B&K CORPORATION LIMITED (“the Company”, Stock Code: 02396.HK) has successfully completed the U.S. FDA Type II Drug Master File (DMF) filing (File No.: 043906) for its investigational rhPDGF-BB drug substance. This milestone signifies that the quality of the drug substance has met international standards, laying a solid foundation for the company's global expansion strategy. PDGF is one of the growth factors secreted by platelets after injury. It promotes the development of new blood vessels, regulation of inflammation, and stimulation of cell proliferation and migration, among other things, which eventually leads to wound closure and healing. PDGF-BB is one of the five dimeric isoforms of PDGF, and rhPDGF-BB is a recombinant form of the naturally occurring PDGF-BB. This product boasts broad application prospects and is characterized by high technical barriers and significant R&D complexity.

The FDA DMF filing requires companies to submit comprehensive and detailed R&D and manufacturing data. This successful filing not only serves as authoritative recognition of R&D capabilities and quality system of B&K, but also facilitate the company's rapid entry into the high-end U.S. market. Furthermore, it provides crucial compliance support for expanding into other global markets, injecting strong momentum into the company's internationalization strategy.