[exclusive] the explosion of anti-tumor drugs! 3-tinib + 5-mab + the first imported class 1 drug has been accelerated and will be available in 2019

In February 2016, the General Administration of food and drug issued the opinions on priority review and approval for solving the backlog of drug registration applications, which was revised and implemented in December 2017 The registration applications in 18 cases, such as anti-tumor drug applications with obvious clinical advantages, were included in the priority review scope According to statistics, with the help of policies, the number of acceptance numbers included in the priority review increased from 134 in 2016 to 242 in 2017, among which, the number of anticancer drugs increased from 21 to 46, and to 60 in 2018 In addition to the great progress in quantity, triprilimab injection, cindilimab injection, aletinib hydrochloride capsule, abiolone acetate tablet, and pabolizumab injection were all approved in 2018 Some of the application time was less than half a year, and they were listed in the market over speed, which attracted the attention of the industry and the media In 2018, 60 anti-tumor drug acceptance numbers were included in the priority review From the perspective of inclusion, in 2012, only one antineoplastic drug began to appear in the priority review varieties, accounting for 10% of the total number of priority review acceptance numbers; after five years, antineoplastic drugs have become the main force in the priority review, and 60 acceptance numbers have been included this year, accounting for 24.1% of the total number, which can be described as a significant increase in quantity Figure 1 the number of antineoplastic drugs included in the priority review in 2012-2018 can also be seen from Figure 1 In 2012-2018, the acceptance number of antineoplastic drugs included in the priority review increased all the way, and in 2015 and 2017, there was a significant increase Specifically, in 2015, the number of imported anti-tumor drugs included in the priority review increased from 2 to 13 Novartis' lucotinib phosphate tablets, Bayer's regofinib tablets, Pfizer's tofacib citrate tablets were all declared in this period, and by 2018, the number of imported drugs included reached 17 In 2017, due to the surge of new drug acceptance numbers, there were 15 new drug acceptance numbers from 2016 to 2017, including 14 innovative drugs of category 1, including 3 heavyweight tinines, enrotinib capsules of Zhengda Tianqing, pyrrolidine maleate tablets of Hengrui medicine, and production acceptance numbers of fujitini capsules of Huangpu medicine; 3 heavyweight immunocytotherapy (car-t ）The clinical acceptance number of the drug, such as Nanjing legendary lcar-b38m cell preparation, was included in the priority review at this stage By 2018, the total acceptance number and new drug acceptance number included in the priority review of anti-tumor drugs have reached the highest value, 60 and 24 respectively Among the 24 new drugs, 9 varieties with 17 acceptance numbers are class 1 innovative drugs (see Table 1 for details) Table 1 class 1 new anti-tumor drugs included in the priority review in 2018 note: preparations and APIs are classified into one variety data source: drug intelligence database, thereplimab injection and sindelimab injection are the heavyweight varieties of this year, creating a precedent for domestic PD-1 antibody drugs The two varieties were accepted on March 20 and April 19 of this year respectively By December 21, 2018 and January 3, 2019, they had been approved for production The period was only about 9 months Compared with the first anti-tumor drug, bortezomib, which was included in the priority review in 2012, the drug was approved for production on November 30, 2017 (see Table 2 for details) The review speed can be seen as a huge increase Table 2 data sources of the first review record included in the priority review of new anticancer drugs: 62 acceptance numbers of the drug intelligence database have been listed, 4 PD-1 monoclonal antibodies, and multiple blockbuster tinib clusters have been approved for overspeed In terms of approval, in 2012-2018, 62 acceptance numbers included in the priority review were approved for listing, including 15 new drugs, 39 imported drugs and 8 generic drugs (details of all anti-cancer drugs that have passed the priority review are attached at the end of the paper) Among them, new drugs and imported drugs were approved for listing in 2017-2018, and 24 acceptance numbers were also declared in these two years, which can be described as speeding up Market variety Of the 15 new drug acceptance numbers, 9 acceptance numbers and 5 varieties have been declared in 2017-2018 and have been approved (see Table 3 for details) Table 3 priority review of new anti-tumor drugs declared and approved in 2017-2018 note: the preparation and API are classified into one variety data source: five varieties of drug intelligence database include three TiNi and two PD-1 monoclonal antibodies, all of which are class 1 innovative drugs Two monoclonal antibodies have been mentioned above, which will not be discussed here; three tinines, including enrotinib hydrochloride capsules of Zhengda Tianqing, pyrrolidine maleate tablets of Hengrui and fuquinotinib capsules of Hutchison Whampoa, were accepted in 2017 and approved for marketing after about one year The three drugs are all Landmark varieties for the enterprise: arotinib hydrochloride capsule (trade name: fukewei), which is used to treat advanced or metastatic non-small cell lung cancer After more than ten years of research and development, the drug is also the most invested variety of datianqing, and has been included in the national medical insurance class B; about 556 million yuan of pyrrolidine maleate (trade name: Irinib), which brings new treatment options for Chinese HER2 positive patients with advanced breast cancer, is the first innovative drug approved by the State Food and Drug Administration for solid tumor treatment based on phase II clinical research results in China; fujietinib capsule (trade name: aiute) of Hutchison Whampoa Pharmaceutical Co., Ltd., which is not listed at home and abroad, is approved for the treatment of metastatic colorectal cancer Of the 39 import acceptance numbers, 15 acceptance numbers and 10 varieties have been declared in 2017-2018 and have been approved (see Table 4 for details) Table 4 priority review of anti-tumor imported drugs declared and approved in 2017-2018 note: preparations