CR Double-Crane subsidiary secures drug registration for tirofiban injection

CR Double-Crane Pharmaceutical's wholly-owned subsidiary, Anhui Double-Crane Pharmaceutical Co., Ltd., has received a drug registration certificate from the National Medical Products Administration for Tirofiban Hydrochloride and Sodium Chloride Injection. This chemical drug, classified as Category 3, is used to prevent early myocardial infarction in adult patients with NSTE-ACS and reduce major cardiovascular events in STEMI patients undergoing PCI.

The product will be available in two specifications: 100ml (5mg Tirofiban Hydrochloride) and 250ml (12.5mg Tirofiban Hydrochloride). Anhui Double-Crane initiated the generic drug's research and development in June 2021, submitting the marketing authorization application on April 16, 2024, and receiving approval on September 9, 2025. Total R&D investment for this product reached RMB3,755,800.

In the domestic market, 18 enterprises have been approved to produce Tirofiban Hydrochloride and Sodium Chloride Injection, with 16 having passed or being deemed to have passed consistency evaluation. The drug's global sales for 2024 totaled $56,220,700, with "Aggrastat" accounting for $16,703,800.