Analysis report on CDE drug review in June 2015

Sph3127, a class 1.1 new drug declared by Shanghai Pharmaceutical Group Co., Ltd., has entered the drug examination center on June 3, 2015, and belongs to the drug variety to be recommended for priority examination for major special projects of major new drug creation technology At present, the clinical work of 1.1 DPP4 inhibitor, repagliptin phosphate and its preparation, developed by Jiangsu Hengrui, has been completed The listing application has been accepted by CDE on June 5, 2015, and now it has entered the NDA sequence Hebei FeNiS Biotechnology Co., Ltd applied for class 1.1 drug - fns007 raw material and injection It was accepted by the drug Audit Center on June 5, 2015 According to the latest statistics of drug intelligence registration and acceptance database, in June 2015, CDE undertook 781 new drug registration applications with acceptance number (excluding reexamination, the same below) Figure 1: total acceptance of CDE drugs from January to June 2015: in June 2015, the total acceptance decreased by 1.6% month on month Figure 2: acceptance of CDE drugs in January June 2015, including 682 chemical drugs, 34 traditional Chinese medicine, 49 biological products, 11 pharmaceutical excipients and 5 in vitro diagnostic reagents There has been a small increase in the number of Chinese medicine and biological products Let's analyze the registration, acceptance and evaluation of Chinese medicine, Chinese medicine and biological products 1、 In June, CDE undertook 682 new chemical registration applications with acceptance number, down 1.7% month on month Figure 3: the acceptance of CDE chemical drugs in April June 2015 continued to decrease after the acceptance of new chemical drugs reached a high value in April In addition to supplementary applications and generic drugs, the number of acceptances increased compared with may, while imports and re registration of imports decreased The following is a detailed analysis of the acceptance of CDE chemicals in June 2015 1 New drug figure IV Registration and classification of new chemical drugs in June 2015 the number of new chemical drugs declared in June was 245, accounting for 35.9% of the total number of chemical drugs declared 3.1 The Application of new drugs of category 1 is far away from other application types of new drugs 5.3% of the new drugs were classified as 1.1 1) There are 13 acceptance numbers of class 1.1 new drugs accepted by CDE in this month, involving 6 varieties The figure below shows the new class 1.1 drugs in June Table I new class 1.1 drugs newly undertaken in June 2015 note: the queue number is up to July 1, 2015 Sph3127, developed by Shanghai Pharmaceutical Group, is one of the drug varieties to be recommended for priority review in major new drug creation science and technology projects At present, it has entered the ind sequence and is waiting in line for review Repagliptin phosphate is a type 1.1 DPP4 inhibitor developed by Jiangsu Hengrui It is an oral antidiabetic drug In April 2009, it was declared to be clinically accepted by CDE On July 15, 2009, Hengrui medicine applied to the US Food and Drug Administration (FDA) for clinical trials of the innovative drug regolitine in the US, which was officially accepted the next day At present, all clinical work has been completed At the end of March 2015, the company applied to CFDA for production At the beginning of June of the same year, the company was undertaken by CDE, and now it has entered the NDA sequence Fns007, a class 1.1 drug declared by Hebei FeNiS Biotechnology Co., Ltd., is known to be a small molecular peptide drug for the treatment of rheumatoid arthritis Its target is HLA-DR molecule It can inhibit the activation of patients' own reactive T cells by blocking the formation of "HLA pathogenic antigen TCR" trimolecular complex, which belongs to antigen-specific treatment In June 2015, 3 new chemical drugs of category 1.1 were approved Table 2: ceftazidime hydrochloride and sterile sub packaged injection of class 1.1 antibiotic of Yangzijiang Pharmaceutical Group, which was approved as a new chemical drug in June 2015, entered the ind sequence in September 2013 They are major special and special approved varieties In October 2014, they experienced a supplement and a supplement At present, they have been reviewed and approved for clinical use The application for clinical trial of 1.1-type chemical disodium l-ornidazole phosphate and its preparation declared by Shaanxi Synthetic Pharmaceutical Co., Ltd was approved The application submitted by Shaanxi Synthetic Pharmaceutical Co., Ltd includes the raw material of disodium levonoconazole phosphate and the preparation of disodium levonoconazole phosphate for injection It is used in the treatment of sensitive protozoa and anti anaerobic infection Ornidazole is a commonly used anti anaerobe drug As the third generation of anti anaerobe drug after metronidazole and Tinidazole, ornidazole has a positive effect and small side effects It has been widely recognized in clinical practice Ramazolam besylate, a new class 1.1 drug of Yichang humanwell Pharmaceutical Co., Ltd and ramazolam besylate for injection, were successfully approved for clinical use Ramazolam besylate was used for surgical anesthesia Humanwell pharmaceutical is mainly engaged in the pharmaceutical industry, and its market segments include anesthetics, analgesics, birth control drugs, blood products, Uyghur ethnic medicine, etc In the field of narcotic drugs in China, humanwell pharmaceutical is the leading enterprise, and the market share of narcotic drugs ranks first in China 2) 3.1 lovatinib mesylate declared by Hengrui medicine is the first one declared in China, which is used to treat patients with local recurrence or metastasis, refractory radioiodine, and progressive differentiated thyroid cancer (DTC) The variety was developed by Weicai The clinical application was accepted by CDE on February 3, 2015, and now it is in the ind sequence 2、 In June, CDE undertook 34 new TCM registration application acceptance numbers There are 9 new drugs and 16 supplementary applications Figure 5: CDE acceptance of traditional Chinese medicine from February to June 2015: the number of new traditional Chinese medicine acceptance in this month has increased compared with that in last month It is worth noting that forsythin and its capsule, a class 1 new traditional Chinese medicine drug declared by Guangdong Laien Pharmaceutical Research Institute Co., Ltd., entered the drug trial on June 5, 2015 Tibet jinhada Pharmaceutical Co., Ltd has applied for a 9-class generic medicine of traditional Chinese medicine, Jiuwei limehua powder, which is a Tibetan prescription According to the drug intelligence registration and acceptance database, since the State Drug Administration issued the measures for the administration of drug registration (2007) and the supplementary provisions for the administration of registration of traditional Chinese medicine (2008), almost no new applications for generic drugs of traditional Chinese medicine have been approved, which has continued to this day 3、 In June, CDE undertook a total of 49 applications for registration of new biological products Figure 6 acceptance of CDE biological products from February to June 2015 Shanghai Renhui biopharmaceutical Co., Ltd applied for a class 1 therapeutic biological product - benalutide injection It is understood that benalutide injection is a pen type water injection of the company's main product recombinant human glucagon peptide-1 (7-36) (rhglp-1 for short, trade name is yishengtai), which is intended to be used for 2 The national first-class therapeutic biological products independently researched and developed by type 2 diabetes have the most obvious therapeutic effect on type 2 diabetes patients, which is to effectively reduce the blood glucose level of patients and significantly reduce the body weight index to improve the blood lipid level under the condition that it is not easy to have hypoglycemia risk 4、 FDA new molecular entity and therapeutic biological products on June 22, 2015, FDA of the United States approved the listing of Medicine's company's antiplatelet injection (trade name: kengreen) to avoid Coro nary Artery Occlusion Caused by coagulation in adult patients during percutaneous coronary intervention (PCI) Clinical trials showed that kengrel and clopidogrel significantly reduced the incidence of myocardial infarction Although the incidence of serious bleeding events was relatively low in both groups, kengrel group (1 / 170) was higher than clopidogrel control group (1 / 275).