26 domestic chemical drugs of Class 1 new drugs were accepted, Hengrui, Beida, Dongguang Pharmaceutical...

According to the latest statistics of PharmaIntelligence Data, in November 2022, CDE undertook a total of 963 new drug registration applications by acceptance number (except for reexamination, the same below), including 686 chemical drugs, 158 traditional Chinese medicines, and 116 biological products; The acceptance status of various drug registration applications from June to November 2022 is detailed in Figure 1
.

Figure 1 CDE drug acceptance status from June to November 2022

Data source: PharmaIntelligence Data, PharmaIntelligence Consulting

Note: The start time of the status (<pharmacointelligence) is from November 1, 2022 to November 30, 2022> a total of 785 acceptance numbers have been completed, including 542 chemical drugs, 69 traditional Chinese medicines, and 174 biological products; The completion of the review of various drugs from June to November 2022 is detailed in Figure 2
.

Figure 2 Review of CDE drugs from June to November 2022

Data source: PharmaIntelligence Data, PharmaIntelligence Consulting

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

1.
Application and review of chemical drugs

(1) Acceptance of chemical drugs

In November, CDE undertook 686 new chemical drug registration applications (based on acceptance numbers), including 71 new drug application acceptance numbers, 62 import acceptance numbers, 184 generic application acceptance numbers, 342 supplementary applications, and 27 import re-registrations.

According to the statistics of review task categories (in terms of acceptance number), there were 87 IND applications, 174 ANDA applications, 14 NDA applications, and 22 import re-registration applications; The acceptance status of applications for each review task category of CDE chemical drugs from June to November 2022 is detailed in Figure 3
.

Fig.
3 Application acceptance status of CDE chemical drug review task categories from June to November 2022

Data source: PharmaIntelligence Data, PharmaIntelligence Consulting

1.
Declaration of chemical drugs Class 1 domestic production

In November, CDE accepted a total of 54 domestic Class 1 new drugs (according to the acceptance number), all of which were IND applications, involving 26 varieties (statistics by drug + enterprise dimension), and most of the acceptance numbers have entered the corresponding sequence to queue for review; The following table shows the Class 1 new drugs
newly produced in November.

Table 1 Class 1 domestic new drugs newly undertaken in November 2022

Note: The queue number is as of December 07, 2022

Data source: PharmaIntelligence Data, PharmaIntelligence Consulting

2.
Declaration of imported drugs of Class 1 chemical drugs

In November, a total of 16 Class 1 acceptance numbers for imported chemical drugs were undertaken, including 13 IND applications and 3 NDA applications, a total of 8 varieties, and 7 of them have entered the corresponding sequence to queue for review; The table below shows the new Class 1 imported new drugs
newly undertaken in November.

Table 2 Class 1 imported new drugs of chemical drugs newly undertaken in November 2022

Note: The queue number is as of December 07, 2022

Data source: PharmaIntelligence Data, PharmaIntelligence Consulting

● ECC4703 capsule

ECC4703 is a β-selective, liver-targeted THR complete agonist
developed by Chengyi Biologics.
In preclinical studies, ECC4703 has demonstrated efficacy over the partial agonist MGL-3196 and has shown excellent efficacy
in animal models of NASH and dyslipidemia.

● BPI-452080 tablets

BPI-452080 is a new molecular entity compound independently developed by Betta Pharma with completely independent intellectual property rights, which is an innovative, oral small molecule inhibitor of HIF-2α (hypoxia inducible factor-2α), which is intended for the treatment
of patients with advanced solid tumors.

● Mofesidine ritonavir tablets

Mofecedine ritonavir is a Class 1 new drug newly declared by Dongguang Pharmaceutical, which is intended to be used for the treatment of hepatitis
B.

● BEBT-503 capsule

BEBT-503, a Class 1 new drug of Bifibet, is a highly active pan-PPAR agonist intended for the treatment of diabetes mellitus and nonalcoholic steatohepatitis (NASH).

● SAL0119 tablets

SAL0119 is an oral small molecule immunosuppressant independently developed by Salubris and currently intends to develop clinical indications including active ankylosing spondylitis and moderate to severe active rheumatoid arthritis
.

