YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 16 drug applications between 3 October 2025 and 9 October 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 7, covering 7 drug names.

2025/10/03 – 2025/10/09

Period
2025/10/03 to 2025/10/09, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
16
Drugs with new generic filings (by drug name, de-duplicated)
7
Accepted this week, now under review
7

DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.

Names with a public page are linked.

New acceptances this week

By application type and drug type

16filings, 7 of them generic

By application type

Application typeFilings
Generic7
Supplement6
New drug2
Import re-registration1

By drug type

Drug typeFilings
Chemical drug13
Therapeutic biologic2
TCM1

DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.

Most new generic filings, by drug

7 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Calcium Folinate Injection114
2Furosemide Injection116
3Fusidic Acid Cream1115
4比卡鲁胺片 · No verified English name111
5Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets(III)1110
6Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ)1115
7Apalutamide Tablets1118

DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.

Most new acceptances, by company

13 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized222
2Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized210
3Jiangsu Vanguard Pharmaceutical Co., Ltd.210
4Roche Pharma (Schweiz) AG110
5Shanxi Pu De Pharma Co., Ltd. romanized111
6Guangdong Hua Nan Pharma Group Co., Ltd. romanized110
7Kun Shan Long Deng Rui Di Pharmaceutical Co., Ltd. romanized111
8Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized111
9Henan Pu Rui Pharma Co., Ltd. romanized111
10Henan Yue Ren Pharma Co., Ltd. romanized110

DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.

Under-review list changes

Compared across this platform's snapshots of the under-review list

Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.

DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

3 this week

AcceptedDrugApplicants
2025/10/09Generic · Class 3 Furosemide InjectionCYHS2503598 Henan Pu Rui Pharma Co., Ltd. romanized
2025/10/09New drug · Class 1 HSK36357胶囊 · No verified English nameCXHL2501060 Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized
2025/10/09New drug · Class 1 HSK36357胶囊 · No verified English nameCXHL2501059 Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized

DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.

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