[exclusive] 2017 approved clinical analysis of special, heavy and excellent varieties, heavyweight drugs cefaziamidine sodium, tirirafen, deoxypodophyllotoxin

2017 has passed, and we have a new year in 2018 Looking back yesterday, the pharmaceutical industry has gone through a difficult year, but also a harvest year I have prepared a series of articles on drug registration in 2017 I will publish them in the official account in the near future If you love, please read on 1 ~ 10 years of new drug registration and approval, and dig out 2017 enterprises' R & D layout, East sunshine, Heng Rui, Qilu, Kang Yuan.. Since the implementation of the system of special approval, major special projects and priority review, it has effectively improved the efficiency of domestic drug review, effectively handled the review accumulation of drugs urgently needed in some markets, highlighted the focus, and solved some of the hidden reefs that often appear in the drug market According to the statistics of drug intelligence data, a total of 1233 clinically approved drugs (calculated by acceptance number, the same below), 189 major projects, 73 priority reviews, 27 special approvals for approved production, 59 major projects and 31 priority reviews have been approved for many years It can be seen that there is still a gap between clinical and production, but there is no doubt that clinical approval is the hope of the final approved production of drugs, and these approved clinical drugs are the most worthy of attention of enterprises According to the data from 2005 to 2017, in 2016, the number of clinical special approvals was the most, 371, and the number of major special projects was the most, 68 In 2017, the number of approved clinical priority reviews was 45 (as shown in Figure 1) Figure 1 special approval, major special projects, priority review (to determine the approved clinical) of approved clinical products in 2005-2017 1 Analysis of approved clinical special review drugs in 2017 1 The list of approved clinical special drug companies in 2017 is shown in Figure 2 It can be seen that the top three companies are Shanghai Pharmaceutical Research Institute of Chinese Academy of Sciences, Jiangsu Hengrui, Zhengda Tianqing and abbvie Inc There are 14 acceptance numbers and 5 varieties of Shanghai Pharmaceutical of Chinese Academy of Sciences; Jiangsu Hengrui has 10 acceptance numbers and 5 varieties; abbvie Inc has 8 acceptance numbers and 4 varieties; Zhengda Tianqing has 8 acceptance numbers and 4 varieties Figure 2 the ranking of the approved clinical special approval enterprises in 2017 2 The drug types are shown in Figure 3 Chemical drugs account for 96.22% of the approved clinical special approval in 2017, with fewer biological products and traditional Chinese medicine A large number of approved dosage forms are tablets, accounting for 45.65% In the drug classification, the most approved clinical drugs are new chemical drugs, class 1 and class 1.1, with 143 and 43 acceptance numbers respectively Figure 3 types of special approved drugs in 2017 3 Variety analysis there are 238 acceptance numbers (as shown in Table 1) of special approved drugs in 2017, involving a large number of drug varieties, among which there are many good drugs with initiative, independent research and significant curative effect that deserve attention Table 1 special approved clinical varieties in 2017 (Note: red for special approval, blue for special review and priority review, green for special approval and major special, here is only to determine the approved clinical varieties, please click the appendix at the end to download the complete data of 2017 special approval status) In 2017, Shanghai Pharmaceutical Research Institute of Chinese Academy of Sciences approved five varieties of clinical drugs, including cyh33 and its three tablets, methyldeoxyuridine and its two tablets, tpn672 and its two tablets, gmetinib and its one tablet, commotaxay and commotaxay for injection Among them, deoxy mushroom purpurine methyl ester is a drug for the treatment of systemic lupus erythematosus; commutase is a drug for the treatment of tumors; gometinib is also a tumor drug, and preclinical research shows that this drug can specifically inhibit the anti-tumor activity mediated by c-Met, especially the anti-c-Met dependent solid tumors such as advanced non-small cell lung cancer and gastric cancer Moreover, the drug resistance of gefitinib mediated by met gene amplification can be overcome in the preclinical model of NSCLC Baiyunshan, Guangzhou - cefaziamidine sodium, cefaziamidine sodium and its four injections were approved for clinical use in December 2017, and were accepted in May, lasting for 7 months Cefathiamidine sodium is a new chemical drug of class 1 It is a new compound based on the structural transformation of cefathiamidine It is in the pioneering position in China It has obtained one U.S patent license and two Chinese invention patents The data shows that cefathiamidine has been the first generation cephalosporin in recent five years, with sales of 610 million yuan in hospitals in key cities of China in 2016 The drug has been recognized by clinical experts as a safe and effective first-line drug of choice against gram-positive cocci infection The modified cefazimidine sodium will have a better clinical value, and the market is expected to be broad In addition, according to the analysis of the insiders, Baiyunshan, a Guangyao drug, obtained the clinical approval of cefazimidine sodium this time, which is of far-reaching significance for the research and development of antibiotic drugs in China, and is a gratifying thing In October 2017, the first class new chemical drug, flunorpiperazil and its tablets, which were approved by Jiangsu Kangyuan - flunorpiperazil, were accepted in April and lasted for 6 months The drug is a new Alzheimer's disease class 1 drug, which was jointly developed by the drug design and discovery research center of Shanghai Institute of medicine, Chinese Academy of Sciences, and the researchers of chemical synthesis and pharmacology Prior to the transfer of technology to Jiangsu Kangyuan Yichang humanwell morphine-6-glucoside acid in October 2017, the first class of new chemical medicine of Yichang humanwell morphine-6-glucoside acid (hereinafter referred to as "M6G") and its two injections were approved for clinical application and accepted from March, lasting for 7 months M6G is an active metabolite of morphine in vivo, which belongs to opioid analgesics and can be