Clinical research progress of China's Class 1 new drugs in 2017

Since March 4, 2016, CFDA issued the work plan on the reform of chemical drug registration and classification, China's class 1 innovative drug has been redefined as unlisted at home and abroad, which refers to the drug with new clear structure, pharmacological effect and clinical value On the basis of the originality and novelty of the material basis, it emphasizes the clinical efficacy and begins to connect with the world According to the drug data index, from 2001 to 2016, CFDA approved 13 class 1 chemical drugs and 16 biological drugs However, from 2008 to 2017, 256 chemical drugs and 146 biological drugs (including biological similar drugs) have been approved to be listed in the world (Europe, America, Japan, South Korea and other major countries) The gap is obvious As of November 15, 2017, there are still no class 1 new drugs on the market in China in clinical application, but there are 9 class 1 Chemicals in the NDA stage, and the indications involve many hot fields such as cardio cerebrovascular, tumor, HIV, infection, etc Table 1 notes of Chinese class 1 new drugs in NDA application in 2017: click the picture to see the clear large picture > > > rosastah is an inhibitor of hypoxia inducible factor prolyl hydroxylase (hif-ph), which can inhibit ubiquitin degradation of hypoxia inducible factor (HIF) and help the body produce more red blood cells Rosas was originally developed by fibrogen, and in 2006 was authorized to develop in Asia, Europe and South Africa Development rights granted to AstraZeneca in the United States, China and other major regions except Japan and Europe in 2013 In April 2014, the compound was applied for class 1.1 clinical study of Sinochem by Beijing fabojin pharmaceutical technology, and obtained the clinical approval document in August 2015 In China, it is jointly developed by Liaoning Lantian Pharmaceutical Co., Ltd., Fudan University and Shanghai Zhongmin New Technology Co., Ltd It is a tumor chemotherapeutic sensitizer The compound obtained the first phase of new drug clinical Certificate in 1998, the second and third phase of new drug clinical Certificate in 1999, the second phase of clinical trial in 2004, the third phase of clinical trial in 2007, and the application for production in September 2011 The approval conclusion is that some clinical trials need to be supplemented In March 2014, it obtained class 1.1 clinical approval document of Sinochem Busylate is developed by the National Cancer Institute of the United States for the treatment of neuroblastoma It is currently in the first phase of clinical practice In December 2016, benzenolide benzenolide submitted a new drug listing application (chemical class 1) for the treatment of dermatitis and psoriasis The compound was originally developed by welichem biotech and later licensed to Stafford (a subsidiary of GlaxoSmithKline) and Tianji pharmaceutical > fqtinif was initially developed by Hutchison Whampoa and authorized to be jointly developed by Lilly in 2013 For the treatment of gastric cancer, advanced or metastatic colorectal cancer and non-small cell lung cancer In June 2017, the NDA application of fiquitinib for the treatment of advanced colorectal cancer was officially accepted by China food and Drug Administration (CFDA) Fiquitinib is a highly selective oral inhibitor of vascular endothelial growth factor receptor (VEGFR) It has the potential to become the best VEGFR inhibitor in the world that can treat a variety of solid tumors According to the data of preclinical and clinical studies to date, the kinase selectivity of fiquitinib has been proved to reduce the Miss target toxicity Under this condition, drug exposure can completely inhibit VEGFR, and it has the potential to be used in combination with other targeted therapies and chemotherapy in a larger population of patients receiving early treatment (VEGFR is a receptor tyrosine kinase that helps neovascularization around the tumor, thus contributing to tumor growth) High efficiency, low toxicity and suitable for combination use are the excellent characteristics of fiquitinib which are different from other approved small molecule VEGFR inhibitors Hutchison Whampoa and Lilly are currently working together in China to carry out various studies on the treatment of colorectal cancer, non-small cell lung cancer and gastric cancer with furquitinib In addition, a factory has been set up in