Articles from HUTCHMED (China) Limited
HUTCHMED Announces NMPA Full Approval for ORPATHYS® (savolitinib) in China for Patients with Locally Advanced or Metastatic MET Exon 14 NSCLC
— Indication expands to include treatment-naïve patients —
By HUTCHMED (China) Limited · Via GlobeNewswire · January 13, 2025
HUTCHMED Announces NDA Acceptance in China with Priority Review Status for ORPATHYS® and TAGRISSO® Combination in Lung Cancer Patients with MET amplification After Progression on First-Line EGFR Inhibitor Therapy
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Jan. 02, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the New Drug Application (“NDA”) for the combination of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (“EGFR”) mutation-positive non-small cell lung cancer (“NSCLC”) with MET amplification after disease progression on first-line EGFR inhibitor therapy has been accepted and granted priority review by the China National Medical Products Administration (“NMPA”). ORPATHYS® is an oral, potent and highly selective MET tyrosine kinase inhibitor (“TKI”). TAGRISSO® is a third-generation, irreversible EGFR TKI. This acceptance also triggers a milestone payment from AstraZeneca.
By HUTCHMED (China) Limited · Via GlobeNewswire · January 1, 2025
HUTCHMED Announces US$608 million Divestment of Non-Core Joint Venture
— HUTCHMED continues to deliver on its strategy outlined in November 2022 to create value, prioritize its portfolio and bring innovative medicines to patients globally —
By HUTCHMED (China) Limited · Via GlobeNewswire · January 1, 2025
HUTCHMED to Receive Milestone Payment from Takeda following First European Reimbursement for FRUZAQLA® (fruquintinib)
— US$10 million milestone payment to HUTCHMED follows first national reimbursement in Europe —
By HUTCHMED (China) Limited · Via GlobeNewswire · December 12, 2024
HUTCHMED Announces Breakthrough Therapy Designation in China for ORPATHYS® and TAGRISSO® Combination in Certain Lung Cancer Patients After Disease Progression on EGFR Inhibitor Therapy
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Dec. 11, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the Center for Drug Evaluation of China’s National Medical Products Administration (“NMPA”) has granted Breakthrough Therapy Designation (“BTD”) to the combination of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (“EGFR”) mutation‑positive non‑small cell lung cancer (“NSCLC”) with MET amplification after disease progression on EGFR inhibitor therapy. ORPATHYS® is an oral, potent and highly selective MET tyrosine kinase inhibitor (“TKI”). TAGRISSO® is a third-generation, irreversible EGFR TKI.
By HUTCHMED (China) Limited · Via GlobeNewswire · December 11, 2024
HUTCHMED and Innovent Jointly Announce NMPA Conditional Approval for ELUNATE® (Fruquintinib) in Combination with TYVYT® (Sintilimab Injection) for the Treatment of Advanced Endometrial Cancer
— First regulatory approval for fruquintinib combination therapy with an immune checkpoint inhibitor —
By HUTCHMED (China) Limited · Via GlobeNewswire · December 3, 2024
HUTCHMED Announces Continued Inclusion of ORPATHYS® (savolitinib) in the National Reimbursement Drug List in China at Current Terms
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Nov. 28, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that following the contract renewal with the China National Healthcare Security Administration (“NHSA”), the updated National Reimbursement Drug List (“NRDL”) effective on January 1, 2025 will continue to include ORPATHYS® (savolitinib) at the same terms as the current two-year agreement.
By HUTCHMED (China) Limited · Via GlobeNewswire · November 28, 2024
HUTCHMED Announces Launch by Takeda of FRUZAQLA® (fruquintinib) in Japan
— Launch follows approval by Japanese Ministry of Health, Labour and Welfare in September 2024 —
By HUTCHMED (China) Limited · Via GlobeNewswire · November 21, 2024
HUTCHMED Announces Appointment of Independent Non-executive Director and Member of Board Committee
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Nov. 20, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED” or the “Company”) (Nasdaq/AIM:HCM, HKEX:13) today announces that Dr Chaohong Hu (Dr Mary Hu) is appointed as an Independent Non-executive Director and a member of the Technical Committee of the Company with effect from November 21, 2024.