3.
Application status of improved new drugs for chemical drugs

In November, 24 new improved new drugs of Class 2 were added (according to the acceptance number), including 21 IND applications and 3 NDA applications, involving a total of 18 varieties; The application acceptance status of CDE improved new drugs from January to November 2022 is shown in Figure 4
.

Figure 4 Application acceptance status of CDE improved new drugs from January to November 2022

Data source: PharmaIntelligence Data, PharmaIntelligence Consulting

(2) The completion of the review of chemical drugs

In November, CDE completed the review of 542 chemical drug registration applications (based on acceptance numbers), including 63 new drug application acceptance numbers, 44 import acceptance numbers, 147 generic application acceptance numbers, and 230 supplementary applications.
According to the statistics of review task categories (by acceptance number), there were 77 IND applications, 146 ANDA applications, 13 NDA applications, 58 import re-registration applications, and 42 consistency evaluations.
The completion of the review of each review task category of CDE chemical drugs in November 2022 is shown in Figure 5.

Figure 5 Review status of each CDE drug review task category in November 2022

Data source: PharmaIntelligence Data, PharmaIntelligence Consulting

According to the conclusion of the acceptance number review, 121 clinics were approved, 125 were approved for production, 11 were approved for import, and 35 were not approved; The conclusion of the completion of the review of CDE chemical drugs in November 2022 is detailed in Figure 6.

Fig.
6 Conclusion of the review of CDE chemical drugs in November 2022

Data source: PharmaIntelligence Data, PharmaIntelligence Consulting

1.
Approval of new chemical drugs

In November, a total of 6 new drugs were approved for marketing, including 3 domestic Class 1 new drugs and 3 imported original research; The following table shows the information
on new drugs approved for marketing in November.

Table 3 Information on new drugs approved in November 2022

Data source: PharmaIntelligence Data, PharmaIntelligence Consulting

● Ansulfaxine hydrochloride sustained-release tablets

Ansulfaxine hydrochloride sustained-release tablets is a class 1 innovative drug independently developed by Shandong Luye Pharmaceutical and has independent intellectual property rights, which is used for the treatment
of depression.
The launch of this drug provides more treatment options
for patients with depression.

● Linplis

Linplisept tablets (Linplisept tablets) is a Class 1 innovative drug independently developed by Shanghai Yingli Pharmaceutical with independent intellectual property rights, which is suitable for adult patients
with relapsed or refractory follicular lymphoma who have received at least two previous systemic treatments.
Linplisept is a selective inhibitor
of the δ isoform (PI3Kδ) of phosphatidylinositol-3-kinase.
Linplisset tablets can inhibit the expression of PI3Kδ protein and reduce the phosphorylation level of AKT protein, thereby inducing apoptosis and inhibiting the proliferation
of malignant B cells and primary tumor cells.

● p-Toluenesulfonamide injection

p-toluenesulfonamide injection is a class 1 innovative drug of Tianjin Hongri Jiandakang Pharmaceutical Technology Co.
, Ltd.
, the drug is developed by Zhong Nanshan, academician of the Chinese Academy of Engineering and a famous medical expert, for the treatment of central non-small cell lung cancer with severe airway obstruction, relieve the clinical symptoms related to airway obstruction, and is the first high-efficiency, broad-spectrum, low-toxicity, specific recognition staining anticancer drug
administered by injection into tumors at home and abroad.

2.
Approval of generic drugs

In November, a total of 99 generic chemical drugs were approved for marketing (statistics by drug name + enterprise dimension), including 33 registered classifications of 3 categories, 61 of 4 categories of registration classification and 3 of 5.
2 categories of registration; ATC classification mainly includes: blood and hematopoietic organs, nervous system, respiratory system and system anti-infective drugs; The classification of ATC for generic drugs approved in November 2022 is shown in Figure 7; The information on generic drugs approved in November is shown in Table 4;

Figure 7 ATC classification of generic drugs approved in November 2022 (from PharmaSmart Data)

Data source: PharmaIntelligence Data, PharmaIntelligence Consulting

Table 4 Information on generic drugs approved in November 2022

Data source: PharmaIntelligence Data, PharmaIntelligence Consulting

2.
Application and review of traditional Chinese medicines

(1) Acceptance of traditional Chinese medicines

In November, CDE undertook a total of 158 traditional Chinese medicine registration application acceptance numbers, including 6 new drugs, 150 supplementary applications, 1 generic application, and 1 one-time import; The acceptance status of CDE Chinese medicine application types from June to November 2022 is shown in Figure 8
.

