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On March 30, the Insight database showed that the listing application for the second indication of Roche's "Eimexizumab" (acceptance number: JXSS2000012/13/14/15) was changed to "under approval", which will be soon Approved.
According to the public information of the prior priority review, the indications that will be approved this time are: routine preventive treatment for adults and children with hemophilia A (congenital factor VIII deficiency) without clotting factor VIII inhibitors.
Iimerizumab is a recombinant humanized bispecific antibody developed by Roche.
At the beginning of the market, the indication range of eimerizumab as a rare disease treatment was narrow, so the sales volume was average, with global sales totaling 230 million Swiss francs from the end of 2017 to 2018.
In China, eimerizumab is the first dual-antibody drug approved for marketing.
In May 2020, Roche's listing application for expanded indications was accepted by CDE, and in September of the same year, it was included in the priority review and approval by CDE.
