The cephalosporin market has changed dramatically! Beite new TOP10 Kelun exclusive new products welcome benefits

Recently, the National Health Commission and other 13 departments jointly formulated the National Action Plan for Curbing Microbial Resistance (2022-2025) and released it to the public, mentioning the need to strengthen industry supervision and rationally apply antimicrobials
.
Cephalosporins are commonly used clinical drugs and are also TOP1 subclasses of systemic antibacterial drugs, which have attracted high
market attention.
Consistency evaluation and collective procurement promote the replacement of high-quality generic drugs with original research, and the dynamic adjustment of medical insurance catalogues accelerates the release of vitality of new varieties and new dosage forms, and accelerates market reshaping
.
In the first half of 2022, the TOP10 companies will change blood, 10 exclusive new products will participate in this year's medical insurance negotiations, and the eighth batch of national procurement may launch a "first round of attacks" on 5 varieties of more than 1 billion, and the cephalosporin market is surging
.

 

Domestic pharmaceutical companies rush! Beite Pharmaceutical is newly promoted to the top 10

 

Under the influence of multiple policies, the terminal cephalosporin market size of China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as China's public medical institutions) hovered at the level of 57 billion yuan in 2021, and the epidemic in many places across the country in the first half of 2022 repeatedly further affected the sales of this category, with a double-digit
decline.

 

Under such a grim situation, the reshuffle of TOP10 enterprises is serious
.
According to data from Intranet, in the first half of 2022, only 3 of the top 10 terminal cephalosporin enterprises in China's public medical institutions had positive sales growth, and 6 domestic pharmaceutical companies withstood the disadvantages and rose
in the ranking.

 

Pfizer has been at the top of the list since 2020, with a growth rate of 30.
14%
in the first half of 2022.
The sales of the company's two ceftiodone compound preparations are very eye-catching, and the sales of cefoperazone sodium sulbactam sodium for injection exceeded 5.
7 billion yuan in 2021, and the growth rate in the first half of 2022 was 27.
71%; Avibactam sodium for injection has exceeded 400 million yuan in 2021, and the growth rate in the first half of 2022 is 78.
38%.

 

In terms of domestic pharmaceutical companies, the growth rate of Southwest Pharmaceutical was 10.
75%, rising 5 places to TOP2; Sinopharm Zhijun (Shenzhen) Pharmaceutical rose 1 place to TOP4, and Sichuan Hexin Pharmaceutical rose 7 places to TOP6; The growth rate of Chengdu Beite Pharmaceutical was 16.
46%, and it rose 7 places to squeeze into the TOP10 list for the first time, ranking TOP7; Yangtze River Pharmaceutical Group and North China Pharmaceutical Hebei Huamin Pharmaceutical both rose two places, ranking TOP9 and TOP10
respectively.

 

Figure 1: Sales of cephalosporins of Chengdu Beite Pharmaceutical (10,000 yuan)

Source: Intranet terminal competition pattern of public medical institutions in China

 

In recent years, the sales of cephalosporins of Chengdu Beite Pharmaceutical have maintained a rapid growth trend, and the sales in the first half of 2022 have been close to the level
of the whole year of 2019.
Up to now, the company has a total of 22 cephalosporins (according to product name, excluding APIs), and in the first half of 2022, the terminal growth rate of more than 100% in China's public medical institutions includes cefodizime sodium for injection, cefmetazole sodium for injection, cefdinib granules, cefzoxime sodium for injection and cefoperazone sodium sulbactam sodium
for injection.

 

47 cephalosporins have been evaluated, and 5 varieties of more than 1 billion are ready for national procurement for the first time

 

Up to now, there are 47 cephalosporins that have been evaluated/deemed to have been evaluated (500 approvals by product name), involving hundreds of companies
.
The TOP3 evaluated enterprises are Chengdu Beite Pharmaceutical, North China Pharmaceutical Hebei Huamin Pharmaceutical Co.
, Ltd.
, and Sinopharm Group Zhijun (Shenzhen) Pharmaceutical, and the number of products that have been evaluated/deemed to have been evaluated are 14, 10 and 10 respectively
.

 

Table 1: Status of cephalosporin products that have been evaluated/deemed to have been evaluated

Source: Intranet China Listed Drugs (MID) Database

 

In addition to the sixth batch of insulin special, up to now, each batch of national procurement has included cephalosporins, 4+7 pilot (and alliance expansion) to the fourth batch involves oral drugs, the fifth batch began to include injections, and the seventh batch has both oral drugs and injections
.
From the perspective of winning bids, Chengdu Beite Pharmaceutical and Sinopharm Group Zhijun (Shenzhen) Pharmaceutical both led with 7 products, and Qilu Pharmaceutical (and its subsidiaries) also won 6 products
.

 

Table 2: Products that are not included in the national procurement and the number of enterprises that have passed the evaluation has exceeded 4 (including 4).

Source: Intranet database comprehensive collation

 

Cefoperadone sulbactam, cefoxitin, cefotaxime, cefodizime and cefotian in 2021 in China's public medical institutions terminal sales of more than 1 billion yuan, at present, no products have been included in the national procurement, 5 large varieties of cephalosporin injections have been evaluated by more than 4 enterprises, is the eighth batch of national hot varieties
.

 

Cefoperazone sodium sulbactam sodium for injection is currently led by Pfizer, with a market share of more than 80% in the first half of 2022, while cefdizime sodium for injection is led by Daxiong Pharmaceutical, with a market share of more than 40% in the first half of 2022, and the competition between domestic brands and original research/imported brands of the two products is about to begin
.