Figure 8 Acceptance status of CDE Chinese medicine application types from June to November 2022

Data source: PharmaIntelligence Data, PharmaIntelligence Consulting

1.
Declaration of new Chinese medicine drugs

In November, a total of 6 Class 1 innovative drugs of traditional Chinese medicine were undertaken, involving a total of 6 varieties, including 4 IND applications and 2 NDA applications; The following table shows the new Chinese medicine drugs
newly undertaken in November.

Table 5 New Chinese medicine drugs newly undertaken in November 2022

Note: The queue number is as of December 2022, 12

Data source: PharmaIntelligence Data, PharmaIntelligence Consulting

(2) The completion of the review of traditional Chinese medicines

In November, CDE completed the review of 69 traditional Chinese medicine registration applications (based on acceptance numbers), of which 1 new drug acceptance number was NDA application, 67 supplementary applications and 1 one-time import;

In terms of the conclusion of the acceptance number review, no new drugs of traditional Chinese medicine were approved in November, and the conclusions included: 67 supplements were approved, 1 one-time import was approved, and 1 was not approved
.

3.
Review of biological products

(1) Acceptance of biological products

In November, CDE undertook a total of 116 new biological product registration application acceptance numbers, 42 new drugs, 46 supplementary applications, 20 imports (including 2 one-time imports), and 8 import re-registrations; The acceptance status of CDE biological products by application type from June to November 2022 is detailed in Figure 9
.

Figure 9 Acceptance status of CDE biological products by application type from June to November 2022

Data source: PharmaIntelligence Data, PharmaIntelligence Consulting

1.
Declaration of Class 1 new drugs of biological products

In November, a total of 49 Class 1 new drug acceptance numbers for biological products were accepted, all of which were clinical trial applications, and all of them have entered the corresponding sequence to queue for review; The following table shows the newly contracted biological products Class 1 innovative drugs
in November.

Table 6 Class 1 new drugs for biological products newly undertaken in November 2022

Note: The queue number is as of December 2022, 12

Data source: PharmaIntelligence Data, PharmaIntelligence Consulting

(2) The completion of the review of biological products

In November, CDE completed the review of 174 applications for registration of biological products (based on acceptance numbers), including 65 new drug application acceptance numbers, 40 import acceptance numbers, and 62 supplementary applications; According to the statistics of review task categories (in terms of acceptance number), there were 80 clinical trial applications, 9 marketing applications and 62 supplementary applications; The completion of the review of each CDE biologics review task category in November 2022 is shown in Figure 10;

In terms of the conclusion of the acceptance number review, no new drugs for biological products were approved in November, and the conclusions included: 101 approved clinics, 5 approved production, 1 approved import, and 14 unapproved
.

Figure 10 Review status of each CDE biological product review task category in November 2022

Data source: PharmaIntelligence Data, PharmaIntelligence Consulting

4.
Evaluate the declared varieties according to consistency

In November, 72 acceptance numbers and 213 deemed acceptance numbers
were added to the declaration according to the consistency evaluation requirements.
(The space limit only shows consistency information, please pay attention to the drug registration and acceptance database of PharmaSmart Enterprise Edition for specific information); The number of consistency evaluations accepted from January to November 2022 is shown in Figure 11.
Table 7 shows the new
consistency evaluation acceptance number information in November.

Figure 11 Number of consistency evaluations accepted from January to November 2022

Data source: PharmaIntelligence Data, PharmaIntelligence Consulting

Table 7 New consistency evaluation acceptance data in November 2022

Data source: PharmaIntelligence Data, PharmaIntelligence Consulting