echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Medical News > Latest Medical News > [exclusive] looking at the application of cardiovascular system drugs in 2017, the first imitation of alisentan and azilsartan, and the import of selexipag and maxitetan are worth looking forward to!

    [exclusive] looking at the application of cardiovascular system drugs in 2017, the first imitation of alisentan and azilsartan, and the import of selexipag and maxitetan are worth looking forward to!

    • Last Update: 2018-02-02
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    Based on the registration and acceptance database of yaozhi.com, from the perspective of pharmacology, we analyzed the application and registration of anti-tumor drugs and diabetes drugs in 2017, and launched the article "overview of the application of anti-tumor drugs in 2017, 2 monoclonal antibodies and 3 TiNi are worth looking forward to!" And "looking at the application of diabetes drugs in 2017, losenapeptide and lilalutide are worth looking forward to Many first generic drugs will be on the market soon!" Next, we will take a look at cardiovascular system drugs, including antihypertensive drugs, heart disease drugs, and drugs acting on renin-angiotension system, to see what are the major areas of concern If you want to know about the field of pharmacology, you can leave a message below, we will launch an article according to the situation! 1、 The application of cardiovascular system drugs in China in the past 10 years can be seen from Figure 1 The overall application trend of cardiovascular system drugs in the past 10 years is the highest in 2013, 966 (calculated according to the acceptance number, the same below) In 2016, it dropped significantly, consistent with the overall trend of drug application, and slightly picked up in 2017 From the drug type curve, we can also see that chemical drugs and traditional Chinese medicine account for the majority of cardiovascular system drugs, biological products and other negligible (Figure 1 declaration of cardiovascular system drugs in 2008-2017) II Declaration of cardiovascular system drugs in 2017 In 2017, there were 387 declaration records of cardiovascular system drugs, including 5 new drugs, 30 generic drugs and 31 imports (see Figure 2 for details) It can also be seen from this that in the cardiovascular field, the research and development of the whole new drug is not good, and most of them rely on imitation or import (Fig 2 application types of cardiovascular system drugs in 2017) last year, the only five new drug application records were all clinical application, including breviscapine orally disintegrating tablets, ligustrazine hydrochloride for injection, butylphthalide injection and nimergolin sustained-release tablets At present, butylphthalide injection has not passed clinical application (see Fig 3 for details) Among the remaining three varieties, ligustrazine hydrochloride for injection declared by Pingguang pharmaceutical should be the most concerned by the market According to the official micro report of Pingguang pharmaceutical, the company started the project of "development of new indications for pulmonary hypertension of Ligustrazine Hydrochloride for injection" as early as 2016, and the pre clinical research has achieved surprising results (Figure 3: application records of five new drugs for cardiovascular system drugs in 2017) next, we will analyze the subdivisions According to the drug intelligence registration and acceptance database, cardiovascular system drugs include nine subdivisions, among which there are more application records of drugs acting on renin-angiotension system, heart disease treatment drugs, lipid regulators and antihypertensive drugs (see Figure 4 for details) Due to the limited space of this article, we focus on the analysis of antihypertensive drugs, heart disease drugs and drugs acting on renin-angiotension system (Figure 4: proportion of cardiovascular system drug related subdivisions) 1 There are 38 application records of antihypertensives and antihypertensives, including 2 traditional Chinese medicines and 36 chemicals According to the application types, there are 5 imitations, 15 imports, and all other supplementary applications (see Figure 5 for details) (Figure 5 application types of antihypertensive drugs in 2017) 1.1 the five application records of the first domestic generic alisentan to be listed are all reported by alisentan, Zhejiang Huahai, Zhengda Tianqing, Lianyungang Runzhong pharmaceutical and Jiangsu Haosen Among them, Jiangsu Haosen has applied for the priority review of class 3 and class 4 of alisentan tablets (see Figure 6 for details) (Figure 6 application records of 5 generic drugs of antihypertensive drugs in 2017) Allison tazidime is a drug for treating pulmonary hypertension Currently, only GlaxoSmithKline has obtained import approval, and no domestic enterprise has obtained production approval In terms of the market situation of imported drugs, the drug has been included in the 2017 medical insurance catalogue of Ningxia and Tibet, and has won the bid in 15 regions The average bidding price of 5 mg * 30 anlishentan tablet reached 9709.47 yuan in 2014 In 2016, the price dropped rapidly, only 2669.75 yuan, and rose to 3763.38 yuan in 2017 Therefore, from the perspective of market demand and price, domestic enterprises will compete to copy In terms of the application over the