苑东生物：2类改良型新药水合氯醛糖浆获得药品注册证书

Core Viewpoint - The approval of the drug "Hydrated Chloral Syrup" by the National Medical Products Administration marks a significant advancement for the company in the pediatric clinical medication sector, addressing specific needs for sedation and hypnosis in children [1][2] Group 1: Product Details - The active ingredient of Hydrated Chloral Syrup is hydrated chloral, designed specifically for pediatric use, with indications for sedation and hypnosis before examinations and procedures [1] - This product is classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2025) [1] - Unlike existing hydrated chloral/syrup combination products, this syrup does not require dilution for administration, allowing for precise dosage control and improved palatability for children [1] Group 2: Market Context - Hydrated chloral is a well-established sedative and hypnotic drug, with its safety and efficacy widely validated and recommended by various authoritative medical institutions [1] - Currently, there are three approved oral formulations of hydrated chloral in China, including those from other pharmaceutical companies [1] Group 3: Company Impact - The approval of Hydrated Chloral Syrup represents the company's first approved Category II modified new drug, enhancing its product pipeline in the anesthesia and analgesia field [2] - This development is expected to have a positive impact on the company's operational growth [2]