used in the treatment of moderate to severe pain Compared with morphine preparation, M6G injection has stronger analgesic activity, longer maintenance time, better tolerance, and can effectively improve some adverse reactions M6G is not on the market at home and abroad Jiangsu Hengrui is conducting phase I clinical trial of the drug The global total sales of the similar product morphine preparation of M6G from March 2016 to March 2017 is about US $1 billion Nanjing Zhongrui tirirafon and its injection, a class 1 new chemical drug of Nanjing Zhongrui, obtained clinical approval in July 2017 It has been accepted since February and lasted for 5 months Terira was used for stroke emergency The nervous system is a large field of treatment, which is widely used Professionals say that the efficacy of tirirafon is twice that of edaravone, and it is predicted that the future sales potential of tirirafon will reach 2 billion Nearly 5 million stroke patients will be added every year (with the aging growth) The annual sales of edaravone is more than 4 billion, which has become the first choice of routine emergency medicine for stroke patients With double advantage of efficacy, tyralavon will replace a large part of edaravone market, or at least the high-end top three hospitals In July 2017, Dalian Wanchun punabulin applied for the imported punabulin concentrated solution medicine for injection, class 1, which was approved by the clinic It has been accepted since February and lasted for 5 months According to Wanchun group, panabrin is a new small molecule intravenous drug with immune enhancing effect and anticancer activity, which can be administered after one hour of chemotherapy It is expected to become an alternative to the existing G-CSF drug for neutropenia, effectively reduce the incidence of bone pain, greatly improve the safety, and have the advantages of convenient use In July 2017, pirocinib and its three tablets, a new chemical class 1 drug of Jilin Sihuan pharmaceutical, were approved clinically It has been accepted since January and lasted for six months Pirocinib is a highly selective CDK4 / 6 (cell cycle dependent kinase 4 and 6) inhibitor, which is intended for the treatment of breast cancer, malignant brain cancer and other solid tumors As a new structure of CDK4 / 6 inhibitor, pirocinib has significant efficacy and is expected to be a specific drug for brain cancer In addition, because of the novel target mechanism of CDK4 / 6, pirocinib can be used with multiple target drugs, which has important clinical significance and broad market prospects Yuekang Pharmaceutical Co., Ltd - umoselta bisulfate, a new chemical drug of category 1.1 of yuekang Pharmaceutical Co., Ltd (foreign name: mesupron; domestic Code: lh011), and two capsules were approved for clinical application in June 2017 It has been accepted since February 2016 and lasted for 16 months According to the information released on October 20, 2017, the FDA approved mesupron as an orphan drug for adjuvant treatment of pancreatic cancer Mesupron is an intellectual property, class 1, oral protease inhibitor, which inhibits tumor invasion and metastasis through a variety of potential mechanisms In the United States, pancreatic cancer is the third deadliest cancer, a cancer disease with huge medical needs It is estimated that the global sales volume of pancreatic cancer drugs in 2017 is about US $1.6 billion In June 2017, naprotinib dimethylbenzenesulfonate and its tablets, a new chemical drug of class 1 of Shenzhen Haiwang Pharmaceutical Research Institute Co., Ltd., were approved for clinical use, and entered CDE in December 2016, lasting for 6 months This drug is a targeted anti-nsclc drug Compared with the same type of foreign drug gilotif, it has a significant lung distribution in vivo Compared with afatinib at the same dose, it has a stronger tumor inhibition ability and a lower risk of potential adverse cardiac reactions Compared with the first generation of drugs, naprotinib mesylate has a stronger inhibition ability on related targets, but it does not Easy to produce drug resistance According to Haiwang biology, the same target drug is gilotrif of Germany's bringer Ingelheim company, with global sales of $231 million in 2015 At present, there is no same product on the market in China, and Haiwang biological p-toluenesulfonate naprotinib and tablets have independent intellectual property rights Zaiding pharmaceutical - alanine britannib, a new chemical drug of zaiding Pharmaceutical (Shanghai) Co., Ltd., and its tablets were approved for clinical application in March 2017 It has been accepted since July 2016 and lasted for 8 months Alanine brunib is a small molecule tyrosine kinase inhibitor of vascular endothelial growth factor receptor VEGFR and fibroblast growth factor receptor FGFR Brinib is a kind of vascular inhibitor Its target is partially overlapped with solafeni, lovatinib, regofinib, etc However, due to its different mechanism of action, its efficacy and side effects are different For domestic patients with liver cancer, it will be a new choice of targeted treatment if it is listed in China The new chemical 1.1 drug and its two capsules of Shandong Henri - pirpiracyclin were approved for clinical application in March 2017, and entered CDE in September 2015, lasting for 18 months Kbp-7072 was once used for multi drug resistant bacterial infection Before that, it was approved by FDA for clinical trials, and was approved for the first time in China Zhejiang Jianfeng - the first global patent for a new chemical drug, podophyllotoxin and its injection, was approved by Zhejiang Jianfeng Pharmaceutical Co., Ltd in March 2017 It has been accepted for 7 months since August 2016 DPT (deoxypodophyllotoxin) of Jianfeng Pharmaceutical Co., Ltd is the first global patent, which is a new anti-tumor drug According to professionals, at present, taxol and docetaxel rank first and second in the sales volume of anti-tumor drugs in China, with an annual sales volume of more than 3 billion yuan DPT, paclitaxel and docetaxel belong to the same class of drugs, and the mechanism of action is similar DPT has a very good effect on drug-resistant tumor strains, with the advantages of low toxicity (especially the lower cardiotoxicity, hepatotoxicity and myelotoxicity of DPT) Shengshityco phosphate shenggliptin may 2017 shengshityco biomedical technology (Suzhou) Co., Ltd.'s chemical medicine class 1 new drug shenggliptin phosphate and its three tablets were approved for clinical use since October 2016