新诺威(300765.SZ)：控股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 - New Horizon (300765.SZ) announced that its subsidiary, Giant Stone Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of Lecanemab injection, marking it as the first biosimilar of Lecanemab in China [1] Group 1: Product Development - The product is a recombinant anti-human beta-amyloid monoclonal antibody, indicated for the treatment of mild cognitive impairment and mild dementia due to Alzheimer's disease [1] - The clinical trial approval is based on the adherence to the relevant research guidelines for biosimilars, ensuring the product's quality, safety, and efficacy are highly similar to the reference drug [1] Group 2: Market Position - This approval positions the company as the first in China to obtain clinical licensing for a Lecanemab injection biosimilar, potentially enhancing its competitive edge in the Alzheimer's treatment market [1]