科兴制药:眼科制剂GB10注射液获得药物临床试验批准通知书

Core Viewpoint - Company Sihuan Pharmaceutical (688136.SH) has received approval from the National Medical Products Administration (NMPA) for clinical trials of its self-developed GB10 injection, marking a significant step in its innovative drug development process [1] Group 1: Product Development - GB10 injection is a high-concentration ophthalmic protein drug formulation targeting both VEGF and Ang-2, with a concentration of 140 mg/mL, which can reduce injection volume or increase dosage, allowing for administration every four months [1] - Preclinical data indicates that GB10 injection's biological activity and animal efficacy meet international competitive standards, effectively inhibiting choroidal neovascularization in laser-induced monkey models [1] Group 2: Strategic Importance - The approval for GB10 injection's clinical trial represents a key advancement in the company's dual-antibody research strategy based on its proprietary technology platform [1] - Successful future commercialization of GB10 injection could diversify the product offerings in the market, enhancing the company's competitive position [1]