[Huachuang Pharma] Tonghua Dongbao Commentary: FDA Approval for Insulin Aspart Significantly Ahead of Schedule, Internationalization Accelerates

English summary

Today the company announced that insulin aspart injection, co-developed by Tonghua Dongbao and Jianyou Pharmaceutical, has officially received U.S. FDA approval. This time, from accepting FDA on-site inspection to final approval, it took only about 4 months. Since the approval date is significantly earlier than the company's original plan, the U.S. market is now expected to start contributing revenue from 2027, and the company's 2027 performance growth is expected to be further raised from previous guidance. The U.S. insulin market has great potential. Based on the breakdown of Novo Nordisk, Eli Lilly, Sanofi, and Biocon financial statements (i.e., net price basis), the 2025 U.S. market sizes for insulin glargine, insulin aspart, and insulin lispro are $1.84 billion, $1.16 billion, and $1.35 billion, respectively, totaling about $4.34 billion (approximately RMB 29.87 billion), a sizable market. In terms of competitive landscape, only the originator, Biocon, and Dongbao/Jianyou are approved for insulin aspart, an excellent competitive structure. Contact: Zheng Chen / Zhu Kechen