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    Home > Medical News > Medical World News > Cardiovascular TOP10 major transfusion, 2 new drugs, 27 first imitations

    Cardiovascular TOP10 major transfusion, 2 new drugs, 27 first imitations

    • Last Update: 2021-07-17
    • Source: Internet
    • Author: User
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    Medical Network News, March 16th.
    Starting in March, Hengrui, the "R&D brother", has ushered in good news in the field of cardiovascular system chemicals.
    It has won the first domestic imitation of tolvaptan, a blockbuster product with global sales of over $1 billion + The first review
    .
    With the continuous improvement of China's drug review and approval system, new domestic products that have been approved for marketing have made a qualitative leap
    .
    In the past few years, in public hospitals in key provinces and cities, has the current situation of the cardiovascular system drug market that has been dominated by the original research drug? What are the major new products worth looking forward to in 2021?
    Mighty! CSPC's innovative drug was first closed to the king
    .
    According to data from the Minet.
    com , in the cardiovascular system drug market of terminal chemical drugs in public hospitals of key provinces and cities , the TOP1 varieties from 2013 to 2016 were all occupied by Alprostadil.
    The 2017 edition of the National Medical Insurance Catalogue has been adjusted.
    After the restricted use of Alprostadil, the sales of this variety began to decline.
    In 2019, this variety was included in the "First Batch of National Key Monitoring and Rational Use Drugs List", and was subsequently removed from the 2019 National Medical Insurance List.
    The first three quarters of 2020 The ranking has fallen out of the top ten
    .
    In 2017-2019, atorvastatin became the top spot in the list.
    However, in the first batch of countries (4+7 pilot at the end of 2018, alliance expansion in September 2019), atorvastatin " "Diving" price cuts have led to a reduction in the overall sales scale, and the ranking in the first three quarters of 2020 has dropped to second place
    .
    Figure 1: The growth rate of sales of butylphthalide-related products.
    Source: The terminal competition pattern of public hospitals in key provinces and cities of Meinenet.
    CSPC’s butylphthalide has moved forward from the tenth place in 2013 and squeezed into the TOP5 in 2018.
    The first three seasons of 2020 finally reached the top and crowned the king
    .
    This product is an innovative drug for the treatment of acute ischemic stroke.
    Butylphthalide soft capsules were the first to be marketed in 2005 and entered the National Medical Insurance List in 2009; Butylphthalide sodium chloride injection was approved for marketing in 2010, and in 2017 Entering the national medical insurance catalog, the sales growth rate of public hospitals in key provinces and cities from 2018 to 2019 is as high as 39.
    97% and 44.
    81%.
    In 2020, under the influence of the epidemic, the frequency of patient visits to the hospital has been reduced, and the sales of the entire category in the first three quarters Against the background of a 23.
    41% decline in scale, the power of butyl phthalide sodium chloride injection "God Assist" has not diminished, and the growth rate has remained above 10%
    .
    At the end of 2020, the national medical insurance negotiations tried for the first time to negotiate a price reduction for the drugs in the catalog.
    The medical insurance payment standards for butylphthalide soft capsules and butylphthalide sodium chloride injection were further reduced by 55.
    6% and 51.
    3%, but the decline did not exceed that of the brokerage firm.
    Previous market expectations
    .
    CSPC said that the price reduction will bring revenue pressure on related products for a certain period of time, but it will also increase the affordability of products, stimulate market demand for products, and drive sales growth; in addition, the medical insurance negotiations will accelerate after the completion of the medical insurance negotiations.
    The product enters the hospital and resolves the risk of being included in the centralized procurement
    .
    At the same time, CSPC is also continuously exploring new therapeutic areas for butylphthalide.
    It is reported that more than 100 research projects are underway
    .

     The TOP10 varieties have undergone major exchanges, and the performance of statins is different.

    Table 1: The TOP10 varieties of cardiovascular system chemicals in the first three seasons of 2020.
    Source: The terminal competition pattern of public hospitals in key provinces and cities of Meinenet.
    Valsartan ranked 11th and 10th in 2019.
    Five places of pitavastatin calcium, seventeenth place norepinephrine and eighteenth place nicorandil successfully squeezed into the TOP10 list in the first three seasons of 2020
    .

