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 is the first biosimilar of its kind to receive clinical trial permission in China [1] Group 1: Product Information - Lunakanai is a biosimilar to Lecanemab, classified under Category 3.3 for therapeutic biological products, and is intended for the treatment of mild cognitive impairment and mild dementia due to Alzheimer's disease [1] - The development of Lunakanai 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 Lunakanai is highly similar to the reference drug in terms of quality, safety, and efficacy, which supports the initiation of subsequent clinical studies [1]
石药集团：仑卡奈单抗注射液在中国获临床试验批准