By HUTCHMED (China) Limited · Via GlobeNewswire · November 20, 2024
HUTCHMED Highlights Clinical Data to be Presented at the 2024 ASH Annual Meeting and the 2024 ESMO Asia Congress
HONG KONG, SHANGHAI, and FLORHAM PARK, N.J., Nov. 05, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from the sovleplenib ESLIM-01 Phase III trial, as well as several investigator-initiated studies of compounds discovered by HUTCHMED will be presented at the American Society of Hematology (“ASH”) Annual Meeting taking place on December 7-10, 2024 in San Diego, USA, and the European Society for Medical Oncology (“ESMO”) Asia Congress 2024, taking place on December 6-8, 2024 in Singapore.
By HUTCHMED (China) Limited · Via GlobeNewswire · November 5, 2024
HUTCHMED to Receive First Commercial Milestone Payment Following Over US$200 Million in FRUZAQLA® (fruquintinib) Sales by Takeda
— US$20 million payment based on sales of FRUZAQLA® in metastatic colorectal cancer —
By HUTCHMED (China) Limited · Via GlobeNewswire · October 31, 2024
HUTCHMED Announces that TAGRISSO® plus ORPATHYS® demonstrated high, clinically meaningful response rate in lung cancer patients with high levels of MET overexpression and/or amplification in SAVANNAH Phase II trial
— New data demonstrate efficacy for the oral treatment combination to address MET-driven resistance in EGFR-mutated lung cancer —
By HUTCHMED (China) Limited · Via GlobeNewswire · October 16, 2024
HUTCHMED Announces Japan Approval for FRUZAQLA® (fruquintinib) Received by Takeda
— Approval based on results from global Phase III FRESCO-2 trial in patients with previously treated metastatic colorectal cancer —
By HUTCHMED (China) Limited · Via GlobeNewswire · September 24, 2024
HUTCHMED Highlights Clinical Data to be Presented at ESMO Congress 2024 and the 2024 World Conference of Lung Cancer
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Sept. 09, 2024 (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 will be presented at the 2024 World Conference on Lung Cancer (“WCLC24”) in San Diego, USA, and the European Society for Medical Oncology (“ESMO”) Congress 2024, taking place in Barcelona, Spain.
By HUTCHMED (China) Limited · Via GlobeNewswire · September 8, 2024
HUTCHMED Provides Update on Fruquintinib for Second-Line Gastric Cancer in China
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Aug. 30, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has voluntarily withdrawn its supplemental New Drug Application (“NDA”) in China for fruquintinib in combination with paclitaxel for the treatment of second-line advanced gastric or gastroesophageal junction adenocarcinoma and will evaluate a new route forward. Following an additional internal review of the current data package, in light of recent discussions with the National Medical Products Administration of China (“NMPA”), HUTCHMED has determined that the submission is unlikely to support an approval in China at this time.
By HUTCHMED (China) Limited · Via GlobeNewswire · August 30, 2024
HUTCHMED to Host Expert Call to discuss Immune Thrombocytopenia
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Aug. 21, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it will host a physician expert call with a professor and key opinion leader in immune thrombocytopenia (“ITP”), to discuss the treatment landscape of ITP via webcast on Wednesday, August 28, 2024, at 7:00 p.m. HKT.
By HUTCHMED (China) Limited · Via GlobeNewswire · August 21, 2024
HUTCHMED Reports 2024 Interim Results and Provides Business Updates
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., July 31, 2024 (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, 2024 and provides updates on key clinical and commercial developments.
By HUTCHMED (China) Limited · Via GlobeNewswire · July 31, 2024
HUTCHMED Announces NDA Acceptance in China for Tazemetostat for the Treatment of Relapsed or Refractory Follicular Lymphoma with Priority Review Status
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., July 04, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the New Drug Application (“NDA”) for tazemetostat for the treatment of adult patients with relapsed or refractory (“R/R”) follicular lymphoma (“FL”) has been accepted for review and granted Priority Review by the China National Medical Products Administration (“NMPA”).
By HUTCHMED (China) Limited · Via GlobeNewswire · July 3, 2024
HUTCHMED to Announce 2024 Half-Year Financial Results
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., June 26, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; SEHK:13) will be announcing its interim results for the six months ended June 30, 2024 on Wednesday, July 31, 2024 at 7:00 am Eastern Daylight Time (EDT) / 12:00 noon British Summer Time (BST) / 7:00 pm Hong Kong Time (HKT).
