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China-based Everest Medicines (HKG: 1952) has announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for its Velsipity (etrasimod), a treatment for moderate to severe active ulcerative colitis (UC). Velsipity’s Mechanism and Licensing BackgroundVelsipity is a once-daily, oral medication that functions as…
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US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK) has revealed its decision to terminate the clinical development of vibostolimab, an anti-TIGIT antibody, and favezelimab, an anti-LAG-3 antibody, following recent disappointing data from Phase III trials. Discontinuation of Vibostolimab TrialsThe Phase III KeyVibe-003 and KeyVibe-007 studies, which were assessing…
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China’s Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (HKG: 2315) has announced that Denmark-based Adcendo ApS has exercised its options within a research, option, and licensing agreement to utilize Biocytogen’s fully human antibodies. This move is aimed at bolstering Adcendo’s antibody drug conjugate (ADC) pipeline. Adcendo’s Focus on First-In-Class ADCsAdcendo is a…
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China-based MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160) has announced that its second-generation transcatheter aortic valve implantation (TAVI) product, VitaFlow Liberty, has received marketing approval from the Turkish Medicines and Medical Devices Agency (TITCK). This marks another global milestone for the product, following its approval in multiple countries and regions,…
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China-based Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced significant progress for its in-house developed VUM02 for injection, receiving approval from the National Medical Products Administration (NMPA) in China to study the treatment of decompensated cirrhosis and obtaining Orphan Drug Designation (ODD) from the Food and Drug…
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Denmark-based pharmaceutical giant Novo Nordisk A/S (NYSE: NVO) is making a significant investment in its homeland by establishing a brand-new manufacturing facility in Odense, marking the first time this century the company has embarked on such a project. The capital infusion of DKK 8.5 billion (USD 1.2 billion) will go…
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US pharmaceutical major Johnson & Johnson (J&J, NYSE: JNJ) has announced the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for its drug Simponi (golimumab), seeking approval to treat children aged two years and older with moderately to severely active ulcerative colitis…
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Johnson & Johnson (J&J, NYSE: JNJ) has announced that the Biologics License Application (BLA) filed with the US FDA for a fixed combination of amivantamab and recombinant human hyaluronidase for subcutaneous administration (SC amivantamab) has received a complete response letter (CRL). The application sought approval for the treatment of patients…
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Grand Pharmaceutical Group Co., Ltd. (HKG: 0512) has announced that the National Medical Products Administration (NMPA) has accepted for review a New Drug Application (NDA) for its innovative drug GPN01768 (TP-03, lotilaner ophthalmic solution, 0.25%). The Chinese company is seeking approval for the drug to treat Demodex blepharitis, a condition…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276), a leading pharmaceutical company based in China, has announced that its trastuzumab rezetecan (SHR-A1811), an HER2 targeted antibody-drug conjugate (ADC), is on course to receive Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation of the National Medical Products Administration (NMPA). The…
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to initiate a regulatory study for its novel small-molecule FGFR4 inhibitor, irpagratinib. Details of the Approved TrialThe approved trial, ABSK-011-205, is…
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GSK plc (NYSE: GSK) has announced that ViiV Healthcare, an HIV specialist majority owned by GSK with Pfizer and Shionogi as shareholders, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The recommendation is for the approval of…
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The UK-based pharmaceutical giant GSK (NYSE: GSK) has received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) for the indication extension approval of its PD-1 inhibitor Jemperli (dostarlimab). The drug is proposed for use in combination with chemotherapy (carboplatin and paclitaxel)…
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UK-based pharmaceutical giant GSK (NYSE: GSK) has announced that it has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for its drug Jemperli (dostarlimab). The designation is for the treatment of patients with locally advanced mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) rectal cancer. Jemperli’s Background…
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China-based vaccines specialist CanSino Biologics Inc. (HKG: 6185) has announced that the National Medical Products Administration (NMPA) has accepted for review a New Drug Application (NDA) for its DTcP vaccine, designed for infants and young children under the age of 2. Quality Consistency and Market GapThe DTcP vaccine, a component…
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China-based MicroPort NeuroTech Limited (HKG: 2172) has announced its commitment to invest RMB 200 million (USD 27.46 million) to jointly establish an investment fund aimed at fostering the development of the brain science and brain-Inspired Intelligence industry, aligning with MicroPort NeuroTech’s strategic future direction. Collaboration with Other InvestorsJoining MicroPort NeuroTech…
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US-based Candid Therapeutics Inc. is fulfilling its ambition to become a leader in advancing T-cell engagers (TCEs) for B-cell depletion to treat autoimmune diseases, with the signing of Chinese firms Nona Biosciences and EpimAb Biotherapeutics, Inc., as well as compatriot firm Ab Studio, Inc., in a single day to strengthen…
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The European Medicines Agency (EMA) has conferred Priority Medicines (PRIME) designation to HS-20093 (GSK5764227), a B7-H3-targeted antibody-drug conjugate (ADC) co-developed by China’s Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) and the UK pharmaceutical major GSK (NYSE: GSK). This PRIME designation follows Breakthrough Therapy Designations (BTDs) received in the United States…
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China-based Bio-Thera Solutions (SHA: 688177) has announced the addition of a third biosimilar to its existing license agreement with Costa Rican partner SteinCares, which was initially struck in March of this year. Under the revised accord, SteinCares will gain exclusive rights to distribute and market the new biosimilar in Brazil…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for its Welireg (belzutifan), a hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor. The CHMP recommends conditional approval for adult patients with von Hippel-Lindau (VHL) disease…