More than 4,000 drugs have passed the consistency evaluation! Yangtze River and Qilu fault-type leading, Kelun and Shiyao are fully catching up

The consistency evaluation of generic drugs in China was launched in 2012, and the 289 catalog issued in 2016 marked the entry into the stage of full promotion.
.
.
In the past ten years, more and more detailed rules have been implemented, and the consistency evaluation work has entered a mature stage
.
As of December 31, 2022 (according to the NMPA approval date), 5,573 acceptance numbers have passed the consistency evaluation (including deemed evaluation), involving 4,013 drugs (by product name + enterprise statistics).

Yangzijiang Pharmaceutical and Qilu Pharmaceutical have more than 100 evaluated products, leading by fault, CP Pharmaceutical is temporarily listed in the TOP3, and Kelun Pharmaceutical and CSPC Pharmaceutical Holdings are catching up
.

Figure 1: Acceptance numbers that have passed the consistency evaluation in the last five years

Source: Minai.
com China Declaration Progress (MED) database

According to data from Minai.
com, from the perspective of the acceptance numbers evaluated in the past five years, it has exceeded 1,000 every year since 2020, and the peak in 2021 will temporarily be more than 2,000.

From the trend point of view, more and more acceptance numbers are regarded as evaluated according to the new classification, accounting for more than 53% in 2022, and high-end generic drugs have gradually become the main force in the market
.
Consistency evaluation is the process of survival of the fittest, and only high-quality generic drugs can ultimately win the affirmation
of the market.

Four major categories of drugs have been evaluated hotly, and 8 products of more than 1 billion have been popular

Table 1: The distribution of products that have been evaluated as of 2022 is in the top 10 categories

Source: Minai.
com China Declaration Progress (MED) database

The evaluated systemic anti-infective drugs were mainly concentrated in 4 subcategories, of which systemic antibacterial drugs accounted for 120.

Kelun Pharmaceutical is the leading group in this category, with 24 systemic antibacterial drugs, 4 systemic antivirals and 3 systemic antifungal drugs evaluated
.

The evaluated neurological drugs were mainly concentrated in 7 subcategories, of which 36 were neuroleptics and 35 were psychostimulants
.
Renfu Pharmaceutical is the leading group in this category, and its evaluated products involve 6 anesthetics, 6 painkillers, 3 neuroleptics, 3 psychostimulants and 2 antiepileptic drugs
.

The evaluated digestive system and metabolites are mainly concentrated in 10 subcategories, of which diabetes drugs account for 47.

CP Pharmaceutical (including Nanjing Chia Tai Tianqing Pharmaceutical, Chia Tai Tianqing Pharmaceutical Group, Jiangsu Chia Tai Qingjiang Pharmaceutical, etc.
) is the leading group in this category, with 7 drugs for diabetes, 3 antiemetics and anti-nausea drugs, 3 drugs for the treatment of diseases related to gastric acid secretion, 2 vitamins, 2 antidiarrheal drugs and intestinal anti-inflammatory/anti-infective drugs
.

The evaluated cardiovascular and cerebrovascular system drugs are mainly concentrated in 4 subcategories, of which hypertension drugs account for 75.

Shanghai Pharmaceutical is the leading group in this category, and its evaluated products involve 12 drugs for hypertension, 4 drugs for heart disease treatment, 2 blood lipid modulators and 1 drug for cerebrovascular treatment
.

Table 2: Top 10 products with the highest evaluation as of 2022

Note: Sales below 100 million yuan are indicated by *

Source: Minainet Comprehensive Database

There are 8 TOP10 products with the largest number of evaluated enterprises, with terminal sales of more than 1 billion yuan
in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as Chinese public medical institutions) in 2021.

Amlodipine besylate tablets have the highest popularity, and 50 manufacturers have passed the consistency evaluation, and domestic star enterprises such as Hengrui, Baiyunshan, Kangyuan Pharmaceutical, Yichang Dongguang, and Chongqing Yaoyou have all been
involved.

It is worth noting that the number of enterprises with amoxicillin capsules, metformin hydrochloride tablets and omeprazole sodium for injection currently has more than 100 approvals, but less than 40%
of the companies have been evaluated.
With the passage of time, more and more provinces and cities will take measures such as withdrawing the network and stopping procurement of unevaluated products, or a batch of drugs will be "eliminated"
by the market one after another.

The latest evaluation TOP10 Group released! Yangtze River and Qilu fault-type leading

Table 3: Top 10 groups in terms of number of evaluated products as of 2022

Source: Minai.
com China Declaration Progress (MED) database

Yangzijiang Pharmaceutical's first evaluated product was approved in 2018 (enalapril maleate tablets), and entered the evaluation blowout period since 2020, and by the end of 2022, a total of 128 products had been evaluated, making it a TOP1 company
.
The evaluated products are distributed in 12 categories, of which systemic anti-infective drugs account for the most 25, and more than 10 products have been evaluated
for nervous system drugs, anti-tumor and immunomodulators, digestive system and metabolic drugs, cardiovascular and cerebrovascular system drugs, respiratory system drugs, musculoskeletal system and blood and hematopoietic system drugs.