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

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.

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.

According to data from Minai.

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.

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

Source: Meinenet MED2.

Nanjing Youke Pharmaceutical's cefotaxime sodium and tazobactam sodium (6:1) category 2.

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.

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.

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.

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 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.

Recently, some provinces have announced the fifth batch of nationally sourced volume lists.

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.

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.

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.