Prasugrel Hydrochloride Tablets Receive Clinical Trial Approval

September 11, 2025  Source: drugdu 117

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An announcement was made on the evening of September 10th that the company's holding subsidiary, Chongqing Pharmaceutical (Group) Co., Ltd., received the "Notice of Approval for Drug Clinical Trials" issued by the State Food and Drug Administration. After review, its applied "Prasugrel Hydrochloride Tablets" met the relevant requirements for drug registration and it was approved to conduct clinical trials.

According to information, prasugrel hydrochloride tablets, originally developed by Daiichi Sankyo Co., Ltd., are a third-generation drug that inhibits ADP-activated platelet aggregation. They are indicated for preventing thrombosis in patients with acute coronary syndrome, stable angina, and previous myocardial infarction after percutaneous coronary intervention. They are currently available in over 70 countries and regions worldwide (though not in China).

The company invested in and acquired the prasugrel hydrochloride tablet technology and exclusive patent license from Daiichi Sankyo Co., Ltd. It submitted its marketing registration application in August 2021 and was accepted. Due to the need to further refine its application materials, after careful consideration, the company voluntarily withdrew its application in July 2023. In June 2025, the company's clinical trial application was accepted.

Chongqing Pharmaceutical Holdings stated that according to China's laws and regulations on drug registration, after receiving a drug clinical trial approval notice, a drug must undergo clinical trials and undergo review and approval by the National Medical Products Administration before it can be produced and marketed. The company will actively promote clinical trials and promptly fulfill its obligations to disclose information on subsequent project progress in accordance with relevant regulations.

Source:https://finance.eastmoney.com/a/202509103510065036.html

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