Shanghai Pharmaceuticals (601607.SH): Ticagrelor Tablets Receive Final FDA Approval via ANDA

Intelligent Finance APP News, SPH (601607.SH) announced recently that its subsidiary, CHANGZHOU PHARMACEUTICAL FACTORY, has received notification from the U.S. Food and Drug Administration (U.S. FDA) that its Abbreviated New Drug Application (ANDA, i.e., U.S. generic drug application) for Ticagrelor Tablets has been finally approved for marketing.

Ticagrelor Tablets are used in patients with acute coronary syndrome, including those receiving medical treatment and percutaneous coronary intervention, to reduce the occurrence rate of thrombotic cardiovascular events. The original research was developed by AstraZeneca and launched in the United States in 2011. In May 2021, CHANGZHOU PHARMACEUTICAL FACTORY submitted an ANDA application for this drug to the US FDA and recently received final approval for marketing. As of the date of this announcement, the company has invested approximately RMB 9.6713 million in R&D expenses for this drug.