Hutchmed Announces Withdrawal of Tazverik in China
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 2 days ago
0mins
Should l Buy HCM?
Hutchmed (HCM) announced an update regarding Tazverik, an oncology therapy licensed from Epizyme, an Ipsen (IPSEY) company, in China. Epizyme is the marketing authorization holder of Tazverik in the Chinese mainland, for which Hutchmed acts as the domestic agent/licensee. Ipsen has informed Hutchmed that it is voluntarily withdrawing Tazverik in the U.S. As a result, steps have been taken to initiate the market withdrawal and product recall in China. Consequently, Hutchmed has initiated a withdrawal and product recall from the Chinese mainland, Hong Kong and Macau, and is discontinuing all active tazemetostat clinical trials. Existing patients should consult their treating physicians immediately to discuss their treatment options. Ipsen is the sponsor of the ongoing Phase Ib/III SYMPHONY-1 trial. As informed by Ipsen, following a review of emerging data from SYMPHONY-1, the study Independent Data Monitoring Committee advised that, based on adverse events of secondary hematologic malignancies, the risks may outweigh potential benefits for patients within this treatment regimen. As a result of these data, Ipsen is withdrawing Tazverik effective immediately, including both for follicular lymphoma and epithelioid sarcoma. Ipsen has announced that, in addition to withdrawing Tazverik from the market, Ipsen has initiated steps to stop treatment with tazemetostat for all patients currently enrolled in the ongoing SYMPHONY-1 trial. All participants will receive standard of care, lenalidomide plus rituximab only. The study will remain open, with no further enrollment, to continue the long-term safety follow-up of all participants. Ipsen is also discontinuing all active tazemetostat clinical trials and expanded access programs. Ipsen is working with the FDA on the next steps to execute the withdrawal of Tazverik and provide all necessary information to complete this process.
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Analyst Views on HCM
Wall Street analysts forecast HCM stock price to rise
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Moderate Buy
Current: 13.770
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22.00
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22.00
Current: 13.770
Low
22.00
Averages
22.00
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22.00
About HCM
HUTCHMED (China) Ltd is an investment holding company principally engaged in the manufacture and sale of pharmaceuticals. The Company operates its business through two segments. Oncology Immunology segment is engaged in the discovery, development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Among it, research and development (R&D) includes research and development activities covering drug discovery, development, manufacturing and regulatory functions, out-licensing of in-house developed drugs, as well as administrative activities to support research and development operations, marketed products comprises the invoiced sales, marketing, manufacture and distribution of drugs developed from research and development activities. Other Ventures segment is engaged in the other commercial businesses which include the sales, marketing, manufacture and distribution of other prescription drugs and healthcare products.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
HUTCHMED Announces Withdrawal of TAZVERIK® from Chinese Market
- Market Withdrawal Announcement: HUTCHMED has initiated the withdrawal and recall of TAZVERIK® from the Chinese mainland, Hong Kong, and Macau due to Epizyme's voluntary withdrawal in the US, which significantly impacts existing patients' treatment options and underscores the company's commitment to patient safety.
- Clinical Trials Halted: The company has discontinued all active tazemetostat clinical trials, particularly the SYMPHONY-1 trial, following the Independent Data Monitoring Committee's advice that the risks of adverse events may outweigh potential benefits, affecting future research directions.
- Regulatory Collaboration: HUTCHMED is actively cooperating with regulatory authorities, including the China National Medical Products Administration and the Hong Kong Department of Health, to ensure a smooth withdrawal process, demonstrating the company's commitment to compliance and transparency.
- Limited Financial Impact: Although TAZVERIK® generated $2.5 million in sales in 2025, the withdrawal is not expected to significantly affect the company's financial guidance, indicating resilience amid market fluctuations.
See More
HUTCHMED Board Member Changes Announced
- Board Member Retirement: HUTCHMED announced that Professor Mok will retire as an Independent Non-executive Director at the upcoming AGM on May 12, 2026, marking a significant governance transition as he approaches the nine-year tenure limit.
- New Appointments Effective: Following Professor Mok's retirement, the Board approved new appointments, including Dr. Renu Bhatia as Senior and Lead Independent Non-executive Director, Dr. Chaohong Hu as Chairman of the Technical Committee, and Professor Tan Shao Weng joining the Sustainability Committee, aimed at enhancing board expertise and diversity.
- Leadership Contributions Acknowledged: HUTCHMED Chairman Dan Eldar highlighted Professor Mok's instrumental role in guiding the company's scientific and clinical development programs, underscoring the importance of leadership continuity in the company's long-term strategy.
- Compliance Statement: In accordance with Hong Kong Listing Rules, Professor Mok confirmed no disagreements with the Board and stated there are no other matters to report to shareholders, ensuring transparency and compliance in corporate governance.
