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HUTCHMED Announces NMPA Conditional Approval for TAZVERIK® (tazemetostat) for the Treatment of Relapsed or Refractory Follicular Lymphoma
Newsfilter· 2025-03-21 10:00
Core Viewpoint - HUTCHMED's TAZVERIK® (tazemetostat) has received conditional approval from the NMPA in China for treating adult patients with relapsed or refractory follicular lymphoma with EZH2 mutations, marking a significant milestone for the company in hematological malignancies [1][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]. - TAZVERIK® is HUTCHMED's fourth product and its first approval in the field of hematological malignancies [1][3]. Product Details - TAZVERIK® is the first and only EZH2 inhibitor approved by the NMPA, following a multicenter Phase II bridging study in China and clinical studies conducted by Epizyme, Inc. [1][2]. - The approval is based on the objective response rate, duration of response, progression-free survival, and overall survival in patients with relapsed or refractory follicular lymphoma [2]. - TAZVERIK® has previously been approved in the Hainan Pilot Zone, Macau, and Hong Kong, indicating a growing acceptance in the Asia-Pacific region [4]. Clinical Studies - The ongoing SYMPHONY-1 study will serve as a confirmatory trial to validate the clinical benefits of TAZVERIK® in combination with rituximab and lenalidomide for patients with relapsed or refractory follicular lymphoma [5]. - The study is designed as an international, multicenter, randomized, double-blind, active-controlled trial [5]. Market Context - Follicular lymphoma is the second most common subtype of non-Hodgkin's lymphoma, accounting for 20-30% of all NHL cases, with an estimated 81,000 new cases in China in 2022 [6]. - The approval of TAZVERIK® addresses a significant unmet medical need for patients suffering from this challenging disease [3].
HUTCHMED Reports 2024 Full Year Results and Provides Business Updates
Newsfilter· 2025-03-19 11:00
Core Viewpoint - HUTCHMED reported strong financial results for 2024, achieving profitability and significant growth in oncology product sales, driven by the successful commercialization of FRUZAQLA® and other key products [5][6][8]. Group 1: Financial Performance - Total revenue for 2024 was $630.2 million, a decrease from $838.0 million in 2023 [32]. - Consolidated revenue from oncology products increased by 65% to $271.5 million, driven by strong sales of FRUZAQLA® and other oncology products [8][34]. - Net income attributable to HUTCHMED was $37.7 million in 2024, down from $100.8 million in 2023, with earnings per share at $0.04 [36][44]. Group 2: Product Sales and Market Performance - FRUZAQLA® (fruquintinib) ex-China in-market sales reached $290.6 million in 2024, a significant increase from $15.1 million in 2023, reflecting rapid uptake in the US and launches in multiple countries [6][8]. - Total oncology product in-market sales increased by 134% to $501.0 million in 2024, compared to $213.6 million in 2023 [8][11]. - ELUNATE® (fruquintinib in China) sales increased by 7% to $115.0 million, maintaining a leading market share in metastatic colorectal cancer [8][34]. Group 3: Clinical Development and Regulatory Updates - Positive results were reported for savolitinib in the SACHI Phase III interim analysis for EGFRm NSCLC with MET amplification, leading to a swift NDA filing in China [6][15]. - The company presented strong data for sovleplenib in the ESLIM-01 Phase III trial, showing a durable response rate of 51.4% for ITP patients [6][22]. - HUTCHMED's new ATTC platform is expected to enhance drug development, targeting a wide range of oncology indications [7][24]. Group 4: Strategic Developments - The company agreed to dispose of its 45% equity interest in SHPL for approximately $608 million, which is expected to support its innovative drug R&D [5][27]. - HUTCHMED aims to continue its global growth strategy, focusing on expanding its pipeline and commercializing its innovative medicines [5][7]. - The company is committed to sustainability and has made progress in integrating sustainability into its operations, receiving improved ESG ratings [28][30].