兴齐眼药:SQ-129玻璃体缓释注射液获得临床试验批准通知书

Core Viewpoint - The company has received approval from the National Medical Products Administration for the clinical trial of SQ-129 vitreous sustained-release injection, a new drug aimed at treating diabetic macular edema and macular edema caused by retinal vein occlusion [2]. Group 1: Product Development - SQ-129 vitreous sustained-release injection is classified as a Category 2.2 modified new chemical drug [2]. - The clinical indications for SQ-129 include treatment for adult patients with diabetic macular edema (DME) and macular edema due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) [2]. - The company has completed various studies, including pharmaceutical and non-clinical pharmacology and toxicology, demonstrating good safety and clinical development value for SQ-129 [2]. Group 2: Market Context - Currently, there are no approved products in the domestic and international markets for SQ-129 [2]. - Following the approval of the clinical trial, the company must conduct clinical research according to the approval document and obtain further approval from the National Medical Products Administration before the product can be marketed [2].