新诺威子公司仑卡奈单抗注射液获得药物临床试验批准通知书

Core Viewpoint - The announcement highlights that New Horizon (300765.SZ) has received approval from the National Medical Products Administration for the clinical trial of its biosimilar drug, Lecanemab injection, which is intended for the treatment of mild cognitive impairment and mild dementia caused by Alzheimer's disease [1] Group 1 - The product is a recombinant anti-human beta-amyloid monoclonal antibody and is classified as a biosimilar to Lecanemab [1] - This marks the first biosimilar Lecanemab injection in China to receive clinical trial approval [1] - The development of the product adheres to the relevant research guidelines for biosimilars, indicating a structured approach to its clinical research [1] Group 2 - Pharmaceutical and non-clinical research results demonstrate that the product is highly similar to the reference drug in terms of quality, safety, and efficacy, supporting the initiation of subsequent clinical studies [1]