      Figure 2: Sales growth rate of nicorandil-related products.
    Source: Terminal competition pattern of public hospitals in key provinces and cities of Minnet.
    Nicorandil can expand all coronary arteries.
    It is suitable for angina pectoris with coronary artery spasm and coronary arteries.
    Patients with microvascular disease
    .
    At present, the related products of this variety on the market include tablets and injections.
    After the tablets entered the National Medical Insurance Catalogue in 2017, sales rose sharply.
    The sales growth rate from 2018 to 2019 was 11.
    83% and 38.
    71%.
    The first three quarters of 2020 will remain unchanged.
    About 25%; for injections, only Beijing Sihuan Kebao Pharmaceutical has obtained approval, adding catalogues for medical insurance in 12 provinces including Jiangsu and Yunnan.
    The sales growth rate from 2018 to 2019 is as high as 309% and 118%.
    The first three quarters of 2020 are also Reached 16.
    49%
    .
    With the aging of the population, the incidence of coronary heart disease is getting higher and higher, and the market potential of this species can be expected
    .
    Among the TOP10 varieties, three statins are on the list.
    Among them, pitavastatin entered the top ten for the first time, while the sales growth of atorvastatin and rosuvastatin fell by more than 50% in the first three quarters of 2020
    .
    Pitavastatin calcium is a potential "super statin".
    The low-dose LDL-C lowering effect is similar to ten times the dose of atorvastatin, and it is more effective for patients with diabetes and hypercholesterolemia
    .
    After this product entered the medical insurance catalog in 2017, sales began to increase.
    The growth rates from 2018 to 2019 were 35.
    17% and 48.
    98%, respectively, and the first three quarters of 2020 also exceeded 14%
    .
    This variety has been included in the third batch of national centralized procurement.
    The market is dominated by domestic pharmaceutical companies, and the next competition will be between domestic pharmaceutical companies
    .
    Atorvastatin and Rosuvastatin were the first batch of nationally collected varieties
    .
    In the 4+7 pilot collection, the price of atorvastatin calcium tablets dropped by 85.
    5%.
    During the alliance expansion stage, the lowest winning bid price (Qilu) was reduced by 78.
    18% compared with the 4+7 bid price; Rosuvastatin 4+7 pilot At the time of centralized procurement, the price was reduced by 81.
    55%.
    During the expansion stage of the alliance, the lowest winning bid price (Hisun) was 74.
    31% lower than the 4+7 winning price.
    .
    .
    Then various provinces successively carried out price linkage, and the overall sales scale of the two major varieties exceeded 1 billion.
    Straight plug
    .
    Figure 3: Pfizer's sales growth rate and market share of atorvastatin Source: Minet.
    com's key provinces and cities public hospitals terminal competition pattern Figure 4: AstraZeneca's sales growth rate and market share of rosuvastatin Source: The two major products in the terminal competition pattern of public hospitals in key provinces and cities of Minai.
    com were included in the first batch of national centralized procurement, and the attitude of original research pharmaceutical companies has attracted market attention
    .
    From the data point of view, the sales growth of Pfizer and AstraZeneca has fallen sharply, but the market share is still rising and still leading the market.
    Why is this? Some people in the industry believe that the combined purchase volume of the first batch of national procurement (4+7 pilot, alliance expansion) corresponds to a small market size, about 1/5 of the overall market, and these two original research products enter the country For many years in the market, it has a prominent reputation among doctors and patients, and its recognition is very high; secondly, the original research drug company has been deeply involved in the domestic market for many years, and its market promotion is also worthy of research by domestic pharmaceutical companies: Pfizer integrates market resources inside and outside the hospital to conduct specialty The construction of the doctor group has stimulated both the doctor group and the patient group.
    Lipitor still maintains a positive growth in the physical pharmacy terminals in Chinese cities ; similarly, AstraZeneca is also very good at "patient-centered" thinking, which is gradually increasing Pay attention to the domestic grassroots market and constantly look for new opportunities
    .

