YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 22 drug applications between 30 January 2025 and 5 February 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 10, covering 8 drug names.

2025/01/30 – 2025/02/05

Period
2025/01/30 to 2025/02/05, 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
22
Drugs with new generic filings (by drug name, de-duplicated)
8
Accepted this week, now under review
1

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

22filings, 10 of them generic

By application type

Application typeFilings
Generic10
Supplement9
New drug3

By drug type

Drug typeFilings
Chemical drug14
TCM5
Therapeutic biologic3

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

8 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets2160
2Imatinib Mesylate Tablets215
3Acetylcysteine Injection1153
4Dienogest Tablets112
5Bumetanide Injection1113
6氧(液态) · No verified English name1113
7磷/碳酸氢钠血滤置换液(4mmol/L钾、1.25mmol/L钙) · No verified English name110
8维生素B??滴眼液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.112

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

19 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized210
2Shandong Lukang Pharmaceutical Co.,Ltd.212
3Shaanxi Tian Yu Pharmaceutical Co., Ltd. romanized212
4Janssen Biologics B.V.110
5Yi Li Pharmaceutical (Luo Ding) Co., Ltd. romanized110
6Beijing De Mo Gao Ke Pharmaceuticals Technology Co., Ltd. romanized110
7Shandong Hua Lu Pharmaceutical Co., Ltd. romanized110
8SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED110
9Shandong Fang Ming Pharma Group Co., Ltd. romanized111
10Guangdong Xiang Shan Tang Pharmaceutical 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

6 this week

AcceptedDrugApplicants
2025/02/05Generic · Class 3 磷/碳酸氢钠血滤置换液(4mmol/L钾、1.25mmol/L钙) · No verified English nameCYHS2500563 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized
2025/02/05Generic · Class 3 Bumetanide InjectionCYHS2500562 Shandong Fang Ming Pharma Group Co., Ltd. romanized
2025/02/05Generic · Class 3 Acetylcysteine InjectionCYHS2500560 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2025/02/05New drug · Class 1 AK139注射液 · No verified English nameCXSL2500100 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2025/02/05New drug · Class 1 AK139注射液 · No verified English nameCXSL2500099 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2025/02/05New drug · Class 2.2 DM2065贴 · No verified English nameCXHL2500148 Beijing De Mo Gao Ke 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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