Rundu Co., Ltd. s application for marketing authorization for norwusine hydrochloride injection was

Mondo Health Updated on 2024-03-04

**: China Securities Network.

China Securities Intelligent Financial News Rundu Co., Ltd. (002923) announced on the evening of March 4 that recently, the company received the "Notice of Acceptance" issued by the State Drug Administration, and the marketing authorization application for norugine hydrochloride injection submitted by the company was accepted by the State Food and Drug Administration.

According to the announcement, the phase B clinical trial of the company's Class 1 innovative drug nornotridinine hydrochloride injection was led by the Chinese Academy of Medical Sciences in Beijing, and adopted a multi-center, randomized, and positive drug self-cross-control design. In March 2023, enrollment in the clinical trial study was completed. As a cardiac stress test drug, norwujiu hydrochloride injection is used for nuclide myocardial perfusion imaging, in the auxiliary diagnosis and evaluation of myocardial ischemia indications, the adverse reactions are mild, relieved or disappeared soon after drug withdrawal, and the safety is good, and it can be safely applied to the drug stress test of myocardial perfusion imaging (MPI).

According to the data, Rundu Co., Ltd. has focused on the research and development, production and sales of antihypertensive sartans, gastrointestinal lazoles, anesthesia and other characteristic APIs and intermediates for more than 20 years, and the main products have now formed a complete industrial chain of vertical integration of intermediates, APIs to preparations, and has formed a diversified business pattern with antihypertensive sartan, anti-peptic ulcer proton pump inhibitor lazole and other pharmaceutical APIs and intermediates, CMOs, CDMOs, etc.

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