Koren: The first domestic sucrose sodium declared on the market

original title: Koren: the first domestic sucrose sodium declared on the market
On November 26th, Pharmaceutical Melting Data - Pharnex Datamonitor Monitor, Colum pharmaceutical schullin sodium injection was the first to be reported to the marketRegistration in the new category 4, if approved, will be considered to be approved through a consistency evaluationThe new muscle pine antagonists may be available in China after two yearsI.:1Sugammmadex Sodium Injection (MK-8616), a product called Bridion, is the world's first and only specific binding neuromuscular resistance antagonist drug developed by Mercado and N.VOrganonit is a modified radon-cyclodextrin, which forms a compound in the plasma with the neuromuscular blocking drug Roku brominated or Viku bromumum, thereby reducing the number of neuromuscular blocking drugs that are combined with the niacin receptor at the nerve muscle joint, thereby antagonising the neuromuscular blocking induced by rokobromine or viku bromum2In April 2017, it was approved for listing by the China Drug AdministrationThe listed specifications approved in China are 2ml: 200mg and 5ml:500mgapproved indicationsneuromuscular block induced by anti-roco bromine or viku bromine in adults, and in children and adolescents (2 to 17 years old), only this product is recommended for conventional antagonistic lorco-ammonium-induced block3The basis for supporting the listing of this product in China includes key clinical studies conducted abroad, as well as 1 pharmacokinetic study (CTR20150325) and 2 Phase III clinical trials (global multicenters) conducted in Chinain 11 Chinese health subjects participated in the evaluation of the drug dynamics of the product 1, 2, 4 mg/kg single dose, the key pharmacokinetic parameters suggest that in the study dose range, the exposure of sodium sucrose was increased in a proportional manner to the dose, in line with linear pharmacokinetic characteristicsThe results were comparable to those of Caucasian and Japanese healthy subjects, which were safe and well tolerated(No difference)4.The original research company's 2016 results were $482 million, compared with $311 million for the first half of 2017IIof generic drugs 1Succans of sugar raw materials from polysaccharide, synthesis process is difficult, quality control requirements are high, high technical barriers, especially in the production process of synthetic iodine-sic-cyclodextrin, but also the need for extremely complex process conditionsColum Pharmaceuticals should have spent a lot of time this time2The original compound patent expires on November 23, 2020 (PCT patent)3However, the indications of sodium sucrose are relatively limited, requiring patients to use aloco bromide ammonium or viku bromine before the patient4Other enterprises that have submitted clinical applications for approval are Hengrui Pharmaceuticals and Hebei Zhiheng, which have not seen clinical registrationThe author predicts that it will be re-declared and submitted for listing directly according to the registration of the chemical drug 4 categorymore relevant pharmaceutical product information, to join the drug ringreference: https:// ; NMPA/CDE; Pharmaceutical Data, Pharnex Datamonitor; FDA/EMA;