echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Medical News > Latest Medical News > 226 drug approvals were written off, and pharmaceutical companies cleaned up nearly two-thirds of the approvals at once!

    226 drug approvals were written off, and pharmaceutical companies cleaned up nearly two-thirds of the approvals at once!

    • Last Update: 2021-03-23
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    32 31,《226(2021 27)》。,18,12。,90。,2/3。、,。
     
    “”
     
    226,。,、、。
     
    ,pharmnet.
    com.
    cn/news/yyzb/" target="_blank">,,1000.
    58,6,1.
    4/。
     
    、“”,6。,,,201924。,20182.
    67,8.
    87%;20191.
    27,(100mg)98.
    43%,1.
    57%。
     
    ,《-》,。,。23266494,80.
    0%。、、。、、。,。
     
      ,。、、、,。
     
      “”
     
      ,。,、、、12。
     
      ,。,241,、、、。,,16.
    6。
     
      Under the three major policy pressures of escalation of restriction orders, consistency evaluation, and restrictions on the proportion of drugs, the antibacterial drug market has reached the key point of seizing market share.
    Especially with the in-depth progress of the consistency evaluation work, the antibiotics market has entered a window period for restructuring the market structure, and the survival of the fittest has become inevitable.
     
      Multinational pharmaceutical companies have also been hit.
    Cefradine Capsule (0.
    25g) under Xinhua Pharmaceutical is the first generic drug to be reviewed.
    Analysts predict that the overcoming cefradine capsule, which had a low market share, will overtake the car in a bend.
    Among them, compared with the shrinking injections and tablets year by year, capsules have firmly occupied an absolute dominant position in recent years, occupying more than 95% of the market share.
    Although from the 2012-2018 sales data of sample hospitals , cefradine capsules showed a downward trend like other cephalosporins, the market decline of this type of product was relatively small compared to the overall situation.
     
      In addition, the impact of centralized procurement is being reflected in the operational level of the enterprise.
    In the fiercely competitive field of captopril tablets, 8 pharmaceutical companies won the bids in the centralized procurement.
    The highest effective price for 12.
    5mg is 0.
    2 yuan/tablet, and the highest effective price for 25mg is 0.
    34 yuan/tablet.
    Shanxi Zhendong Pharmaceutical's 25mg captopril tablets won the bid, the winning price was 0.
    0218 yuan/tablet, and they were supplied to the four provinces of Shanxi, Jiangxi, Henan and Hainan.
     
      You should know that in the variety of Captopril, the eight bid-winning companies have basically achieved ultra-low prices-the quotations are basically between 1 and 3 cents.
    From the perspective of the competitive landscape of manufacturers, in 2019, the terminal captopril tablets of China's public medical institutions, Changzhou Pharmaceutical, accounted for 54.
    97% of the market share, and Bristol-Myers Squibb accounted for 9.
    66%.
    However, the pattern will change after the centralized procurement.
    It can be judged that the effective utilization rate of approval documents in the past three years will continue to increase, and there will be more cancellation of approval documents.
      Medical Network News, March 2 On March 1, the official website of the State Food and Drug Administration issued the "Announcement on the Cancellation of 226 Drug Registration Certificates including Bromelain Enteric-coated Tablets (2021 No.
    27).
    " What has attracted the industry’s attention is that 18 companies have voluntarily applied for cancellation of registration certificates, including 12 products of different dosage forms from Sino-US Shanghai Squibb Pharmaceutical Co.
    , Ltd.
    To the shock of the industry, Jiangsu Huanghe Pharmaceutical Co.
    , Ltd.
    cancelled 90 drug product regulatory approvals at one time.
    According to public information, the number of cancelled approvals accounts for about 2/3 of the total number of approvals.
    With the combined efforts of the policies of limited resistance, consistency evaluation and volume procurement, the application of some drugs to exit the market has accelerated.
     
      Antibiotics "exit" substantially
     
      Judging from the 226 drugs cancelled, antibiotic products are more concentrated.
    Taking the more noticeable Jiangsu Huanghe Pharmaceutical Industry this time around, all of its cancellations are hot products such as azithromycin dispersible tablets, aspirin enteric-coated tablets, and ibuprofen capsules, which are in huge clinical use.
     
