Hecan Pharmaceutical Nears Approval for $12 Billion Blockbuster Anticoagulant Apixaban

Recently, apixaban tablets submitted for production under the new registration classification by HEC CJ PHARM and other pharmaceutical companies have entered the administrative approval stage, with expectations of imminent approval and equivalence to passing the consistency evaluation. Apixaban is a novel oral anticoagulant; in 2019, global sales of the originator drug reached USD 12.149 billion. Although apixaban tablets were included in the third batch of centralized volume-based procurement in China, multiple domestic pharmaceutical companies are still actively positioning themselves in this market.

Data from Menet shows that apixaban tablets submitted for production under the new registration classification by four companies, including HEC CJ PHARM, Wanbang Pharmaceutical, Qilu Pharmaceutical, and BRILLIANT PHARMACEUTICALS, have recently entered the administrative approval stage, with market authorization imminent. Previously, apixaban tablets (2.5 mg) submitted as generic Class 4 applications by Qilu Pharmaceutical and BRILLIANT PHARMACEUTICALS had already been approved.

Apixaban is a highly selective direct Factor Xa inhibitor jointly developed by Bristol-Myers Squibb and Pfizer. As a novel oral anticoagulant, it is primarily indicated for the prevention of venous thromboembolic events in adult patients undergoing elective hip or knee replacement surgery. In 2019, global sales of apixaban tablets reached $7.929 billion for Bristol-Myers Squibb and $4.220 billion for Pfizer, totaling $12.149 billion, thereby ranking among the top 10 best-selling drugs worldwide.

According to data from Menet, the sales of apixaban tablets at the terminal level of China’s public medical institutions—including urban public hospitals, county-level public hospitals, urban community health centers, and township health centers—amounted to RMB 61.45 million in the first half of 2020, representing a year-on-year increase of 198.16%. Among them, Chia Tai Tianqing Pharmaceutical Group held a market share of 40.99%, while Hansoh Pharmaceutical accounted for 35.77%.

Apixaban tablets are included in the third batch of centralized volume-based procurement. Previously, apixaban tablets from eight domestic pharmaceutical companies had been approved and deemed to have passed the consistency evaluation, including Hansoh Pharmaceutical, Chia Tai Tianqing Pharmaceutical Group, Kelun Pharmaceutical, Qingfeng Pharmaceutical, Nanjing Chia Tai Tianqing, Qilu Pharmaceutical, Jiayi Pharmaceutical, and BRILLIANT PHARMACEUTICALS.

Currently, multiple pharmaceutical companies in China are still positioning themselves in the generic apixaban tablet market. Marketing authorization applications for apixaban tablets submitted under the new registration classification by 21 pharmaceutical companies, including Yangtze River Pharmaceutical Group, CSPC Pharmaceutical Group, Huahai Pharmaceutical, Hisun Pharmaceutical, and Lepu Medical, are currently under review and approval. The registration status of apixaban tablets submitted for production under the new registration classification by HEC CJ PHARM, Anhui Wanbang Pharmaceutical Technology Co., Ltd., Qilu Pharmaceutical, and BRILLIANT PHARMACEUTICALS has been updated to “Under Approval.” If successfully approved, these products will be considered as having passed the consistency evaluation.

Source: Menet Database