Aptamer Sciences Inc. has filed an IND application with the Korean Ministry of Food and Drug Safety seeking clearance to conduct a phase I trial of AST-201 in patients with GPC3-positive advanced solid tumors.
Vertex Pharmaceuticals Inc. has obtained IND clearance from the FDA for VX-407, an investigational first-in-class small-molecule corrector that targets the underlying cause of autosomal dominant polycystic kidney disease (ADPKD) in patients with a subset of PKD1 genetic variants.
CSPC Pharmaceutical Group Ltd. has obtained clearance by China’s National Medical Products Administration (NMPA) to conduct clinical trials in China with SYS-6023 for advanced solid tumors.
CSPC Pharmaceutical Group Ltd. has received clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials in China with SYH-2039, a highly selective methionine adenosyltransferase 2A (MAT2A) inhibitor, for advanced malignant tumors.
Xgene Pharmaceutical Pty Ltd., a subsidiary of Xgene Pharmaceutical Co. Ltd., has received approval in Australia to initiate a phase I trial of the selective TRPM8 blocker XG-2002 (RQ-00434739).
Shanghai Henlius Biotech Inc.’s IND application for HLX-6018, a novel anti-glycoprotein-A repetitions predominant (GARP)/transforming growth factor-β1 (TGF-β1) monoclonal antibody (mAb), has received approval by China’s National Medical Products Administration (NMPA) for the treatment of idiopathic pulmonary fibrosis (IPF).
Simcere Zaiming, a subsidiary of Simcere Pharmaceutical Group Ltd., has received approval from the FDA and China’s National Medical Products Administration (NMPA) to conduct clinical trials with SIM-0500 in patients with relapsed or refractory multiple myeloma.