2014 China Drug Evaluation List

Guide: 2014 has been turned over In this year, the drug with the most popular topic is hepatitis C drug sofosbuvir, whose popularity runs through the first year to the end of the year; the policy with the most popular topic is the time limit of drug review, and the problem of too slow review is still there, but it can't stop the enthusiasm of domestic enterprises to declare The declaration of Tinian tumor drugs came in a rush, and Hengrui first rushed out of the encirclement to take apatinib The global diabetes drug DPP-4 inhibitors, SGLT2 inhibitors and GLP-1 receptor agonists have been on the market one after another, and many domestic enterprises have been competing to declare "Ice bucket challenge" has aroused the public's attention to rare diseases, and orphan drug declaration has also been made With the expiration of a large area of global patent drugs, the spring of the first generic drugs came, and Baiyunshan Jinge was the first to go on the market Generic drugs are still heavily repeated, but they cannot be repeated without hope for the Chinese drug market Apatinib mesylate: apatinib mesylate tablets of Jiangsu Hengrui (trade name: aitan) is the first safe and effective small molecule anti angiogenesis targeted drug for advanced gastric cancer, which can significantly prolong the survival period after failure of standard chemotherapy for advanced gastric cancer Apatini made a lot of money this year, and also made a lot of shares for Jiangsu Hengrui It won the best "original" drug award in 2014 Morpholinidazole sodium chloride injection is the first new drug independently developed by Jiangsu Haosen, which was approved for marketing in March 2014 (see Table 1) Another new drug approved for marketing is adefovir dipivoxil, which is not the first time on the market Seven enterprises have already produced the approved type 1.1 adefovir dipivoxil (APIs and tablets) Meanwhile, CFDA reported the adverse reactions of hypophosphatemia and osteomalacia of adefovir dipivoxil in December, which makes the market of adefovir dipivoxil not optimistic 3.1 most popular award of class 1 drugs azilsartan: the number of declared enterprises 25 azilsartan is an angiotension II receptor antagonist for hypertension, and the original manufacturer is Takeda pharmaceutical 3.1 azilsartan added 25 new declaration enterprises in 2014, and its total number of declaration enterprises reached 49, winning the "2014 most popular declaration award of 3.1 drugs" In addition to azilsartan, Pfizer's tofatinib has become a new favorite of 3.1 drugs with 21 new domestic declaration enterprises However, pharmaceutical companies seem to prefer rofluorostat, which ranks third with alcotiramine The total number of enterprises applying for rofluorostat has reached 66, among which 2 imported enterprises and 5 domestic enterprises have been approved for clinical application Esomeprazole, the most "concerned" award for 6 categories of generic drugs: number of companies to declare 44 before that, "how serious is the repeated declaration of generic drugs? The article lists the varieties declared by more than 100 or even 500 enterprises, and the problem of repeated declaration of generic drugs is self-evident Esomeprazole, which is used for the treatment of gastroesophageal reflux disease, has been applied for more generic drugs year by year In 2014, 44 new generic drugs were added and won the "most concerned" award of six generic drugs in 2014 In the second place is moxifloxacin, a star in the field of antibiotics With the approval of Chengdu Tiantai Mountain to produce moxifloxacin of 3.1 class, the number of applications for generic drugs may continue to rise Novartis pharmaceutical, the most powerful award of multinational pharmaceutical enterprises in pharmaceutical enterprise chapter: the total number of declaration and approval documents of imported drugs 43 Novartis pharmaceutical won the "2014 most powerful award of multinational enterprises" with the absolute advantage of 43 varieties approved and declared, which is far ahead of other multinational enterprises In 2014, Novartis received two import approvals, metformin and viagliptin tablets (trade name: yiherui) and travotimol eye drops (trade name: sulitan) from its subsidiary Alcon Novartis has been approved 22 clinical varieties involving hepatitis C, tumor, rare disease, chronic pulmonary obstruction and other treatment fields Moreover, among the 20 application varieties under review, there are no lack of new molecular entities developed synchronously in the world It seems that the Chinese market plays an increasingly important role in Novartis' strategy GlaxoSmithKline applied for 16 varieties, obtained 5 clinical approvals and was approved to market the Parkinson's disease drug ropiniro Bayer medicine ranked second with GlaxoSmithKline in terms of a large number of clinical approvals and application acceptance However, Bayer pharmaceutical has just completed the acquisition of Kunming Dianhong pharmaceutical, so the approved traditional Chinese medicine of Kunming Dianhong is not included The most innovative award of domestic enterprises Jiangsu Hengrui: the total number of class 1.1 new drug applications and approvals 7 in 2014, Jiangsu Hengrui achieved good results in 1 production approval, 2 clinical approval and 4 Application