Qilu Joins the Fray as Yuandong, Hansoh, and BeiTe Target the $1.5 Billion Antithrombotic Blockbuster Dabigatran Etexilate

On December 2, data from the CDE website showed that Qilu Pharmaceutical’s Class 4 generic marketing application for Dabigatran Etexilate Capsules had been accepted. The originator of dabigatran etexilate is Boehringer Ingelheim, which reported global sales exceeding US$1.5 billion in 2019 and sales of over RMB 600 million at public healthcare institutions in China. Chia Tai Tianqing Pharmaceutical Group secured the first domestic generic approval in March this year, which is deemed equivalent to passing the consistency evaluation.

Figure 1: Registration Status of Dabigatran Etexilate Capsules by Qilu Pharmaceutical

Source: CDE Official Website

Figure 2: Global Sales of Boehringer Ingelheim’s Dabigatran Etexilate (in million USD)

Source: Menet Database of Sales by Multinational Listed Companies

It is reported that dabigatran etexilate, a β-alanine-derived thrombin inhibitor and prodrug of dabigatran, is indicated for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, the treatment of acute deep vein thrombosis or pulmonary embolism, and the prevention of their recurrence. This product overcomes many of the drawbacks associated with the traditional anticoagulant warfarin. Due to its reliable anticoagulant efficacy, favorable safety profile, and convenient administration, it has been approved in more than 80 countries worldwide.

The global sales of the original research product have exceeded US$1.5 billion. It was approved for import into China in March 2013, and its sales began to grow significantly after it was included in the National Reimbursement Drug List in 2017. In 2019, its terminal sales at Chinese public medical institutions—including urban public hospitals, county-level public hospitals, urban community health centers, and township health centers—exceeded RMB 600 million.

Table 1: Status of Marketing Applications for Dabigatran Etexilate-Related Products Currently Under Review

Source: Menet MED2.0 China Drug Review Database

In March 2020, China Biopharmaceutical Corporation announced that its subsidiary, Chia Tai Tianqing Pharmaceutical Group, had received drug registration approval from the National Medical Products Administration (NMPA) for Dabigatran Etexilate Capsules, a novel oral anticoagulant. This marked the first domestic approval for this product, which is deemed to have passed the consistency evaluation of quality and efficacy for generic drugs. Data from Menet shows that, to date, in addition to Qilu Pharmaceutical newly entering the market, Chengdu Yuandong Bio-pharmaceutical, Jiangsu Hansoh Pharmaceutical Group, and Chengdu Better Pharmaceutical have all submitted Class 4 generic drug marketing applications, which are currently under review and approval.

Source: CDE Official Website, Menet Database