东阳光药递交甘精胰岛素美国注册申请 加快布局美国百亿胰岛素市场

Core Viewpoint - Dongyangguang Pharmaceutical is accelerating its international business expansion after completing the first "H-share absorption merger privatization + introduction listing" in the Hong Kong stock market, with a focus on launching its insulin products in the U.S. market [1] Group 1: Product Development - Dongyangguang Pharmaceutical has submitted a registration application for glargine insulin in the U.S., potentially becoming the first Chinese innovative pharmaceutical company to list a similar drug in the U.S. [1] - The company is also set to initiate overseas clinical trials for aspart insulin [1] Group 2: Market Opportunity - The U.S. insulin market exceeds $10 billion, and successful approval of glargine insulin could open a significant market for the company [1] - The company may qualify for exemption from Phase III clinical trials, which would significantly shorten the time to market and reduce R&D costs [1] Group 3: International Expansion - Dongyangguang Pharmaceutical's overseas sales network covers eight countries and regions, including the U.S., Germany, and the U.K., with over 250 overseas generic drug approvals across more than 70 varieties [1] - These international expansions lay a solid foundation for the company's innovative drugs to accelerate their entry into global markets [1]