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].

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., April 24, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED including savolitinib, fruquintinib and surufatinib, which will be presented at the upcoming American Association of Cancer Research (AACR) Annual Meeting 2025, taking place on April 25-30, 2025 in Chicago, Illinois. Details of the presentations are as follows: Abs ...

Core Viewpoint - HUTCHMED has completed enrollment for the registration phase of its Phase II trial of savolitinib in gastric cancer patients with MET amplification, indicating progress in developing targeted therapies for this patient population [1][4]. Group 1: Clinical Trial Details - The Phase II trial is a single-arm, multi-center, open-label study aimed at evaluating the efficacy, safety, and tolerability of savolitinib in treating gastric cancer or gastroesophageal junction adenocarcinoma patients with MET amplification, with a total of 64 patients enrolled [2]. - The primary endpoint is the objective response rate (ORR) evaluated by the Independent Review Committee (IRC), while secondary endpoints include progression-free survival (PFS) and the incidence of adverse events [2]. Group 2: Interim Results - Interim results from the study reported a 45% ORR confirmed by IRC and a 50% ORR in patients with high MET gene copy number, with an 85.7% duration of response rate over four months and a median follow-up time of 5.5 months [3]. - The most common grade 3 or higher treatment-related adverse events included decreased platelet count, hypersensitivity, anemia, neutropenia, and hepatic function abnormalities, with only one patient discontinuing treatment due to a grade 4 liver function abnormality [3]. Group 3: Regulatory Designation and Market Potential - The National Medical Products Administration (NMPA) in China has granted Breakthrough Therapy Designation to savolitinib for treating locally advanced or metastatic gastric cancer or GEJ adenocarcinoma patients with MET amplification who have failed at least two lines of standard therapies [4]. - If the trial results are positive, HUTCHMED may apply for marketing authorization for savolitinib in China by late 2025, highlighting the potential market opportunity for this treatment [4]. Group 4: Background on Gastric Cancer and MET Amplification - MET-driven gastric cancer has a poor prognosis, with MET amplification accounting for approximately 4-6% of gastric cancer patients, translating to an estimated annual incidence of about 18,000 cases in China [5]. - Previous studies, including the VIKTORY study, have shown a 50% ORR in patients with MET amplification treated with savolitinib monotherapy, supporting the ongoing clinical development of this drug [5]. Group 5: About Savolitinib - Savolitinib is an oral, potent, and highly selective MET tyrosine kinase inhibitor developed jointly by AstraZeneca and HUTCHMED, currently approved in China for treating non-small cell lung cancer with MET exon 14 skipping alteration [6][7]. - The drug is also under clinical development for multiple tumor types, including lung, kidney, and gastric cancers, both as a monotherapy and in combination with other treatments [8].

Core Viewpoint - HUTCHMED has completed enrollment for the registration phase of its Phase II trial of savolitinib in gastric cancer patients with MET amplification, indicating progress in developing targeted therapies for this patient population [1][4]. Group 1: Clinical Trial Details - The Phase II trial is a single-arm, multi-center, open-label study aimed at evaluating the efficacy, safety, and tolerability of savolitinib in treating gastric cancer or gastroesophageal junction adenocarcinoma patients with MET amplification, with a total of 64 patients enrolled [2]. - The primary endpoint is the objective response rate (ORR) evaluated by the Independent Review Committee (IRC), while secondary endpoints include progression-free survival (PFS) and the incidence of various adverse events [2]. Group 2: Interim Results - Interim results from the study reported a 45% ORR confirmed by IRC and a 50% ORR in patients with high MET gene copy number, with an 85.7% duration of response (DOR) rate over a median follow-up of 5.5 months [3]. - The most common grade 3 or higher treatment-related adverse events included decreased platelet count, hypersensitivity, anemia, neutropenia, and hepatic function abnormalities, with only one patient discontinuing treatment due to a grade 4 liver function abnormality [3]. Group 3: Regulatory Designation and Market Potential - The National Medical Products Administration (NMPA) in China has granted Breakthrough Therapy Designation to savolitinib for treating locally advanced or metastatic gastric cancer or GEJ adenocarcinoma patients with MET amplification who have failed at least two lines of standard therapies [4]. - If the trial results are positive, HUTCHMED may apply for marketing authorization for savolitinib in China by late 2025, highlighting the potential market opportunity for this treatment [4][5]. Group 4: Background on Gastric Cancer and Savolitinib - MET-driven gastric cancer has a poor prognosis, with MET amplification accounting for approximately 4-6% of gastric cancer patients, translating to an estimated annual incidence of about 18,000 cases in China [5]. - Savolitinib is an oral, potent, and highly selective MET tyrosine kinase inhibitor developed by AstraZeneca and HUTCHMED, currently approved in China for treating non-small cell lung cancer with MET exon 14 skipping alteration [6][7].