      Take aspirin enteric-coated tablets as an example.
    Among the enterprises pharmnet.
    com.
    cn/news/yyzb/" target="_blank">purchasing in quantity in Shandong Province , Jinan Yongning's aspirin enteric-coated tablets are the cheapest.
    The price of 100 tablets is only 0.
    58 yuan, which is less than 6% of the single-tablet price, which is the third place.
    Approved the record of 1.
    4 points per piece of Chongqing Kericatopril.
     
      While continuously developing new indications and "new use of old drugs", the direct bargaining of purchases in quantities to 6 cents per tablet has attracted aspirin's attention.
    According to data from Minai.
    com, in recent years, the sales of aspirin in the terminals of public medical institutions in China have continued to rise, reaching 2.
    4 billion yuan in 2019.
    Among them, the market for aspirin enteric-coated tablets in public hospitals in key provinces and cities in 2018 was 267 million yuan, a year-on-year increase of 8.
    87%; the market for aspirin enteric-coated tablets in the first half of 2019 was 127 million yuan, of which the original drug Bayer aspirin enteric-coated tablets (100mg) Occupying 98.
    43% of the market share, domestic drugs only accounted for 1.
    57%.
     
      Recently, "The Lancet-Infectious Diseases" published an important paper in collaboration with relevant teams from the Peking University School of Public Health and the Seventh Medical Center of the PLA General Hospital to evaluate the rationality of antibiotic prescriptions for outpatients in China's secondary and tertiary hospitals.
    Among all the sample antibiotic prescriptions, more than half are unreasonable.
    The research covered prescriptions involved 23,266,494 doses of antibiotics, of which broad-spectrum antibiotics accounted for 80.
    0% of the total.
    Including second to fourth generation cephalosporins, fluoroquinolones, macrolides, etc.
    The top four antibiotics with the most prescriptions are third-generation cephalosporins, second-generation cephalosporins, macrolides and fluoroquinolones.
    From this perspective, the use of antibiotics will shrink further.
     
      In other words, many antibiotic products will exit the market.
    This time, the same batch of companies that applied for cancellation of approval documents include Fujian Dawnrays Pharmaceuticals, Guangshengtang Pharmaceuticals, Zhejiang Jinliyuan Pharmaceuticals, Guizhou Beite Pharmaceuticals and other companies.
    Many companies have chosen to cancel the registration certificates of relevant antibiotic drugs.
     
      Foreign companies are also clearing "inventory"
     
      Among the drugs cancelled this time , Bristol-Myers Squibb is the only representative of foreign companies.
    The list shows that 12 of its acetaminophen chewable tablets, captopril tablets, pravastatin sodium tablets, and cefradine capsules were cancelled upon application.
     
      For example, cefradine capsules also face a similar competitive landscape.
    After inquiry, there are currently 241 cefradine capsules in the State Food and Drug Administration, and domestic listed companies include Xinhua Pharmaceutical, Sino-US Shanghai Squibb Pharmaceuticals, Qilu Pharmaceuticals, and Hunan Kelun Pharmaceuticals.
    It is reported that cefradine capsules are the largest oral cephalosporins produced and sold in the domestic market, with a domestic market capacity of approximately 1.
    66 billion yuan.
     
      Under the three major policy pressures of escalation of restriction orders, consistency evaluation, and restrictions on the proportion of drugs, the antibacterial drug market has reached the key point of seizing market share.
    Especially with the in-depth progress of the consistency evaluation work, the antibiotics market has entered a window period for restructuring the market structure, and the survival of the fittest has become inevitable.
     
      Multinational pharmaceutical companies have also been hit.
    Cefradine Capsule (0.
    25g) under Xinhua Pharmaceutical is the first generic drug to be reviewed.
    Analysts predict that the overcoming cefradine capsule, which had a low market share, will overtake the car in a bend.
    Among them, compared with the shrinking injections and tablets year by year, capsules have firmly occupied an absolute dominant position in recent years, occupying more than 95% of the market share.
    Although from the 2012-2018 sales data of sample hospitals , cefradine capsules showed a downward trend like other cephalosporins, the market decline of this type of product was relatively small compared to the overall situation.
     
