
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
Author | Baihuawen
On July 24, the apixaban tablets submitted by Qilu Pharmaceutical and Nanjing Chia Tai Tianqing under the New Category 4 application pathway were respectively approved for market launch by the National Medical Products Administration (NMPA), deemed as having passed the consistency evaluation.
Apixaban (Eliquis), developed by BMS/Pfizer, is a reversible, highly selective direct Factor Xa inhibitor belonging to the class of novel oral anticoagulants. Compared with other commonly used anticoagulants such as warfarin, apixaban demonstrates favorable safety and tolerability, a wide therapeutic window, and effectively reduces the incidence of stroke and systemic embolism without increasing the risk of bleeding. It has minimal food interactions, requires fixed dosing, and does not necessitate routine hematological monitoring, thereby offering greater convenience in clinical application.
Since its initial approval in the European Union on May 17, 2011, Eliquis has consistently ranked among the top 10 global pharmaceutical products by sales for multiple consecutive years. In 2018, the drug generated $9.8 billion in sales, ranking second; in 2019, its sales reached $12.1 billion, maintaining the second position. EvaluatePharma predicts that its sales will exceed $12.5 billion in 2026, placing it third.
Top 10 Drugs by Sales Forecast for 2026
Apixaban has been included in the third batch of the National Centralized Drug Procurement list. Currently, four generic versions have been approved in the Chinese market and are deemed to have passed the consistency evaluation, produced by Chia Tai Tianqing, Hansoh, Kelun, and Qingfeng Pharmaceutical, with median winning bid prices ranging from RMB 23 to 40 per tablet. With the recent approvals granted to Qilu Pharmaceutical and Nanjing Chia Tai Tianqing, competition for this product will become even more intense.