Review of the development of chemical medicine in 2021

01 Development Trend Analysis

Chemical drugs still dominate the Chinese pharmaceutical market, accounting for 48.
9%
.

The scale of China's chemical drug market increased from 722.

Figure 1: 2015-2021E China's chemical drug market size (100 million yuan) Source: Frost & Sullivan, China Business Industry Research Institute, Firestone Creation

02 Product Analysis

1.
Consistency evaluation of generic drugs ushered in an outbreak

1.
Consistency evaluation of generic drugs ushered in an outbreak

In 2021, a total of 876 acceptance numbers have been accepted for consistency evaluation, a decrease of 3.
52% compared with 908 in 2020; 1,714 drugs of different specifications passed the consistency evaluation (including deemed approval), about two years in 2020.
times, and the varieties that have been evaluated for the consistency of generic drugs ushered in explosive growth
.

Figure 2: Acceptance and Over-evaluation of Consistency Evaluation of Generic Drugs in 2021 Source: CDE, NMPA, created by Firestone

In terms of enterprises, leading enterprises remain in the lead
.

In 2021, 26 varieties of Qilu Pharmaceutical will pass the consistency evaluation and come out on top

Figure 3: Top 10 varieties of enterprises that have passed the consistency evaluation in 2021 Source: CDE, NMPA, Firestone Creation and finishing

Figure 4: The TOP10 varieties of enterprises passed the consistency evaluation Source: CDE, NMPA, Firestone Creation and finishing

Regionally, the traditionally dominant regions are ranked high
.

In 2021, 167 varieties in Jiangsu Province will pass the consistency evaluation, surpassing the total in the province last year, ranking first, and also ranking first in the total number of varieties that have been evaluated

Figure 5: TOP10 varieties of regional consistency evaluation in 2021 Source: CDE, NMPA, Firestone Creation and finishing

Figure 6: TOP10 varieties of regional consistency evaluation sources: CDE, NMPA, Flint created and organized

In 2021, there have been more than 3 companies that have reviewed 206 products with the same generic name, of which 46 companies have reviewed Amlodipine Besylate Tablets, ranking first, Metformin Hydrochloride Tablets, Amoxicillin Capsules, Ambroxol Hydrochloride There are also more than 30 companies that have passed the evaluation of Suo injection
.

In the context of the normalization of bulk purchases, the competition for popular products has become increasingly fierce

Table 1: Products of the same generic name that have been reviewed by more than 20 companies

Source: CDE, NMPA, Flint Creation

2.
Improved new drugs enter the harvest period

2.
Improved new drugs enter the harvest period

Since March 2016, the original CFDA issued the "Work Plan for the Reform of Chemical Drug Registration Classification", which further divided new drugs into Category 1 new drugs (innovative drugs) and Category 2 new drugs (improved new drugs).
Popular directions
.

In 2021, the improved new drugs have entered the harvest period, and a total of 14 varieties have been approved for marketing (8 injections, 6 oral preparations), of which there are as many as 10 varieties of category 2.

Table 2: List of Class 2 Improved Chemical New Drugs Approved for Marketing in 2021

Source: NMPA, Created by Flint

3.
The number of innovative drug approvals has reached a new high

3.
The number of innovative drug approvals has reached a new high

In 2021, a total of 21 domestic Class 1 new chemical drugs will be approved for marketing, and the number of approvals will exceed that in 2020, once again setting a record high after the implementation of the new drug registration classification standards
.

These 21 new chemical drugs include 8 anti-infective drugs, 6 anti-tumor drugs, 2 blood system drugs, 2 digestive system drugs, 1 nervous system drug, 1 cardiovascular system drug, 1 urinary system drug, and A total of 16 products have been approved under the "Priority Review" method, among which levonidazole disodium phosphate for injection, nerofloxacin malate and sodium chloride injection, pamiparib capsules, and contezolid tablets , Fumetinib Mesylate Tablets, Donafenib Tosylate Tablets, Hetrombopag Ethanolamine Tablets, Hipomabu Tablets, Ainovirine Tablets, Amitofovir Tablets 10 products have passed the national The medical insurance negotiation has entered the medical insurance catalog

