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A few days ago, Chengdu Baiyu Pharmaceutical entered the administrative examination and approval stage with its generic apixaban tablets, which were reported for production in Category 4, and is expected to become the second antithrombotic drug that has been reviewed by the company
Source: State Food and Drug Administration official website
Apixaban is a potent, oral, reversible, direct and highly selective factor Xa active site inhibitor jointly developed by Pfizer and Bristol-Myers Squibb.
Apixaban was first approved by the EMA in May 2011, approved by the FDA and PMDA in December 2012, and approved to enter the domestic market in January 2013.
Global sales of apixaban
Image source: Sales database of multinational listed companies on Minet.
At present, there are more than 20 domestic enterprises that have the approval for the production of apixaban tablets, and the sales scale of this product in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as Chinese public medical institutions) will break through in 2020.
Review of Apixaban Tablets
Source: Minet Consistency Evaluation Database
According to the data of Minet.
Some antithrombotic drugs deployed by Chengdu Baiyu Pharmaceutical Co.
Source: MED2.
In terms of antithrombotic drugs, Chengdu Baiyu Pharmaceutical submitted 3 generic drug marketing applications under new classifications, among which rivaroxaban tablets have been approved for production and are deemed to have been reviewed, and apixaban tablets are expected to become the company's second approved drug Reviewed antithrombotic drugs