 

The "winning bidder" Chengdu Beite Pharmaceutical's cefdizime sodium for injection, cefoperazone sodium sulbactam sodium for injection and cefdinib granules have been evaluated, Sinopharm Group Zhijun (Shenzhen) Pharmaceutical's cefoxitin sodium for injection has been evaluated, and Qilu Pharmaceutical's cefoperazone sodium for injection sulbactam sodium has been evaluated, if the above products can finally enter the eighth batch of catalog, the three companies are expected to add more winning products
.

 

The countdown to medical insurance negotiations in 2022 has 10 new products breaking through strongly

 

The newly released National Action Plan for Curbing Microbial Resistance (2022-2025) mentions that it is necessary to give full play to the role of medical insurance payment in promoting rational drug use, dynamically adjust the medical insurance drug catalogue according to clinical needs and medical insurance funds, and include antimicrobial drugs with high clinical value, obvious patient benefits and excellent economic evaluation into the scope
of medical insurance payment according to procedures.
Industry sources said that medical insurance negotiations in 2022 may be held
this month.

 

According to the statistics of Intranet, a total of 58 cephalosporins have entered the 2021 version of the medical insurance catalogue (1 is a negotiated product), and there are 11 cephalosporins in the list of drugs that have passed the formal review adjusted by the 2022 version of the medical insurance catalogue announced earlier, of which 10 belong to the off-list condition 1 (that is, newly listed products) and 1 belongs to the catalogue condition 1 (expired renewal products).

 

Table 3: Status of cephalosporin products that have passed the 2022 Medicare Catalogue Adjustment Form Review

Source: National Health Insurance Administration's public information

 

In recent years, the research and development of powder liquid double-chamber bag injection is very hot, and it has obvious advantages
over traditional powder injection infusion products in terms of safety, practicality, economy and environmental protection.
It is difficult to develop new cephalosporins, and seeking new ways out through dosage form innovation has gradually become the best choice
for pharmaceutical companies.

 

At present, the main approved companies for cephalosporin powder double-chamber bag injection on the market are Beijing Ruiye Pharmaceutical, Otsuka Pharmaceutical and Kelun Pharmaceutical, and the 8 new products have attracted much attention from the market, these products are newly approved exclusive products in recent years, and the "barefoot variety" is expected to leverage medical insurance to release volume
.

 

In addition, Nanjing Ruckus Pharmaceutical's cefotaxime sodium tazobactam sodium for injection is a compound preparation, referring to the superior performance of Pfizer's two blockbuster compound preparations after entering the domestic market, it can be seen that the efficacy of cephalosporin compound preparations has been recognized by patient groups and doctor groups, and the current clinical demand in China is gradually increasing, and "insurance" is conducive to the rapid expansion
of products.

 

Kelun stormed high-end dosage forms, and Qilu made efforts to make a number of new products

 

The eighth batch of national procurement and medical insurance negotiations in 2022 will become important factors in the reshuffle of the cephalosporin market, replacing the original research with imitations and filling the market gap
with new products.
The patient population of cephalosporins is huge, attracting more and more companies to enter the market for a piece of the pie
.

 

Table 4: New cephalosporins approved for marketing from January to October 2022

Source: China Declaration Progress (MED) database of Intranet

 

From January to October this year, a total of 9 new cephalosporins (according to product name + enterprise statistics) were approved for marketing, all of which were reported according to the new classification and regarded as evaluation, which shows that domestic cephalosporins are steadily advancing
towards the goal of high-quality development.
Kelun's ceftriaxone sodium/sodium chloride injection for injection is the first imitation in China (the first to be evaluated), Chengdu Beite Pharmaceutical is the second domestic cefuroxime dry suspension (the first to be evaluated), and Jinhong Pharmaceutical is the second domestic production of cefdinib tablets (the first to be evaluated).

 

Table 5: New cephalosporins declared for marketing from January to October 2022

Source: China Declaration Progress (MED) database of Intranet

 

Beijing Ruiye Pharmaceutical and Kelun Pharmaceutical continue to add code powder liquid double chamber bag injection, cefoperadone sulbactam and ceftazidime avibactam are compound preparations, the synergistic effect of the two drugs can enhance antibacterial activity, the current cefoperazone sodium sulbactam sodium / sodium chloride injection and ceftazidime avibactam sodium / sodium chloride injection for injection are not approved for marketing in China, if successfully approved not only become the first imitation in China, but also the company's first approved compound cephalosporin liquid double chamber bag products, market potential
。

 

In addition, Qilu is also secretly making efforts
.
Up to now, Qilu Pharmaceutical (and its subsidiaries) has 27 cephalosporins, and has submitted 7 new product marketing applications in one breath since 2022, which will open up the four major variety markets of cefdinib, cefaclor, cefpoxime and cefotian for the company, and further broaden the company's layout
in the cephalosporin market.

 

Source: Intranet database, National Health Insurance Administration, etc

 

Note: Intranet's "Terminal Competition Pattern of China's Public Medical Institutions", the statistical scope is: China's urban public hospitals, county-level public hospitals, urban community centers and township health centers, excluding private hospitals, private clinics, and village clinics; The above sales are calculated
based on the average retail price of the product at the terminal.
Data statistics as of October 31, if there are any omissions, welcome to correct!