Zhuhai Rundu Pharmaceutical(002923.SZ): Application for the listing permit of Methoxamine Hydrochloride Injection has been accepted.
Run Du shares (002923.SZ) issued an announcement that the company recently received a notification from the State Food and Drug Administration ("State Food...
Zhuhai Rundu Pharmaceutical (002923.SZ) announced that the company recently received a "Notice of Acceptance" from the National Medical Products Administration ("NMPA"). The company's application for the market approval of Mepivacaine Hydrochloride Injection was accepted by the NMPA.
It is reported that the company's Class 1 innovative drug Mepivacaine Hydrochloride Injection has completed Phase IIIb clinical trials, led by Peking Union Medical College Hospital of the Chinese Academy of Medical Sciences. The trial utilized a multicenter, randomized, positive drug crossover design. The clinical trial research was completed in March 2023. The results of the study show that Mepivacaine Hydrochloride Injection, when used as a cardiac stress test drug for nuclear myocardial perfusion imaging, has minor adverse reactions that quickly resolve or disappear after discontinuation, demonstrating good safety and suitability for use in myocardial perfusion imaging (MPI) drug stress tests.
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