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    Home > Medical News > Latest Medical News > New cephalosporin drug, cefoperazone sodium and tazobactam sodium (6:1) for injection was approved for marketing

    New cephalosporin drug, cefoperazone sodium and tazobactam sodium (6:1) for injection was approved for marketing

    • Last Update: 2021-05-09
    • Source: Internet
    • Author: User
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    Recently, NMPA has continued to send good news: Cefoperazone Sodium Tazobactam Sodium (6:1) for injection, a new cephalosporin drug, was approved for marketing on April 20.
    The product is registered as a category 1.
    5 new drug, that is, it has not been marketed at home and abroad.
    The sales of new compound preparations, Xiangbei Wellman Pharmaceuticals declared for the market in December 2013, which lasted more than 7 years.
    In recent years, under the influence of the policy of limited delivery and limited resistance, the sales of some heavyweight products in the past have shown a downward trend.
    However, four batches and five rounds of national procurement have included a total of 8 oral cephalosporin products, which shows that their clinical value is still attracting attention.
    Ceftriaxone injections appeared in the fifth batch of national procurement catalogues for the first time.
    Chengdu Better and Peking University Pharmaceutical's ceftriaxone sodium for injection also sprinted for evaluation on April 21.
    Driven by centralized procurement, what will the market welcome? Change?

    In 2021, the first new cephalosporin drug was approved, and this pharmaceutical company stormed the new compound drug

    In 2021, the first new cephalosporin drug was approved, and this pharmaceutical company stormed the new compound drug

    Table 1: New cephalosporin drugs approved for marketing since 2011 (statistics by date of approval)

    Source: Meinenet MED2.
    0 Chinese Drug Evaluation Database

    According to data from Minai.
    com, there are 14 new cephalosporin drugs approved for marketing since 2011.
    Among them, Xiangbei Wellman Pharmaceuticals won the approval for the listing of ceftriaxone sodium and sulbactam sodium for injection in 2011.
    After ten years, we won another 1.
    5 category new drug approval.
    The new drug approved this time is cefoperazone sodium and tazobactam sodium for injection (6:1).

    In terms of anti-infective treatment, both compound cephalosporins and carbapenems belong to broad-spectrum antibacterial drugs, but compound cephalosporins have better performance against current common multi-drug resistant bacteria, and the market potential is promising.

    Table 2: Status of key compound cephalosporin products of Wellman Pharmaceuticals in Xiangbei

    Source: Company's official website, Minet database

    Xiangbei Wellman Pharmaceuticals has now obtained four production approvals for compound cephalosporin products.
    In addition, the company has also received cefoperazone sodium and sulbactam sodium for injection (3:1), ceftriaxone sodium for injection and tazoba.
    New drug clinical approvals for 5 compound preparations of tan sodium, cefotaxime sodium and tazobactam sodium for injection, ceftazidime and sulbactam sodium for injection, and ceftazidime and tazobactam sodium for injection.
    The company is expected to continue to introduce new products to enrich cephalosporin drugs Product line.

    Figure 1: The application status of the compound cephalosporin drugs currently under review

    Source: Meinenet MED2.
    0 Chinese Drug Evaluation Database

    Nanjing Youke Pharmaceutical's cefotaxime sodium and tazobactam sodium (6:1) category 2.
    3 new drug listing application for injection was declared and accepted in 2019.
    It is currently under review and approval, and no similar product has been approved for listing in the domestic market.
    .
    With the continuous application and approval of new domestic drugs, my country's cephalosporin drug market will usher in a major reshuffle.

    The tens of billions market continues to be under pressure, and 80% of injections remain high

    The tens of billions market continues to be under pressure, and 80% of injections remain high

    In recent years, under the influence of the country's continuous strengthening of supervision, my country's antibacterial drug market has shown fatigue.
    As the largest subcategory of systemic antibacterial drugs, the overall sales scale of cephalosporin products has declined more severely.
    In 2019, it will be in public hospitals in key provinces Terminal sales are 12.
    4 billion yuan, and the impact of the epidemic will be superimposed in 2020, and the overall scale will only be about 9.
    5 billion yuan.

    In April 2021, the National Health Commission issued a notice calling for further strengthening of antimicrobial drug management to curb drug resistance, and proposed that the rational use of antimicrobial drugs should be included in hospital review, public hospital performance evaluation, and rational drug use evaluation, and Appropriately increase the requirements for assessment weight.
    The industry believes that with the tightening of supervision, it will be difficult for the antibacterial drug market to return to its former glory.

