Core Viewpoint - The company, Stone Pharmaceutical Group, has received approval from the National Medical Products Administration of the People's Republic of China to conduct clinical trials for its drug, Daratumumab injection [1] Group 1: Product Development - The product is a recombinant fully human IgG1 monoclonal antibody targeting ADP-ribosyl cyclase (CD38) [1] - It is a biosimilar to the original drug, Darzalex, and is classified under Category 3.3 for therapeutic biological products [1] - The drug is intended for the treatment of adult patients with multiple myeloma [1] Group 2: Research and Compliance - The development of the product adheres to the relevant research guidelines for biosimilars [1] - Pharmaceutical and non-clinical research results indicate that the product is highly similar to the reference drug in terms of quality, safety, and efficacy, supporting further clinical research [1]

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]