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Recently, NMPA official website data shows that Osaikon’s posaconazole injection 3 types of imitation listing applications have entered the "under review" status, and it is expected to win the first domestic imitation + first review.
Figure 1: Registration progress of Osaikon's posaconazole injection
Source: NMPA official website
Figure 2: Sales of posaconazole
Source: Mi Nei.
Posaconazole developed by Merck is a new generation of triazole antifungal drug with global sales of US$662 million in 2019.
Table 1: Applications for imitation of posaconazole on the market
Source: Meinenet MED2.
Note: * is the enterprises included in the priority review
In terms of domestic generic drugs, Shanghai Xuantai Pharmaceutical Technology's posaconazole enteric-coated tablets, which were declared and marketed in accordance with 4 types of generics, were contracted in February 2019, and were included in the priority review in September of the same year.
If Osaikon successfully wins the first domestic imitation of posaconazole injection, it can form a combined attack with posaconazole enteric-coated tablets, and Merck’s monopoly of the market is expected to be broken.