Table 3: List of Class 1 New Chemical Drugs Approved for Marketing in 2021

Source: NMPA, Created by Flint

03 Capital Market Analysis

1.
Listed companies

1.
Listed companies

In 2021, a total of 17 companies in the chemical medicine field will be listed, among which Qilian International will be listed on NASDAQ, Zhaoke Ophthalmology and Tengsheng Biopharma will be listed on the Hong Kong Stock Exchange, and Deyuan Pharmaceutical and Senxuan Pharmaceutical will become the first batch of companies listed on the Beijing Stock Exchange.
Listed companies; in addition, 6 companies are listed on the Shanghai Stock Exchange, 5 companies are listed on the Shenzhen Stock Exchange, and 1 company is listed on the New Third Board
.

Table 4: Listed companies in the field of chemical medicine in 2021

Source: Flint Creation Database

2.
Financing analysis

2.
Financing analysis

In 2021, a total of 57 financing events with a financing amount of more than 100 million yuan occurred in the domestic chemical drug field, with a total financing amount of 17.
2 billion yuan
.

Among them, 2 financing events of 1 billion yuan and above were strategic financing of 1.

From a regional perspective, Shanghai (18), Jiangsu (12), Zhejiang (9), and Guangdong (9) are the four provinces and cities with the largest number of financings and the four provinces and cities with the highest total financing amount
.

In addition, there was only one financing event in Jiangxi Province, but the single amount was the highest

Figure 7: In 2021, provinces and cities have disclosed financing in the field of chemical drugs with an amount exceeding 100 million yuan Source: Firestone Creation Database

04 Policy Analysis

1.
The environmental protection policy of the API industry is tightened, and industrial upgrading and transformation are imminent

1.
The environmental protection policy of the API industry is tightened, and industrial upgrading and transformation are imminent

In 2021, the state's environmental protection policies for the API industry will continue to increase.
On November 9, the National Development and Reform Commission and the Ministry of Industry and Information Technology jointly issued the "Implementation Plan for Promoting the High-quality Development of the API Industry", which clearly proposed to promote production technology innovation.
The main tasks of upgrading, promoting the green and low-carbon transformation of the industry, and promoting the optimization and adjustment of the industrial structure are of great significance to the transformation, upgrading and sustainable development of the API industry.
It will further accelerate the pace of high-quality development of the API industry under the new situation and enhance the core competitiveness of the industry.
force
.
Table 5: Some environmental protection policies of the chemical API industry since 2016

Source: Flint Creation Arranged based on public information

2.
The patent link system was officially implemented to promote the construction of the drug patent system

2.
The patent link system was officially implemented to promote the construction of the drug patent system

In July 2021, the State Drug Administration and the State Intellectual Property Office jointly issued the "Implementation Measures for the Early Resolution Mechanism of Drug Patent Disputes (for Trial Implementation)", marking the arrival of the era of drug patent linkage in China
.
In order to promote the implementation of the drug patent link system, on July 5, 2021, the Supreme People's Court and the State Intellectual Property Office issued the "Regulations on Several Issues Concerning the Application of Law in Civil Cases of Patent Disputes Related to Drugs Applied for Registration" and "Drug Patents" respectively.
Administrative Adjudication Measures for the Early Resolution Mechanism of Disputes to improve judicial connection
.
The implementation of the drug patent link system will play an important role in enhancing China's drug R&D and innovation capabilities, promoting the high-quality development of generic drugs and promoting the progress of the pharmaceutical field, and will further accelerate the construction of the Chinese version of the drug patent system
.

3.
From following innovation to source innovation, innovative drugs are the beginning of the era of kings

3.
From following innovation to source innovation, innovative drugs are the beginning of the era of kings

On November 19, the Center for Drug Evaluation (CDE) of the State Food and Drug Administration officially issued the "Guidelines for Clinical Research and Development of Antitumor Drugs Oriented to Clinical Value", proposing that new drugs must exceed the already marketed drugs in terms of efficacy before they can be marketed.
Clinical value and barriers to innovation
.
In the long run, the transition from Me-too/Me-better to BIC and the final development of FIC is an important way for China to transform from a big pharmaceutical country to a pharmaceutical power.
The release of the guiding principles means that it is time for us to shift from following innovation to source innovation.
Open a new era in which innovative drugs are king
.