智通财经网·2025-09-16 07:30Core Viewpoint - 康龙化成's stock rose over 7% following the announcement of successful FDA inspection of its Shaoxing facility, marking a significant milestone in its compliance with international quality standards [1] Group 1: Company Achievements - 康龙化成's Shaoxing facility received the Establishment Inspection Report from the FDA, confirming it passed the quality inspection [1] - This is the first time the Shaoxing active pharmaceutical ingredient (API) production base has passed the FDA's pre-approval inspection for new drugs [1] - Following the successful inspection of the Ningbo facility in April 2025, this marks another achievement for 康龙化成 in ensuring its production facilities meet FDA standards [1] Group 2: Market Implications - The successful FDA inspection indicates that 康龙化成's quality system is aligned with international standards, enabling it to supply commercialized innovative drug APIs to the US and global markets [1] - Currently, 康龙化成 has four commercialized API production bases in China, the UK, and the US that have all passed FDA inspections, allowing it to provide tailored production solutions for different markets [1]