Nanofloxacin malate is the first innovative drug to be listed in China

Source: drug consistency evaluation 2017-06-26 On March 27, 2017, nanofloxacin malate API and its capsule (trade name: taijiexin) of Zhejiang Pharmaceutical Co., Ltd (hereinafter referred to as "Zhejiang Pharmaceutical") were approved by the State Food and Drug Administration (hereinafter referred to as "CFDA") to obtain the license of drug listing with the humanities number, which is the benefit of the pilot implementation of China's drug listing license holder system The first innovative drug In June 2016, Zhejiang Pharmaceutical's nanofloxacin malate API and its capsule obtained the new drug certificate and drug production approval, which is the only class 1.1 new drug approved by CFDA in 2016, and the first new drug approved after the most stringent clinical data verification order in history was issued in July 2015 On October 23, 2016, Zhejiang Pharmaceutical's "taijiexin" was successfully listed in China Nanofloxacin malate is a new type of fluoroquinolones free drug It not only retains the main antibacterial activity of traditional quinolones, but also strengthens the antibacterial activity of drug-resistant positive bacteria It has good drug safety and excellent tissue penetration It can be used as the first-line drug for community acquired pneumonia and has other indications It is a new choice for clinical treatment The system of drug marketing license holder adopts the management mode of separating drug marketing license and production license, that is, to allow drug marketing license holders (drug manufacturers, research and development institutions or scientific researchers) to produce drugs by themselves, or to entrust one or more production enterprises to produce drugs together, avoiding the shortage of drugs due to the increase of market demand, and at the same time strengthening the holding Someone's main responsibility provides guarantee for drug quality The holder system is the current management mode of "binding system" of listing license and production license in China, and the restriction of drug registration system on the development of drug industry in China is lifted The implementation of the drug listing license holder system will be a "property right revolution" in the pharmaceutical industry, which can improve the innovation enthusiasm of drug research and development institutions and researchers, promote the supply side reform of the pharmaceutical industry, improve product quality, and inhibit the repeated construction of low-level production enterprises In addition, the development of class 1.1 innovative drugs in our city is at the forefront of the country The new drug for hepatitis C developed by Zhejiang Geli Pharmaceutical Co., Ltd - danorevir sodium bulk drug and tablet has also applied for the drug listing license holder, and is expected to be approved in October 2017.