Green leaf pharmaceutical modified new drug "injection of lipe ketone slow release microbe" is about to be approved for market

Recently, green leaf pharmaceutical according to the chemical drug registration classification 2.2 category of declared injection lipe ketone slow release microball (acceptance number: CXHS1900036, CXHS1900037, CXHS1900038) listing application is in the "in the approval" stage, is expected to be approved by NMPA in the near future.
will become the first domestic market injection with slow-release micro-ball dosage form.
Injection of leptazone retardative microglotopathy is an obvious positive symptom for the treatment of acute and chronic schizophrenia and various other psychiatric conditions (e.g. hallucinations, delusions, thought disorders, hostility, suspicion) and obvious negative symptoms (e.g. unresponsiveness, emotional indifference and social indifference, little speech).
and reduce the emotional symptoms associated with schizophrenia (e.g. depression, guilt, anxiety).
is a selective monoamine-energy antagonist whose therapeutic effect on schizophrenia is the result of a joint effect of antagonism on D2 and 5HT2.
at present, the domestic variety listed more dosage forms, including ordinary tablets, dispersion tablets, oral collapse tablets, slow release tablets, capsules, oral fluids, injection micro-balls.
sales of Lipe ketone PDB in 2019 amounted to 126 million yuan, which enlarged to about 400 million yuan in the national market.
injection of lipe ketone micro-ball original research is Xi'an Yangsen (commodity name: Hengde), in January 2006 was first approved by the State Drug Administration for import.
than normal oral dosage forms, microball injections require only 1 injection every 2 weeks.
can significantly improve drug compliance in the mentally ill.
first submitted a clinical application for the injection of lippolycerone to the State Drug Administration in June 2011 and was approved in November 2012.
completed the phase I clinical study of lepedone re-release micro-I in 2014 (clinical trial registration number: CTR20140160) and then in 2015 carried out a study on the relative biomass of the variety with xi'an Jansen injection lipe ketone microbe (commodity name: Henderson) (clinical trial registration number: CTR20150023).
to the NMPA in November 2019.
is more than nine years away from approval.
Rubik's Cube PharmaGo is currently approved for listing in addition to green leaf pharmaceutical injection slow-release microballs.
pharmaceutical has declared the application for the listing of injection lipid microbes in the old 6 categories, but the CDE approval conclusion is to approve clinical.
Then Qilu Pharmaceuticals and the CBCC Global Clinical Research Contract Organization of India jointly conducted a global study on the relative bio-utilization of the species with Xi'an Jansen Hengde in September 2018 (clinical trial registration number: ChiCTR1800018599), which is expected to be completed shortly.
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