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HUTCHMED Highlights Clinical Data to be Presented at the ESMO Congress 2025
Globenewswire· 2025-10-02 00:00
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]
大行评级|招银国际:下调和黄医药目标价至31.39港元 维持“买入”评级
Ge Long Hui· 2025-08-12 06:13
Core Viewpoint - The report from CMB International indicates that Hutchison China MediTech's revenue from oncology and immunology products decreased by 15% year-on-year to $144 million, achieving only 36% of the annual forecast due to a decline in domestic sales of core products [1] Group 1: Financial Performance - Revenue from oncology and immunology products fell to $144 million, a 15% decrease compared to the previous year [1] - The company has revised its full-year revenue target for oncology and immunology products from $350 million to $450 million down to $270 million to $350 million [1] Group 2: Management Outlook - Management remains optimistic for the second half of the year, citing the launch of fruquintinib for endometrial cancer and the approval of savolitinib for MET+ EGFRm non-small cell lung cancer as key drivers [1] - The sales team restructuring has been completed, and management noted that sales hit a bottom in the first quarter and began to recover in the second quarter [1] Group 3: Analyst Ratings and Price Target - CMB International maintains a "Buy" rating on the stock despite the underwhelming first-half performance and lowered guidance [1] - The target price has been adjusted from HKD 34.03 to HKD 31.39 [1]
和黄医药- 2025 年上半年回顾 - 期待中国市场复苏;Fruzaqla 在海外持续增长-HUTCHMED (HCM)_ 1H25 Recap_ Looking for a recovery in China markets; Fruzaqla growth continues abroad
2025-08-11 01:21
Summary of HUTCHMED (HCM) Conference Call Company Overview - **Company**: HUTCHMED (HCM) - **Industry**: Biotechnology and Pharmaceuticals Key Points Financial Performance - **1H25 Earnings Results**: Total topline revenue of $277.7 million, which is -13% and -18% below Goldman Sachs estimates of $337.8 million and Visible Alpha consensus of $318.1 million respectively [1][4] - **Earnings per Share (EPS)**: Reported at $0.52, significantly above estimates due to a one-time gain of $477.5 million from reducing stake in SHPL from 45% to 5% [1][4] - **Revenue Guidance**: FY25 consolidated oncology revenue guidance reduced to $270 million - $350 million from $350 million - $450 million [1][4] Market Dynamics - **Challenges in China**: Increased competition for core products (Elunate, Sulanda, Orpathys) and regulatory changes affecting sales and marketing teams [1][4] - **Sales Performance**: - **Elunate**: Sales decreased by -29% year-over-year due to competition and generics [4] - **Sulanda**: Sales decreased by -50% attributed to competition from new somatostatin analogue drugs [4] - **Orpathys**: Sales declined by -41% due to competing drugs being added to the National Reimbursement Drug List (NRDL) [4] - **Fruzaqla Growth**: Sales increased by 25% outside China, primarily driven by market expansion in Europe and Japan, though growth in the US was moderate due to competition [1][4] Pipeline and Future Outlook - **Sovleplenib**: NDA re-submission delayed; targeting re-submission in 1H26 [5] - **Savolitinib**: Enrollment ongoing in Phase 3 SAFFRON study, potential for global regulatory filings if successful [5] - **ATTC Platform**: New antibody-targeted therapy conjugates platform with preclinical data expected later this year, initial partner responses are positive [6] Model Adjustments - **Revenue Estimates**: Adjustments made to reflect 1H25 actuals and increased competition, leading to lower near-term revenue estimates [8] - **2025 Estimates**: Revenue revised down to $583.3 million from $688.3 million, reflecting a -15.3% change [9] Valuation and Risks - **Price Target**: Maintained at $18 for ADR listed in the US, with a 12-month upside of 10.4% [12][14] - **Key Risks**: Include clinical success/failure, regulatory risks, financial risks under HFCAA, and potential for better-than-expected commercial sales [12] Conclusion - **Investment Rating**: Neutral, with ongoing monitoring of pipeline progress and commercial recovery potential in China [1][12]
HUTCHMED Highlights SACHI Phase III Study Data Presented at the 2025 ASCO Annual Meeting
Globenewswire· 2025-06-02 00:00
Core Insights - The SACHI Phase III study demonstrated that the combination of savolitinib and osimertinib significantly improves progression-free survival (PFS) in patients with EGFR mutation-positive non-small cell lung cancer (NSCLC) with MET amplification compared to chemotherapy [1][4][9] Study Overview - SACHI is a Phase III clinical trial focusing on the combination of savolitinib and osimertinib for treating patients with locally advanced or metastatic EGFR mutation-positive NSCLC with MET amplification after progression on first-line EGFR inhibitor therapy [2] Efficacy Results - In the intention-to-treat population, the median PFS was 8.2 months for the savolitinib plus osimertinib group versus 4.5 months for the chemotherapy group, with a hazard ratio (HR) of 0.34 [4] - The independent review committee assessed median PFS at 7.2 months for the combination therapy compared to 4.2 months for chemotherapy, with an HR of 0.40 [4] - The objective response rate (ORR) was 58% for the combination group compared to 34% for chemotherapy, and the disease control rate (DCR) was 89% versus 67% [5] Safety Profile - The combination therapy exhibited a tolerable safety profile, with treatment-emergent adverse events of Grade 3 or above occurring in 57% of patients in both the savolitinib plus osimertinib and chemotherapy groups [7][8] Regulatory Status - The Independent Data Monitoring Committee concluded that the study met its primary endpoint of PFS, leading to the conclusion of patient enrollment [9] - A New Drug Application (NDA) for the combination therapy has been accepted and granted priority review by the China National Medical Products Administration (NMPA) [9] Company Background - HUTCHMED is an innovative biopharmaceutical company focused on the discovery and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases [13]
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
Globenewswire· 2025-04-24 00:00
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].
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].
HUTCHMED Completes Patient Enrollment of a Phase II Registration Study of Savolitinib in Gastric Cancer in China
Globenewswire· 2025-04-22 00:00
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].
HUTCHMED Completes Patient Enrollment of a Phase II Registration Study of Savolitinib in Gastric Cancer in China
Newsfilter· 2025-04-22 00:00
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].
HUTCHMED Highlights Savolitinib SAVANNAH Phase II and Other Data at European Lung Cancer Congress 2025
Newsfilter· 2025-03-20 00:00
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]