新诺威:控股子公司达雷妥尤单抗注射液获药物临床试验批准通知书

Core Viewpoint - The company XinNuoWei (300765.SZ) announced that its subsidiary, JuShi Bio, 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 allows the company to proceed with clinical trials for the drug [1] - Daratumumab is a biosimilar of the original drug, known as Zhaoke® [1] - The drug is specifically aimed at treating adult patients diagnosed with multiple myeloma [1] Group 2 - Following the approval, the drug must undergo clinical trials and receive further approval from regulatory authorities before it can be marketed and sold [1] - There are inherent risks associated with the clinical trial process, including the possibility of trial results not meeting expectations, failure to obtain necessary approvals, delays in market entry, or lower-than-expected sales post-launch [1]

CSPC Innovation-新诺威:控股子公司达雷妥尤单抗注射液获药物临床试验批准通知书 - Reportify