Avatrombopag

Chronic immune thrombocytopenia (ITP) and chronic liver disease-related thrombocytopenia have long faced the clinical dilemma of limited treatment options and high bleeding risk for patients. The advent of avatrombopag provides a safer oral treatment option for these populations. As a second-generation oral thrombopoietin receptor agonist (TPO-RA), it can selectively bind to the transmembrane domain of the human TPO receptor, activate downstream signaling pathways to promote the proliferation and differentiation of megakaryocytes, thereby physiologically increasing platelet count. Compared with first-generation products, it has more prominent advantages of no dietary restriction and lower hepatotoxicity. At present, it has been approved for platelet elevation therapy in adult patients with chronic liver disease-related thrombocytopenia before elective invasive procedures or surgery, as well as for adult patients with chronic immune thrombocytopenia who have insufficient response to glucocorticoid and immunoglobulin therapy.

The global market size of avatrombopag exceeded USD 1.2 billion in 2023, with a compound annual growth rate of approximately 27% in the past three years. The growth rate of the Chinese market is significantly higher than that of the global market. In 2023, the terminal sales in public medical institutions exceeded RMB 2.5 billion, with a year-on-year growth of over 40%. At present, the original research product still dominates the domestic market. Generic preparations from 7 local enterprises have been approved for marketing, and more than 10 other enterprises are in the declaration stage. In 2023, this variety was included in the seventh batch of national centralized drug procurement, with the winning price reduced by more than 90%, and the accessibility at the primary level has been greatly improved, driving the continuous expansion of upstream API demand.

The original research enterprise of avatrombopag is AkaRx, a Swedish company, and the original brand name is Doptelet®. Its Chinese compound patent will expire in 2026, and the crystal form patent will expire in 2031. The main dosage form approved for the original research product is tablet, with specifications including 20mg and 40mg. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also a reference preparation collected by the FDA. At present, avatrombopag APIs from 18 domestic enterprises have completed registration at CDE (status A), and 10 domestic generic preparation products have been approved for marketing. The centralized procurement supply is fully undertaken by local generic preparation enterprises. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for avatrombopag, covering starting materials, intermediates, process impurities and degradation impurities, which fully comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia, FDA and ICH. Most impurity products are in stock regularly. Orders placed before 16:00 can be shipped on the same day, which can provide stable reference standard support for the whole process of API R&D, quality research and declaration.