CSPC Pharmaceutical Group Nears Approval of $9B Blockbuster Anticoagulant Apixaban Generic

Recently, CSPC’s apixaban tablets, submitted as a Class 4 generic drug, have entered the administrative approval stage and are expected to receive marketing authorization shortly. Apixaban is a novel oral anticoagulant. In 2020, Bristol-Myers Squibb’s Eliquis generated global sales exceeding USD 9 billion, and the domestic market for apixaban has surged rapidly in recent years.

Apixaban is a highly selective direct factor Xa inhibitor jointly developed by Bristol-Myers Squibb and Pfizer, primarily used to prevent venous thromboembolic events in adult patients undergoing elective hip or knee replacement surgery. In 2020, global sales of Bristol-Myers Squibb's Eliquis (apixaban tablets) exceeded $9.168 billion, consistently ranking among the top ten best-selling drugs globally.

Bristol-Myers Squibb Eliquis Global Sales (in millions of USD)

Source: Menet Multinational Listed Companies Sales Database

Apixaban was first approved for marketing in China in 2013. Initial market sales were sluggish, but the market scale has expanded rapidly in recent years. Data from MENET indicates that in 2020, terminal sales of apixaban across China's public medical institutions—comprising urban public hospitals, county-level public hospitals, urban community health centers, and township health centers—exceeded 100 million RMB, representing a year-on-year increase of 104.8%.

Apixaban Tablets have been included in the third round of national centralized drug procurement. Four companies, including Qilu Pharmaceutical, Hansoh Pharmaceutical, Jiayi Pharmaceutical, and Chia Tai Tianqing Pharmaceutical, won the bids and secured their respective market shares. Currently, 16 companies have been approved to manufacture Apixaban Tablets, with their approvals deemed equivalent to passing the consistency evaluation. These include Kelun Pharmaceutical, Qilu Pharmaceutical, HEC Pharm, Best Pharmaceutical, and Nanjing Chia Tai Tianqing Pharmaceutical, among others.

As a highly sought-after drug, over 30 pharmaceutical companies have entered the Apixaban Tablets market. The marketing authorization applications for Apixaban Tablets from 14 companies—including Yangzijiang Pharmaceutical, Huahai Pharmaceutical, Lepu Pharmaceutical, Changzhou Pharmaceutical Factory...—are currently under regulatory review and approval. CSPC's registration status for this product has been updated to "under approval." If successfully approved, it will be deemed to have passed the consistency evaluation.

Data Source: MENET Database