By HUTCHMED (China) Limited · Via GlobeNewswire · June 26, 2024
Save the Date: HUTCHMED to Present R&D Updates on July 9, 2024
— HUTCHMED will host in-person presentation and online webinar on Tuesday, July 9 —
By HUTCHMED (China) Limited · Via GlobeNewswire · June 24, 2024
HUTCHMED Announces European Commission Approval for FRUZAQLA® (fruquintinib) Received by Takeda
— Approval for previously treated metastatic colorectal cancer based on results from positive, global, Phase III FRESCO-2 Trial —
By HUTCHMED (China) Limited · Via GlobeNewswire · June 21, 2024
HUTCHMED Highlights Publication of Phase III ESLIM-01 Results in The Lancet Haematology
— Publication shows treatment demonstrated durable response rate of 48.4% vs. 0% with placebo —
By HUTCHMED (China) Limited · Via GlobeNewswire · June 16, 2024
HUTCHMED Initiates Phase I Trial of Menin Inhibitor HMPL-506 in Patients with Hematological Malignancies in China
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., June 06, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated Phase I clinical trial of its menin inhibitor HMPL-506 in patients with hematological malignancies in China. The first patient received their first dose on May 31, 2024.
By HUTCHMED (China) Limited · Via GlobeNewswire · June 6, 2024
HUTCHMED Highlights Publication of Phase III FRUTIGA Results in Nature Medicine
Updated subgroup efficacy and quality of life data were also presented on June 1 at ASCO 2024
By HUTCHMED (China) Limited · Via GlobeNewswire · June 2, 2024
HUTCHMED Highlights Presentations at the 2024 ASCO Annual Meeting
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., May 23, 2024 (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 will be presented at the upcoming American Society of Clinical Oncology (“ASCO”) Annual Meeting, taking place May 31 – June 4, 2024 in Chicago, IL and online.
By HUTCHMED (China) Limited · Via GlobeNewswire · May 23, 2024
HUTCHMED announces retirement of Chairman, appointment of new Chairman and change of members of board committees
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., May 17, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED” or the “Company”) (Nasdaq/AIM:HCM, HKEX:13) today announces:-
By HUTCHMED (China) Limited · Via GlobeNewswire · May 17, 2024
HUTCHMED Highlights Sovleplenib Phase III ESLIM-01 Study and Hematological Malignancy Programs Data to be Presented at the upcoming EHA2024 Congress
HONG KONG, SHANGHAI and FLORHAM PARK, N.J., May 17, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that topline and subgroup results from the ESLIM-01 Phase III study of sovleplenib, as well as new and updated data related to novel investigational hematological malignancy therapies HMPL-306, HMPL-760 and tazemetostat, will be presented at the upcoming European Hematology Association (“EHA”) Hybrid Congress, taking place on June 13-16, 2024 in Madrid, Spain and online.
By HUTCHMED (China) Limited · Via GlobeNewswire · May 16, 2024
HUTCHMED Initiates the RAPHAEL Registrational Phase III Trial of HMPL-306 for Patients with IDH1- and/or IDH2-Mutated Relapsed/Refractory Acute Myeloid Leukemia in China
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., May 14, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated a registrational Phase III clinical trial of HMPL-306 in patients with mutated isocitrate dehydrogenase (“IDH”) 1 or 2 relapsed / refractory acute myeloid leukemia (“AML”) in China. The first patient received their first dose on May 11, 2024.
By HUTCHMED (China) Limited · Via GlobeNewswire · May 13, 2024
HUTCHMED Initiates Phase II/III Trial of the Combination of Surufatinib and Camrelizumab for Treatment-Naïve Pancreatic Ductal Adenocarcinoma in Collaboration with Hengrui
— Almost half a million people diagnosed each year across the globe —
By HUTCHMED (China) Limited · Via GlobeNewswire · May 13, 2024
HUTCHMED Announces Appointment of Independent Non-executive Director and Member of Board Committee
HONG KONG, SHANGHAI, China and FLORHAM PARK, N.J., May 08, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED” or the “Company”) (Nasdaq/AIM: HCM, HKEX: 13) today announces that Dr Renu Bhatia is appointed as an Independent Non-executive Director and a member of Technical Committee of the Company with effect from May 13, 2024.
