新诺威:控股子公司达雷妥尤单抗注射液获得药物临床试验批准通知书
Core Viewpoint - The announcement indicates that the subsidiary of XinNuoWei, 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, which is intended for the treatment of adult patients with multiple myeloma [1] Group 1 - The clinical trial approval notification for Daratumumab injection has been issued, allowing the company to commence clinical trials shortly [1] - Daratumumab injection is a recombinant fully human IgG1 monoclonal antibody targeting ADP-ribosylation factor (CD38) [1] - The drug is a biosimilar to the original drug, Zhaoke®, which is used for treating multiple myeloma [1]