Core Insights - HUTCHMED will present new and updated data from several studies at the ESMO Congress 2025, scheduled for October 17-21, 2025, in Berlin, Germany [1][2] Group 1: Study Presentations - Results from the FRUSICA-2 study on the combination of fruquintinib and sintilimab for second-line treatment of advanced renal cell carcinoma will be presented in a Mini Oral session [2] - Additional analyses from the FRUSICA-1 study in endometrial cancer and the SACHI and SAVANNAH studies in non-small cell lung cancer will be showcased during poster sessions [2] - Specific presentations include a phase 3 study comparing fruquintinib plus sintilimab against axitinib or everolimus for renal cell carcinoma [2] Group 2: Drug Information - Fruquintinib is a selective oral inhibitor of VEGFRs and is co-developed by HUTCHMED and Eli Lilly, marketed as ELUNATE® in China [4] - Savolitinib is a selective MET tyrosine kinase inhibitor developed by AstraZeneca and HUTCHMED, commercialized as ORPATHYS® [5] - Surufatinib is an oral angio-immuno kinase inhibitor marketed in China as SULANDA® and retains all rights with HUTCHMED [8]

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]

Core Insights - HUTCHMED is presenting new and updated data on its compounds savolitinib, fruquintinib, and surufatinib at the AACR Annual Meeting 2025, highlighting ongoing research and development efforts in oncology [1][2]. Company Overview - HUTCHMED is an innovative, commercial-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases [11]. - The company has successfully marketed three medicines in China, with its first drug also approved in the US, Europe, and Japan [11]. Product Information - **Savolitinib**: An oral, selective MET tyrosine kinase inhibitor developed in collaboration with AstraZeneca, approved in China for treating advanced or metastatic NSCLC with MET exon 14 skipping alterations [5][6]. - **Fruquintinib**: Undergoing clinical development for various tumor types, including colorectal cancer, and is being studied in combination with other therapies [2][5]. - **Surufatinib**: Currently in clinical trials for advanced neuroendocrine tumors and other cancers, with ongoing studies to assess its efficacy in combination with other treatments [2][3]. Clinical Trials and Research - The **SAVANNAH** study is evaluating the combination of savolitinib and osimertinib in NSCLC patients who have progressed after EGFR TKI treatment, with promising results leading to further Phase III trials [7][9]. - The **SACHI** trial has met its primary endpoint of progression-free survival, supporting the combination of savolitinib and TAGRISSO for specific NSCLC patients [9][10]. - The **SAFFRON** trial is assessing the efficacy of savolitinib plus TAGRISSO against platinum-based chemotherapy in a similar patient population [10]. Market Context - Lung cancer remains the leading cause of cancer death globally, with a significant patient population in China, where over a third of the world's lung cancer patients reside [4]. - Non-small cell lung cancer (NSCLC) accounts for approximately 80% of lung cancer cases, with a notable prevalence of EGFR mutations and MET alterations among patients [4].

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].

Core Insights - The SAVANNAH Phase II trial demonstrated high and durable response rates for savolitinib combined with TAGRISSO® in patients with MET-high lung cancer, indicating a promising oral treatment strategy for advanced cases [1][2][3] - Long-term survival benefits and safety were observed in the Phase IIIb study of savolitinib for patients with METex14 NSCLC, particularly in treatment-naïve patients [1][7] Group 1: SAVANNAH Phase II Trial Results - The SAVANNAH Phase II trial showed a confirmed objective response rate (ORR) of 56% (95% CI: 45%–67%) and a median duration of response (DoR) of 7.1 months (95% CI: 5.6–9.6) for savolitinib plus TAGRISSO® [3][4] - The median progression-free survival (PFS) was reported as 7.4 months (95% CI: 5.5–7.6) [3] Group 2: Safety Profile - Safety results indicated that Grade 3 or higher adverse events occurred in 57% of patients, with 32% experiencing Grade 3 or higher treatment-related adverse events [4] - No new safety concerns were reported, aligning with the established safety profiles of the medications involved [4] Group 3: Phase IIIb Study Outcomes - In the Phase IIIb study, treatment-naïve patients had a median overall survival (OS) of 28.3 months (95% CI: 17.5–not evaluable), with a 36-month OS rate of 44.7% [7] - Previously treated patients had a median OS of 25.3 months (95% CI: 20.5–30.5), with a 24-month OS rate of 51.7% [7] Group 4: Drug Development and Approval - Savolitinib is a selective MET tyrosine kinase inhibitor developed by AstraZeneca and HUTCHMED, which received Fast Track Designation from the FDA in 2023 [5][14] - The drug is approved in China under the brand name ORPATHYS® for patients with MET exon 14 skipping alterations [8][15] Group 5: Surufatinib Study Insights - Surufatinib combined with PD-1/PD-L1 antibodies showed durable survival benefits in extensive-stage small cell lung cancer (SCLC) patients, with 12-month and 18-month OS rates of 57.1% for maintenance therapy [9] - The exploratory study involved 21 patients, with a median follow-up duration of 17.1 months for maintenance therapy [9] Group 6: Company Overview - HUTCHMED is a biopharmaceutical company focused on the discovery and commercialization of targeted therapies for cancer and immunological diseases [19] - The company has successfully brought multiple drug candidates to market, with its first three medicines approved in China and one also approved globally [19]