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

Highlights in November

• The total number of drug review centers accepted in November was 963 (excluding re-examination)

• In November, 26 new drugs of Class 1 domestic drugs were accepted by CDE

• In November, 72 new acceptance numbers were added for the application based on the consistency evaluation of the quality and efficacy of generic drugs

• Three domestic Class 1 new drugs, namely ansulfaxine hydrochloride sustained-release tablets, p-toluenesulfonamide injection and linplisset tablets, were approved for marketing

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 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

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 .

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;

• ECC4703 capsules

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.

• Mofexidine 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 capsules

BEBT-503, a class 1 new drug of Bibet, 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.

(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. 

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.

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

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