See More
HUTCHMED Reports $457 Million Net Income for 2025 Amid Strategic Growth
- Significant Sales Growth: HUTCHMED reported a net income of $457 million for 2025, a substantial increase from $37.7 million in 2024, reflecting the profitability of core operations and successful non-core asset disposals, thereby enhancing the company's financial stability.
- New Technology Advancements: The Antibody-Targeted Therapy Conjugate (ATTC) platform has entered clinical trials, with the first candidate HMPL-A251 initiated in December 2025, marking rapid progress in innovative drug development and promising a rich pipeline of future candidates.
- Market Expansion Strategy: FRUZAQLA® saw a 26% increase in market sales to $366.2 million, driven by successful launches and reimbursement coverage in 38 countries, demonstrating the company's strong performance in global markets and effective response to the demand for novel non-chemotherapy treatments.
- Enhanced Financial Robustness: As of December 31, 2025, HUTCHMED's cash and short-term investments totaled $1.367 billion, supporting the accelerated development of its ATTC technology platform while providing ample funding for future innovative assets.
See More
HUTCHMED Reports FY 2023 Financial Results
- Earnings Highlights: HUTCHMED reported a GAAP EPS of $2.62 for FY 2023, indicating resilience in challenging market conditions, although it fell short of market expectations.
- Revenue Decline: The company's revenue for FY 2023 was $548.51 million, down 13% year-over-year, reflecting intensified market competition and weakened product demand, which could impact future investor confidence.
- Market Reaction: Given the revenue decline and pressure on profitability, HUTCHMED's stock price may face downward pressure, prompting investors to monitor the company's future strategic adjustments and market recovery efforts.
- Outlook: Despite the current financial underperformance, HUTCHMED must formulate effective growth strategies to address industry challenges and regain market share, ensuring long-term sustainable development.
See More
HUTCHMED Initiates Phase I/IIa Trial for HMPL-A580
- Trial Initiation: HUTCHMED has commenced a Phase I/IIa clinical trial for HMPL-A580 on March 4, 2026, targeting patients with unresectable advanced or metastatic solid tumors in China and the US, marking a significant advancement in the company's antibody-targeted therapy portfolio.
- Innovative Drug Characteristics: HMPL-A580 is a first-in-class Antibody-Targeted Therapy Conjugate that combines a highly selective and potent PI3K/PIKK small-molecule inhibitor linked to an anti-EGFR antibody via a cleavable linker, aiming to enhance anti-tumor activity while minimizing systemic toxicity.
- Multicenter Study Design: The study consists of two parts, with the Phase I dose escalation determining the maximum tolerated dose, while the subsequent Phase IIa expansion will further evaluate the safety and preliminary efficacy of HMPL-A580, providing crucial data for future treatments.
- Future Outlook: HUTCHMED plans to leverage its ATTC platform's strengths by combining monoclonal antibodies with small-molecule inhibitors to drive the development of new drugs, addressing significant unmet medical needs globally and showcasing strong market potential and strategic significance.
See More
HUTCHMED to Announce 2025 Final Results on March 5
- Earnings Announcement Schedule: HUTCHMED will announce its final results for the year ended December 31, 2025, on March 5, 2026, at 6:00 am EST, marking a critical moment for the company's annual performance.
- Webcast Presentations: The management will host two webcasts on the same day for analysts and investors to discuss the final results and conduct Q&A sessions, enhancing transparency and investor relations.
- Multilingual Support: The English webcast is scheduled for March 5 at 8:00 am EST, while the Chinese webcast will take place on March 6 at 8:30 am HKT, ensuring participation from investors in different languages.
- Company Background: HUTCHMED is an innovative, commercial-stage biopharmaceutical company focused on targeted therapies and immunotherapies for cancer and immunological diseases, committed to bringing drug candidates from in-house discovery to the global market.
See More
HUTCHMED Announces Withdrawal of TAZVERIK® from Chinese Market
- Market Withdrawal Announcement: HUTCHMED has initiated the withdrawal and recall of TAZVERIK® from the Chinese mainland, Hong Kong, and Macau due to Epizyme's voluntary withdrawal in the US, which significantly impacts existing patients' treatment options and underscores the company's commitment to patient safety.
- Clinical Trials Halted: The company has discontinued all active tazemetostat clinical trials, particularly the SYMPHONY-1 trial, following the Independent Data Monitoring Committee's advice that the risks of adverse events may outweigh potential benefits, affecting future research directions.
- Regulatory Collaboration: HUTCHMED is actively cooperating with regulatory authorities, including the China National Medical Products Administration and the Hong Kong Department of Health, to ensure a smooth withdrawal process, demonstrating the company's commitment to compliance and transparency.
- Limited Financial Impact: Although TAZVERIK® generated $2.5 million in sales in 2025, the withdrawal is not expected to significantly affect the company's financial guidance, indicating resilience amid market fluctuations.
