Core Viewpoint - The approval of the recombinant anti-human beta-amyloid monoclonal antibody injection, Lunakanai, by the National Medical Products Administration of China marks a significant milestone for the company as it becomes the first biosimilar of Lunakanai to receive clinical trial permission in China [1] Company Summary - The product is a biosimilar to Leqembi, classified under Category 3.3 of therapeutic biological products, and is intended for the treatment of mild cognitive impairment and mild dementia caused by Alzheimer's disease [1] - The development of the product adheres to the relevant research guidelines for biosimilars, ensuring that it meets the necessary standards for quality, safety, and efficacy [1] - Pharmaceutical and non-clinical research results indicate that the product is highly similar to the reference drug, supporting the initiation of subsequent clinical studies [1]
石药集团(01093)：仑卡奈单抗注射液在中国获临床试验批准