— First-in-human trial of candidate from the next-generation ATTC platform — — Simultaneous China and global clinical development strategy to expedite development process — HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Dec. 17, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces the initiation of its global Phase I clinical development program for HMPL-A251, a first-in-class PI3K/PIKK-HER2 Antibody-Targeted Therapy Conjugate (“ATTC”) comprising a highl ...

Core Insights - HUTCHMED announced preclinical data for HMPL-A251, a first-in-class PI3K/AKT/mTOR-HER2 Antibody-Targeted Therapy Conjugate, at the AACR-NCI-EORTC International Conference, showcasing its potential in cancer treatment [1][5] Summary by Sections Drug Candidate Overview - HMPL-A251 utilizes HUTCHMED's ATTC technology platform to create targeted therapy payloads while reducing associated toxicities [1] - The drug is designed to exploit the advantages of antibody-conjugates, featuring a highly potent PI3K/PIKK inhibitor payload linked to a humanized anti-HER2 IgG1 antibody [1][2] Mechanism of Action - The PI3K/PIKK inhibitor payload demonstrated high potency and selectivity across 130 tumor cell lines, inducing apoptosis in HER2-positive cells regardless of PAM pathway alterations [3] - HMPL-A251 showed a bystander effect on HER2-null cells when co-cultured with HER2-positive cells, indicating its broad anti-tumor activity [3] Efficacy and Safety - In vivo studies revealed that HMPL-A251 had superior anti-tumor efficacy and tolerability compared to traditional naked antibodies and payloads [4] - A single intravenous dose of HMPL-A251 led to tumor regression in various models, with efficacy correlating strongly with payload concentration and target inhibition [4] Comparison with Existing Treatments - When compared to T-DXd (trastuzumab deruxtecan), HMPL-A251 achieved superior or comparable efficacy at equivalent doses in most tested models [4] - The plasma exposure of free payload was significantly lower than for HMPL-251, suggesting reduced toxicity [4] Future Development Plans - HUTCHMED plans to initiate global clinical trials for HMPL-A251 by the end of 2025, with additional Investigational New Drug filings for more ATTC candidates in 2026 [5] ATTC Platform Insights - The ATTC platform represents a next-generation approach to precision oncology, combining monoclonal antibodies with small-molecule inhibitor payloads for enhanced anti-tumor activity and safety [6][7] - This platform aims to overcome challenges associated with traditional small-molecule inhibitors and improve long-term safety and efficacy in cancer treatments [7] Company Background - HUTCHMED is a commercial-stage biopharmaceutical company focused on the discovery and development of targeted therapies and immunotherapies for cancer and immunological diseases [8]

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].