See More
HUTCHMED Board Member Changes Announced
- Board Member Retirement: HUTCHMED announced that Professor Mok will retire as an Independent Non-executive Director at the upcoming AGM on May 12, 2026, marking a significant governance transition as he approaches the nine-year tenure limit.
- New Appointments Effective: Following Professor Mok's retirement, the Board approved new appointments, including Dr. Renu Bhatia as Senior and Lead Independent Non-executive Director, Dr. Chaohong Hu as Chairman of the Technical Committee, and Professor Tan Shao Weng joining the Sustainability Committee, aimed at enhancing board expertise and diversity.
- Leadership Contributions Acknowledged: HUTCHMED Chairman Dan Eldar highlighted Professor Mok's instrumental role in guiding the company's scientific and clinical development programs, underscoring the importance of leadership continuity in the company's long-term strategy.
- Compliance Statement: In accordance with Hong Kong Listing Rules, Professor Mok confirmed no disagreements with the Board and stated there are no other matters to report to shareholders, ensuring transparency and compliance in corporate governance.
See More
HUTCHMED Reports $457 Million Net Income for 2025 Amid Strategic Growth
- Significant Sales Growth: HUTCHMED reported a net income of $457 million for 2025, a substantial increase from $37.7 million in 2024, reflecting the profitability of core operations and successful non-core asset disposals, thereby enhancing the company's financial stability.
- New Technology Advancements: The Antibody-Targeted Therapy Conjugate (ATTC) platform has entered clinical trials, with the first candidate HMPL-A251 initiated in December 2025, marking rapid progress in innovative drug development and promising a rich pipeline of future candidates.
- Market Expansion Strategy: FRUZAQLA® saw a 26% increase in market sales to $366.2 million, driven by successful launches and reimbursement coverage in 38 countries, demonstrating the company's strong performance in global markets and effective response to the demand for novel non-chemotherapy treatments.
- Enhanced Financial Robustness: As of December 31, 2025, HUTCHMED's cash and short-term investments totaled $1.367 billion, supporting the accelerated development of its ATTC technology platform while providing ample funding for future innovative assets.
See More
HUTCHMED Reports FY 2023 Financial Results
- Earnings Highlights: HUTCHMED reported a GAAP EPS of $2.62 for FY 2023, indicating resilience in challenging market conditions, although it fell short of market expectations.
- Revenue Decline: The company's revenue for FY 2023 was $548.51 million, down 13% year-over-year, reflecting intensified market competition and weakened product demand, which could impact future investor confidence.
- Market Reaction: Given the revenue decline and pressure on profitability, HUTCHMED's stock price may face downward pressure, prompting investors to monitor the company's future strategic adjustments and market recovery efforts.
- Outlook: Despite the current financial underperformance, HUTCHMED must formulate effective growth strategies to address industry challenges and regain market share, ensuring long-term sustainable development.
See More
HUTCHMED Initiates Phase I/IIa Trial for HMPL-A580
- Trial Initiation: HUTCHMED has commenced a Phase I/IIa clinical trial for HMPL-A580 on March 4, 2026, targeting patients with unresectable advanced or metastatic solid tumors in China and the US, marking a significant advancement in the company's antibody-targeted therapy portfolio.
- Innovative Drug Characteristics: HMPL-A580 is a first-in-class Antibody-Targeted Therapy Conjugate that combines a highly selective and potent PI3K/PIKK small-molecule inhibitor linked to an anti-EGFR antibody via a cleavable linker, aiming to enhance anti-tumor activity while minimizing systemic toxicity.
- Multicenter Study Design: The study consists of two parts, with the Phase I dose escalation determining the maximum tolerated dose, while the subsequent Phase IIa expansion will further evaluate the safety and preliminary efficacy of HMPL-A580, providing crucial data for future treatments.
- Future Outlook: HUTCHMED plans to leverage its ATTC platform's strengths by combining monoclonal antibodies with small-molecule inhibitors to drive the development of new drugs, addressing significant unmet medical needs globally and showcasing strong market potential and strategic significance.
See More
HUTCHMED to Announce 2025 Final Results on March 5
- Earnings Announcement Schedule: HUTCHMED will announce its final results for the year ended December 31, 2025, on March 5, 2026, at 6:00 am EST, marking a critical moment for the company's annual performance.
- Webcast Presentations: The management will host two webcasts on the same day for analysts and investors to discuss the final results and conduct Q&A sessions, enhancing transparency and investor relations.
- Multilingual Support: The English webcast is scheduled for March 5 at 8:00 am EST, while the Chinese webcast will take place on March 6 at 8:30 am HKT, ensuring participation from investors in different languages.
- Company Background: HUTCHMED is an innovative, commercial-stage biopharmaceutical company focused on targeted therapies and immunotherapies for cancer and immunological diseases, committed to bringing drug candidates from in-house discovery to the global market.
See More