By HUTCHMED (China) Limited · Via GlobeNewswire · May 8, 2024
HUTCHMED Announces Positive CHMP Opinion for Fruquintinib in Previously Treated Metastatic Colorectal Cancer Received by Takeda
— If approved in the European Union, fruquintinib will be the first novel targeted therapy for metastatic colorectal cancer regardless of biomarker status in over a decade —
By HUTCHMED (China) Limited · Via GlobeNewswire · April 26, 2024
HUTCHMED Highlights Data to be Presented at AACR Congress 2024
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., April 05, 2024 (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 will be presented at the upcoming American Association of Cancer Research (“AACR”) Annual Meeting 2024, taking place on April 5-10, 2024 in San Diego, California.
By HUTCHMED (China) Limited · Via GlobeNewswire · April 5, 2024
HUTCHMED and Innovent Jointly Announce NDA Acceptance in China for Fruquintinib Combination with Sintilimab for the Treatment of Advanced Endometrial Cancer with Priority Review Status
— NDA accepted and both fruquintinib and sintilimab granted Priority Review, following Breakthrough Therapy designation in July 2023 —
By HUTCHMED (China) Limited · Via GlobeNewswire · April 2, 2024
HUTCHMED Announces Savolitinib sNDA Accepted in China for Treatment-Naïve or Previously Treated Patients with Locally Advanced or Metastatic MET Exon 14 NSCLC
— Oral presentation at the European Lung Cancer Congress 2024 of Phase IIIb data demonstrating median PFS of 13.7 months and median OS not reached in treatment-naïve patients —
By HUTCHMED (China) Limited · Via GlobeNewswire · March 27, 2024
HUTCHMED Reports 2023 Full Year Results and Provides Business Updates
Revenue grew 97% (102% CER) to US$838 million, with net income of US$101 million
By HUTCHMED (China) Limited · Via GlobeNewswire · February 28, 2024
HUTCHMED Highlights Presentation of Phase III Data on Fruquintinib in Second-Line Gastric Cancer at ASCO Plenary Series Session
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Feb. 06, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that data from FRUTIGA, HUTCHMED’s Phase III trial of fruquintinib in combination with paclitaxel for the treatment of second-line advanced gastric cancer in China, were presented at the American Society of Clinical Oncology (“ASCO”) Plenary Series Session on February 6, 2024. The full presentation can be found here. Fruquintinib is a selective oral inhibitor of vascular endothelial growth factor receptors (“VEGFR”) -1, -2 and -3, which play a pivotal role in blocking tumor angiogenesis.
By HUTCHMED (China) Limited · Via GlobeNewswire · February 6, 2024
HUTCHMED Announces that Inmagene Exercises Option to License Two Drug Candidates as Part of Strategic Partnership
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Feb. 02, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announced that, Inmagene Biopharmaceuticals (“Inmagene”) has exercised options to license two drug candidates discovered by HUTCHMED, IMG-007 and IMG-004 (the “Options”) pursuant to the terms of the strategic partnership announced on January 11, 2021. Following the exercise of the Options and subject to receipt by HUTCHMED of ordinary shares representing approximately 7.5% of shares (fully diluted) in Inmagene, Inmagene will be granted an exclusive license to further develop, manufacture and commercialize these two drug candidates worldwide.
By HUTCHMED (China) Limited · Via GlobeNewswire · February 2, 2024
HUTCHMED to Announce 2023 Final Results
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Feb. 01, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; SEHK:13) will be announcing its final results for the year ended December 31, 2023 on Wednesday, February 28, 2024 at 6:30 am Eastern Standard Time (EST) / 11:30 am Greenwich Mean Time (GMT) / 7:30 pm Hong Kong Time (HKT).
