Shanghai Pharmaceuticals (601607.SH) Announces Approval of Avatrombopag Maleate Tablets for Production

Gelonghui January 23rdSPH(601607.SH) announced that recently, the Malate Avatrombopag Tablets produced by its subsidiary, Shanghai SPH Xinyi Pharmaceutical Co., Ltd., received the "Drug Registration Certificate" (Certificate No.: 2026S00156) issued by the National Medical Products Administration (NMPA), and the drug has been approved for production.

Avatrombopag Maleate Tablets are applicable for adult patients with chronic liver disease-related thrombocytopenia undergoing elective diagnostic procedures or surgery; and for adult patients with chronic primary immune thrombocytopenia (ITP) who have previously shown inadequate response to treatments such as glucocorticoids and immunoglobulins, to increase platelet counts and reduce or prevent bleeding. This product was originally developed by U.S.-based AkaRx Inc. and launched in the U.S. in 2018. In August 2024, SPH Xinyi submitted a registration and marketing application for this drug to the National Medical Products Administration (NMPA), which has been accepted. As of the date of this announcement, the company has invested approximately RMB 9.8961 million in research and development for this drug.

As of the date of this announcement, the main manufacturers of this drug in China are Fosun Wanbang (Jiangsu) Pharmaceutical Group Co., Ltd., Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd., Qilu Pharmaceutical Co., Ltd., etc.