Core Viewpoint - The approval of the recombinant anti-human beta-amyloid monoclonal antibody injection, Lecanemab, by the National Medical Products Administration of China marks a significant milestone for the company as it is the first biosimilar of its kind to receive clinical trial permission in China [1] Group 1: Product Details - The product is a biosimilar to Lecanemab, indicated for the treatment of mild cognitive impairment and mild dementia due to Alzheimer's disease [1] - The development of the product adheres to the relevant research guidelines for biosimilars, ensuring compliance with regulatory standards [1] Group 2: Research Findings - 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 the initiation of subsequent clinical studies [1]
石药集团(01093.HK)：仑卡奈单抗注射液在中国获临床试验批准