Recent domestic listing of new drugs (degu insulin, etc.)

1 On October 19, 2017, China's State Food and Drug Administration (CFDA) approved the new drug registration application of "recombinant Ebola virus vaccine (adenovirus vector)" The vaccine is an innovative recombinant vaccine product independently researched and developed by our country, with completely independent intellectual property rights It is jointly developed by the Institute of bioengineering of the Academy of Military Medical Sciences and kangxinuo biology In 2014, the most serious Ebola outbreak ever broke out in West Africa, killing at least 11300 people, which was listed as one of the most serious diseases to human beings by the World Health Organization Prior to that, only the United States and Russia had available Ebola vaccine in the world Compared with the foreign liquid form of Ebola vaccine, the freeze-dried form of Ebola vaccine in China has better stability, especially when it is transported and used in high temperature areas such as Africa 2 sophopewer tablets on September 25, 2017, Gilead announced that its chronic hepatitis C treatment drug, suowaldi ® (400 mg of sophopewer), a nucleoside NS5B polymerase inhibitor for hepatitis C virus, has been approved by CFDA for use in combination with other drugs to treat the whole genotype (type 1-6) of adults and 12-18-year-old adolescents Hepatitis C virus infection The data of the three phase clinical research conducted in China released at the Asia Pacific Annual Meeting of liver diseases in early 2017 provided strong support for the approval of suowati: for Chinese hepatitis C patients with hepatitis C virus genotype 1, 2, 3 and 6, suowati's 12 week sustained response rate (HCV RNA 12 weeks after the end of treatment) The proportion of unmeasurable patients in all subjects was 92% - 100% This phase of clinical study also evaluated the efficacy of combination of suowaldi ® and ribavirin, suowaldi ® and pegylated interferon and ribavirin in the treatment of refractory patients (including patients with treated and compensated cirrhosis) In terms of safety, the treatment regimen is consistent with known side effects of pegylated interferon and / or ribavirin The most common adverse reactions were abnormal blood system and fever At present, the single tablet drugs harvoni ® and epclusa ® of Gilead in the treatment of hepatitis C have also entered the clinical trial stage in China 3 The treatment plan of obipali tablets and dabibivir sodium tablets and ibuprofen (obipali tablets) combined with yichiri (dabibivir sodium tablets) was approved by CFDA on September 20, 2017, for the treatment of adult patients with genotype 1 chronic hepatitis C, including patients without cirrhosis or with compensatory cirrhosis The treatment is all oral, interferon free, combined with or without ribavirin A number of clinical studies have shown that in the treatment of Chinese patients with genotype 1b chronic hepatitis C, obipali combined with dacebuvir sodium can achieve nearly 100% sustained virus response rate (SVR) in 12 weeks As for the treatment plan of vectorol and vectore (obipali tablets) combined with vectore (dacebwei sodium tablets), it is all oral, interferon free, combined or not combined with ribavirin The program includes three kinds of direct antiviral drugs, namely NS5A inhibitor, NS3 / 4A protease inhibitor and NS5B polymerase non nucleoside analogue inhibitor, which can inhibit the replication of hepatitis C virus against three main targets in the life cycle of hepatitis C virus Vectorol (obipali tablets) is a compound preparation, which is composed of 12.5mg obitavir, 75mg paliravir and 50mg ritonavir Yichiri ® (dacebuvir sodium tablet) contains 250mg of dacebuvir sodium 4 On September 27, 2017, bringer Ingelheim, a soft capsule of nedanib ethanesulfonate, announced that the company's self-developed innovative targeting drug against pulmonary fibrosis, Viagra ® (nedanib), has recently obtained the import drug registration certificate issued by CFDA and is approved to be used for the treatment of idiopathic pulmonary fibrosis (IPF) The approval of the drug provides a new treatment option for Chinese patients with IPF, which can effectively delay the progress of the disease and reduce the risk of acute exacerbation; at the same time, it also helps to promote the diagnosis and treatment level of IPF in China The incidence rate of IPF in China is not yet available The disease progression of IPF is unpredictable, and acute exacerbation will significantly reduce the survival chance of patients Nearly half of IPF patients died within 2-3 years after diagnosis, and the 5-year survival rate was lower than 30%, which was lower than that of most cancers IPF patients mainly delay the progress of disease through a series of comprehensive treatment methods such as lung rehabilitation exercise, oxygen therapy, lung transplantation and drug treatment, but for a long time, there are few drug options for IPF treatment, and patients are facing the threat of rapid progress of disease and high risk of death In June of this year, nidanib was included in the list of priority varieties for evaluation by CDE, and was approved for listing just three months later 5 On September 21, 2017, the new diabetes drug of bolingyingehan, otangin ® (engeliejing), was approved by CFDA for marketing Englitazine is a new generation of oral high selective sodium glucose cotransporter 2 (SGLT2) inhibitor, which is suitable for improving blood glucose control in patients with type 2 diabetes mellitus with single drug, combined metformin or combined metformin and sulfonylurea Otanjin ® has a unique insulin-independent hypoglycemic pathway, i.e direct excretion of glucose from urine by reducing the reabsorption of glucose in the kidney The drug has good safety and can reduce the risk of cardiovascular disease and the progress of kidney disease in diabetic patients It is the first type 2 diabetes drug in the world that can reduce the risk of death due to cardiovascular causes confirmed by the large-scale cardiovascular outcome study (empa-reg outcome ®) 6 telmisartan amlodipine tablets this product - the new compound antihypertensive drug Shuangjia ® (telmisartan amlodipine tablets), also comes from bringer ingelham At present, the number of hypertension patients in China is estimated to be 270 million The serious complications of hypertension, including stroke, coronary heart disease, heart failure and kidney disease, have become a heavy burden to our family and society Shuangjia ® is a fixed compound antihypertensive drug, which contains two components, i.e angiotensin II receptor antagonist and calcium ion antagonist, for the treatment of essential hypertension The data of global clinical trials show that the blood pressure can reach the standard within 2 weeks after the treatment of double plus ® with a maximum drop of 50mmhg, and the standard rate of 24-hour ambulatory blood pressure monitoring is up to 82.7% It is the only ARB + CCB compound preparation with a half-life of more than 24 hours 7 The novoderma ® developed and produced by Novo Nordisk, degu insulin injection, was launched in China on September 20, 2017 The drug is used to treat adult type 2 diabetes and is the first super long-acting basic insulin analogue approved in China About the effect time of degulin Under the premise of once daily administration, the drug can provide more flexible choice of injection time and solve the problem that the existing basic insulin needs to be injected in a fixed time every day The clinical effect of degu insulin has been verified in many studies at home and abroad: it can effectively reduce glycosylated hemoglobin and fasting blood glucose, and the diurnal variability of hypoglycemic effect is 1 / 4 of insulin glargine At the same time, compared with insulin glargine, the risk of hypoglycemia in type 2 diabetic patients using insulin glargine was significantly reduced, especially the incidence of severe hypoglycemia at night was significantly reduced by 53% compared with insulin glargine.