Beijing News (Reporter Liu Xu) — On January 16, the National Medical Products Administration released information showing that four companies' applications for eltrombopag olamine tablets received drug registration certificates on the same day. These four companies are Jiangsu Aosaikang Pharmaceutical Co., Ltd., Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Qilu Pharmaceutical Co., Ltd., and Sichuan Kelun Pharmaceutical Co., Ltd. Prior to this, only Novartis' imported eltrombopag olamine tablets had been approved in China.
Eltrombopag Olamine Tablets, a non-peptide thrombopoietin receptor agonist developed by Novartis, were approved for marketing by the U.S. Food and Drug Administration (FDA) in November 2008 and gained approval to enter the Chinese market in 2017. They are used to treat chronic immune (idiopathic) thrombocytopenia (ITP) that has previously shown inadequate response to treatments such as glucocorticoids and immunoglobulins.
Immune Thrombocytopenia (ITP) is an acquired autoimmune bleeding disorder, accounting for approximately one-third of all bleeding disorders. Statistical data shows that in China's adult population, the incidence rate of ITP is 5-10 per 100,000 people, and it predominantly affects elderly individuals over 60 years old, women of childbearing age, and children. Eltrombopag is the world’s first oral medication for treating ITP. Compared to other injectable therapies, it offers more convenient administration, higher patient compliance, and can significantly reduce bleeding rates and the frequency of blood transfusions. It has been recommended for use by authoritative guidelines both domestically and internationally, including the "Chinese Guidelines for the Diagnosis and Treatment of Adult Primary Immune Thrombocytopenia (2020)," the "Adapted Chinese Guidelines for the Diagnosis and Treatment of Childhood Primary Immune Thrombocytopenia (2021)," and the "American Society of Hematology 2019 Guidelines for ITP."
Eltrombopag Ethanolamine Tablets are classified as a Class B drug under China's national medical insurance scheme and have been included in the country’s "Third Batch of Encouraged Generic Drug List," with sales in China reaching 700 million yuan in 2022. In addition to the four companies that have recently been approved, several other enterprises, including Grand Pharmaceutical and Changzhou Pharmaceutical, have also submitted applications.
Proofread by Chunyin Fu