In 2021, the 2 types of improved new drugs of chemical drugs will welcome the climax of "growth rate and increase".

In recent years, in the context of the stabilization of the global epidemic, the attention of the pharmaceutical industry has continued to increase, which has promoted the innovation and development of the pharmaceutical industry to a certain extent
.
In the context of the rapid output of Category 1 innovative drugs, its "close relatives" Category 2 improved new drugs have also ushered in a small wave of R&D upsurge, especially domestic pharmaceutical companies' investment in R&D resources in this field has increased significantly
.
So, what kind of rise will my country's improved new chemical drugs usher in in 2021? Which fields, which varieties, and which companies have entered this registration track? What are the implications for the future? Please see this manuscript
.
1.
In the past 3 years, the registration trend of Class 2 improved new drugs of chemical drugs By querying the public data (full-text data as of 2021-12-26), from 2019 to 2021, the number of new drugs of Class 2 improved chemical drugs has been registered.
The overall trend of registration acceptance is an upward trend
.
The total number of acceptances has risen from 188 in 2019 to 418 in 2021, with an annual growth rate of nearly 49%; among them, the number of INDs has risen from 141 in 2019 to 304 in 2021, with an annual growth rate Nearly 47%; but the number of NDA undertakings has not changed much
.
In terms of new drug & import classification, it has nearly doubled from almost the same level in 2019, and the number of acceptance numbers of domestic improved new drugs has achieved an annual growth rate of 64%
.
In terms of batch production/batch import, the total number of acceptance numbers in 2019 has dropped from 28 acceptance numbers to a total of 4 acceptance numbers
.
Figure 1.
1 2019-2021/Registration trend of Type 2 improved new drug for chemical drugs 2.
Characteristics of Type 2 improved new drug registration for chemical drugs in 2021 Refers to drugs whose structure, dosage form, prescription process, route of administration, indications, etc.
are optimized on the basis of known active ingredients, and have obvious clinical advantages.
for the following four cases
.
Table 2.
1 Description of Category 2 of Chemical Drug Registration According to the above classification method, when applying for registration classification of varieties, applicants must choose according to the characteristics of their own products and the purpose of registration application
.
According to the statistics of the number of 2.
1/2.
2/2.
3/2.
4 acceptance numbers in 2021, it is found that the number of 2.
1 and 2.
3 varieties is relatively small, far less than 2.
2 and 2.
4; of course, this is very related to the characteristics of the new drug registration process, but It can also be seen from the above registration classification that China's more characteristic improved new drugs and more cutting-edge pharmaceutical technologies still need to be further explored, and there is a lot of room for it
.
Figure 2.
1 2.
1/2.
2/2.
3/2.
4 category acceptance numbers in 2021.
Here are the specific varieties that have been undertook in 2021 for chemical drug category 2.
1 registration applications: MBT-1608 tablets from Beijing Shuanglu Pharmaceutical Co.
, Ltd.
, Tolvaptan Sodium Phosphate for Injection from Otsuka Pharmaceutical R&D (Beijing) Co.
, Ltd.
, RF16001 for Injection and Dexmedetomidine Transdermal Patch from Yichang Renfu Pharmaceutical Co.
, Ltd.
, Shanghai Huiyong Pharmaceutical Research Co.
, Ltd.
LN001 from Chia Tai Tianqing Pharmaceutical Group Co.
, Ltd.
, Colistin Sulfate E2 Granules from Chia Tai Tianqing Pharmaceutical Group Co.
, Ltd.
, HR18034 for Injection from Shanghai Hengrui Pharmaceutical Co.
, Ltd.
, HECB1701301 Long-acting Intramuscular Injection from Guangdong Dongguang Pharmaceutical Co.
, Ltd.
, and Lurasidone Delayed Ivabradine Hydrogen Sulfate Sustained-Release Tablets from Jiangsu Hengrui Pharmaceutical Co.
,
Ltd.
3.
Analysis of IND varieties of Class 2 new drugs in 2021 Further statistical analysis of IND varieties: In 2021, CDE will undertake a total of 304 IND varieties of Class 2 new drugs, including 200 new drug varieties and 104 imported varieties, which are close to 2:1
.