Suzhou, and a complete set of preparation production facilities has been equipped, which is responsible for the production and supply of furaquinotinib capsules > pyrrolidine maleate pyrrolidine maleate was developed by Jiangsu Hengrui In August 2017, it submitted a listing application in China for the treatment of HER2 positive metastatic breast cancer In May 2011, Jiangsu Hengrui Pharmaceutical Co., Ltd and Shanghai Hengrui Pharmaceutical Co., Ltd jointly submitted the clinical trial application (chemical 1.1) to CFDA, and obtained the class 1.1 clinical approval document of Chinese chemical in April 2012 AI Bo Wei Tai AI Bo Wei Tai is a fusion inhibitor of human immunodeficiency virus (HIV-1) It is effective for the main HIV-1 virus and drug-resistant virus It is used to treat HIV-1 infected people who have been treated with antiviral drugs In July 2016, frontier biology submitted NDA application (chemical medicine class 1) to CFDA In December 2016, danorevir sodium and danorevir sodium submitted an NDA application in China for HCV protein inhibitor, which was combined with pegylated interferon, ribavirin and ritonavir to treat hepatitis C infection The compound was initially developed by intermune (R & D Code: itmn-191, itmn-b), authorized to Roche in 2006 (R & D Code: r-7227, rg-7227, ro-5190591), terminated in 2010, Roche obtained the R & D right of the drug, in 2014, intermune was acquired by Roche; in 2013, Roche authorized the R & D right of China and Taiwan to Geli (R & D Code: asc-08, ar-00334191 、AR-334191）。 Colistin is a macrolide antibiotic for the treatment of bacterial infection Colamycin is developed by Institute of pharmaceutical biotechnology, Chinese Academy of Medical Sciences, and has been transferred to Shenyang Tonglian Pharmaceutical Group In September 2010, the compound was jointly applied for class 1.1 new drugs by the Institute of pharmaceutical biotechnology, Chinese Academy of Medical Sciences, Shenyang Tonglian and Beijing Shouke group Noraconitine hydrochloride noraconitine hydrochloride is in the period of application for production and approval It is a β - adrenergic receptor agonist for the treatment of coronary heart disease In August 2012, Zhuhai Rundu Pharmaceutical Co., Ltd., Guangdong South China new drug development center and Institute of medicine of Chinese Academy of Medical Sciences jointly applied for the production review of Sinochem 1.1 There are two varieties of biological drugs in the application for biological product license (BLA), which are expected to go on sale next year Table 2 biological drug note in the application of BLA in 2017: click the picture to see the clear large picture Recombinant human newlangreen is a kind of recombinant protein drug, which is derived from the active peptide fragment of neuregulin-1 naturally existing in human body It can mediate the formation of ERBB2 / ErbB4 heterodimer by binding with ErbB4 receptor, a member of the epidermal growth factor receptor family on the surface of cardiomyocytes, activate a series of downstream signal pathways, and play the role of repairing the structure of cardiomyocytes and improving heart function 。 The drug can be used to treat moderate and severe chronic heart failure (CHF) Newland green was initially developed by Shanghai Zesheng Technology Development Co., Ltd in 2013, sciclone obtained the commercial authorization of the drug in China, Hong Kong and Macao In April 2012, Shanghai Zesheng technology submitted to CFDA an application for production of recombinant human Newland green (Class 1 biological products for treatment) The recombinant vaccine of rotavirus gene, developed by Lanzhou Institute of biological products, is used to prevent rotavirus infection In November 2016, Lanzhou Institute of biological products submitted to CFDA an application for the production of the vaccine (Class 1 biological products for prevention) As of November 15, 2017, there were 506 new class 1 drugs in clinical research stage in China, including 52 in clinical phase III, 75 in clinical phase II, 300 in clinical phase I and 79 in clinical applications The following is a list of chemical and biological drugs in clinical phase III Table 3 10 varieties of biological drug note in phase III clinical trial: click the picture to see the clear big picture table 4 38 varieties of chemical drug note in phase III clinical trial: click the picture to see the clear big picture data source: drug data pro v2.0