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HutchMed to Present Updated Data from Solvleplenib ESLIM-01 Phase III Trial at ASH and ESMO Congress 2024
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China-based HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced plans to present new and updated data from the sovleplenib ESLIM-01 Phase III trial, along with several investigator-initiated studies of compounds discovered by HutchMed, at the American Society of Hematology (ASH) Annual Meeting and the European Society for Medical Oncology…
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HutchMed to Receive $20 Million Milestone Payment from Takeda for Fruzaqla Sales
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China-based HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) is poised to receive a USD 20 million milestone payment from its Japanese partner Takeda (TYO: 4502; NYSE: TAK), following the achievement of over USD 200 million in sales of Fruzaqla (fruquintinib) for metastatic colorectal cancer (CRC). Fruquintinib, a selective oral inhibitor…
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HutchMed Halts China Filing for Gastric Cancer Drug Fruquintinib Following Regulatory Feedback
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HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013), a China-based biopharmaceutical company, has announced the withdrawal of its New Drug Application (NDA) for fruquintinib, a VEGFR inhibitor, in combination with paclitaxel for the second-line treatment of advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJ) in China. The decision to withdraw was made…
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Hutchmed Withdraws Fruquintinib’s New Indication Application in China, Seeks Alternative Regulatory Path
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HONG KONG—Hutchmed (HKG: 0013) has announced its decision to proactively withdraw the new indication application for Fruquintinib in combination with paclitaxel for the second-line treatment of advanced gastric cancer and gastroesophageal junction adenocarcinoma in China. The company will now evaluate a new registration pathway following discussions with the National Medical…
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Takeda’s Fruquintinib for Metastatic Colorectal Cancer Receives European Commission Marketing Approval
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HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that its partner Takeda (TYO: 4502, NYSE: TAK) has received marketing approval from the European Commission for fruquintinib, a treatment for adult patients with metastatic colorectal cancer (CRC) who have previously been treated with chemotherapy regimens based on fluorouracil, oxaliplatin, and…
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MSD China’s Vaccine Head Tang Xiaochun Departs; HutchMed Welcomes MSD’s Yuan Zezhi as Executive Vice-President
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that Tang Xiaochun, who served as the head of vaccine business and assistant vice-president at MSD China, has left the company. Tang initially joined MSD China in 2018 as the executive director of the company’s oncology medical affairs department. During his…
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HutchMed Initiates Phase I Clinical Trial for HMPL-506 in Hematologic Malignancies
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HutchMed (HKG: 0013, NASDAQ: HCM) has announced the commencement of a Phase I clinical study for its investigational compound HMPL-506 in China, with the first patient having already been dosed. The molecule is being evaluated as a potential treatment for various hematologic malignancies. This multi-center, open-label Phase I study is…
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HutchMed Chairman Simon To Steps Down, Dr. Dan Eldar Appointed Successor
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HutchMed (NASDAQ: HCM, HKG: 0013) today announced a significant change in leadership with the long-serving Chairman Simon To preparing to step down from his executive role. After a tenure of 23 years with the company, To will transition to a non-executive board director role while also serving as a strategic…
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HutchMed’s Sovleplenib Phase III Results to be Showcased at EHA 2024
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HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013), a biopharmaceutical company based in China, is preparing to unveil the topline and subgroup results from the Phase III ESLIM-01 study at the European Hematology Association’s (EHA) 2024 annual conference. Additionally, the company will present updated clinical data for its hematological malignancy therapies…
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HutchMed’s HMPL-306 Advances to Phase III Trial in R/R AML Patients
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HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced the commencement of the RAPHAEL study, a pivotal multi-center, randomized, open-label, regulatory Phase III trial. The study aims to evaluate the efficacy and safety of HMPL-306 in patients with recurrent/refractory (R/R) acute myeloid leukemia (AML) featuring isocitrate dehydrogenase (IDH) 1 or…
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HutchMed’s Partner Takeda Gets CHMP Nod for Fruquintinib as CRC Treatment in Europe
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HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that its collaborator Takeda (TYO: 4502, NYSE: TAK) has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the approval of fruquintinib for the treatment of adult patients with…
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Jiangsu Hengrui Medicine Gets NMPA Go-Ahead for Camrelizumab Combination Therapy Study in Pancreatic Cancer
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a multi-center, randomized, controlled Phase II/III clinical study. The study will assess the efficacy and safety of its programmed death-1 (PD-1)…
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HutchMed’s Orpathys Files for Expanded Indication in NSCLC Treatment in China
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HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that the National Medical Products Administration (NMPA) in China is currently reviewing a new market approval filing for Orpathys (savolitinib), a MET inhibitor co-developed with AstraZeneca. The company is seeking a new indication for the drug as a first-line treatment for…
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HutchMed Launches Phase II/III Study for Sovleplenib in Autoimmune Hemolytic Anemia
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HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced the initiation of the Phase II/III ESLIM-02 study for its investigational drug, sovleplenib, in patients with warm antibody autoimmune hemolytic anemia (wAIHA) in China. The ESLIM-02 trial is a randomized, double-blind, placebo-controlled study aimed at confirming the safety and efficacy of…
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Innovent and HutchMed’s Combination Therapy Set for Priority Review in China for Advanced Endometrial Cancer
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China’s Center for Drug Evaluation (CDE) has indicated that the combination therapy of Innovent Biologics Inc.’s (HKG: 1801) PD-1 inhibitor Tyvyt (sintilimab injection) and HutchMed’s (HKG: 0013, NASDAQ: HCM) Elunate (fruquintinib) is on track to receive priority review status in China. This designation pertains to the treatment of advanced mismatch…
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HutchMed’s 2023 Financials Show 102% YOY Revenue Growth and Robust Collaboration with Takeda
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HutchMed (HKG: 0013, NASDAQ: HCM), a China-based biopharmaceutical company, has released its financial report for 2023, recording a significant increase in revenue to USD 838 million, marking a 102% year-on-year growth calculated on a constant currency basis. The company’s net profits reached USD 101 million, attributed to its collaboration with…
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Inmagene Biopharmaceuticals Secures Exclusive License for HutchMed’s Drug Candidates IMG-007 and IMG-004
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HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that Sino-US biotech Inmagene Biopharmaceuticals has exercised its option to license two drug candidates discovered by HutchMed, IMG-007 and IMG-004, under the terms of a strategic partnership signed on January 11, 2021. Upon the exercise of these options and subject to…
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HutchMed’s Sovleplenib Set for Priority Review in China for Chronic Immune Thrombocytopenia
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China’s Center for Drug Evaluation (CDE) has indicated that HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) is on track to receive priority review status for its investigational drug, sovleplenib. This designation is granted due to the drug’s potential to treat adults with primary chronic immune thrombocytopenia (ITP) who are unresponsive…
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HutchMed and Takeda Submit Fruquintinib NDA for Metastatic CRC in Japan
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China-based HutchMed (HKG: 0013, NASDAQ: HCM) has announced that its partner Takeda (TYO: 4502) has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for the approval of fruquintinib as a treatment for adult patients with previously treated metastatic colorectal cancer (CRC).…
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HutchMed Advances Tazverik Phase II Trial for Follicular Lymphoma in China
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China-based HutchMed (HKG: 0013, NASDAQ: HCM) has announced the completion of patient enrollment in a bridging study for Tazverik (tazemetostat) in China. Tazverik, originated by US firm Epizyme Inc., was licensed to HutchMed for development in Greater China in an agreement reached in August 2021. Tazverik’s Background and Previous ApprovalsThe…