Industry Overview - The Zacks Internet - Delivery Services industry is facing challenges due to macroeconomic uncertainty, inflation, and high interest rates, which are affecting the near-term outlook [1] - Escalating tariff tensions are threatening to squeeze both consumers and businesses, potentially leading to reduced discretionary and enterprise spending [1] - Companies in the industry are experiencing increased costs due to aggressive hiring and heavy investments in sales and marketing [1][8] - The industry primarily includes companies offering services via Internet-based platforms, such as food delivery, online travel booking, and web hosting [3] Growth Opportunities - Industry participants like GoDaddy, QuinStreet, and Asure Software are well-positioned for growth due to their adaptation to changing consumer preferences [2] - The rise of smartphones and improved Internet access are creating significant opportunities for the industry, with 4G and emerging 5G technology enhancing user experiences [4] - The shift in consumer preferences towards online services, particularly in food ordering and travel booking, is expected to benefit industry players [5] - Technological advancements, such as smart routing algorithms and real-time GPS tracking, are improving customer experiences and operational efficiencies [6] Challenges - The industry is facing risks from tariff wars, which can indirectly impact revenue growth and margins due to reduced spending from small businesses and startups [7] - Higher upfront costs associated with expansion strategies may hurt profitability, especially in the face of competition from larger tech companies like Amazon and Alphabet [8][9] - The industry's Zacks Industry Rank is 209, placing it in the bottom 15% of nearly 250 Zacks industries, indicating dim near-term prospects [10][11] Performance Metrics - The Zacks Internet - Delivery Services industry has outperformed the S&P 500 and the broader Computer and Technology sector over the past year, rising 17.7% compared to declines of 2.2% and 7.6%, respectively [15] - The industry is currently trading at a forward 12-month price-to-sales (P/S) ratio of 1.63X, significantly lower than the S&P 500's 4.37X and the sector's 4.92X [18] Company Highlights - **GoDaddy**: Engaged in domain registration and web hosting, benefiting from strong momentum in its Applications & Commerce business and expanding global footprint [23][24] - **QuinStreet**: A provider of online direct marketing services, positioned to capitalize on the shift to online business models and increasing ad spending [28][30] - **Asure Software**: Focused on human capital management solutions, driving growth through new client additions and innovation in its offerings [33][34]

Core Insights - Edgewise Therapeutics, Inc. reported topline data from the Phase 2 CIRRUS-HCM trial for EDG-7500, targeting obstructive and nonobstructive Hypertrophic Cardiomyopathy (HCM) [1][2] Group 1: Trial Results - In Part A of the trial, a single oral dose of EDG-7500 showed significant reductions in left ventricular outflow tract gradient (LVOT-G) without affecting left ventricular ejection fraction (LVEF) [2] - Part B included 17 participants with obstructive HCM, while Part C included 12 with nonobstructive HCM, both evaluating the safety and efficacy of once-daily doses of 50 or 100 mg of EDG-7500 for four weeks [3] - Participants receiving 100 mg experienced mean reductions of 71% in resting LVOT-G and 58% in provokable (Valsalva) gradients, achieved without meaningful changes in LVEF [6] Group 2: Biomarker and Clinical Improvements - In nonobstructive HCM participants, a 42% mean decrease in NT-proBNP was observed at the 100 mg dose [4] - Significant improvements in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS) and Clinical Summary Scores were noted, with mean increases of 17 points and 22 points, respectively, at the 100 mg dose after four weeks [4] - Treatment with 100 mg of EDG-7500 resulted in a 62% mean reduction in NT-proBNP, a key heart failure biomarker, and 78% of participants improved by at least one NYHA Class, with 67% improving to NYHA Class I [6] Group 3: Future Outlook - Initial data from Part D of the trial is expected in the second half of 2025, with Phase 3 initiation planned for the first half of 2026 [4]

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].

Core Viewpoint - HUTCHMED (China) Limited announces the retirement of two Independent Non-executive Directors, Mr. Paul Rutherford Carter and Mr. Graeme Allan Jack, effective after the upcoming annual general meeting on May 13, 2025, leading to changes in the board's composition and committee leadership [1][2][3]. Board Changes - Mr. Paul Rutherford Carter and Mr. Graeme Allan Jack will not seek re-election and will retire from the Board at the AGM, ceasing their roles as chairmen and members of board committees [1][2]. - Professor Mok Shu Kam, Tony will be appointed as Senior and Lead Independent Non-executive Director, and Mr. Wong Tak Wai will become the chairman of the Audit Committee [2][6]. - Dr. Chaohong Hu will join the Audit Committee, and Dr. Renu Bhatia will chair the Remuneration Committee [6]. Contributions of Retiring Directors - Mr. Carter has significantly influenced the company's remuneration policies, aiding in employee retention and motivation [3]. - Mr. Jack has played a crucial role in overseeing financial reporting and audit processes, ensuring integrity and transparency [3]. Company Overview - HUTCHMED is a biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases [4]. - The company has successfully marketed three medicines in China, with the first also approved globally, including in the US, Europe, and Japan [4].

Core Viewpoint - HUTCHMED (China) Limited announces the retirement of two Independent Non-executive Directors, Mr. Paul Rutherford Carter and Mr. Graeme Allan Jack, effective after the upcoming annual general meeting on May 13, 2025, leading to changes in the board composition and committee leadership [1][2][3]. Board Changes - Mr. Paul Rutherford Carter and Mr. Graeme Allan Jack will not seek re-election and will retire from the Board at the AGM, ceasing their roles as chairmen and members of board committees [1][2]. - Professor Mok Shu Kam, Tony will be appointed as Senior and Lead Independent Non-executive Director, and Mr. Wong Tak Wai will become the chairman of the Audit Committee and a member of the Remuneration Committee [2][6]. - Dr. Chaohong Hu will join the Audit Committee, and Dr. Renu Bhatia will chair the Remuneration Committee [6]. Contributions of Retiring Directors - Mr. Carter has significantly influenced the company's remuneration policies and practices, aiding in employee retention and motivation [3]. - Mr. Jack has played a crucial role in overseeing financial reporting and audit processes, ensuring integrity and transparency [3]. 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 [4]. - The company has successfully marketed its first three medicines in China, with the first also approved globally, including in the US, Europe, and Japan [4].

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]