285.5 million, down 21% year-over-year. While overseas sales of the flagship product, Fuzorafur (brand name: Ai You Te; English name: FRUZAQLA), increased, domestic sales of Fuzorafur and sales of Sunitinib (brand name: SUTEDA) and Savolitinib (brand name: VORISSA) declined.

Financial data shows that in 2025, the overseas version of Fuzorafur, FRUZAQLA, achieved $366 million in market sales, up 26%; however, its domestic version, Ai You Te, had sales of $100 million, down 13%. Meanwhile, Sunitinib’s 2025 sales were $27 million, a sharp decline of 45%. Hutchison China MediTech explained that this was mainly due to increased market competition after the drug was included in the national insurance catalog. Sales of Savolitinib were $28.9 million, down 36%, also attributed to intensifying market competition.

Against the backdrop of existing product growth pressures, Tazverke was once expected to bring new growth to Hutchison China MediTech. However, just as sales were beginning to pick up, the global withdrawal abruptly ended its prospects.

This global withdrawal means that Hutchison China MediTech not only faces difficulty recovering the $25 million upfront payment but also sees the market investment, team building, and commercialization costs for the drug go to waste.

Regarding patient follow-up arrangements and potential compensation after Tazverke’s withdrawal, Times Finance sent interview questions to Dr. Su Weiguo, CEO and Chief Scientific Officer of Hutchison China MediTech, on March 10. As of press time, no response has been received.