健康元药业集团股份有限公司 关于莱康奇塔单抗注射液上市许可申请获受理的提示性公告

Drug Information - The drug "Lai Kang Qi Ta" monoclonal antibody injection has received acceptance for domestic production registration from the National Medical Products Administration (NMPA) [1] - It is classified as a Class 1 therapeutic biological product and is intended for adult patients with moderate to severe plaque psoriasis suitable for systemic therapy or phototherapy [1] - The drug is a self-developed innovative IL-17A/F dual-target inhibitor, which is the first of its kind in China and the second globally [1][2] Clinical Development - A clinical trial for the drug is set to achieve primary and secondary efficacy endpoints by July 2025, demonstrating superior efficacy compared to the control group [1] - The trial results indicate faster onset, better short-term efficacy, long-lasting effects, and less frequent dosing compared to the control drug [1] - The cumulative R&D investment for the drug is approximately RMB 204.03 million [2] Market Situation - As of the announcement date, there are no approved products in China for psoriasis indications targeting the IL-17A/F dual-target [3] - There are three imported and two domestic products approved for IL-17A and IL-17RA single-target indications [3] - The estimated domestic terminal sales for IL-17A and IL-17RA single-target drugs in 2024 is RMB 2.833 billion [3]