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HutchMed’s Tazverik Receives Conditional Approval from China’s NMPA for Lymphoma Treatment
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China-based HutchMed (NASDAQ: HCM, HKG: 0013) has announced receiving conditional marketing approval from the National Medical Products Administration (NMPA) for its drug Tazverik (tazemetostat), an EZH2 methyltransferase inhibitor. The approval allows Tazverik to treat relapsed or refractory (R/R) follicular lymphoma (FL) with EZH2 mutations in patients who have previously received…
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HutchMed’s 2024 Financial Report Shows Dip in Revenue Amid Oncology Product Growth
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China-based HutchMed (NASDAQ: HCM, HKG: 0013) released its 2024 financial report, revealing a total revenue of USD 630.2 million, marking a 25% year-on-year decline. The oncology/immune business segment reported USD 363.4 million, a decrease of 31% compared to the previous year. Oncology Product PerformanceDespite the overall decline, oncology product sales…
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HutchMed and Innovent Announce Positive Results for Fruquintinib and Sintilimab in Renal Cell Carcinoma Trial
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Chinese companies HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) and Innovent Biologics, Inc. (HKG: 1801) jointly announced positive results from the Phase II/III FRUSICA-2 study. The trial evaluated the combination of fruquintinib and sintilimab as a second-line treatment for locally advanced or metastatic renal cell carcinoma (RCC) in China, with…
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HutchMed’s Orpathys Approved for Expanded NSCLC Indication in China
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HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) has announced that the National Medical Products Administration (NMPA) has approved another indication for its Orpathys (savolitinib). This approval means that the MET inhibitor can now be used to treat adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with…
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HutchMed’s Orpathys Receives Priority Review for NSCLC Treatment in China
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HutchMed (China) Ltd (HKG: 0013, NASDAQ: HCM) has announced that the China National Medical Products Administration (NMPA) has accepted and granted priority review to the New Drug Application (NDA) for its Orpathys (savolitinib). The Chinese company is seeking approval for its MET tyrosine kinase inhibitor (TKI), when combined with Tagrisso…
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HutchMed to Divest 45% Stake in Shanghai Hutchison Pharmaceuticals for $608 Million
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China-based HutchMed (China) Ltd (HKG: 0013, NASDAQ: HCM) has reached an agreement to divest its 45% equity interest in Shanghai Hutchison Pharmaceuticals Limited (SHPL) to GP Health Service Capital Co., Ltd and Shanghai Pharmaceuticals Holding Co., Ltd. (SPH, HKG: 2607, SHA: 601607) for a combined total of USD608 million. Background…
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CDE Indicates Priority Review for Boehringer Ingelheim’s Zongertinib and Peers
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The China’s Center for Drug Evaluation (CDE) website has indicated that several drugs, including German giant Boehringer Ingelheim’s (BI) zongertinib, Visirna Therapeutics’ plozasiran, Chia Tai Tianqing’s anlotinib, and HutchMed (China) Ltd’s (HKG: 0013, NASDAQ: HCM) Orpathys (savolitinib), are on course to obtain priority review statuses. Boehringer Ingelheim’s Zongertinib for HER2-Mutated…
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HutchMed’s Orpathys Receives Breakthrough Therapy Designation in China for Advanced Lung Cancer
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HutchMed (China) Ltd (HKG: 0013, NASDAQ: HCM) has announced that its MET inhibitor, Orpathys (savolitinib), co-developed with AstraZeneca (AZ, NASDAQ: AZN), has been granted Breakthrough Therapy Designation (BTD) by China’s National Medical Products Administration (NMPA). The designation is for the use of Orpathys in combination with Tagrisso (osimertinib) for the…
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HutchMed to Receive Milestone Payment as Takeda’s Fruzaqla Gets Reimbursement Nod in Spain
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China-based HutchMed (China) Ltd (HKG: 0013, NASDAQ: HCM) is poised to receive another milestone payment from its partner Takeda (TYO: 4502, NYSE:TAK), following the Japanese firm’s achievement of a national reimbursement recommendation for Fruzaqla (fruquintinib) for patients with previously treated metastatic colorectal cancer (CRC) in Spain. This event marks the…
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HutchMed and Innovent Biologics’ Fruzaqla-Tyvyt Combo Gets NMPA Conditional Approval for Endometrial Cancer
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Chinese firms HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) and Innovent Biologics, Inc. (HKG: 1801) have jointly announced that they have received conditional approval from the National Medical Products Administration (NMPA) for the combination of Fruzaqla (fruquintinib) and Tyvyt (sintilimab). This treatment is intended for patients with advanced endometrial cancer…
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HutchMed Anticipates Milestone Payment as Takeda Launches Fruzaqla in Japan for CRC
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China-based HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) is poised to receive a milestone payment from its partner Takeda (TYO: 4502), following the successful pricing approval and launch of Fruzaqla (fruquintinib) 1mg/5mg capsules in Japan. The drug is indicated for patients with previously treated metastatic colorectal cancer (CRC). Fruzaqla’s Approval…
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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 Establishes Global R&D Hub in Hong Kong Science Park to Accelerate Translational Medicine
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HutchMed (NASDAQ: HCM), a China-based biopharmaceutical company, has announced the establishment of a global research and development center within the Hong Kong Science Park. This strategic move positions HutchMed amidst a thriving ecosystem of over 270 biotechnology companies, fostering collaboration and innovation. Specializing in translational medicine, HutchMed leverages artificial intelligence…
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HutchMed Reports 2024 H1 Financials with Mixed Results Amid Strategic Focus on R&D and Commercial Efficiency
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China-based HutchMed (NASDAQ: HCM) has released its financial report for the first half of 2024, showing a 41% year-on-year decrease in total revenues to $305.7 million, in constant currency terms. The company’s oncology products segment reported a 64% increase in revenues to $127.8 million, while the oncology/immune business saw a…
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HutchMed’s Tazverik for Follicular Lymphoma Accepted for Review by China’s NMPA
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HutchMed (NASDAQ: HCM), a China-based biopharmaceutical company, has announced that the National Medical Products Administration (NMPA) has accepted its market approval filing for Tazverik (tazemetostat) for review. The company is seeking initial approval for Tazverik as a treatment for recurrent or refractory follicular lymphoma (FL), and the filing has been…
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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…