years, in addition to the four enterprises produced in the 2017 annual report, 12 enterprises / institutions, including Wuhan Renfu, Tianjin HongRi, Sichuan meidakang Huakang, have reported production records However, at present, only Jiangsu Haosen declared an lisentan to enter the priority approval 1.2 there will be 5 declaration records of imported drugs for the treatment of pulmonary hypertension, including naftopidil tablets, reserpine 2 declaration production drugs and three clinical drugs, i.e maxitan dispersible tablets, selexipag tablets and maxitan tablets It is worth mentioning that the selexipag tablet, which was applied for clinical application by actalon, was approved by the FDA on December 21, 2015 for the treatment of adult pulmonary hypertension, and currently there is no listing information in China In addition to selexipag tablets, the therapeutic drugs for pulmonary hypertension declared and imported by actalon include maxittentan tablets, bosentan and macitentan (macitentan) The first two have been approved for import and macitentan has also been approved for clinical use 2 There are 89 application records of heart disease treatment drugs, including 11 Traditional Chinese medicine and 78 chemical drugs According to the application types, they include 9 generic drugs, 6 imported drugs and 2 new drugs (see Figure 7 for details) New drugs (butylphthalide injection and breviscapine orally disintegrating tablets) are mentioned above and will not be described here (Figure 7 application types of heart disease drugs in 2017) 2.1 nine application records of two generic drugs to be launched are reported production, including trimetazidine hydrochloride sustained-release tablets, sodium butylphthalide chloride injection, butylphthalide, milrinone and alprostadil (see Figure 8 for details) Milrinone, which was declared by huluwa in Hainan, and qianliedier, which was declared by Kailin in Chongqing, failed to pass the examination and approval, while the other three drugs are under examination and approval According to the domestic drug database of pharmaceutical intelligence, at present, only one enterprise of trimetazidine hydrochloride sustained-release tablets and one enterprise of butylphthalide have obtained the production approval, which are Servier (Tianjin) pharmaceutical and petrochemicals respectively The market pressure is relatively small (Figure 8: application records of 9 generic drugs for heart disease treatment in 2017) 2.2 six clinical application records of shakubaquvalsartan sodium tablets declared by hausen include 4 varieties of trimetazidine hydrochloride sustained release capsule, levosimendan injection, amiodarone hydrochloride and shakubaquvalsartan sodium tablets The first two are for clinical application and the last two for production (see figure 9 for details) Among them, sakubatrevalsartan sodium tablet declared by Novartis is the priority for review and approval, and was approved for import on September 26, 2017 At present, no domestic manufacturer has obtained the production approval According to the application information over the years, at present, there is only class 3.1 information of new drugs and chemicals declared by Jiangsu Haosen, and it has been approved for clinical use on October 11, 2016 (Figure 9 declaration records of 6 imported drugs for heart disease treatment in 2017) 3 91 declaration records of drugs acting on renin-angiotension system acting on renin-angiotension system are all chemicals, including 7 generic drugs and 7 imported drugs (see Figure 10 for details) (Figure 10 declaration types of drugs acting on renin-angiotension system in 2017) 3.1 the first generic azilsartan is worth looking forward to Seven generic drugs are all reported for production, including olmesartan ester tablet, valsartan hydrochlorothiazide tablet, irbesartan hydrochlorothiazide tablet and azilsartan (see Figure 11 for details) Valsartan hydrochlorothiazide tablets declared by Zhejiang Huahai Pharmaceutical Co., Ltd., azilsartan tablets declared by Zhejiang Tianyu and Jiangsu Hengrui have been included in the priority review and approval Among them, azilsartan is favored in the international market, and there is no listing information in China, so it is worth looking forward to in the future (FIG 11 application records of 7 generic drugs acting on renin-angiotension system in 2017) 3.2lcz696 tablets are subject to patent disturbance The application records of 7 imported drugs to be imitated in China are all clinical application, including lcz696 tablets, olmesartan tersulastatin calcium tablets and perindopril indapamide amlodipine tablets (see Fig 12 for details) (Figure 12 declaration records of 7 imported drugs acting on renin-angiotension system in 2017) Among them, lcz696 tablet is Novartis' 10 billion class heavyweight drug On January 3, the Patent Reexamination Board of the State Intellectual Property Office issued the patent examination result of Novartis' heavyweight drug entresto (sakubaququvalsartan sodium tablet, lcz696): the invention and creation of pharmaceutical composition containing valsartan and NEP inhibitors by the patentee Novartis Co., Ltd "declared all patents invalid" At present, many companies have applied for lcz696 generic drugs, including Fosun Pharmaceutical, Hengrui pharmaceutical, xinlitai and China Bio pharmaceutical and other listed companies.
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.