[CICC Pharma] Tonghua Dongbao Company Update: Insulin Aspart Approved by FDA, Overseas Milestone Achieved

English summary

On July 27, the company announced that insulin aspart injection, co-developed with Jianyou Pharmaceutical, officially received the Biologics License Application (BLA) approval letter from the U.S. Food and Drug Administration (FDA), approved for marketing in the US. Comments: Insulin aspart has significant market space in the US. According to Novo Nordisk's 2025 annual report, its US sales of insulin aspart were DKK 7.166 billion, approximately USD 1.126 billion, and global sales were DKK 15.765 billion, approximately USD 2.477 billion. The company's insulin aspart injection being approved in the US indicates that its R&D capabilities, production processes, and quality management systems have officially gained recognition from the world's strictest regulators. This lays a solid foundation for the company's products to serve diabetic patients globally and may also increase the coverage of its products in hospitals at home and abroad in the future. Actively exploring European and other global markets. According to the company's annual report, its insulin aspart MAA for the EU has been accepted by EMA, and it has been approved for marketing in Indonesia and the Dominican Republic;…