Shanghai Pharmaceuticals (601607.SH) Receives FDA Approval for Ticagrelor Tablets

Stock News11-06

Shanghai Pharmaceuticals Holding Co., Ltd. (601607.SH) announced that its subsidiary, Changzhou Pharmaceutical Factory Co., Ltd., recently received notification from the U.S. Food and Drug Administration (FDA) that its Abbreviated New Drug Application (ANDA) for Ticagrelor Tablets has been granted final approval for marketing.

Ticagrelor Tablets are indicated for patients with acute coronary syndrome, including those undergoing medical treatment or percutaneous coronary intervention, to reduce the incidence of thrombotic cardiovascular events. The original drug was developed by AstraZeneca and approved in the U.S. in 2011.

Changzhou Pharmaceutical Factory submitted the ANDA for this product to the FDA in May 2021 and has now obtained final approval. As of the announcement date, the company has invested approximately RMB 9.6713 million in R&D for this drug.

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