Sichuan-Based Baiyu Pharma Nears Approval for Apixaban, a Blockbuster Anticoagulant Generating Over $10 Billion Globally

Recently, Chengdu Baiyu Pharmaceuticals Co., Ltd.'s Apixaban Tablets, reported for production as a Category 4 generic drug, have entered the administrative approval stage and are expected to become the company's second anti-thrombotic drug to pass the review. Data from Menet shows that global sales of Apixaban reached a new high in 2021, exceeding 10 billion US dollars.

Source: Official website of the National Medical Products Administration

Apixaban is a potent, orally administered, reversible, direct, and highly selective inhibitor of the Xa factor active site. This novel oral anticoagulant drug was jointly developed by Pfizer and Bristol-Myers Squibb. It is indicated for adult patients undergoing elective hip or knee replacement surgery to prevent venous thromboembolic events.

Apixaban was first approved for marketing by the EMA in May 2011, followed by approvals from the FDA and PMDA in December 2012. It entered the Chinese market in January 2013, and its global sales reached a new high in 2021, exceeding 10 billion US dollars.

Global Sales of Apixaban

Source of the image: MenetNet Cross-Border Listed Company Sales Database

Currently, more than 20 companies in China possess the production approval for Apixaban Tablets. In 2020, the sales revenue of this product in Chinese urban public hospitals, county-level public hospitals, urban community health centers, and township health clinics (referred to as Chinese public medical institutions) exceeded 100 million yuan, with a year-on-year increase of over 100%. Affected by the centralized procurement policy, the growth rate declined somewhat in the first half of 2021.

Approval Status of Apixaban Tablets

Source: MiNei Consistency Evaluation Database

Data from MiNe Network shows that more than 20 companies’ Apixaban Tablets have passed or are considered to have passed the consistency evaluation, including well-known enterprises such as Qilu, Yangtze River, Shiyao, Kelun, and Hansoh.

Part of the Anti-Thrombotic Drugs Layout by Chengdu Baiyu Pharmaceuticals Co., Ltd.

Source: MiNeiNet MED2.0 China Drug Evaluation Database

In terms of antithrombotic drugs, Chengdu Baiyu Pharmaceuticals Co., Ltd. has submitted three generic drug marketing applications under a new classification. Among them, the rivaroxaban tablet has been approved for production and is considered to have passed the evaluation, while the apixaban tablet is expected to become the company's second antithrombotic drug to pass the evaluation. Vorapaxar, a cardiovascular drug approved by the FDA in 2014, has not yet received import approval for the original research product, and there are currently no approved generic versions in China.