Workflow
睑板腺功能障碍相关干眼病治疗
icon
Search documents
恒瑞医药: 恒瑞医药关于获得药品注册批准的公告
Zheng Quan Zhi Xing· 2025-07-03 16:15
Core Viewpoint - Jiangsu Hengrui Medicine Co., Ltd. has received approval from the National Medical Products Administration for its product, Perfluorohexyl Octanoate Eye Drops, aimed at treating Meibomian Gland Dysfunction (MGD) related dry eye [1][2]. Group 1: Product Information - Product Name: Perfluorohexyl Octanoate Eye Drops (SHR8058) [1] - Dosage Form: Ophthalmic preparation [1] - Specification: 3ml [1] - Registration Category: Reference to Class 3 generic drug [1] - Prescription Status: Prescription drug [1] - Approved Indication: Treatment of dry eye related to Meibomian Gland Dysfunction [1]. Group 2: Market Context - The prevalence of dry eye in China is reported to be between 21% and 30% [1]. - Clinical studies indicate that 69% to 86% of dry eye patients suffer from MGD, highlighting the need for targeted treatments [1]. - Current treatments for MGD lack a specific drug, emphasizing the demand for effective and safe therapeutic options [1]. Group 3: Product Development and Investment - The eye drops consist of 100% Perfluorohexyl Octanoate, which stabilizes the tear film and prevents excessive evaporation [2]. - The product can penetrate the Meibomian glands to dissolve viscous secretions, addressing MGD-related dry eye [2]. - The total research and development investment for the product has reached approximately 107.53 million yuan [2].