    Figure 2: Sales of cephalosporin products in recent years (unit: ten thousand yuan)

    Source: The terminal competition pattern of public hospitals in key provinces and cities of Meinenet

    According to data from Mi Nei.
    com, although the overall sales of cephalosporin products have fallen under the impact of policies in recent years, the market leadership of injection products still cannot be shaken, and the market share will rise to 88.
    28% in 2020.
    Through intravenous infusion or intramuscular injection, the effect of cephalosporin can be achieved quickly and the effect is good.
    Oral administration needs to pass through the hepato-intestinal circulation, which is easy to be destroyed, and the effect may be slow.
    From the perspective of clinical use, the amount of injection is still important .

    Table 3: TOP10 varieties of cephalosporin injection in 2020

    Source: The terminal competition pattern of public hospitals in key provinces and cities of Meinenet

    Note: * is the product planned to participate in the fifth batch of national sourcing

    There are two compound preparations in the TOP10 injection varieties, but their fates are different.
    The sales of cefoperazone and sulbactam have been steadily increasing after reaching a scale of 1 billion in 2016.
    The epidemic in 2020 will affect the frequency of patients' visits to the hospital, and most of the cephalosporin injections are over-the-counter drugs, and the sales of the entire sub-category have fallen by more than 20% , And the sales decline of this variety is only about 9%, and it is also the variety with the smallest decline in the TOP10 injections.
    The sales in 2020 will be at the level of 1.
    5 billion yuan.
    At present, Pfizer's market share is as high as 90%.
    There are many domestic generic drug approvals but no company has reviewed it.
    The supplementary applications for consistency evaluation of 6 pharmaceutical companies including Qilu Pharmaceutical and Chengdu Better Pharmaceutical are under review and approval.
    Whether to seize the original research drug market remains to be observed.

    The market for cefoperazone and tazobactam is currently controlled by domestic pharmaceutical companies, and the overall sales model for this variety in 2020 is about 500 million yuan.
    Cefoperazone Sodium and Tazobactam Sodium for Injection (4:1) and Cefoperazone Sodium and Tazobactam Sodium for Injection (8:1) are already on the market earlier.
    Both are non-exclusive products.
    The new drug Cefoperazone Sodium Tazobactam for Injection has been approved this time.
    Batane (6:1) is expected to "break a bloody path".

    Recently, some provinces have announced the fifth batch of nationally sourced volume lists.
    The 4 cephalosporin injections are particularly eye-catching.
    Ceftazidime, cefazolin, ceftriaxone, and cefuroxime are all included in the list of TOP10 injection products, 2020 The annual terminal sales of public hospitals in key provinces and cities are 600 million yuan, 500 million yuan, 400 million yuan, and 400 million yuan.
    From the perspective of leading companies, ceftriaxone sodium for injection and cefuroxime sodium for injection are led by Roche and Esseti respectively, and domestic high-end generic drugs can seize the opportunity of centralized procurement to seize the market.

    Guocai has included 8 oral products, and the market structure has been reshuffled

    Guocai has included 8 oral products, and the market structure has been reshuffled

    Table 4: The situation of cephalosporin products that have been included in the national procurement earlier

    Source: The terminal competition pattern of public hospitals in key provinces and cities of Meinenet

    The cephalosporin products that have been included in the national procurement earlier are all TOP20 varieties for oral administration.
    Not only are they high in clinical value, but also in fierce competition among enterprises.
    After the market baptism, the market share of the winning bidders that can stand out has increased.
    The fourth batch is currently Many provinces and cities have announced the implementation time.
    Whether Shanghai Meiyou Pharmaceutical and Nanjing Yihua Pharmaceutical can reverse the trend after winning the bid is yet to be verified by the market.

    In terms of high-end domestic alternatives to original research, the leading company of cefradine oral preparations is Bristol-Myers Squibb, but after national procurement, the market share of original research pharmaceutical companies has dropped from nearly 80% in 2018 to 65% in 2020, showing obvious results.

    Table 5: Situation of cephalosporin products that have been reviewed but not yet included in the national procurement

    Source: The terminal competition pattern of public hospitals in key provinces and cities of Meinenet

    Judging from the current situation of the products that have been reviewed, the two major oral varieties of cefixime and cefadroxil, as well as the injection varieties of cefodizime, cefmetazole, cefminox, cefoxitin, and cefepime, have not yet been released for related products.
    Included in the national procurement, of which cefodizime is currently occupied by Daxiong Pharmaceutical, and domestic high-end generic drugs are promising to replace the original research.

    Source: Mi Nei.
    com database, NMPA official website

    The review data statistics are as of April 26, if there are any errors or omissions, please correct me.

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