In terms of indications for new drug varieties, "tumor drugs + immunomodulatory drugs" accounted for nearly 50%, followed by nervous system drugs, cardiovascular system drugs, systemic anti-infective drugs, etc.

.
In terms of companies applying for new drug varieties, there are more than 80 companies applying for IND varieties of Class 2 new drugs, among which Jiangsu Hengrui Pharmaceutical Co.
, Ltd.
has the largest number of acceptance numbers, followed by Chia Tai Tianqing Pharmaceutical Co.
, Ltd.
and Yichang Renfu Pharmaceutical Industry, Beijing Nuocheng Jianhua Pharmaceutical Technology Co.
, Ltd.
, Guangdong Dongguang Pharmaceutical Co.
, Ltd.
, etc.
, all have multiple varieties and acceptance numbers that have been undertaken by CDE
.
Figure 3.
1 2021/Distribution of major companies related to the IND of domestic chemical class 2 new drugs In terms of indications of imported varieties, "anti-tumor + immunomodulatory drugs" accounted for nearly 80%, followed by cardiovascular system drugs, sensory organ drugs, digestive tract drugs , metabolism,
etc.
In terms of declaration enterprises for imported varieties, there are more than 30 declaration enterprises related to 2 types of imported IND varieties.
Among them, the enterprises with the largest number of acceptance numbers are AstraZeneca, followed by Novartis, Eisai, Takeda, Johnson & Johnson,
etc.
4.
Analysis of NDA varieties of Class 2 new drugs in 2021 The number of acceptance numbers corresponding to the varieties of Class 2 new drugs entering the NDA stage in 2021 is greater than 40, and the ratio of the number of acceptance numbers of domestic new drugs/imported varieties is close to 3.
5:1
.
In terms of domestic new drugs, Hengrui Medicine still has the largest number of NDA acceptance numbers.
The main varieties are apatinib mesylate tablets, pyrotinib maleate tablets, remazolam tosylate for injection, and tadalafil.
Oral dissolving film, dexmedetomidine hydrochloride nasal spray; after that, the varieties are relatively scattered, such as Betta Pharmaceuticals' Ensatinib Hydrochloride Capsules, Jiangsu Haosen's Ametinib Mesylate Tablets, Liaoning Haisco's Cyclopofol Injection, Fumetinib Mesylate Tablets from Shanghai Allis, Remazolam Besylate for Injection from Yichang Renfu Pharmaceutical Co.
, Ltd.
, Anlotinib Hydrochloride from Chia Tai Tianqing Pharmaceutical Co.
, Ltd.
Capsules, etc.
; most of them are contracted under the registration type Chem 2.
4
.
In terms of imported varieties, the number is small, with a total of 7 varieties, namely Atropine Sulfate Eye Drops from Occidental Biopharmaceuticals, Empagliflozin Tablets from Boehringer Ingelheim, Copanlisib Injection Freeze-dried Preparations from Bayer Pharma, Sanofi oxaliplatin for injection, Pfizer’s tofacitinib citrate tablets, AstraZeneca’s dapagliflozin tablets, AbbVie’s uppatinib sustained-release tablets
.
5.
Prospects To sum up, the general situation of the registration and application of Class 2 new chemical drugs in 2021 can be summarized as follows: ● Domestic pharmaceutical companies have increased their R&D investment in Class 2 new drugs, and the number of acceptance numbers has increased significantly; ● Registration classification, The number of 2.
1&2.
3 is obvious <2.
2&2.
4, and the number of domestic products is obviously> imported; ● IND varieties are widely dispersed, mainly leading innovative companies, but some start-up new drug companies have begun to dabble; ● NDA varieties are still concentrated in Most of the Class 1 new drugs that have just been marketed in recent years are registered and declared in Class 2.
4
.
In general, the "growth rate increase" for the registration and application of the improved new drug category 2 of chemical drugs can be expected in the future! Reference sources: 1.
CDE official website data 2.
NMPA official website data 3.
Annual reports of major companies/pharmaceutical companies