Workflow
fruquintinib
icon
Search documents
瑞银:中国医疗健康-欧盟对中国医疗科技企业的市场准入限制
瑞银· 2025-06-10 07:30
ab 6 June 2025 Global Research Drug-related news China Healthcare Weekly recap: EU's market access restrictions for Chinese medtech firms A and H healthcare indices maintained upward trend this week Over 2-6 June, HSHCI rose 4.1% and HSHKBIO rose 4.5%. SW healthcare A/H rose 1.1%/1.9%, ranking 17th/13th among A/H share sectors, with chemicals outperforming both in A (up 1.7%) and H (up 3.8%), mainly due to the positive ASCO data presentations of multiple companies, in our view. Our top picks: Wuxi Apptec an ...
Innovent and HUTCHMED Jointly Announce NDA Acceptance in China for Sintilimab Combination with Fruquintinib for the Treatment of Advanced Renal Cell Carcinoma
Prnewswire· 2025-06-05 00:00
SAN FRANCISCO and SUZHOU, China, June 4, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, and HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13), today jointly announce that the New Drug Application (NDA) for the combination of sintilimab and fruquint ...
HUTCHMED Highlights Clinical Data to be Presented at the 2025 ASCO Annual Meeting
Globenewswire· 2025-05-23 00:00
Core Insights - HUTCHMED is set to present new data on its compounds at the ASCO Annual Meeting from May 30 to June 3, 2025, in Chicago, USA [1] Group 1: Savolitinib - The SACHI Phase III study results of savolitinib in combination with osimertinib for EGFR mutation-positive NSCLC will be presented, showing that it met the primary endpoint of progression-free survival (PFS) [2] - Additional data from the SAVANNAH Phase II study indicates that the combination of savolitinib and osimertinib showed better efficacy outcomes compared to savolitinib plus placebo, with promising CNS activity [3] Group 2: Ranosidenib - Results from the Phase I study of ranosidenib (HMPL-306) indicate it was well tolerated, with target inhibition and durable responses, particularly in lower-grade glioma patients, showing an objective response rate (ORR) of 7.1% and a disease control rate (DCR) of 100% [4] Group 3: Fruquintinib - The FRUSICA-1 Phase II study results for fruquintinib plus sintilimab in advanced endometrial cancer patients showed an ORR of 37.0% and a DCR of 88.9%, with durable responses regardless of prior chemotherapy [5] - A Phase IV study involving 2,798 colorectal cancer patients demonstrated a manageable safety profile for fruquintinib, with Grade 3 or above treatment-emergent adverse events occurring in 23.94% for monotherapy and 26.06% for combination therapy [6]
HUTCHMED Highlights Data to be Presented at AACR Annual Meeting 2025
Newsfilter· 2025-04-24 00:00
Company Overview - HUTCHMED (China) Limited is an innovative, commercial-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases [12]. Recent Developments - HUTCHMED announced new and updated data from studies of its compounds, including savolitinib, fruquintinib, and surufatinib, which will be presented at the American Association of Cancer Research (AACR) Annual Meeting 2025 [1]. - The company is actively involved in multiple clinical trials, including the SACHI and SAFFRON trials, assessing the combination of savolitinib with TAGRISSO® (osimertinib) for treating patients with advanced non-small cell lung cancer (NSCLC) [10][11]. Product Information - Savolitinib is a selective MET tyrosine kinase inhibitor developed by HUTCHMED and AstraZeneca, approved in China for treating adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alterations [7][6]. - Fruquintinib is being studied in various treatment regimens for metastatic colorectal cancer (mCRC), with ongoing trials evaluating its efficacy in combination with other therapies [2][3]. Market Context - Lung cancer is the leading cause of cancer death globally, with NSCLC accounting for approximately 80% of cases. A significant portion of NSCLC patients in Asia have epidermal growth factor receptor (EGFR) mutations, which are targetable by therapies like savolitinib [4][5]. - The prevalence of MET aberrations in NSCLC patients who progress after EGFR TKI treatment is notable, with studies indicating that 15-50% of these patients may present with such mutations [8][9]. Clinical Trial Highlights - The SACHI trial met its primary endpoint of progression-free survival (PFS) during its interim analysis, leading to the acceptance of a New Drug Application (NDA) in China [10]. - The SAFFRON trial is ongoing, assessing the combination of savolitinib and TAGRISSO® against platinum-based chemotherapy in a specific patient population [11]. Future Prospects - HUTCHMED is focused on expanding the clinical development of its compounds, with promising data from ongoing trials expected to support potential regulatory filings in the US and other global markets [9][11].