Core Insights - HUTCHMED has completed patient enrollment for the SANOVO Phase III study, evaluating the combination of ORPATHYS and TAGRISSO in treating non-small cell lung cancer (NSCLC) patients with specific genetic mutations [1][2][3] Group 1: Study Details - The SANOVO trial is a randomized, controlled study focusing on previously untreated patients with locally advanced or metastatic NSCLC, specifically those with activating EGFR mutations and MET overexpression [2] - The primary endpoint of the study is progression-free survival (PFS), with additional endpoints including overall survival (OS), objective response rate (ORR), and safety assessments [2] - Topline results from the SANOVO study are expected in the second half of 2026, which may lead to a supplementary New Drug Application submission to China's National Medical Products Administration (NMPA) if results are favorable [3] Group 2: Drug Information - ORPATHYS (savolitinib) is a selective MET tyrosine kinase inhibitor developed by AstraZeneca and HUTCHMED, while TAGRISSO (osimertinib) is a third-generation EGFR TKI [4][10] - ORPATHYS is already approved in China for specific NSCLC indications, including treatment for patients with MET exon 14 skipping alterations and in combination with TAGRISSO for EGFRm-positive NSCLC [8] - TAGRISSO has been used to treat over one million patients globally and has shown improved outcomes in various stages of NSCLC [10][11] Group 3: Market Context - Lung cancer is the leading cause of cancer death, with NSCLC accounting for 80-85% of cases, and a significant portion of patients diagnosed with advanced disease [5] - Approximately 10-15% of NSCLC patients in the US and Europe, and up to 40-50% in Asia, have EGFR-mutated NSCLC, highlighting a substantial market for targeted therapies [5][6] - The combination of ORPATHYS and TAGRISSO aims to address resistance mechanisms in advanced NSCLC, representing a promising treatment strategy [15][14]

— $455 million in net income attributable to HUTCHMED driven by non-core partial disposal — HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Aug. 07, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ("HUTCHMED", the "Company" or "we") (Nasdaq/AIM:HCM; HKEX:13) today reports its financial results for the six months ended June 30, 2025 and provides updates on key clinical and commercial developments. HUTCHMED to host results webcasts today at 8:00 a.m. EDT / 1:00 p.m. BST / 8:00 p.m. HKT in English on Thursday ...

Core Insights - The combination of ORPATHYS (savolitinib) and TAGRISSO (osimertinib) has been approved by the China National Medical Products Administration (NMPA) for treating patients with locally advanced or metastatic EGFR mutation-positive non-squamous non-small cell lung cancer (NSCLC) with MET amplification after progression on EGFR TKI therapy [1][2][3] - This combination treatment is the only all-oral option available for these patients, providing a chemotherapy-free approach [1][3] - The SACHI Phase III trial demonstrated a 66% reduction in the risk of disease progression or death compared to platinum-based chemotherapy, with a median progression-free survival (PFS) of 8.2 months for the combination versus 4.5 months for chemotherapy [1][3][12] Company Overview - HUTCHMED is an innovative biopharmaceutical company focused on the discovery and commercialization of targeted therapies for cancer and immunological diseases [15] - The approval of the ORPATHYS and TAGRISSO combination marks a significant milestone in HUTCHMED's mission to address MET-driven progression in NSCLC patients [3][15] - AstraZeneca collaborates with HUTCHMED to market both ORPATHYS and TAGRISSO in China, enhancing the reach of this new treatment option [3][15] Industry Context - Lung cancer is the leading cause of cancer death, with NSCLC accounting for 80-85% of cases [5] - Approximately 30-40% of NSCLC patients in Asia have EGFR mutations, highlighting the need for effective treatment options [5][6] - MET amplification is a common mechanism of acquired resistance to EGFR TKI therapy, affecting 15-50% of patients who experience disease progression [11][12]

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]