of class 1.1 new drugs, undoubtedly leading the way of R & D and innovation of Chinese pharmaceutical enterprises, and won the "2014 most innovative award of domestic enterprises" Followed by Jiangsu Haosen and Guangdong dongyangguang, the number of clinical approval and application of class 1.1 new drugs is more than 4 At the same time, Jiangsu Yasheng, Zhejiang Haizheng and other enterprises are not willing to lag behind, and they are speeding up the pace of application when they are approved for clinical application 3.1 most "love" award of class 1 drugs Nanjing Huawei pharmaceutical: apply for the number of class 3.1 drugs 21 as a class 3.1 new drug with the advantages of 4-year new drug monitoring and testing period and the first generic drug, naturally becoming the most intense field for domestic enterprises to seize Nanjing Huawei pharmaceutical declared 21 varieties in this year, and won the "favorite" award of class 3.1 drugs in 2014 In addition, Zhengda Tianqing is also fond of class 3.1 new drugs, with a total of 16 varieties declared in 2014 At the same time, Jiangsu Haosen, which has a good performance in class 1.1 new drugs, applied for 12 class 3.1 new drugs Although Qilu pharmaceutical is not as good as Jiangsu Haosen in the performance of class 1.1 new drugs, the number of class 3.1 drugs declared by Qilu pharmaceutical is third with Jiangsu Haosen The most "favorite" award of category 6 generic drugs is just in the sky: when we talk about category 6 generic drugs, we may think of the enterprises whose R & D strength is not good, but in fact they are not In addition to its love for category 3.1 drugs, Zhengda Tianqing also loves generic drugs and has applied for 35 varieties, so it won the "favorite" award of category 6 generic drugs in 2014 In addition to Zhengda Tianqing, there are many large pharmaceutical companies that are most fond of generic drugs on the list, such as Qilu pharmaceutical, Sichuan Kelun, with 30 application varieties ranking second, while the number of application of the third, fourth, and fifth stone Pharmaceutical Group, Luoxin pharmaceutical and Hainan Lingkang is not the same The furthest distance in the world is not the distance between life and death, but the distance between the time limit of evaluation and the time limit of application for the same kind of drugs When the time limit for drug review is one of the hottest topics of drug policy in 2014, what is the difference between the time limit for drug review approved in 2014? The furthest time limit for clinical evaluation, whether imported or generic drugs, 1.1 or 3.1 drugs, has no significant difference in the fastest clinical approval speed, and the evaluation is completed within 10 months However, the time limit for the slowest review is not only far beyond the average of the past four years, but also at least 47 months, about four years away from the time limit for the fastest review From the perspective of the drugs with the fastest and slowest time limit for clinical application review of various drugs and their declaration enterprises, the time limit for clinical application review of drugs declared by bolingyingehan, Hangzhou Huadong, Zhejiang Haizheng and Zhuhai UL is relatively short But Takeda pharmaceutical, Hebei Medical University, Changsha Huamei pharmaceutical and Beijing Liling Hengtai have been waiting for at least four years (see Table 2) Among the drugs with the fastest and slowest time limit for market review in 2014, the drugs with the least difference in the review time limit are class 1.1 new drugs, which are 32 months, and class 6 generic drugs, which are 102 months, which are about 8.5 years Among the drugs approved for quick listing, GlaxoSmithKline, Jiangsu Haosen and Shiyao group have been waiting for 1-3 years to declare for listing Among the slow listed drugs, Suzhou Erye's class 1.1 drugs and laboratorios' imported drugs were both listed and reviewed for 5 years, Jiangsu Hengrui's class 3.1 drugs, lafutidine, had been waiting for 1 year, and Suzhou Erye's generic drug, enoxaparin sodium, had been waiting for 8 years, and finally kept blooming (see Table 3) In summary, the 2014 China drug review list carefully created by DXY insight has come to an end In the past, no matter whether an enterprise is listed or not, or how fierce the competition for drug declaration is, it's business to look forward and move forward Even though the competition of class 3.1 new drugs will become increasingly fierce, even if the time limit for drug review still exists, however, more and more class 1.1 new drugs bring hope to Chinese drug R & D innovation, multinational enterprises pay more and more attention to the domestic market, bring advanced technology and ideas of drug R & D, and the liberalization of drug price policy will also benefit many domestic enterprises This is the worst of times, and it will be the best of times Note: 1 The quantity of drugs declared by the enterprise shall be calculated in terms of ingredients; 2 The subsidiary of the enterprise shall not be calculated repeatedly by the drug declaration enterprise; 3 The quantity of drugs approved for import shall be calculated in terms of the first approval in China; 4 The time limit for evaluation shall be calculated in terms of the date of acceptance and undertaking and the date of sending the approval document