新诺威达雷妥尤单抗注射液临床试验获批

Core Viewpoint - The announcement indicates that the company’s subsidiary, Shiyao Group Jushi Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of Daratumumab injection, a biosimilar to the original drug, targeting multiple myeloma patients [1] Group 1 - The clinical trial approval notification for Daratumumab injection was recently issued [1] - Daratumumab injection is a recombinant fully human IgG1 monoclonal antibody targeting ADP-ribosyl cyclase (CD38) [1] - The drug is classified as a biosimilar to the original drug, Zhaoke®, and is submitted under category 3.3 for therapeutic biological products [1] Group 2 - The drug is intended for the treatment of adult patients with multiple myeloma [1]