By HUTCHMED (China) Limited · Via GlobeNewswire · February 1, 2024
HUTCHMED Receives ELUNATE® (fruquintinib) Marketing Approval in Hong Kong for Treatment of Metastatic Colorectal Cancer
— First medicine approved under new “1+” mechanism by HKSAR Government, providing an important treatment option to patients in Hong Kong —
By HUTCHMED (China) Limited · Via GlobeNewswire · January 29, 2024
HUTCHMED Announces NDA Acceptance in China for Sovleplenib for the Treatment of Primary Immune Thrombocytopenia with Priority Review Status
— NDA accepted and granted Priority Review following its Breakthrough Therapy designation granted in January 2022 —
By HUTCHMED (China) Limited · Via GlobeNewswire · January 10, 2024
HUTCHMED Announces Continued Inclusion of ELUNATE® (fruquintinib) and SULANDA® (surufatinib) in the National Reimbursement Drug List in China at Current Terms
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Dec. 13, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM, HKEX:13) today announces that under the 2023 simple renewal mechanism of the China National Healthcare Security Administration (“NHSA”), on January 1, 2024 the updated National Reimbursement Drug List (“NRDL”) will continue to include ELUNATE® (fruquintinib) and SULANDA® (surufatinib) at the same terms as the current two-year agreement.
By HUTCHMED (China) Limited · Via GlobeNewswire · December 12, 2023
HUTCHMED Highlights Clinical Data to be Presented at 2023 ESMO Asia and ESMO Immuno-Oncology Congresses
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Nov. 30, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today highlights that new clinical data from several ongoing studies with HUTCHMED investigational drug candidates fruquintinib, surufatinib and HMPL-295, which will be presented at the upcoming European Society for Medical Oncology (“ESMO”) Asia Congress, taking place on December 1-3, 2023 in Singapore, and the ESMO Immuno-Oncology Congress, taking place on December 6-8, 2023 in Geneva, Switzerland.
By HUTCHMED (China) Limited · Via GlobeNewswire · November 30, 2023
HUTCHMED Announces that Takeda Receives U.S. FDA Approval of FRUZAQLA™ (fruquintinib) for Previously Treated Metastatic Colorectal Cancer
— FRUZAQLA is the first targeted therapy approved in the U.S. for metastatic colorectal cancer regardless of biomarker status or prior types of therapies in more than a decade —
By HUTCHMED (China) Limited · Via GlobeNewswire · November 8, 2023
HUTCHMED Highlights Clinical Data to be Presented at ESMO Congress 2023
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Oct. 16, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated clinical data from several ongoing studies of fruquintinib, in combination with chemotherapies and/or immunotherapies, will be presented at the upcoming European Society for Medical Oncology (“ESMO”) Congress 2023, taking place on October 20-24, 2023 in Madrid, Spain.
By HUTCHMED (China) Limited · Via GlobeNewswire · October 16, 2023
HUTCHMED Announces Submission of New Drug Application for Fruquintinib for Previously Treated Metastatic Colorectal Cancer in Japan
— Third major market authorization application based on data from the FRESCO-2 global Phase III trial —
By HUTCHMED (China) Limited · Via GlobeNewswire · September 29, 2023
HUTCHMED Highlights Presentation of Results from the Phase IIIb Trial of Savolitinib at the 2023 World Conference of Lung Cancer
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Sept. 12, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM, HKEX: 13) today announces that results from the confirmatory Phase IIIb clinical trial of savolitinib in patients with mesenchymal epithelial transition factor (“MET”) exon 14 skipping alteration non-small cell lung cancer (“NSCLC”), were presented during the IASLC 2023 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (“WCLC”), which took place from September 9 to 12, 2023 in Singapore.
By HUTCHMED (China) Limited · Via GlobeNewswire · September 12, 2023
HUTCHMED Completes Patient Enrollment of a Bridging Study of Tazemetostat in Patients with Relapsed/Refractory Follicular Lymphoma in China
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Sept. 11, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has completed patient enrollment of a bridging study of tazemetostat in China.
By HUTCHMED (China) Limited · Via GlobeNewswire · September 11, 2023
HUTCHMED Receives Breakthrough Therapy Designation in China for Savolitinib for Gastric Cancer
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Aug. 28, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the Center for Drug Evaluation of China’s National Medical Products Administration (“NMPA”) has granted Breakthrough Therapy Designation (“BTD”) to savolitinib for the treatment of locally advanced or metastatic gastric cancer or gastroesophageal junction (“GEJ”) adenocarcinoma patients with mesenchymal epithelial transition factor (“MET”) amplification who have failed at least two lines of standard therapies.