      Imported new drugs, the first domestic imitation, the first to be reviewed.
    .
    .
    Accelerating the market reshuffle
    Table 2: New cardiovascular drugs approved for import/marketing since 2021 (statistics based on the date of approval) Source: Meinenet MED2.
    0 Chinese Medicines Review database In January 2021, Takeda's new class 1 drug measartan potassium tablets was approved for import by NMPA for the treatment of essential hypertension
    .
    Measartan potassium tablets are an oral prodrug, which can be rapidly metabolized by esterases in the body into the active ingredient Azilsartan during the absorption process.
    Azilsartan has a significant effect on lowering blood pressure
    .
    Measartan potassium tablets were first approved by the FDA in 2011 and are currently on the market in more than 15 countries around the world, including the United States, Canada, France, and the United Kingdom.

    .
    On March 9, 2021, Hengrui issued an announcement stating that the company's application for the listing of 4 types of imitation tolvaptan tablets was approved for production and deemed to have been reviewed
    .
    Tolvaptan is a selective and competitive vasopressin V2 receptor antagonist, suitable for the treatment of clinically obvious hypervolemic and normal volume hyponatremia, including those with heart failure, liver cirrhosis and Patients with syndrome of abnormal secretion of antidiuretic hormone; used for loop diuretics and other diuretics to treat body fluid retention caused by heart failure where the effect of other diuretics is unsatisfactory
    .
    The original research product was developed by Otsuka Pharmaceutical and was first approved by the FDA in 2009.
    Now it has grown into a large variety with global sales exceeding $1 billion; the original research product entered the Chinese market in 2011 and entered the national medical insurance catalogue through negotiations in 2017.
    The amount has skyrocketed, and the terminal sales of public hospitals in key provinces and cities have increased by 123% and 77% from 2018 to 2019, but the renewal of the contract in the 2020 edition of the national medical insurance negotiations failed
    .
    We will continue to observe how Hengrui will deploy the market after winning the first domestic imitation
    .
    The original research company for amiodarone hydrochloride injection was Sanofi.
    Only two domestic pharmaceutical companies obtained production approvals earlier.
    In January 2021, Shandongbei University High-tech Huatai Pharmaceutical's 4 types of imitations were approved and deemed to have been reviewed.
    The first company to pass the product review
    .
    Table 3: Status of domestic new drugs and first imitation products of cardiovascular drugs that are expected to be approved in 2021 and later Source: Meinenet MED2.
    0 Chinese drug review database Meinenet data shows that the current Beijing Sihuan Kebao Pharmaceutical’s Ato The application for the generic listing of 4 types of Vastatin calcium tablets has entered the approval status, and it is expected to be approved in the near future, adding new forces to the cardiovascular system drug market
    .
    In addition, since 2018, there are still a large number of applications for the marketing of cardiovascular system chemicals under review and approval.
    Among them, the domestic new drugs Heze Maibu Tablets and Butylphthalide Injection have attracted much attention.

    .
    Hezeimibe tablets are used to treat primary hypercholesterolemia, and have the same mechanism of action as the marketed ezetimibe; Nanjing Youke Pharmaceutical’s butylphthalide injection is the first to use Enbipu (butylphthalide chloride).
    Sodium Injection) is the first class 2.
    2 new drug to be listed in the bioequivalence study for the reference drug, which is a potential competitive threat for CSPC
    .
    In terms of impact on the first imitation, amlodipine atorvastatin calcium tablets, metoprolol succinate sustained-release tablets, and sacubitril valsartan sodium tablets are currently under review by more than 5 companies.
    The dispute for the first imitation is quite fierce.
    There is no shortage of domestic giants, and we will wait and see who will win the championship
    .
    In terms of imported new drugs, Bayer's Class 1 new drug Vericiguat tablets have attracted market attention.
    This new drug is the first first-in-class soluble guanylate cyclase (sGC) agonist used to treat patients with worsening chronic heart failure
    .
    It is reported that Bayer submitted marketing applications in the European Union, Japan and the United States in June and July 2020, and submitted a marketing application in China in August of the same year, which means that the new drug is expected to be simultaneously listed in the four major markets of China, the United States, Europe and Japan
    .

      Source: Minet.
    com database, company announcement
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