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On January 9, Qilu Pharmaceutical's class 1 new drug injection QLS31901 clinical application was accepted by CDE contractor, acceptance number CXSL2100012.
injection QLS31901 is the first new class 1 drug to be declared clinically by Qilu Pharmaceuticals in 2021.
recent years, Qilu Pharmaceuticals in the field of innovative drugs, in 2020 a total of 4 new class 1 drugs submitted clinical applications, all therapeutic biological products.
2020 Qilu Pharmaceuticals declared clinical class 1 new drug Class 2 modified new drug Qilu Pharmaceutical has also begun to lay out, is about to enter the harvest period.
meters of intranet data show that Qilu Pharmaceuticals has 5 new class 2.2 drugs submitted for listing, respectively, Tadara non-oral dissolved membrane, O nitrogen flat mouth solution film, Mengluste sodium mouth solution membrane, hydrochloric acid methicillin oral dissolution membrane, alium oral dissolution membrane, are oral solution film.
, the registration status of the O nitrogen flat-mouth soluble film has been changed to "in the approval", is expected to be approved for listing recently, becoming the company's first oral soluble film agent.
Qilu Pharmaceuticals O nitrogen flat mouth dissolved membrane listing application Source: Mi net one-click search O nitrogen flat is mainly used for the treatment of schizophrenia, Minanet data show that in 2019 China's urban public hospitals, county-level public hospitals, urban community centers and township hospitals (referred to as China's public medical institutions) terminal O nitrogen flat sales of more than 4 billion yuan.
At present, the domestic market of O nitrogen flat products have O nitrogen flat tablets, O nitrogen flat mouth collapse tablets and O nitrogen flat mouth dissolved membrane, O nitrogen flat mouth dissolved membrane only Howson Pharmaceuticals was approved, Qilu Pharmaceuticals is expected to become the second domestic.
source: Minet database, CDE