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HUTCHMED Announces Expanded Coverage on National Reimbursement Drug List and Inclusion in the First Commercial Insurance Drug List in China
Globenewswire· 2025-12-08 00:00
Core Viewpoint - HUTCHMED has successfully renewed contracts with the China National Healthcare Security Administration (NHSA), ensuring the inclusion of its drugs ELUNATE, ORPATHYS, and SULANDA in the updated National Reimbursement Drug List (NRDL) effective January 1, 2026, and the addition of TAZVERIK to the National Commercial Health Insurance Innovative Drug List [1][4]. Group 1: Drug Inclusion and Details - ELUNATE (fruquintinib) is included for treating advanced endometrial cancer with pMMR tumors and metastatic colorectal cancer patients who have undergone prior chemotherapy [2]. - ORPATHYS (savolitinib) is included for adult patients with locally advanced or metastatic non-small cell lung cancer with MET exon 14 skipping alteration [3]. - SULANDA (surufatinib) is renewed for treating unresectable, locally advanced or metastatic, progressive non-functional well-differentiated neuroendocrine tumors [3]. - TAZVERIK (tazemetostat) is included in the Commercial Insurance Drug List for adult patients with relapsed or refractory follicular lymphoma with EZH2 mutation [4]. Group 2: Reimbursement Framework - The new Commercial Insurance Drug List, established by the NHSA, focuses on innovative medicines with significant clinical value, enabling reimbursement through various commercial health insurance products [4]. - As of the end of 2024, approximately 1.33 billion people in China had basic medical insurance coverage, representing around 95% of the population, highlighting the government's commitment to improving drug affordability [5]. Group 3: Company Overview - HUTCHMED is an innovative biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases [10]. - The company has successfully brought its first three medicines to market in China, with one also approved globally [10].
HUTCHMED Reports 2025 Interim Results
Globenewswire· 2025-08-07 11:00
Core Insights - HUTCHMED reported a significant increase in net income to $455 million for the first half of 2025, primarily due to a $416.3 million gain from the divestment of a non-core joint venture [5][33][31] - The company is expanding its pipeline with new drug candidates from its Antibody-Targeted Therapy Conjugate (ATTC) platform, which is expected to enter clinical development by late 2025 [19][20][6] Financial Performance - Total revenue for the six months ended June 30, 2025, was $277.7 million, a decrease from $305.7 million in the same period of 2024 [29][10] - Oncology/Immunology consolidated revenue was $143.5 million, down from $168.7 million in H1 2024, reflecting competitive pressures and changes in sales strategy [10][32] - The company achieved a cash balance of $1.36 billion as of June 30, 2025, up from $836.1 million at the end of 2024 [34] Commercial Operations - FRUZAQLA's in-market sales increased by 25% to $162.8 million, driven by expansion into over 30 countries [5][8] - ELUNATE's in-market sales decreased to $43.0 million, reflecting competitive pressures, while SULANDA's sales dropped by 50% to $12.7 million due to competition from new therapies [12][32] - ORPATHYS revenue decreased to $9.0 million, impacted by competition despite recent approvals for new indications [32][10] Pipeline and Clinical Development - ORPATHYS received approval for a third lung cancer indication, which is expected to be eligible for national reimbursement negotiations [5][6] - Positive results from the SACHI and SAVANNAH trials for ORPATHYS were presented at major conferences, showing significant improvements in progression-free survival compared to chemotherapy [5][7] - The company plans to initiate clinical trials for multiple ATTC drug candidates by late 2025, leveraging its expertise in targeted therapies [19][20] Regulatory Updates - The company has streamlined its sales force to enhance productivity and adapt to the evolving competitive landscape in the pharmaceutical sector [9][10] - HUTCHMED is focusing on science-driven commercial activities to differentiate its products amid increasing competition [9][10] Collaboration and Strategic Focus - HUTCHMED aims to partner with multinational pharmaceutical companies to explore licensing opportunities, reflecting a favorable market sentiment towards Chinese biotech [6][7] - The company is actively deploying resources to expedite the development of drug candidates from its ATTC platform, which is expected to create collaboration opportunities [7][19]
HUTCHMED Reports 2024 Full Year Results and Provides Business Updates
Globenewswire· 2025-03-19 11:00
Core Insights - HUTCHMED reported a significant growth in oncology products revenue, achieving a 65% increase to $271.5 million in 2024, driven by a 134% rise in total oncology product in-market sales to $501.0 million [6][8][10] - The company reached profitability ahead of schedule, with a net income of $37.7 million for 2024, supported by a strong cash balance of $836.1 million as of December 31, 2024 [6][36][37] - HUTCHMED is advancing its pipeline with promising clinical results and the introduction of a new Antibody-Targeted Therapy Conjugate (ATTC) platform, which is expected to enhance drug development [5][24][38] Commercial Operations - Oncology product in-market sales increased by 134% to $501.0 million in 2024, compared to $213.6 million in 2023, with FRUZAQLA (fruquintinib) ex-China sales reaching $290.6 million [8][12] - ELUNATE (fruquintinib in China) sales grew by 7% to $115.0 million, maintaining a leading market share in metastatic colorectal cancer [9][34] - The company achieved a consolidated revenue of $630.2 million in 2024, down from $838.0 million in 2023, primarily due to lower revenue from other ventures [32][39] Pipeline Progress - HUTCHMED's pipeline includes several key products, with savolitinib achieving positive interim analysis results in the SACHI Phase III trial for EGFRm NSCLC, leading to a swift NDA filing [6][16][18] - Positive results from the SAVANNAH global pivotal Phase II trial for savolitinib in combination with TAGRISSO were shared with global regulatory authorities [6][18] - The ATTC platform is expected to yield new drug candidates that are more selective and tolerable than previous generations, enhancing the company's R&D capabilities [24][29] Financial Performance - The company reported a net income of $37.7 million in 2024, a decrease from $100.8 million in 2023, with earnings per share dropping to $0.04 from $0.12 [36][44] - Total operating expenses decreased to $673.9 million in 2024 from $819.6 million in 2023, reflecting strong cost control measures [35][44] - Cash and cash equivalents decreased to $836.1 million as of December 31, 2024, compared to $886.3 million in the previous year [37][43] Regulatory Updates - Savolitinib received NDA acceptance with Priority Review status for 2L EGFRm NSCLC patients with MET amplification, and full approval for METex14 NSCLC was granted in January 2025 [16][19] - Fruquintinib was approved in multiple countries, including the EU and Japan, for colorectal cancer, with significant sales milestones achieved [19][24] - The company is actively engaging with regulatory authorities to expedite the approval process for its innovative medicines [6][16]