Analysis report on CDE drug review in October 2015

Source: yaozhi.com.2015-11-05 highlights: ŸŸŸŸŸŸŸŸŸŸŸŸŸŸŸŸŸŸŸŸŸŸŸ 2 Vorarevir and its preparations declared by Taijing pharmaceutical R & D (Beijing) for the treatment of hepatitis C are NS3-4A protease inhibitors They entered the drug Audit Center on October 13, 2015, and no queuing information has been found at present 3 The centralized review of this month has achieved results, and the clinical approval documents have blowout In October, the centralized review continued According to the statistics of drug intelligence database, from the National Day holiday to October 31, the number of acceptance numbers changed from "in review" to "in approval" reached 1300 +, while the number of newly undertaken drugs this month continued to decline According to the latest statistics, in October 2015, CDE jointly undertook new drug registration applications with acceptance numbers 541 (except reexamination, the same below) Figure 1 the acceptance of CDE drugs from January to October 2015 In October 2015, the total acceptance decreased by 14.9% month on month Among them, 470 are chemical drugs, 23 are traditional Chinese medicine, 36 are biological products, 11 are pharmaceutical excipients, and 1 is in vitro diagnostic reagent The number of chemical, traditional Chinese medicine and biological products accepted has decreased compared with last month Let's analyze the registration, acceptance and evaluation of chemical drugs, traditional Chinese medicine and biological products In October, the number of new chemical registration applications undertaken by CDE was 470, down 15.2% month on month Figure II Acceptance of CDE chemicals in various application types from January to October 2015 The following is a detailed analysis of acceptance of CDE chemicals in October 2015 1 In October, 178 new chemical drugs were declared, accounting for 37.9% of the total 1) new drugs of category 1.1: this month, CDE accepts 17 acceptance numbers of chemical drugs of category 1.1, involving 8 varieties The figure below shows the new class 1.1 drugs in October Table 1 a new class 1.1 new drug, qusatabain for injection and its preparation, which was newly undertaken by Guangxi huibaoyuan in October 2015, was undertaken by the drug examination center on October 12, 2015 This variety is an antineoplastic cytidine analogue, which was developed by shire company and abandoned later It is understood that the drug has entered phase II clinical practice in the United States and entered the drug trial center on October 13, 2015 Currently, no queuing information has been found Sar107375e and its injection declared by Beijing Kleiber is a project jointly developed with Sanofi, which belongs to thrombin and XA factor inhibitor and is used for anticoagulant treatment Sar107375e may be a tartrate Lanthanum polystyrene sulfonate was used to treat hyperphosphatemia of chronic renal failure (CRF) 2) new drugs of category 3.1 Figure 3: acceptance quantity of new drugs of category 3.1 for chemical drugs from January to October 2015 Since August, the number of chemical drugs of category 3.1 has been reduced The release of relevant announcements such as clinical self-examination has indeed had a great impact on the enterprise 3) imitated drugs Figure 4: the number of accepted imitated drugs and imitated drugs from January to October 2015 At the 17th meeting of the Standing Committee of the 12th National People's Congress this year, the decision (Draft) on Authorizing the State Council to carry out the pilot work of drug listing license holder system and drug registration and classification reform attracted wide attention Draft proposal: first, refer to the practice of the United States, the European Union and other countries and regions, implement the drug listing license holder system, and allow the drug registrant, i.e the drug listing license holder, to be separated from the production enterprise This scheme has the advantages of mobilizing the enthusiasm of the R & D personnel and effectively avoiding low-level duplication; second, authorize the State Council to organize drug injection in the field of chemicals In the pilot reform of drug classification, the "drugs with national standards" stipulated in the drug administration law has been temporarily adjusted to "drugs with the same quality and efficacy as the original drugs", so as to effectively improve the access threshold of generic drugs The duration of the pilot of drug listing license holder system and drug registration classification reform is two years, which is a great challenge for pharmaceutical enterprises and even the whole pharmaceutical research and development circle 2 In October, CDE undertook a total of 23 new TCM registration application acceptance numbers, including 5 new drugs and 17 supplementary applications Figure 5: CDE's acceptance of traditional Chinese medicine from January to October 2015 3 Biological products In October, CDE undertook 36 new biological product registration application acceptance numbers, 9 new drugs and 24 supplementary applications Figure 6 acceptance of CDE biological products from January to October 2015: there was a decrease in new drug applications for biological products this month, among which 2 class 1 biological products projects were undertaken Table II category 1 biological products newly undertaken in October 2015 note: queue No up to November 3, 2015 IV completion of CDE review: this month, the centralized review is coming According to the latest statistics of drug intelligence registration and acceptance database, 6669 acceptance numbers were reviewed from January to October 2015 (the start time of status is from January 1, 2015 to October 31, 2015) Figure 7: the number of CDE drug type audits from January to October 2015 can be seen that up to now, the completed audits mainly focused on chemical drugs, accounting for 83.1% Other types refer to in vitro diagnostic reagents and excipients Figure 8 the number of monthly CDE reviews from January to October 2015 Since July, CDE has started centralized reviews By October 31, the number of acceptance of CDE reviews has reached 2894, showing a significant increase, up 551.8% month on month compared with September Especially in the aspect of approval of clinical approval documents, in the past years, an average pharmaceutical company received one or two clinical approval documents a year, while in the recent one or two weeks, five or six or even more than a dozen clinical approval documents were taken at one time For details, please refer to the previous report "clinical approval document blowout" Data source: drug intelligence registration and acceptance database