Hengrui paclitaxel and Lizhu eprazole accelerate the review

CDE, which has been silent for a long time, has started the habit of issuing announcements every weekend On Friday (October 28), it released the announcement of drug registration application to be included in the priority review procedure, with 29 acceptance numbers getting the opportunity of priority review On Saturday (October 29), the notice on soliciting the technical guidance on the use of adult drug data extrapolation in pediatric clinical trials and related information was released, which will promote the enthusiasm of pediatric drug research and development At least, the research cost of pediatric human clinical trials has been relatively reduced, which is good for the registration and application of improved specifications that have already exceeded the adaptive population The list published by cde10 on 28 is shown in the table below Cxsl1600011 once publicized viral hepatitis as the reason for priority review in the publicity of drug registration application to be included in the priority review procedure on September 14, and applied again for hepatitis B treatment drugs this time In fact, the announcement on the determination of drug registration application to be included in the priority review procedure has been missing since April 18, 2016, when the announcement on the application for drug registration to be included in the priority review procedure was issued by CDE Table 1 list of priority reviews to be published by CDE on October 28 Only three products have been declared for production, namely, Lizhu's innovative drug with obvious clinical value, major special iprazole sodium and its injection, and Hengrui's first imitation of paclitaxel for injection (albumin binding type), and two declared products are all injection products Compared with the approved products of new drugs published by CFDA recently, CFDA has a preference for approved injection recently 。
The remaining 26 product specifications are mainly for clinical application, among which 11 acceptance numbers belong to hepatitis C direct antiviral treatment drugs, 3 belong to AIDS treatment drugs, and 2 acceptance numbers belong to hepatitis B treatment drugs Xianda data v3.2 found that a total of 26 acceptance numbers entered the CDE priority review and approval list due to the indications for the treatment of hepatitis C virus infection Table 2 priority list of drugs for treatment of hepatitis C virus infection The self inspection checklist announced on July 22, 2015 is regarded as "the first batch of self inspection", the self inspection list announced on April 1, 2016 is regarded as "the second batch of self inspection", the self inspection list announced on September 1 is regarded as "the third batch of self inspection", the first batch of self inspection has 11 acceptance numbers for priority review, the second batch of self inspection has only 4 acceptance numbers, and the third batch of self inspection has 6 acceptance numbers, including lipra for injection Sodium azolium 17 of the above 21 acceptance numbers have been notified for clinical on-site verification It is expected that the 17 products will be approved as soon as they pass the clinical verification
Four products that have not been notified of clinical on-site verification but belong to the priority review and self-examination catalogue are respectively megestar capsule of Aike Tailong pharmaceutical trade (Shanghai) Co., Ltd., megestar capsule of Chengdu Tiantaishan Pharmaceutical Co., Ltd., zuoeilacetan injection of Sichuan dingnuotaichen Technology Co., Ltd., clofarabine injection of Beida Pharmaceutical Co., Ltd and Lizhu group Iprazole sodium for injection in Lizhu pharmaceutical factory Table 3 self inspection catalogue products to be prioritized for review