YKYY018雾化吸入剂是悦康科创依托全流程AI平台，自主开发的一款国际原创的膜融合抑制剂药物， 用于与呼吸道合胞病毒患者接触后的暴露后预防和用于RSV感染的治疗。该产品具有全新的作用机制， YKYY018能够与呼吸道合胞病毒融合蛋白（F蛋白）F1亚基的七肽重复序列区1（HR1）特异性结合， 抑制病毒自身HR1与HR2结构域之间同源6-HB的形成，阻断病毒与宿主细胞的融合过程，实现抗病毒效 果，兼具治疗和预防的双重功能。公司已获得该产品的核心专利授权，并拥有其全球独占权益。 格隆汇12月2日丨悦康药业(688658.SH)公布，公司全资子公司北京悦康科创医药科技股份有限公司（简 称"悦康科创"）于近日获得国家药品监督管理局（简称"NMPA"）核准签发的关于同意YKYY018雾化吸 入剂用于与呼吸道合胞病毒患者接触后的暴露后预防和用于RSV感染的治疗的两份《药物临床试验批准 通知书》，公司将开展本品I期临床试验。 ...

Core Viewpoint - The approval of SYH2066 by the National Medical Products Administration of China for clinical trials marks a significant milestone for the company, potentially positioning it as a leader in the treatment of respiratory syncytial virus (RSV) infections [1] Company Summary - The stock price of the company, 石药集团 (Stone Pharmaceutical Group), increased by over 3%, currently trading at 10.58 HKD with a transaction volume of 526 million HKD [1] - The company has developed SYH2066, a new oral small molecule candidate drug targeting RSV, which has shown promising pharmacokinetic properties and safety in preclinical studies [1] - There are currently no targeted small molecule drugs for RSV available in the domestic and international markets, indicating a high clinical development value for SYH2066 [1] Industry Summary - The approval of SYH2066 for clinical trials addresses a significant unmet medical need in the treatment of RSV, a common cause of respiratory infections [1] - The potential introduction of an effective treatment for RSV could impact the pharmaceutical landscape, particularly in the respiratory disease segment [1]

Core Viewpoint - The company Shiyao Group has received approval from the National Medical Products Administration of the People's Republic of China for its self-developed drug SYH2066, which targets respiratory syncytial virus (RSV) and is set to enter clinical trials in China by September 2025 [1] Company Summary - SYH2066 is a new chemical entity classified as a Class 1 new drug, specifically designed as an oral small molecule candidate for treating respiratory infections caused by RSV [1] - The drug has demonstrated good oral bioavailability and favorable pharmacokinetic properties in preclinical studies, significantly reducing RSV viral load in animal models while showing high safety [1] - Currently, there are no targeted small molecule drugs for RSV available in the domestic and international markets, positioning SYH2066 as a potentially effective treatment with high clinical development value [1] Industry Summary - The approval of SYH2066 marks a significant advancement in the treatment options for RSV, a disease that currently lacks targeted small molecule therapies [1] - The development of this drug could address a critical gap in the market, potentially leading to improved patient outcomes and establishing a new standard of care for RSV infections [1]