Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. has reached a key regulatory milestone in its international expansion. On July 24, 2026, its wholly‑owned Singapore‑based subsidiary, Emerge Bioscience Pte. Ltd., received U.S. FDA approval for its Biologics License Application (BLA No. 761497/Original 1) for insulin aspart injection.
Insulin aspart is a rapid‑acting analog indicated for glycemic control in adults and children with diabetes. The approved product formats—a 10 mL multi‑dose vial and a 3 mL single‑use prefilled pen—are designed for both hospital and home‑use settings. The company invested approximately RMB 199.6 million in this R&D program. The U.S. diabetes market offers significant commercial potential: an estimated 38.54 million people aged 20—79 were living with diabetes in 2024, with total annual healthcare spending exceeding USD 404.5 billion and sustained demand for insulin therapies.
With over two decades of operations in Nanjing Jiangbei New Area (Nanjing High‑Tech Development Zone), King-Friend has strategically transitioned from manufacturing pharmaceutical intermediates and heparin raw materials to developing high‑end injectables and biologics. As a leading biomedical enterprise in Jiangbei New Area, the company has benefited from the region’s robust innovation ecosystem and internationally focused policy support. Initiatives such as import whitelists for research reagents, special subsidies for global regulatory filings, cross‑border compliance services, and international talent programs have helped shorten filing timelines and lower development costs for companies pursuing global market access.
Leveraging local industrial resources, King-Friend has built a global commercial network covering North America, Europe, and South America. Its overseas commercial team of over 100 employees drives direct sales of multiple injectable products in international markets. The company’s liraglutide biosimilar, launched in the U.S. in 2025, has generated steady revenue. Export sales have continued to rise, with growing earnings in both the U.S. and European markets—underscoring the success of the company’s strategic upgrade.
This FDA approval for insulin aspart further diversifies King‑Friend’s international product pipeline and strengthens its competitive position in the global endocrine therapeutics segment. Most importantly, it builds strong momentum for the company to expand its footprint in the high‑value U.S. pharmaceutical market and advance its broader global growth strategy.
