Saturday, January 07, 2023
CASI Pharmaceuticals, Inc., a leading U.S. biopharmaceutical company dedicated to the development and commercialization of cutting-edge therapeutics and pharmaceutical products, is pleased to announce that the China National Medical Products Administration (NMPA) has granted approval for the Company's Clinical Trial Application (CTA) for CB-5339. CB-5339 is a groundbreaking VCP/p97 inhibitor developed by Cleave Therapeutics.
CASI has outlined plans for a Phase 1 development program in China, focusing on CB-5339 as a standalone treatment. The primary objectives of this program include assessing the pharmacokinetic and safety profile of CB-5339, determining the Recommended Phase 2 Dose, and evaluating early indications of clinical efficacy. The anticipated launch date for the Phase 1 development program is scheduled for 2023.
Dr. Wei-Wu He, Chairman, and Chief Executive Officer of CASI, expressed his enthusiasm about the milestone reached, stating, "This is an exhilarating achievement for CASI, bringing us closer to making CB-5339 accessible to patients and healthcare providers throughout Greater China. CB-5339 holds immense potential as a selective VCP/p97 targeting agent in the treatment of various cancers. It is an excellent addition to our expanding portfolio of approved and investigational therapies for hematologic oncology indications. CASI takes full responsibility for conducting the clinical trials in China and will expedite the initiation of studies at the earliest opportunity.