Some "unexpected" data of exclusive priority review

Source: Medical magic cube data 2018-06-08 on January 29, 2016, CDE released the announcement on the basic principles for the evaluation and approval of the application for priority review of drugs for children in clinical urgent need and the first batch of priority review varieties, indicating that the priority review system was officially implemented in China, and 2016 was thus called the first year of priority review Since then, CDE has released 29 batches of drug lists to be included in the priority review at the pace of one batch per month If the earliest batch of children's drugs without serial number is included in the priority review, in fact, 30 batches of priority review lists have been publicized, and a total of 555 drugs are to be included in the priority review (calculated by acceptance number, the same below) According to the publicity rules of CDE, there is a publicity period of 5 days for the drugs to be included in the priority review Industry personnel have the right to raise objections during the publicity period If there is no objection, CDE will finally grant priority review qualification and start priority review procedure According to the path shown in the above picture, you can find that there are 520 drugs that CDE has finally confirmed to be awarded the priority evaluation qualification Since the 29th batch of priority review list (74) has not been officially included by CDE within the publicity period, we hereby assume that this batch of drugs will finally be qualified for priority review, and then there will be 594 drugs finally included in the priority review by CDE 555 will be included, and 594 will be included finally An accident? In fact, every time a new batch of drugs to be included in the priority review list is publicized, it will cause a sensation in the industry However, there is little patience and deep concern about the final result after the end of the publicity period Today, I'd like to share with you some unnoticed data According to the exclusive statistics of medical magic cube, the differences between the above two groups of data are mainly caused by the following three situations: 1) the applicant applies for the priority review, CDE publicity is proposed to be included in the priority review, the industry personnel raise objections, and finally the priority review qualification is cancelled, there are 17 such drugs 2) The list of drugs to be included in the priority review publicized by CDE is duplicated, and there are 11 such drugs 3) There are 67 drugs that are not included in the CDE 30 batches to be included in the priority review list, but are qualified for the priority review The arithmetic problem is relatively simple: (555-17-11 + 67 = 594), but we need to pay attention to these "unexpected" drugs The first thing that needs to be explained for the 17 drugs that have been disqualified is: 1) the disqualification only means that the application at that time does not meet the conditions of the priority review and approval, and thus cannot enjoy the policy of speeding up the market, and does not directly reflect the safety or effectiveness of the drug itself 2) The disqualification at that time does not mean that the follow-up application of the same variety can no longer obtain the priority review qualification Note of 17 drugs disqualified from priority review: as of June 7th, 74 acceptance numbers of the twenty-ninth batch are still in the publicity period, assuming no objection It can be found from the above disqualified drugs that the biggest industry objection is the ownership of the "first imitation" identity, and then how to define the applicant's claim that "it is more advantageous than the existing treatment means" must be true, which is obviously the place for players of related varieties The following is mainly about the introduction of individual varieties Although Zhengda Tianqing linezolid injection and Hengrui ' The paclitaxel for injection (albumin binding) (cyhs1300522) of Hengrui pharmaceutical was publicized in the 11th batch as the "first imitated variety", and failed to obtain the qualification of priority evaluation finally, but it was approved on January 23, 2017 Before the magic prescription of medicine, the article had analyzed and discussed the approval result with you Looking back afterwards, it was obvious that the clinical approval was obtained at that time After Hengrui completed be clinic, the listing application (cyhs1790004) submitted by Hengrui was publicized in the 20th batch for priority review, for the reason of "clinical urgent need, market shortage", and finally achieved the goal However, cyhs1600152 of Sinopharm group is also qualified for the priority review at the same time, in the same variety and for the same reason Obviously, Hengrui and Shiyao, two tycoons, are more concerned about the ownership of the "first imitation" of the variety, but they have completed each other after temporarily abandoning their differences The current situation is that the variety of Shiyao group has been approved for listing, and Hengrui's variety is still in the stage of review and approval Metformin hydrochloride tablets of Sinopharm group are a double report product of China and the United States, which have been listed in the United States At the same time, three specifications of generic drug listing applications (cyhs1790012, cyhs1790013, cyhs1790014) have been submitted in China, all of which appear in the 15th batch to be included in the priority review list Finally, only one of the acceptance numbers cyhs1790012 was disqualified from the priority review, and the acceptance number 2017 / 11 / 30 was approved and the approval document was distributed The other two acceptance numbers of the normal priority review are currently in the "review and approval" status This situation is very similar to that of valsartan, which has just been approved for listing by the priority review channel It is speculated that the metformin hydrochloride tablet of lithopone is also a specification that has been directly killed However, after valsartan took the lead in establishing the China US dual reporting path, the metformin of lithopone is not far from being approved According to statistics of 11 drugs that are repeatedly included in the priority review, there are 22 duplicate data in different batches to be included in the priority review list, which is equivalent to 11 drugs that are repeatedly included, including 9 foreign enterprise varieties and 2 domestic enterprise varieties According to the analysis of the reasons, there is no significant difference in the reasons for the 11 drugs included in the priority review before and after the first publicity, and they are officially qualified for the priority review five days later From the perspective of batch interval, it is more like the omissions or defects in the statistical publicity CDE repeatedly publicized 67 drugs that were not publicized for priority review and directly included in the priority review CDE has issued formal instructions If it has obtained the priority review in the clinical application stage, it can not be publicized after obtaining the priority review in the marketing application stage This situation is in line with the policy, accounting for the majority of 67 drugs In another case, CDE only publicizes the raw materials and unpublished preparations in the list to be included in the priority review If the acceptance number of the raw materials is included in the priority review, the preparations will be directly evaluated together though they are not publicized; or only the preparations and unpublished raw materials will be publicized If the acceptance number of the preparations is included in the priority review, the raw materials will be evaluated together This is also a common situation among these 67 drugs It seems that the unpublished drugs are just some procedural defects However, in addition to the above two cases, there are some drugs that have not been publicized and directly included in the priority review The reasons or basis are not clear Here are just a few examples for discussion Drugs directly included in the priority review without publicity (part)