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Source: The official website of the State Drug Administration, danqulin sodium, is a synactical muscle relaxant that can reduce the contraction of skeletal muscle and is clinically used to treat and prevent malignant hyperthermal fever.
malignant hyperthermal fever, also known as anaesthetic fever, is a genetic myopathy characterized by high metabolism, which is a rare disease.
is currently listed in the United States, the European Union, Japan and other countries and regions, mostly capsules and injections.
only 2 enterprises in China hold the Danqulin sodium capsule production approval, no injection of Danqulin sodium was approved for listing, Lizhu's products are expected to fill the gap in the market.
: Lizhu Group injection with Danqulin sodium declaration Source: Mi net one-click retrieval Lizhu Group in 2009 project development of injection of danqulin sodium, 2015 with new drug class 3.3 declared clinical, February 2017 with "rare Illness" was included in the priority review, approved clinical in December of the same year, in February 2019, the company to copy 3 categories of exclusive production and CDE contractor acceptance, in April of the same year on the grounds of "rare diseases" into the priority review, in October 2020 into the administrative approval stage. Table
: 2020 to date Lizhu Group's new classification products source: Minet MED2.0 China Drug Review Database Minet data show that 2020 so far Lizhu Group has 4 varieties to copy 4 categories of declared listing, 3 for injections, including long-chain fat milk injection (OO), injection acetate octreotide micro-ball has not been approved for generic drugs listed.
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