and APIs are classified into one variety data source: drug intelligence database, among which, the third generation lung cancer target drug declared by AstraZeneca (trade name: Teresa) is the fastest on the market, which takes less than two months from declaration to import approval At present, it has been included in the national medical insurance class B In addition, aletinib hydrochloride capsule, abiolone acetate tablet and pabolizumab injection are also the varieties declared and listed in the same year, and the first two drugs have been approved only about half a year Pabolizumab injection (trade name: keytruda), the only PD-1 inhibitor approved for the treatment of advanced melanoma in China, is also the second approved immunotumor treatment drug in China The first approved nivolumab injection (trade name: opdivo) of Bristol Myers Squibb was approved for import on June 15, 2018, for local advanced or metastatic non-small drugs Adult patients with NSCLC Aleatinib hydrochloride capsule (trade name: ansanza) is the latest generation of targeted drug for the treatment of anaplastic lymphoma kinase positive local advanced or metastatic non-small cell lung cancer (NSCLC) It only took about 6 months from the submission of the application to the approval of the drug, which has achieved the basic simultaneous listing of China and Europe and the United States In addition, four heavy-duty anticancer varieties, namely, seretinib capsule, lovatinib mesylate capsule, olapari tablet and palbociclib capsule, were approved in less than one year, among which seretinib capsule has been included in the national medical insurance class B 3 tinib + 5 mAb + the first class 1 imported drug will be accelerated to be listed in 2019, which has been included in the priority review, but among the unlisted anti-tumor drug acceptance numbers, the following heavyweight varieties have submitted the listing application, and are expected to be listed next year Among them, there are three class 1 innovative TiNi from Baiji Shenzhou, hausen pharmaceutical and Essen pharmaceutical; class 1 innovative mAb from Hengrui pharmaceutical and bringer Ingelheim; class 1 imported drugs from Qilu and Fuhong Hanlin, as well as Johnson & Johnson's first class 1 drugs submitted for listing in China Baiji Shenzhou zanbutinib zanbutinib capsule is the second generation BKT inhibitor independently developed by Baiji Shenzhou, which has the potential of bestinclass In August and October 2018, Baiji Shenzhou successively submitted the listing application of zambutinib for the treatment of mantle cell lymphoma and chronic lymphocytic leukemia / small lymphocytic lymphoma, which is expected to be approved for listing in August 2019, becoming the first approved domestic Btk inhibitor Hausen pharmaceutical - flumatinib mesylate flumatinib mesylate, a BCR protease inhibitor independently developed by hausen pharmaceutical, is a second-generation molecular targeting drug optimized on the molecular structure of nilotinib, which significantly reduces the damage of pancreas, liver and kidney functions Its listing application has been undertaken by CDE on July 20, 2018, and the application indication should be chronic myelogenous leukemia It is expected to be approved for listing in August 2019 Eisen pharmaceutical - ivetinib maleate, developed by Zhejiang Eisen pharmaceutical, is the first original third-generation EGFR targeting inhibitor in China, and one of the important achievements of the 12th Five year national "major new drug creation" science and technology major projects Its listing application has been undertaken by CDE on June 25, 2018 According to its clinical trial records, its application indication should be non-small cell lung cancer, which is expected to be listed in August 2019 Hengrui medicine - carrizumab for injection carrizumab is a PD-1 monoclonal antibody independently developed by Hengrui medicine In the recently published "a phase 2 clinical study of carrizumab in Chinese patients with relapsed / refractory classic Hodgkin's lymphoma", it shows very good efficacy The orr evaluated by IRC reaches 84.8%, and the CR rate reaches 30.3% In April 2018, the listing application of carrizumab injection has been accepted by CDE, and the application indication is relapsed / refractory classic Hodgkin's lymphoma, which is expected to be listed in March 2019 On September 6, CDE undertook the listing application of PD-1 tirelizumab injection declared by bringlingham and Baiji Shenzhou The indication of PD-1 for thalidomide is Hodgkin's lymphoma In addition, the drug is also used in clinical trials for the treatment of non-small cell lung cancer, liver cell carcinoma and esophageal squamous cell carcinoma Fuhong Hanlin rituximab injection rituximab injection is a macromolecular bio similar drug independently developed by Fuhong Hanlin, the platform of Fuxing Pharmaceutical bio medicine, which is mainly applicable to the treatment of non Hodgkin's lymphoma and rheumatoid arthritis As of December 2017, Fosun Pharmaceutical has invested about 300 million yuan in research and development of the new drug at this stage It is expected to be available in January 2019 Qilu pharmaceutical - recombinant anti VEGF humanized monoclonal antibody injection Recombinant anti VEGF humanized monoclonal antibody injection is a biological analogue of bevacizumab developed by Qilu pharmaceutical industry In addition to Qilu pharmaceutical industry, Hengrui pharmaceutical, Fuhong Hanlin, Xinda biology and many other enterprises are carrying out phase III clinical trials, with fierce competition At present, only Qilu application is listed, which is expected to become the first domestic biological analogue of bevacizumab The first monoclonal antibody drug to treat multiple myeloma, developed by Johnson & Johnson, was approved by FDA through priority review in November 2015 The drug was undertaken on October 19, 2018 and is expected to be approved for marketing in October 2019 Dacomitinib, a second generation EGFR inhibitor developed by Pfizer, is used for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with EGFR activated mutations The drug is the first class 1 imported drug to be put on the market in China and is expected to be on the market in April 2019 Data source: Yao Zhi data statement: This article only represents the author, not the position of Yao Zhi Com Welcome to exchange and supplement in the message area If you need to reprint, please be sure to indicate the author and source of the article.