      In addition, the impact of centralized procurement is being reflected in the operational level of the enterprise.
    In the fiercely competitive field of captopril tablets, 8 pharmaceutical companies won the bids in the centralized procurement.
    The highest effective price for 12.
    5mg is 0.
    2 yuan/tablet, and the highest effective price for 25mg is 0.
    34 yuan/tablet.
    Shanxi Zhendong Pharmaceutical's 25mg captopril tablets won the bid, the winning price was 0.
    0218 yuan/tablet, and they were supplied to the four provinces of Shanxi, Jiangxi, Henan and Hainan.
     
      You should know that in the variety of Captopril, the eight bid-winning companies have basically achieved ultra-low prices-the quotations are basically between 1 and 3 cents.
    From the perspective of the competitive landscape of manufacturers, in 2019, the terminal captopril tablets of China's public medical institutions, Changzhou Pharmaceutical, accounted for 54.
    97% of the market share, and Bristol-Myers Squibb accounted for 9.
    66%.
    However, the pattern will change after the centralized procurement.
    It can be judged that the effective utilization rate of approval documents in the past three years will continue to increase, and there will be more cancellation of approval documents.
      Medical Network News, March 2 On March 1, the official website of the State Food and Drug Administration issued the "Announcement on the Cancellation of 226 Drug Registration Certificates including Bromelain Enteric-coated Tablets (2021 No.
    27).
    " What has attracted the industry’s attention is that 18 companies have voluntarily applied for cancellation of registration certificates, including 12 products of different dosage forms from Sino-US Shanghai Squibb Pharmaceutical Co.
    , Ltd.
    To the shock of the industry, Jiangsu Huanghe Pharmaceutical Co.
    , Ltd.
    cancelled 90 drug product regulatory approvals at one time.
    According to public information, the number of cancelled approvals accounts for about 2/3 of the total number of approvals.
    With the combined efforts of the policies of limited resistance, consistency evaluation and volume procurement, the application of some drugs to exit the market has accelerated.
     
      Antibiotics "exit" substantially
      Antibiotics "exit" substantially
     
      Judging from the 226 drugs cancelled, antibiotic products are more concentrated.
    Taking the more noticeable Jiangsu Huanghe Pharmaceutical Industry this time around, all of its cancellations are hot products such as azithromycin dispersible tablets, aspirin enteric-coated tablets, and ibuprofen capsules, which are in huge clinical use.
     
      Take aspirin enteric-coated tablets as an example.
    Among the enterprises pharmnet.
    com.
    cn/news/yyzb/" target="_blank">purchasing in quantity in Shandong Province , Jinan Yongning's aspirin enteric-coated tablets are the cheapest.
    The price of 100 tablets is only 0.
    58 yuan, which is less than 6% of the single-tablet price, which is the third place.
    Approved the record of 1.
    4 points per piece of Chongqing Kericatopril.
    pharmnet.
    com.
    cn/news/yyzb/" target="_blank">Procurementpharmnet.
    com.
    cn/news/yyzb/" target="_blank"> Procurement Procurement
     
      While continuously developing new indications and "new use of old drugs", the direct bargaining of purchases in quantities to 6 cents per tablet has attracted aspirin's attention.
    According to data from Minai.
    com, in recent years, the sales of aspirin in the terminals of public medical institutions in China have continued to rise, reaching 2.
    4 billion yuan in 2019.
    Among them, the market for aspirin enteric-coated tablets in public hospitals in key provinces and cities in 2018 was 267 million yuan, a year-on-year increase of 8.
    87%; the market for aspirin enteric-coated tablets in the first half of 2019 was 127 million yuan, of which the original drug Bayer aspirin enteric-coated tablets (100mg) Occupying 98.
    43% of the market share, domestic drugs only accounted for 1.
    57%.
     
