新诺威(300765.SZ)子公司达雷妥尤单抗注射液获得药物临床试验批准

Core Viewpoint - The announcement indicates that the company’s subsidiary, 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 is for Daratumumab injection, a recombinant fully human IgG1 monoclonal antibody targeting ADP-ribosyl cyclase (CD38) [1] - The product is classified as a biosimilar to the original drug, known as Zhaoke®, and is submitted under the category of biological products for therapeutic use [1] - The research results indicate that the biosimilar shows high similarity in quality, safety, and efficacy compared to the reference drug, supporting the initiation of subsequent clinical studies [1]