31 domestic chemical drugs Class 1 new drugs were accepted, and a number of PD-1 declarations for new indications! Henlius, BeiGene, Roche...

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The total number of acceptances by the Drug Review Center in August was 1290 (excluding review)

In August, 31 new drugs of class 1 domestically produced drugs were accepted by CDE

In August, 84 new acceptance numbers were added according to the consistency evaluation of the quality and efficacy of generic drugs

Roche Class 1 new drug Cololiumab injection was accepted for sale

According to the latest statistics of Pharmaceutical Intelligence Data, in August 2022, CDE undertook a total of 1290 new drug registration applications with acceptance numbers (except for review, the same below), of which 922 were accepted by chemical drugs, 166 were accepted by Traditional Chinese medicines, and 202 were accepted by biological products; The acceptance of applications for registration of various drugs from March to August 2022 is detailed in

Figure 1 CDE drug acceptance from March to August 2022 Data source: Yaozhi data, Yaozhi consulting collation

The following is a detailed analysis of the registration acceptance and review of chemical drugs, traditional Chinese medicines and biological products

Review of chemical drugs

In August, CDE undertook 922 new chemical drug registration applications (in terms of acceptance numbers), including 91 new drug application acceptance numbers, 93 import acceptance numbers, 261 imitation application acceptance numbers, and 447 supplementary applications;

According to the category of review tasks (in terms of acceptance numbers), there were 132 IND applications, 261 ANDA applications, 15 NDA applications, and 27 import re-registration applications; The acceptance of applications for each review task category of CDE chemical drugs from March to August 2022 is detailed in Figure 2

Figure 2 Application acceptance of each review task category of CDE chemical drugs from March to July 2022 Data source: Pharmaceutical intelligence data and pharmaceutical intelligence consulting and collation

1.

Table 1 New domestic drugs of class 1 of chemical drugs newly undertaken in August 2022

Note: Queue numbers are up to September 6, 2022

2.

Table 2 New imported drugs of Class 1 of chemical drugs newly undertaken in August 2022

Note: Queue numbers are up to September 6, 2022

LP-108 tablets

LP-108 tablets are a novel, highly selective BCL-2 inhibitor of Lupeng Pharmaceuticals, which is clinically intended to be used for the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma (NHL

BEBT-503 capsules

BEBT-503 is a class 1 new drug of Guangzhou Bibrate, a highly active pan-PPAR agonist intended for the treatment of diabetic hepatitis rather than alcoholic steatohepatitis

LOXO-783 tablets

LOXO-783 is a highly selective PI3Kα H1047R inhibitor

JAB-2485 tablets

JAB-2485 is the world's first innovative drug

APG-5918 tablets

APG-5918 is a new potent, selective small molecule EED inhibitor under study by Yasheng Pharmaceutical, with a high binding affinity

3.

Figure 3 Application Acceptance of CDE Chemical Drug Improved New Drug Applications from January to August 2022 Data Source: Yaozhi Data, Yaozhi Consulting and Collation

Evaluation of Chinese medicines

In August, CDE undertook a total of 166 application numbers for registration of Chinese medicines, including 6 new drugs and 160 supplementary applications; From March to August 2022, the acceptance of CDE Chinese medicine application types is detailed in Figure 4

Figure 4 Acceptance of various application types of CDE Chinese medicines from March to August 2022 Data sources: Yaozhi data, Yaozhi consulting and collation

1.
Declaration of new Chinese medicine drugs

In August, a total of 5 Chinese medicine Class 1 innovative drugs and 1 Chinese medicine Class 2 improved new drugs were undertaken, involving a total of 5 varieties, all of which were IND applications; The following table shows the new Chinese medicine drugs
newly undertaken in August.

Table 3 New Chinese medicine drugs newly undertaken in August 2022

Note: Queue numbers are up to September 2022, 09

Review of biological products

In August, CDE undertook a total of 202 new biological product registration application acceptance numbers, 84 new drugs, 79 supplementary applications, 30 imports (including 2 one-time imports), and 9 import re-registrations; The acceptance of each application type of CDE biologics from March to August 2022 is detailed in Figure 5
.

Figure 5 Acceptance of application types of CDE biological products from March to August 2022 Data sources: Yaozhi data, Pharmaceutical intelligence consulting and collation

1.
Declaration of new drugs of class 1 of biological products

In August, 3 Category 1 preventive biologics and 74 therapeutic biologics acceptance numbers were undertaken, and 77 clinical trial applications and 1 listing application have been queued up in the corresponding sequence for review; The following table shows the new therapeutic biologics class 1 innovative drugs
in August.

Table 4 New class 1 drugs for therapeutic biological products newly undertaken in August 2022

Note: Queue numbers are up to September 6, 2022
.

Evaluate the declared varieties according to consistency

In August, 84 acceptance numbers and 287 deemed acceptance numbers were added for declarations in accordance with the requirements of consistency evaluation
.
(The space limit only shows the consistency information, please pay attention to the drug registration and acceptance database of the pharmaceutical enterprise version for the same and specific information); The number of acceptances of consistency evaluation from January to August 2022 is detailed in Figure 6; Table 5 shows the information of the new consistency evaluation acceptance number in August
.

Figure 6 Number of acceptances of consistency evaluation from January to August 2022 Data sources: Yaozhi data, Yaozhi consulting and collation

Table 5 New consistency evaluation acceptance data in August 2022

Data source: Yaozhi data, Yaozhi consulting collation