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On October 24, Lizhu Group announced that its subsidiary Lizhu Pharmaceutical Factory received the "Drug Registration Certificate" for injection of Danqulin sodium, which was approved for listing for the prevention and treatment of malignant hyperthermal fever.
Group's injection with danqulin sodium for the domestic first imitation.
malignant hyperthermal fever is a rare disease, a familial genetic muscle disease, mainly triggered by volatile inhalation of anesthetics and depolarized muscle relaxants - amberylcholine, an abnormally high metabolic state of skeletal muscle.
in the absence of specific therapeutic drugs, general clinical cooling measures are difficult to control the increase in body temperature, which can eventually lead to patient death.
injections using the original variety of danqulin sodium for Dantrium, Par Sterile Products LLC, USA, were first approved for market approval in the United States in 1979 to control the explosive metabolism of skeletal muscles manifested in malignant hyperthermal risk groups at all ages with appropriate supportive therapies.
according to the CDE Review Center website and The Salta database shows that as of this announcement date, only Lizhu Pharmaceutical Factory obtained the registration approval of danqulin sodium for injection, did not see other manufacturers declare.
Lizhu Group declared clinical in 2015 according to the (original) chemical category 3.3 and was approved in 2017, in February 2019 declared class 3 imitation listing, in April of the same year was successfully included in the priority review process.
date of this announcement, the cumulative direct investment in research and development of Danqulin sodium for injection by Lizhu Group was approximately RMB17.2234 million.
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