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 China Pharma's Lymphoma Drug Withdrawn and Recalled from Market, Generated $2.5 Million in Sales Last Year

Due to safety concerns, the world’s first-in-class new drug, hydrogen bromide tezacaftor (brand name: Dauvike), experienced a sudden change in fate just three months after being included in the commercial insurance innovative drug list.

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

Tezacaftor, developed by Ipsen’s subsidiary Epizyme, is a globally first-in-class EZH2 methyltransferase inhibitor. It 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 the drug in Greater China for a payment of $25 million upfront and milestone payments up to $285 million.

The direct cause of the withdrawal and recall was the SYMPHONY-1Ib/III phase clinical trial conducted by Ipsen. The study found that when tezacaftor was combined with lenalidomide and rituximab for treating follicular lymphoma, adverse events related to secondary hematologic malignancies occurred. An 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 had already been issued at the time of drug approval. According to information from Times Finance, the FDA’s prescribing information explicitly states that treatment with tezacaftor increases the risk of secondary malignancies. In a clinical trial involving 758 adult patients who received tezacaftor 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%. Patients require long-term monitoring for secondary malignancies.

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

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

Notably, after its approval in March 2025, tezacaftor experienced a sales growth inflection point. Mainland sales continued to rise from July, with an annual growth rate of 158%. Its inclusion in the 2025 commercial insurance innovative drug list was also seen as a sign of imminent commercialization acceleration.

However, this growth was based on a very low baseline. According to sales data disclosed by Hutchison China MediTech, since its launch in Hainan in 2022, cumulative sales of tezacaftor amounted to only $4.5 million, far below the initial $25 million upfront payment.

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, tezacaftor’s sales are projected to be $2.5 million.

Times Finance notes that Hutchison also had high expectations for the continued commercialization of tezacaftor. The 2025 annual report shows that the company has assembled a dedicated team responsible for sales of tezacaftor and other hematology drugs in development, with plans to achieve commercialization through its own team in the coming years. Additionally, the company highlighted ongoing collaboration 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 modest. Total annual revenue was $549 million, down 13% year-over-year; net profit reached $456.9 million, up 483%. The revenue decline was mainly due to the disappearance of a $20 million milestone payment from Takeda and decreased sales of core products; the profit increase was largely due to a one-time gain of $416 million from selling a 45% stake in Shanghai Hutchison China MediTech.

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, fruquintinib (brand name: Ai Youtai; generic: FRUZAQLA), increased, domestic sales of fruquintinib and sales of sorafenib (brand name: Suteda) and sunitinib (brand name: Wori Sha) declined.

Financial data shows that in 2025, the overseas version of fruquintinib, FRUZAQLA, achieved $366 million in market sales, up 26%. However, its Chinese version, Ai Youtai, had a market sales of $100 million, down 13%. Meanwhile, sorafenib’s sales in 2025 were $27 million, a sharp decline of 45%. Hutchison explained that this was mainly due to increased market competition after the drug was included in the national insurance catalog. Sunitinib’s sales were $28.9 million, down 36%, also attributed to intensifying market competition.

Amidst the pressure on existing product growth, tezacaftor was 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 initial $25 million payment but also loses the investments made in market development, team building, and commercialization preparations.

Regarding patient follow-up and potential compensation after the withdrawal of tezacaftor, 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.