8 billion large varieties, the first North China Pharmaceutical company to pass the consistency evaluation

Medical Network, March 18, news of
8 billion large varieties, Huayao’s first over-evaluation
On March 16, North China Pharmaceutical issued an announcement that it received approval from the National Medical Products Administration to issue piperacillin sodium and tazobactam sodium for injection (1.
125).
g, 2.
25g, 4.
5g) "Drug Supplementary Application Approval Notice", the drug passed the consistency evaluation of the generic drug, and North China Pharmaceutical has also become the first domestic company to pass the evaluation of the drug
.
Piperacillin sodium and tazobactam sodium for injection is a compound anti-infective drug composed of piperacillin (semi-synthetic penicillin antibiotic) and tazobactam (β-lactamase inhibitor).
It is suitable for piperacillin Drug-resistant, but sensitive to piperacillin and tazobactam, moderate to severe infections caused by β-lactamase-producing bacteria
.
It is understood that piperacillin sodium and tazobactam sodium is a large variety with a very important clinical position and market position.
It ranked 12th among all drugs in the general name sales ranking of CPA city sample hospitals in 2019, and systemic antibiotics.
Ranked No.
5 for infectious drugs, No.
5 for antibacterial drugs, and No.
1 for penicillins; in 2019, Mi Neiwang ranked No.
10 for all generic drugs and No.
1 for anti-infectives in three public medical institutions
.
According to data from Menet.
com, in 2019, the sales of piperacillin sodium and tazobactam sodium for injection in China's public medical institutions exceeded 8 billion yuan, a year-on-year increase of 2.
4%.
In the competitive landscape of generic drugs for bacterial drugs, piperacillin sodium and tazobactam still ranks first with a market share of 5.
76%
.
(Data source: Mi Nei.
com) At present, there are 66 domestic production approvals and 3 import approvals for piperacillin sodium and tazobactam sodium for injection.
The approved specifications include 0.
5625g, 1.
125g, 2.
25g, 3.
375g, 4.
5g , The imported specification is 4.
5g
.
According to data from Minai.
com, North China Pharmaceuticals ranks first with nearly 20% of the drug's market share.
In addition, United Laboratories and Ruiyang Pharmaceuticals have more than 10% market shares, while the original research Wyeth has a market share of more than 10%.
Squeezed to 8.
51%
.
(Data source: Mi Nei.
com) In addition, according to CPA sample hospital data, there are 6 manufacturers with a 4:1 ratio.
The main manufacturers are North China Pharmaceutical, Ruiyang Pharmaceutical, Jiangsu Haihong, Zhejiang Anglikang, etc.
; 8:1 ratio a total of 21 companies, accounting for a total of eight former market share of 91.
5%, major manufacturers are Wyeth, Zhuhai Federation, Qilu, Sunrise, North China pharmaceutical and so on
.
Among them, the US Wyeth accounted for 37% of the market share in the 8:1 ratio
.
However, there are not many companies that deploy the consistency evaluation of piperacillin sodium and tazobactam sodium for injection.
Huabei Pharmaceutical is the first in China.
Qilu Pharmaceutical has not only submitted a supplementary application for consistency evaluation, but also submitted a new classification for production.
It is currently under review.
Approval in progress
.
(Data source: Mi 　　Nei.
com )
Centralized procurement is in sight For a
long time, the core focus of national centralized procurement has been oral preparations, but it is foreseeable that the selection of varieties purchased with volume has gradually tilted towards injection formulations
.
Although bulk procurement started with oral dosage forms, in fact injections put more pressure on medical insurance funds.
In the "Chinese Pharmaceutical Association Hospital Drug Monitoring Report" issued by the Chinese Pharmaceutical Association, the purchase amount of hospital injections in 2019 accounted for 63.
66% of the total drug
.
In addition, in 2019, the scale of China's injection drugs reached 635.
493 billion yuan.
Although the growth rate of the injection market has slowed down due to the "anti-injection restriction order", it still maintains absolute growth, which meets the requirements of high amounts and large dosages
.
On the other hand, this event has a foretaste
.
In the fourth batch of bulk purchases, we see more injections included in the centralized procurement, including ambroxol hydrochloride injection, doxofylline injection, parecoxibna for injection and other large varieties of injections
.
The provinces have also tested the water before.
On February 10, the Wuhan City Pharmaceutical Equipment Centralized Purchase Service Platform announced the results of the first batch of centralized drug purchases in Hubei Province.
The first batch of centralized drug purchases were all injections
.
And in the centralized procurement 500 drug catalog that was released in the third quarter of 2020, it was also found that a large number of injection formulations were listed among them
.
In addition, although the "anti-resistance order" has been escalating in recent years, various localities have successively required the implementation of hierarchical management of the clinical application of antibacterial drugs.
However, considering the high profit and large amount of antibiotic injection formulations, the state, provinces and cities have begun to pay attention to this field.
The national 500 centralized drug catalogs have been sent to local centralized procurement catalogs.
A batch of antibiotic injection formulations have been included, such as cefoperazone sodium and sulbactam sodium injection, mezlocillin sodium and sulbactam sodium injection, and cefotaxime sodium injection
.
As a broad-spectrum antibiotic injection, piperacillin sodium and tazobactam sodium has a wide range of applications and a large clinical dosage.
Once it meets the standards for centralized collection, it is very likely to enter the collection
.
At present, North China Pharmaceutical has been reviewed, and Qilu is expected to review it in the near future.
With the number of reviewed companies reaching two, plus Wyeth’s original research drug in the United States, this product will soon reach the requirements for mass procurement, and this product may face major issues.
Changes in the market
.
Once entered, the market share of some small manufacturers will be further squeezed, and the market share of leading companies may increase
.
In addition, the original research Wyeth will also face greater challenges
.