April 2014 CDE drug review report

Recently, the drug registration applications accepted by CDE in April 2014 were analyzed in the insight pharmaceutical database of dingxiangyuan, with a total of 774 applications (calculated by acceptance number, the same below) Among them, 687 chemical applications were accepted, accounting for 89% of the total; 33 traditional Chinese medicine applications; 47 biological products applications; and 7 pharmaceutical excipients applications See Table 1 for specific acceptance conditions: Table 1 The acceptance conditions of CDE drugs in April 2014 are as follows, which are acceptance and evaluation data of chemical drugs, traditional Chinese medicine and biological products in April 2014 （1） Chemical acceptance and review in April is shown in Figure 1: Figure 1: CDE chemical acceptance in April 2014 1 New drug acceptance: in April, CDE accepted 231 new chemical drug applications Among them, 21 are registered as category 1, involving 11 varieties Among the 11 varieties, the phnquin bromide nasal spray is the application of new drug listing (production), and the rest of the products are new drug clinical applications Benzocycloquinolammonium bromide is a new muscarinic receptor antagonist synthesized for the first time in China If this listing application is approved, it is expected to become the world's first listing variety Figure 2 In April 2014, among the class 1 new chemical drugs declared and accepted by various registration categories of new chemical drugs, data related to class 1.1 new drugs: Table 2 In April 2014, the class 1.1 new chemical drugs accepted by CDE are worthy of attention In April, there were two class 1.1 NEW chemical drugs declared, i.e ditinib and beretinib According to the query of Insight China Pharma da ta database, from January 1 to the end of May 2014, there were 106 applications for TiNi drugs, including 12 new drugs of category 1.1 involving 4 varieties, all of which were clinical applications From January 1 to the end of May 2011, 15 new Tinian class 1.1 drugs have been approved in clinical practice, but at present, only cetinib of Zhejiang Beida Pharmaceutical Co., Ltd is on the market in China The research and development of TiNi drugs is still hot In April, there was only one class 2 new chemical drugs (preparations that have changed the route of administration and have not yet been marketed at home and abroad) declared, which is jimifloxacin mesylate for injection declared by Lizhu pharmaceutical factory of Lizhu group Jimifloxacin is the most active oral fluoroquinolones against Streptococcus pneumoniae The indications are community acquired pneumonia, acute attack of chronic bronchitis and urinary tract infection There are only tablets at home and abroad At present, only LG life science, the original research manufacturer, and Lizhu pharmaceutical factory of Lizhu group, the first imitation manufacturer, are listed in China, and they have entered the national medical insurance and provincial and municipal medical insurance In July 2009, Lizhu pharmaceutical factory once declared jimifloxacin mesylate for injection, which was not approved This is the second time for Lizhu pharmaceutical factory to apply for class 2 new drug jimifloxacin mesylate for injection There are 209 applications for new chemical drugs in 3-5 categories, including 150 clinical applications and 59 listing applications Its treatment fields mainly focus on antineoplastic drugs and immunomodulators, nervous system, cardiovascular system, followed by blood and hematopoietic organs, genitourinary system, sexual hormones, respiratory system drugs also have more applications As shown in Figure 3: Figure 3 The composition of three to five categories of new drug treatment fields accepted by CDE in April 2014 1 Acceptance of generic drugs in April 2014, CDE accepted 187 chemical generic drugs applications, involving 100 varieties and 106 enterprises (not combined with subsidiaries under the same group) Among them, Shandong Luoxin Pharmaceutical Co., Ltd applied for 4 varieties in total, which was the enterprise that applied for the most generic drugs in April Esomeprazole sodium for injection has been applied for imitation by 5 enterprises, which is the most variety applied for by enterprises Esomeprazole is the first isomer proton pump inhibitor in the world It was launched by AstraZeneca in 2000 and first listed in Sweden It is a first-line drug for the treatment of peptic ulcer Because of its strong and long-lasting inhibition of gastric acid, and low side effects, it soon became a star drug in peptic ulcer and gastric motility drugs, and the market return was quite ideal In 2002, it obtained the approval of domestic import and began to enter the Chinese market, and entered the national medical insurance in 2004, which has been very popular up to now Due to the patent protection in place, only esomeprazole magnesium enteric coated tablets and esomeprazole sodium for injection from the original manufacturer AstraZeneca are on sale in the domestic market In recent years, AstraZeneca is the only one However, AstraZeneca's compound patent for esomeprazole sodium salt expired in May 2014 Since 2012, domestic manufacturers have joined the team of generic drugs, which has already exceeded ten However, the team is still growing Only from January to the end of May 2014, the number of applications for esomeprazole has reached 49 The esomeprazole enteric coated capsule approved by Chongqing Laimei Pharmaceutical Co., Ltd in August 2013 with four new drugs is the first one to be imitated in China, but it has not yet been put into production However, Laimei has obtained the new GMP certificate at the beginning of April, and it should be ready for the official launch （2） Acceptance and review of traditional Chinese medicine in April 2014, as shown in Figure 4: 4 Acceptance of traditional Chinese medicine in April 2014 (3) acceptance and review of biological products in April 2014 CDE accepted a total of 47 applications for biological products, as shown in Figure 5: Figure 5 Acceptance of biological products in April 2014 Among the new drug applications accepted, there are two class 1 new drugs (biological products not listed and sold at home and abroad), namely, recombinant human thymosin β 4 for injection of Beijing Northland Biotechnology Co., Ltd and recombinant human follicle stimulating hormone Fc fusion protein injection of Corning Jerry (Jilin) Biotechnology Co., Ltd (da ta source: Insight China Pharma da ta database)