Analysis report of CDE drug review in August 2015 - drug intelligence registration and acceptance database

Highlights: 1 The class 1.1 new drug, ximinperix and its tablets, applied by Shanghai Institute of pharmaceutical research, Chinese Academy of Sciences, entered the drug Audit Center on August 17, 2015, and is currently in line in the ind sequence for audit 2 The innovative drug zl-2102 and its preparation for the treatment of chronic respiratory diseases declared by zaiding medicine have been undertaken by CDE At present, it has entered the ind sequence and is waiting for approval 3 The c118p and injection declared by Nanjing Shenghe Pharmaceutical Co., Ltd were approved The variety is a major special variety and a special approved variety, which has not been supplemented during the period The self inspection and report of drug clinical trial data ended at 24:00 on August 25, 2015 1622 varieties were involved in the clinical trial Among them, there are 1094 registration applications submitted by the applicant for self-examination, accounting for 67%; 317 registration applications voluntarily withdrawn, accounting for 20%; 193 registration applications that do not need to be submitted, accounting for 12% Next let's see what's new with drug registration in August? According to the latest statistics of drug intelligence registration and acceptance database, in August 2015, CDE undertook 575 new drug registration applications with acceptance number (excluding reexamination, the same below) Figure 1: total acceptance of CDE drugs from January to August 2015: in August 2015, the total acceptance decreased by 31.9% month on month, a total of 269 acceptance numbers decreased compared with July Figure 2: CDE drug acceptance from January to August 2015, including 500 chemical drugs, 32 traditional Chinese medicines, 30 biological products, 12 pharmaceutical excipients and 1 in vitro diagnostic reagent The number of Chinese medicine applications was the same as that of last month, while the number of chemical and biological products applications dropped significantly Let's analyze the registration, acceptance and evaluation of chemical drugs, traditional Chinese medicine and biological products 1 In August, CDE undertook a total of 500 new chemical registration applications based on the acceptance number, a decrease of 33.9% on a month on month basis Figure 3 acceptance of CDE chemicals in April August 2015 the number of new chemical drugs accepted decreased by 53.3% The following is a detailed analysis of the acceptance of CDE chemicals in August 2015 1 In August, 162 new chemical drugs were declared, accounting for 32.4% of the total 1) there are 10 acceptance numbers of class 1.1 new drugs accepted by CDE in this month, involving 3 varieties The figure below shows the new class 1.1 drugs in August Table I new class 1.1 drugs newly undertaken in August 2015 note: the queue number is up to September 1, 2015 Shiminperi, a PARP inhibitor declared by Shanghai Institute of pharmaceutical research, Chinese Academy of Sciences, entered the drug Audit Center on August 17, 2015, and is currently waiting in the ind sequence for audit According to relevant reports, Shanghai Pharmaceutical Research Institute and Chenxin Pharmaceutical Co., Ltd have also jointly developed a highly selective personalized anti-tumor candidate drug, mefurepiride hydrochloride, which belongs to the national class 1.1 chemical drug, a highly selective personalized anti-tumor candidate drug At present, no relevant application information has been found The innovative drug zl-2102 and its preparation applied by zaiding pharmaceutical for the treatment of chronic respiratory diseases were undertaken by CDE According to reports, zl-2102 is the first of two innovative drugs introduced by zaiding pharmaceutical from Sanofi in August 2014 to enter Australian clinical trials On March 17, 2015, zaiding Pharmaceutical Co., Ltd announced that zl-2102 had started to complete the first clinical patient medication Table 2: on August 2015, the approved new chemical drugs of category 1.1 were used as GPIIb / IIIa receptor antagonists for antithrombotic treatment Asc08, a new direct anti HCV drug developed by Geli bio, was changed to be under approval on August 25, 2015 Keme, which is declared by Beijing fabergin, is a blood and hematopoietic system drug and an effective second-generation selective HIF stabilizer for oral administration C118p and injection declared by Nanjing Shenghe Pharmaceutical Co., Ltd were approved for clinical use The variety is a major special variety and a special approved variety, which has not been supplemented during the period This product is a new type of tubulin polymerization inhibitor Compared with the listed tubulin inhibitors (such as vincristine, paclitaxel, etc.) and molecular targeted drugs (such as sorafenib, sunitinib, etc.) which act on blood vessels, it has a unique anti-tumor mechanism 2) 3.1 new drugs Figure 4 acceptance of class 3.1 new drugs from January to August 2015 many class 3.1 new drugs, such as acitinib, abitrone, palamivir, rabeprazole, etc., are not approved due to Article 72 of the drug registration management measures The main task of the opinions of the State Council on the reform of the review and approval system for pharmaceutical and medical devices issued on August 18, 2015 clearly states: "drugs are divided into new drugs and generic drugs Adjust the new drug from the current "drugs not listed and sold in China" to "drugs not listed and sold in China and abroad" In this way, the three categories of new drugs will come to an end 2、 In August, CDE undertook a total of 32 new TCM registration application acceptance numbers, including 5 new drugs and 27 supplementary applications Figure 5: acceptance of CDE traditional Chinese medicine from April to August 2015 3 In August, CDE undertook a total of 30 applications for new biological products registration Figure 6 acceptance of CDE biological products from April to August 2015 application for new biological products decreased in this month, including 3 class 1 biological products projects Table 3 notes to category 1 biological products newly undertaken in August 2015: queue No up to September 1, 2015 IV in August 2015, FDA approved two new molecular entities and therapeutic biological products Table 4 data source of new molecular entities and therapeutic biological products newly approved by FDA in August 2015: drug intelligence registration and acceptance database note: the intellectual property rights of the above articles are owned by drug intelligence If you need to reprint, please indicate the source and the link of this article Drug evaluation center of State Food and Drug Administration