Hengrui Huahai is the most of the 300 priority evaluation varieties!

In the past three years since the implementation of the priority review system, what changes have taken place in the policy? Which company has the most applications? Which reasons are included most? Which reasons are approved most? How long is the priority review? Is it faster to finish the trial? Insight tries to share the results of the "priority review" from these perspectives The evolution of the priority review and approval policy on February 26, 2016, the State Food and Drug Administration announced the opinions on solving the backlog of drug registration applications and implementing the priority review and approval, which opened the curtain of the priority review and approval On October 8, 2017, the State Council issued the opinions on deepening the reform of the review and approval system to encourage innovation of pharmaceutical and medical devices, clearly indicating that the direction of reform is innovation On December 28, 2017, CFDA issued the opinions on encouraging drug innovation to implement priority review and approval, and strongly encouraged the research and development of innovative drugs and the introduction of foreign innovative drugs On November 7, 2018, CDE issued a notice that the varieties to be included in the priority review will no longer be publicized in batches, but will be publicized on the official website of "immediate review" for comments Hengrui and Huahai have benefited the most since the implementation of the priority review and approval As of November 7, CDE has published 33 batches of acceptance numbers to be included in the priority review and approval list, involving 300 varieties Among them, 62 varieties (113 acceptance numbers) were approved for import, and 47 varieties (82 acceptance numbers) were approved for production We have sorted out the distribution of 713 acceptance numbers to be included in the list Jiangsu Hengrui and Huahai Pharmaceutical Co., Ltd occupy the first place in the priority review and approval no matter the number of acceptance numbers or the number of varieties The specific ranking is shown in the following figure: the reasons for the inclusion of 713 acceptance numbers to be included in the list are shown in the following figure for rare diseases and more and more domestic varieties to be reported abroad We count the number of varieties that have been included in the priority approval for each reason in the past three years The following five reasons have changed a lot We will analyze the reasons one by one Since the priority review and approval of the state has been implemented, the application of innovative drugs increased rapidly from 2016 to 2017, and decreased in 2018 The rapid rise is related to national policies The main reasons are as follows: ① due to the strong attraction to enterprises when the preferential review and approval policies were just opened in 2016, coupled with the drug gap in the field of major diseases in China at that time, a batch of new drugs are urgently needed to fill the gap ② In 2017, in order to shorten the listing time of foreign new drugs in China, China announced to accept overseas clinical trial data, greatly improving the listing efficiency of new drugs in China Thanks to this policy, a number of original research drugs were included in the priority review and approval queue, so there was a peak of innovative drugs in 2017 ③ The state strongly supports the development of domestic innovative drugs The ultimate goal of encouraging domestic innovation and vigorously developing generic drug conformity evaluation is to replace the original research, so that the majority of patients can use drugs with high quality and low price With the approval of the concentration of innovative drugs in 2017 and 2018, to some extent, it has made up for the drug blank in some disease areas in China, and the demand for drugs such as major diseases in China has declined The subsequent introduction of new overseas drugs is mainly aimed at rare diseases and other major diseases, so the number of applications will slow down With the arrival of the consistency evaluation limit, the number of generic drugs included in the priority review and approval has increased explosively Since 2018, the number of generic drugs included in the priority review is close to the sum of the previous two years This is because on March 5, 2016, GBF [2016] No 8 document clearly stipulated that the same production line and the varieties listed abroad and reported to the domestic market after being approved are deemed to pass the consistency evaluation, and more and more preparation export-oriented enterprises have transferred to the domestic market through this shortcut, realizing the "overtaking on the curve" in the consistency evaluation and passing the evaluation quickly Before 2016, the number of drugs for rare diseases continued to rise The policy of drugs for rare diseases did not receive enough attention, resulting in the lack of drugs and the introduction of foreign drugs for rare diseases into China as soon as possible Since the implementation of the priority review and approval policy in 2016, drugs with rare diseases have been explicitly included, and the approval speed of such drugs has been accelerated As a result, more and more rare disease drugs that have been on the market for a long time abroad are entering the Chinese market under the encouragement of policies, so that the patients with rare diseases in China can have drugs available At the same time, some powerful innovative enterprises are gradually distributing the drug research and development of rare diseases Although most of them are in the clinical stage, we believe that in the near future, patients with rare diseases can benefit from domestic rare disease drugs From the perspective of approved production, the most varieties for priority evaluation of innovative drugs are approved, and the most varieties for priority evaluation are innovative drugs At present, 45 innovative drugs have been approved for listing in China, of which imported drugs account for 88% (based on acceptance number) Approved domestic innovative anticancer drugs, such as pyrrolidine of Hengrui medicine, furquitini of Hutchison Huangfu, and androtinib of Zhengda Tianqing, etc The approval of these domestic new drugs is benefited from the national priority review and approval policy With the encouragement of this policy, the number of new domestic new drugs included in each year is increasing; in the next few years, the approval peak of domestic innovative drugs will come Here are six rare disease drugs approved for marketing in China In addition, the first approved imitated varieties, varieties before the expiration of the patent, and varieties and affiliated enterprises approved to be transferred to China by foreign countries for joint production as of November 7, 2018 are also counted Priority approval is becoming faster and faster for enterprises To enter the "priority review" means to shorten the time cost of drug review and reduce the risk of issuance, supplement or even disapproval Since the start of the policy, CFDA has been pushing forward and improving As shown in the figure below, it took an average of 2361 days to declare and complete the review of varieties in 2011, and we counted the varieties declared and completed the review in 2018, which took an average of 114 days Note: the above figure shows the function of calculating the review time length of insight database The time from CDE undertaking to approval (blue column in the figure) is the time from the drug undertaking to approval (clinical / marketing / import) The abscissa is the year of CDE undertaking The data is only for reference Compared with all the varieties approved for listing, the review time of acceptance number of priority review is slightly longer than that of all varieties (priority and non priority varieties), and the review is not completed faster because of the priority review It is speculated that there are two reasons One is that most of the priority review varieties are innovative and need more communication and guidance The other is that more and more varieties are declared and the review staff is limited Of course, it does not rule out that there are some varieties that lag behind If we want to reach the speed of "green channel" far faster than "non green channel", there are still many details to be done The above data is from insight database