By HUTCHMED (China) Limited · Via GlobeNewswire · August 28, 2023
HUTCHMED Announces that the Sovleplenib Phase III ESLIM-01 Study Met Its Primary Endpoint in Primary Immune Thrombocytopenia in China
— Randomized, double-blind, controlled trial met primary endpoint of durable response rate and all secondary endpoints —
By HUTCHMED (China) Limited · Via GlobeNewswire · August 20, 2023
HUTCHMED Reports 2023 Interim Results and Provides Business Updates
Strong execution on strategic direction, delivering near-term value while charting a path for growth, exemplified by global partnership with Takeda
By HUTCHMED (China) Limited · Via GlobeNewswire · July 31, 2023
HUTCHMED Receives Breakthrough Therapy Designation in China for Fruquintinib Combination with Sintilimab for Treatment of Advanced Endometrial Cancer, and Completes Enrollment of Registration Study
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., July 20, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the Center for Drug Evaluation of China’s National Medical Products Administration (“NMPA”) has granted Breakthrough Therapy Designation (“BTD”) to the combination of fruquintinib and sintilimab (a PD-1 antibody) for the treatment of patients with advanced endometrial cancer (“EMC”) with pMMR1 tumors that have failed at least one line of platinum-based therapy. A study for potential registration of this combination in patients with previously treated advanced EMC in China has recently completed enrollment.
By HUTCHMED (China) Limited · Via GlobeNewswire · July 19, 2023
HUTCHMED Announces Changes to Board of Directors and Technical Committee
Ms Ling Yang to replace Mr Lefei Sun as Non-executive Director; Professor Solange Peters appointed as Special Advisor to the Technical Committee
By HUTCHMED (China) Limited · Via GlobeNewswire · July 13, 2023
HUTCHMED Initiates Phase I Study of its novel SHP2 inhibitor HMPL-415 for Advanced Malignant Solid Tumors in China
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., July 09, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated a Phase I study in China of HMPL-415, an investigational novel selective allosteric inhibitor targeting Src homology-2 domain-containing protein tyrosine phosphatase-2 (“SHP2”). The first patient received their first dose on July 6, 2023.
By HUTCHMED (China) Limited · Via GlobeNewswire · July 9, 2023
HUTCHMED to Announce 2023 Half-Year Financial Results
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., June 26, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; SEHK:13) will be announcing its interim results for the six months ended June 30, 2023 on Monday, July 31, 2023 at 7:00 am Eastern Daylight Time (EDT) / 12:00 noon British Summer Time (BST) / 7:00 pm Hong Kong Time (HKT).
By HUTCHMED (China) Limited · Via GlobeNewswire · June 26, 2023
HUTCHMED and Takeda Announce Publication of Phase III FRESCO-2 Results in The Lancet
— Publication shows FRESCO-2 demonstrated treatment with fruquintinib reduced the risk of death by 34% in previously treated metastatic colorectal cancer (0.66 HR) —
By HUTCHMED (China) Limited · Via GlobeNewswire · June 15, 2023
Takeda and HUTCHMED Announce Marketing Authorization Application of Fruquintinib for Previously Treated Metastatic Colorectal Cancer Validated by the European Medicines Agency
— Application Includes Data from Phase III FRESCO-2 and FRESCO Clinical Trials, which Demonstrated Superiority of Fruquintinib Plus Best Supportive Care (“BSC”) vs. Placebo plus BSC for Adult Patients with Previously Treated Metastatic Colorectal Cancer —
By HUTCHMED (China) Limited · Via GlobeNewswire · June 15, 2023
HUTCHMED Highlights Presentations for Hematological Malignancy Programs at the 2023 EHA and ICML Meetings
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., June 09, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated clinical data related to two novel investigational hematological malignancy therapies, HMPL-306 and amdizalisib, will be presented at the upcoming European Hematology Association (“EHA”) Annual Meeting, taking place June 8-11, 2023 in Frankfurt, and the 17th International Conference on Malignant Lymphoma (“ICML”) taking place June 13-17, 2023 in Lugano.
By HUTCHMED (China) Limited · Via GlobeNewswire · June 9, 2023
Takeda and HUTCHMED Announce New Drug Application (NDA) for Fruquintinib for Treatment of Previously Treated Metastatic Colorectal Cancer Granted Priority Review
— Prescription Drug User Fee Act (PDUFA) Target Action Date set for November 30, 2023 —
By HUTCHMED (China) Limited · Via GlobeNewswire · May 25, 2023
HUTCHMED Highlights Presentations at the 2023 ASCO Annual Meeting
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., May 25, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated clinical data related to HUTCHMED’s novel investigational cancer therapies fruquintinib, surufatinib and HMPL-453 in 21 abstracts that will be presented at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 2-6, 2023 in Chicago, IL and online.
