China-based Jiangxi Jemincare Group has announced that its market filing for avatrombopag maleate (20mg) has been accepted for review by the Center for Drug Evaluation (CDE). The company is seeking approval for the Category 4 chemical drug to treat chronic liver disease-associated thrombocytopenia (CLDT) in patients undergoing elective diagnostic procedures or surgery.
Avatrombopag Background and Market Entry
Avatrombopag, originally developed by US-based AkaRx Inc., received market approval in the US in May 2018 under the trade name Doptelet. In March 2018, Fosun Pharma secured a licensing deal with AkaRx, obtaining exclusive distribution rights for avatrombopag in mainland China and Hong Kong. In April 2020, Fosun received an Import Drug License from China’s National Medical Products Administration (NMPA) for Doptelet, approved for use in adults with chronic liver disease-associated thrombocytopenia undergoing elective procedures. The drug is marketed under the trade name Su Ke Xin in China.
Market Dynamics and Generic Landscape
Avatrombopag maleate, currently without a generic version on the market, generated RMB 360 million (USD 53.36 million) in sales in 2021. Several generic versions by competitors, including Chia Tai Tianqing, Continent Pharma, Brilliant Pharma, and Kawingreen Bio, are awaiting regulatory decisions in China. Jemincare aims to be the first-mover generic, positioning itself to capture significant market share.-Fineline Info & Tech
