HK Stock Market Move | WUXI BIO(02269) Rises Nearly 7% in Early Trading; Wuxi Mashan Base Successfully Passes U.S. FDA GMP On-Site Inspection

WUXI BIO (02269) rose nearly 7% in early trading. As of press time, it was up 6.64% at HK$51.4, with a turnover of HK$979 million. On the news front, WUXI BIO recently announced that its Wuxi Mashan base successfully passed an unannounced GMP on-site inspection by the U.S. FDA. The inspection found no major or critical deficiencies, and the site was successfully closed out. The inspection covered the full production system for multiple biologics products from the base that have already been approved and marketed in the U.S., and the company's quality control system has once again been recognized by the world's highest regulatory standards. Public information shows that WUXI BIO's Wuxi Mashan base is China's first biopharmaceutical base approved by the FDA and EMA for commercial production, and is also an important production base for the company's coordinated operations of drug substance and drug product. Northeast noted that the successful clearance this time verifies the stability and reliability of the company's standardized production system, alleviates overseas pharmaceutical companies' concerns about the compliance of domestic capacity, helps the company continue to undertake major commercial products from Europe and the U.S., deepen long-term cooperation with multinational giants, and further widen the industry's quality and delivery barriers.