CSPC Pharmaceutical Group Ltd. has received IND approval from the FDA for a phase I study in the U.S. of its antibody-drug conjugate CPO-204 in patients with locally advanced or metastatic urothelial cancer.
Gmax Biopharm LLC has received FDA clearance of its IND filing for GMA-131 injection, an ETa receptor-specific monoclonal antibody, for a phase Ib study in diabetic kidney disease (DKD).
Asieris Pharmaceuticals Co. Ltd. has received FDA clearance of its IND for APL-1401 for the treatment of moderate to severely active ulcerative colitis.
Eccogene (Shanghai) Co. Ltd. has received FDA clearance to begin a phase I study of its glucagon-like peptide 1 (GLP-1) receptor agonist ECC-5004 for type 2 diabetes.
Turnstone Biologics Corp. has received IND clearance from the FDA for the company's lead selected tumor-infiltrating lymphocyte (TIL) therapy program, TIDAL-01.
Simcere Pharmaceutical Group announced that the FDA has cleared the company’s IND application for SIM-0237 for the treatment of adult patients with advanced solid tumors.
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