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赛升药业(300485.SZ):撤回注射用甲磺酸萘莫司他药品注册申请

Saisheng Pharmaceutical (300485.SZ): Withdrawal of registration application for injectable napalimostat mesylate

Gelonghui Finance ·  Oct 20, 2023 18:16

Gelonghui October 20?Saisheng Pharmaceutical (300485.SZ) announced that according to the adjustment of enterprise declaration strategy, Beijing Saisheng Pharmaceutical Co., Ltd. submitted an "application for withdrawing the application for registration of nemolastat for injection" to the Drug Review Center of the State Drug Administration. Recently, Saisheng Pharmaceutical Company received the notice of termination of Drug Registration Application, which was agreed by the State Drug Administration to withdraw the registration application.

Nemosulfonate for injection is used to improve acute symptoms of pancreatitis; to treat disseminated intravascular coagulation syndrome (DIC); and to prevent clotting of perfused blood during cardiopulmonary bypass (hemodialysis and plasmapheresis) in patients with hemorrhagic lesions or hemorrhagic tendencies. At the same time, naphthol mesylate for injection is a new type of protease inhibitor, which has a strong and extensive inhibitory effect on trypsin, complement system, coagulation and fibrinolysis system and platelet agglutination. The pharmacological effect is exerted by reversible inhibition of trypsin-like serine protease.

Saisheng Pharmaceutical submitted an application for registration of the product to the State Drug Administration in December 2021 and accepted it. Affected by the changes in policies and regulations and other factors, after careful study, the company decided to withdraw this application on its own initiative, and the product declaration strategy will be decided according to market conditions in the future.

The translation is provided by third-party software.


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