Youcare Pharmaceutical (SH:688658) Shang Hai Zheng Quan Bao·2025-11-27 19:37Core Viewpoint - YKYY018 aerosol inhalation agent developed by the company has received FDA approval for clinical trials aimed at preventing and treating respiratory syncytial virus (RSV) infections, highlighting a significant advancement in the company's drug development capabilities [1][4]. Group 1: FDA Approval and Clinical Trials - The FDA has granted approval for the clinical trial of YKYY018 aerosol inhalation agent, allowing the company to proceed with the study as per the submitted protocol [1]. - The IND number for the clinical trial is 178457, and the application is specifically for the prevention and treatment of RSV infections [4]. Group 2: RSV Infection Overview - RSV is a highly infectious RNA virus that primarily affects children, the elderly, and immunocompromised individuals, with approximately 90% of children infected by the age of two [2]. - Globally, RSV is the leading cause of lower respiratory tract infections in children under five, resulting in about 3.6 million hospitalizations and approximately 100,000 deaths annually [2]. - In 2024, it is estimated that 91.4 million children under five will be infected with RSV worldwide, with 13.4 million cases in China [2]. Group 3: YKYY018 Product Details - YKYY018 is an innovative membrane fusion inhibitor developed using a full-process AI platform, designed to prevent and treat RSV infections [3]. - The drug works by specifically binding to the F protein of RSV, blocking the fusion process between the virus and host cells, thus providing both therapeutic and preventive effects [3]. - The company holds core patent rights for YKYY018, granting it global exclusive rights [3]. Group 4: Preclinical Research Findings - Preclinical studies have shown that YKYY018 effectively inhibits various RSV strains and clinical isolates, demonstrating significant antiviral activity [5]. - In animal models, the drug significantly reduced viral loads and alleviated lung tissue damage, indicating its potential efficacy [5]. - Safety assessments in animal trials revealed no significant adverse effects on respiratory function or other health indicators, suggesting good safety and tolerability [5].