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兴齐眼药:SQ-129玻璃体缓释注射液临床试验获批

Core Viewpoint - Xingqi Eye Pharmaceutical has received clinical trial approval for SQ-129 vitreous sustained-release injection, aimed at treating diabetic macular edema and macular edema caused by retinal vein occlusion, indicating potential for market entry as no similar products are currently approved in China [1][2]. Group 1: Product Development - SQ-129 is classified as a Class 2 modified new chemical drug, demonstrating good safety and clinical development value based on extensive research [1]. - The company has established a comprehensive product system covering ten categories of ophthalmic drugs, including treatments for myopia, dry eye, and infections [2]. - The R&D center has developed seven technical platforms and various evaluation technologies, enhancing the company's ability to convert technical achievements into marketable products [2]. Group 2: Clinical Trials and Approvals - As of mid-2025, the company has made significant progress in clinical trials, with multiple products at various stages, including the completion of Phase I trials for voriconazole eye drops and the initiation of Phase III trials for lidocaine eye gel [3]. - SQ-22031 eye drops have also progressed to Phase II trials for neurotrophic keratitis, which was included in China's rare disease list in 2023 [3]. Group 3: Market Position and Strategy - The company focuses on the high-tech, high-risk, and high-value characteristics of pharmaceutical products, emphasizing the long and complex process from clinical trials to market launch [2]. - Xingqi Eye Pharmaceutical is committed to actively advancing its R&D projects in compliance with national regulations and will disclose information based on development progress [2].