Qilu Pharmaceutical's Abbreviated New Drug Application for Eltrombopag Olamine Tablets Accepted by CDE

On January 20, the Center for Drug Evaluation (CDE) accepted Qilu Pharmaceutical’s marketing application for eltrombopag olamine tablets, filed under Category 4 of generic drug regulations. According to forecast data from Menet, sales of eltrombopag olamine tablets in China’s urban physical pharmacy terminals reached nearly RMB 300 million in 2020E, representing a year-on-year increase of 67.92%, thereby surpassing recombinant human coagulation factor VIII for injection to become the best-selling hemostatic agent.

Source: CDE Official Website

Eltrombopag olamine is an orally bioavailable, small-molecule thrombopoietin (TPO) receptor agonist that interacts with the transmembrane domain of the human TPO receptor. It is clinically indicated for patients with thrombocytopenia, including immune thrombocytopenia (ITP), who have an increased risk of bleeding due to low platelet counts and their clinical condition.

Marketing Authorization Application Status of Eltrombopag Olamine Tablets

Source: Menet MED2.0 China Drug Review Database

Currently, only the originator’s eltrombopag olamine tablets are marketed and sold in China; no generic versions have yet been approved for marketing. However, three companies—Aosaikang, Chia Tai Tianqing, and Qilu Pharmaceutical—have submitted marketing applications for this product under Category 4 generics. Who will secure the first generic approval? We will continue to monitor developments closely.

Data from Menet shows that in 2019, the sales revenue of Eltrombopag Olamine Tablets at urban physical pharmacy terminals in China reached RMB 170 million, a year-on-year increase of 289.63%. It is predicted that the sales revenue in 2020 will reach RMB 290 million, a year-on-year increase of 67.92%, replacing Recombinant Human Coagulation Factor VIII for Injection to become the best-selling hemostatic drug in physical pharmacies.

Top 10 Hemostatic Drug Products at Physical Pharmacy Terminals in Chinese Cities, 2020E

Source: Menet’s Competitive Landscape of China’s Urban Physical Pharmacy Terminals

In 2020, the market concentration of hemostatic drugs at physical pharmacy terminals in Chinese cities was relatively high, with the combined market share of the top 10 products exceeding 90%. Eltrombopag olamine tablets and porcine-derived fibrin sealant experienced significant growth, with both categories registering year-on-year increases of over 60%.

Based on the ranking changes of 10 products, Eltrombopag Olamine Tablets have replaced Recombinant Human Coagulation Factor VIII for Injection to become the best-selling hemostatic drug in the terminal market of physical pharmacies in Chinese cities; Recombinant Human Coagulation Factor IX for Injection rose by two ranks, while Human Fibrinogen and Porcine-derived Fibrin Sealant each rose by one rank.

Source: Menet Database, CDE Official Website

Note: The Menet China Urban Physical Pharmacy Terminal Competitive Landscape Database is an expanded urban physical pharmacy database that continuously monitors all product categories across physical pharmacies in 293 prefecture-level and above cities nationwide (excluding physical pharmacies in counties, townships, and villages). The aforementioned sales figures are calculated based on the average retail price of products at the terminal. Review data statistics are current as of January 20. Please feel free to point out any omissions or errors.