Analysis report on CDE drug review in November 2014

According to the latest statistics of drug intelligence registration and acceptance database, in November, CDE undertook 667 new drug registration applications with acceptance number (excluding reexamination, the same below) Among them, 591 are chemical drugs, 31 are traditional Chinese medicine, 41 are biological products Next, let's analyze the registration acceptance and evaluation of chemical medicine, traditional Chinese medicine and biological products Figure 1 The total acceptance of CDE drugs in September, October and November 2014 increased slightly compared with October, but decreased compared with September Figure II comparison of acceptance of CDE drugs between November 2013 and November 2014 it can be seen from the figure above that acceptance of chemical drugs increased by 70.3% year on year in November 2014 1、 In November, CDE undertook a total of 591 new chemical registration applications with acceptance number, focusing on new drugs, generic drugs and supplementary applications Figure 3 The acceptance of CDE chemicals in November 2013 and 2014 is noteworthy that in terms of new drug acceptance, the number of acceptance in November 2014 is nearly three times that in 2013, which shows the rapid development of pharmaceutical enterprises in China The following is a detailed analysis of the acceptance of CDE chemicals in November 2014 1 In November, new drug applications accounted for 34.9% of chemical applications 1) There are 2 new drugs in 1.1 category accepted by CDE this month The figure below shows the new class 1.1 drugs in November Attachment: on November 2014, the approved new drug of class 1.1 was developed by Shanghai Hepu Pharmaceutical Co., Ltd., which belongs to class 1.1 chemical of national innovation It is a major national science and technology project of "major new drug creation" and a new type of chronic hepatitis B treatment drug (first in class) At present, only interferon and nucleoside analogues have been approved for the treatment of chronic hepatitis B, which can not protect the new healthy hepatocytes from HBV infection, and can not interrupt the clearance infection clearance cycle, which may be one of the reasons for the poor long-term efficacy of hepatitis B treatment drugs The new strategy of hepatitis B virus entry blocking was used to block the receptor of HBV infection, protect the new healthy hepatocytes from HBV infection, interrupt the cycle of clearance infection clearance, improve the anti HBV dynamics of the body, and bring new hope for the treatment of hepatitis B The indication of imitavir phosphate declared by Guangdong dongyangguang Pharmaceutical Co., Ltd is influenza, which is a Na inhibitor of influenza virus 1) In November, the center accepted 171 applications for class 3.1 new drugs Among them, the acceptance of the clinical application for the raw materials and tablets of the hepatitis C drug suofebuvir is of great concern Sofebovir is regarded as a breakthrough drug for the treatment of hepatitis C It was acquired by Gilead in 2011 by pharmaset It was approved by the US FDA in December 2013 and the EU in January 2014 It is the first drug that can be used in the full oral treatment of hepatitis C Before that, patients with hepatitis C must be treated for at least six months, including the injection of interferon and ribavirin, which can cause serious flu like symptoms and side effects such as rash and anemia, respectively The cure rate of these regimens in clinical trials was 75%, while the cure rate of sufebuvir was more than 90% CFDA website information shows that at present, there is no manufacturer of API and tablet in China In addition to Kelun pharmaceutical industry, sinogy Pharmaceutical Technology (Shijiazhuang) Co., Ltd of Shiyao group has also applied for clinical trials of the drug 2、 In October, CDE undertook 31 new applications for registration of traditional Chinese medicine with the acceptance number, most of which were supplementary applications Figure 4 The acceptance of CDE for traditional Chinese medicine in November 2013 and 2014 is as follows: new applications for traditional Chinese medicine accepted in November 3 There are 41 new applications for biological products registered by CDE in November with acceptance number Figure v acceptance of CDE biological products in November 2013 and November 2014 is as follows: new biological products and new drug applications accepted in November The above data comes from the registration and acceptance database of pharmaceutical intelligence