By HUTCHMED (China) Limited · Via GlobeNewswire · May 25, 2023
HUTCHMED Announces Board of Directors and Board Committee Membership
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., May 12, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED” or the “Company”) (Nasdaq/AIM:HCM, HKEX:13) refers to its announcement on May 10, 2023 of the appointment of Professor Solange Peters as an Independent Non-executive Director, member of the Technical Committee and member of the Audit Committee of the Company with effect from the conclusion of the annual general meeting of the Company to be held on May 12, 2023 (“AGM”). The Company today announces that the effective date of such appointments will be deferred until a later date to be announced by the Company.
By HUTCHMED (China) Limited · Via GlobeNewswire · May 12, 2023
HUTCHMED Announces Appointment of Independent Non-executive Director and Member of Board Committees
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., May 10, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED” or the “Company”) (Nasdaq/AIM:HCM, HKEX:13) today announces that Professor Solange Peters is appointed as an Independent Non-executive Director, member of the Technical Committee and member of the Audit Committee of the Company with effect from the conclusion of the annual general meeting of the Company to be held on May 12, 2023. Professor Peters is a renowned scientist and educator who possesses expertise and extensive experience in oncology and immunology. The Board of HUTCHMED is of the view that Professor Peters will make significant contributions to the Company.
By HUTCHMED (China) Limited · Via GlobeNewswire · May 10, 2023
HUTCHMED Announces NDA Acceptance in China for Fruquintinib in Second-Line Gastric Cancer
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J. , April 17, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that its New Drug Application (“NDA”) for fruquintinib in combination with paclitaxel for the treatment of second-line advanced gastric or gastroesophageal junction adenocarcinoma in China has been accepted for review by the China National Medical Products Administration (“NMPA”).
By HUTCHMED (China) Limited · Via GlobeNewswire · April 17, 2023
HUTCHMED Highlights Presentations at American Association for Cancer Research Annual Meeting 2023
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., April 11, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM, HKEX: 13) today announces that new and updated clinical and non-clinical data related to five HUTCHMED investigational drug candidates will be presented during the American Association for Cancer Research Annual Meeting 2023 (AACR 2023), which will take place from April 14 to 19, 2023 in Orlando, Florida.
By HUTCHMED (China) Limited · Via GlobeNewswire · April 11, 2023
Intended Retirement of Independent Non-executive Director
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., April 11, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED” or the “Company”) (Nasdaq/AIM:HCM, HKEX:13) today announces that Dr Karen Jean Ferrante has informed the Company that she would retire from the Board at the forthcoming annual general meeting of the Company to be held on May 12, 2023 (“AGM”), and that she would not be seeking re-election at the AGM so that she could devote more time to her personal engagements. Dr Ferrante will therefore cease to be an Independent Non-executive Director of the Company at the conclusion of the AGM. Upon her retirement as a Director, Dr Ferrante will also cease to be chairman of the Technical Committee and member of the Audit Committee of the Company.
By HUTCHMED (China) Limited · Via GlobeNewswire · April 11, 2023
HUTCHMED Initiates Registration Phase Enrollments of HMPL-453 for IHCC and Savolitinib for Gastric Cancer following NMPA Consultations
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., April 04, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has consulted the China National Medical Products Administration (“NMPA”) and reached an agreement to initiate the registration phase of the ongoing Phase II trial of HMPL-453 for intrahepatic cholangiocarcinoma (“IHCC”) patients with fibroblast growth factor receptors (“FGFR”) 2 fusion. If positive, the data from the registration phase may be used to support a future New Drug Application (“NDA”) filing. The first patient received their first dose in March 2023.