      Recently, "The Lancet-Infectious Diseases" published an important paper in collaboration with relevant teams from the Peking University School of Public Health and the Seventh Medical Center of the PLA General Hospital to evaluate the rationality of antibiotic prescriptions for outpatients in China's secondary and tertiary hospitals.
    Among all the sample antibiotic prescriptions, more than half are unreasonable.
    The research covered prescriptions involved 23,266,494 doses of antibiotics, of which broad-spectrum antibiotics accounted for 80.
    0% of the total.
    Including second to fourth generation cephalosporins, fluoroquinolones, macrolides, etc.
    The top four antibiotics with the most prescriptions are third-generation cephalosporins, second-generation cephalosporins, macrolides and fluoroquinolones.
    From this perspective, the use of antibiotics will shrink further.
     
      In other words, many antibiotic products will exit the market.
    This time, the same batch of companies that applied for cancellation of approval documents include Fujian Dawnrays Pharmaceuticals, Guangshengtang Pharmaceuticals, Zhejiang Jinliyuan Pharmaceuticals, Guizhou Beite Pharmaceuticals and other companies.
    Many companies have chosen to cancel the registration certificates of relevant antibiotic drugs.
     
      Foreign companies are also clearing "inventory"
      Foreign companies are also clearing "inventory"
     
      Among the drugs cancelled this time , Bristol-Myers Squibb is the only representative of foreign companies.
    The list shows that 12 of its acetaminophen chewable tablets, captopril tablets, pravastatin sodium tablets, and cefradine capsules were cancelled upon application.
    Medicine, medicine, medicine
     
      For example, cefradine capsules also face a similar competitive landscape.
    After inquiry, there are currently 241 cefradine capsules in the State Food and Drug Administration, and domestic listed companies include Xinhua Pharmaceutical, Sino-US Shanghai Squibb Pharmaceuticals, Qilu Pharmaceuticals, and Hunan Kelun Pharmaceuticals.
    It is reported that cefradine capsules are the largest oral cephalosporins produced and sold in the domestic market, with a domestic market capacity of approximately 1.
    66 billion yuan.
    Enterprise business enterprise
     
      Under the three major policy pressures of escalation of restriction orders, consistency evaluation, and restrictions on the proportion of drugs, the antibacterial drug market has reached the key point of seizing market share.
    Especially with the in-depth progress of the consistency evaluation work, the antibiotics market has entered a window period for restructuring the market structure, and the survival of the fittest has become inevitable.
     
      Multinational pharmaceutical companies have also been hit.
    Cefradine Capsule (0.
    25g) under Xinhua Pharmaceutical is the first generic drug to be reviewed.
    Analysts predict that the overcoming cefradine capsule, which had a low market share, will overtake the car in a bend.
    Among them, compared with the shrinking injections and tablets year by year, capsules have firmly occupied an absolute dominant position in recent years, occupying more than 95% of the market share.
    Although from the 2012-2018 sales data of sample hospitals , cefradine capsules showed a downward trend like other cephalosporins, the market decline of this type of product was relatively small compared to the overall situation.
    Hospital hospital hospital
     
      In addition, the impact of centralized procurement is being reflected in the operational level of the enterprise.
    In the fiercely competitive field of captopril tablets, 8 pharmaceutical companies won the bids in the centralized procurement.
    The highest effective price for 12.
    5mg is 0.
    2 yuan/tablet, and the highest effective price for 25mg is 0.
    34 yuan/tablet.
    Shanxi Zhendong Pharmaceutical's 25mg captopril tablets won the bid, the winning price was 0.
    0218 yuan/tablet, and they were supplied to the four provinces of Shanxi, Jiangxi, Henan and Hainan.
     
      You should know that in the variety of Captopril, the eight bid-winning companies have basically achieved ultra-low prices-the quotations are basically between 1 and 3 cents.
    From the perspective of the competitive landscape of manufacturers, in 2019, the terminal captopril tablets of China's public medical institutions, Changzhou Pharmaceutical, accounted for 54.
    97% of the market share, and Bristol-Myers Squibb accounted for 9.
    66%.
    However, the pattern will change after the centralized procurement.
    It can be judged that the effective utilization rate of approval documents in the past three years will continue to increase, and there will be more cancellation of approval documents.
    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.