Shares of WUXI BIO (02269) surged more than 6% during the trading session. At the time of writing, the stock was up 4.99%, trading at HK$37.44 with a turnover of HK$660 million.

The company announced that its biologics drug substance manufacturing facility eight (MFG8), located at its Shijiazhuang base in Hebei, has successfully passed a Pre-License Inspection (PLI) by the U.S. Food and Drug Administration (FDA). This clearance supports the commercial production of a therapy for autoimmune diseases.

Dr. Chris Chen, Chief Executive Officer of WUXI BIO, stated that passing this FDA PLI not only validates the company's ongoing commitment to building a world-class quality system but also demonstrates its reliable capability to support partners in advancing global commercial production. He expressed pleasure in leveraging high-standard production capabilities to help bring this potential "blockbuster" innovative autoimmune therapy closer to commercial supply and contribute to improving access to high-quality biologics. WUXI BIO will continue to empower global partners with its dependable quality system to accelerate the delivery of innovative biologics to more patients.