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Pharmaceutical Network December 4th, December 2nd, CDE official website data show that Qilu Pharmaceuticals declared the Dabiga group ester capsule 4 imitation listing application was accepted.
2019 global sales of more than $1.5 billion, and terminal sales of public medical institutions in China exceeded 600 million yuan.
Zhengda Tianqing Pharmaceutical Group in March this year won the first domestic imitation and as a review.
Figure 1: The registration of Dabiga group ester capsules by Qilu Pharmaceuticals Source: CDE Official Chart 2: Global sales of Dabiga esters in Bringelingham (in millions of dollars) Source: Mienet Multinational Listed Companies Sales Database Group esters belong to β-Alanine-type clotting enzyme inhibitors, are prebiotic drugs of the Dabiga group, used to prevent stroke and systemic embolism in patients with non-valve atrial fibrillation, treat acute deep vein thyroid formation or pulmonary embolism, and prevent recurrence.
the product overcomes many shortcomings of the traditional anticoagulant drug huafalin, with its anticoagulant efficacy is reliable, safe to use, easy to take and other advantages, has been approved in more than 80 countries around the world.
's original research products have exceeded US$1.5 billion in global sales, were approved for import in China in March 2013, entered the national health insurance catalogue in 2017 after sales began to grow significantly, in 2019 in China's urban public hospitals, county-level public hospitals, urban community centers and township hospitals (China's public medical institutions) terminal sales of more than 600 million yuan.
Table 1: Application for the listing of Dabiga group esters-related products currently under review Source: Minet MED2.0 China Drug Review Database In March 2020, China Biopharmaceuticals announced that the new oral anticoagulant drug Dabiga esters developed by subsidiary Zhengtian Qing Pharmaceutical Group has been issued by the State Drug Administration drug registration approval, the first batch of the variety, and is considered to be consistent with the quality and efficacy evaluation of generic drugs.
meters of intranet data show that, as of now, in addition to Qilu new joined the war situation, Chengdu Yuandong Biopharmaceuticals, Jiangsu Hausen Pharmaceutical Group, Chengdu Bett Pharmaceuticals have declared four types of imitation listing applications, is being reviewed and approved.
source: CDE official website, Mienet database