By HUTCHMED (China) Limited · Via GlobeNewswire · April 4, 2023
HUTCHMED Completes Rolling Submission of NDA to U.S. FDA for Fruquintinib for the Treatment of Refractory Metastatic Colorectal Cancer
— NDA supported by data from global Phase III FRESCO-2 study in the U.S., Europe, Japan and Australia along with data from Phase III FRESCO study conducted in China —
By HUTCHMED (China) Limited · Via GlobeNewswire · March 30, 2023
HUTCHMED Announces Closing of Fruquintinib License to Takeda Outside China
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., March 14, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM, HKEX:13) today announces that, further to its announcement on January 23, 2023 and following the completion of customary closing conditions including antitrust regulatory reviews, the exclusive license agreement with a subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502, NYSE:TAK) to further the global development, commercialization and manufacture of fruquintinib outside China has closed.
By HUTCHMED (China) Limited · Via GlobeNewswire · March 14, 2023
HUTCHMED Confirms No Assets Held at Silicon Valley Bank
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., March 13, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED” or the “Company”) (Nasdaq/AIM:HCM, HKEX:13) today confirms that it does not have any exposure to Silicon Valley Bank (“SVB”) or Silicon Valley Bank UK Limited (“SVBUK”). The Company does not hold any cash deposits or securities with SVB or SVBUK.
By HUTCHMED (China) Limited · Via GlobeNewswire · March 12, 2023
HUTCHMED Reports 2022 Full Year Results and Provides Business Updates
Landmark licensing deal with Takeda for fruquintinib outside of China, bringing HUTCHMED up to US$1.13 billion, plus royalties, and demonstrating execution of the new global strategy
By HUTCHMED (China) Limited · Via GlobeNewswire · February 28, 2023
HUTCHMED Completes Patient Enrollment of Phase II Registration Trial of Amdizalisib in Follicular Lymphoma in China
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Feb. 27, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM, HKEX:13) today announces that it has completed patient enrollment of Phase II registration trial of amdizalisib in patients with relapsed or refractory follicular lymphoma (“FL”), a subtype of non-Hodgkin’s lymphoma (“NHL”). The last patient was enrolled on February 24, 2023.
By HUTCHMED (China) Limited · Via GlobeNewswire · February 27, 2023
HUTCHMED to Announce 2022 Final Results
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Jan. 31, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; SEHK:13) will be announcing its final results for the year ended December 31, 2022 on Tuesday, February 28, 2023 at 3:30 am Eastern Standard Time (EST) / 8:30 am Greenwich Mean Time (GMT) / 4:30 pm Hong Kong Time (HKT).
By HUTCHMED (China) Limited · Via GlobeNewswire · January 31, 2023
HUTCHMED Announces License to Takeda to Develop and Commercialize Fruquintinib Outside China
— HUTCHMED to receive US$400 million upfront on deal closing and up to US$730 million in potential future milestone payments, totaling up to US$1.13 billion, plus royalties on net sales —
By HUTCHMED (China) Limited · Via GlobeNewswire · January 23, 2023
HUTCHMED Announces Agreement with NHSA for Inclusion of ORPATHYS® in the National Reimbursement Drug List in China
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Jan. 18, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX:13) today announces, following negotiations with the China National Healthcare Security Administration (“NHSA”), ORPATHYS® (savolitinib) has been included in the updated National Reimbursement Drug List (“NRDL”) for the treatment of locally advanced or metastatic non-small cell lung cancer (“NSCLC”) adult patients with MET exon 14-skipping alterations who have progressed after or unable to tolerate platinum-based chemotherapy. The updated NRDL will take effect from March 1, 2023.
By HUTCHMED (China) Limited · Via GlobeNewswire · January 18, 2023
HUTCHMED Completes Patient Enrollment of ESLIM-01, a Phase III Trial of Sovleplenib in Primary Immune Thrombocytopenia in China
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Jan. 03, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM, HKEX:13) today announces that it has completed patient enrollment of ESLIM-01, a pivotal Phase III clinical trial of sovleplenib for the treatment of adult patients with primary immune thrombocytopenia (“ITP”) in China. The last patient was enrolled on December 31, 2022.
By HUTCHMED (China) Limited · Via GlobeNewswire · January 3, 2023
HUTCHMED Initiates Rolling Submission of NDA to U.S. FDA for Fruquintinib for the Treatment of Refractory Colorectal Cancer
— Company plans to complete rolling submission to the U.S. in the first half of 2023, followed by filings in Europe and Japan —
By HUTCHMED (China) Limited · Via GlobeNewswire · December 19, 2022