Core Points - The company has received acceptance for its clinical trial application for GB10 injection, marking a significant step in its innovative drug development process [1][2][3] - GB10 injection is a high-concentration ophthalmic injection developed by the company, targeting age-related macular degeneration and diabetic macular edema [2] - Successful development and potential market launch of GB10 injection could enhance the company's product portfolio and market competitiveness [3] Summary by Sections Application Registration Details - Product Name: GB10 Injection [2] - Application Type: Domestic production drug registration clinical trial [2] - Acceptance Number: CXSL2500841 [2] - Indications: Treatment for neovascular diseases such as age-related macular degeneration (nAMD) and diabetic macular edema (DME) [2] - Dosage Form: Injection [2] - Product Overview: GB10 injection is a dual-target antibody with global intellectual property rights, showing efficacy in preclinical studies comparable to international competitors [2] Impact on the Company - The acceptance of the clinical trial application is a crucial milestone in the company's dual-antibody research strategy, indicating progress in its innovative drug development [3] - If successful, the drug could meet market demands with a more diverse product offering, thereby enhancing the company's competitive position [3]
科兴生物制药股份有限公司 自愿披露关于GB10注射液临床试验注册申请获得受理的公告