WuXi Biologics (02269) rose nearly 7% in early trading. As of press time, the stock was up 6.64% at HK$51.4, with a turnover of HK$979 million.
On the news front, WuXi Biologics (ASX: 02269) recently announced that its Wuxi Mashan facility successfully passed an unannounced GMP on-site inspection by the U.S. FDA. The inspection found no major or critical deficiencies, and the facility was successfully closed out. The inspection covered the entire production system for multiple biologics already approved and marketed in the United States at the site, and the company's quality management system has once again received recognition from the world's highest drug regulatory standards.
According to public information, WuXi Biologics' Wuxi Mashan facility is China's first biologics manufacturing site approved by both the FDA and EMA for commercial production, and is also an important production base for the company's integrated drug substance and drug product operations.
Northeast Securities noted that this successful clearance 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., deepens long-term cooperation with multinational giants, and further widens the industry's quality and delivery barriers.
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