YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 244 drug applications between 2 February 2021 and 8 February 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 42, covering 33 drug names.

2021/02/02 – 2021/02/08

Period
2021/02/02 to 2021/02/08, 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
244
Drugs with new generic filings (by drug name, de-duplicated)
33
Accepted this week, now under review
5

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

244filings, 42 of them generic

By application type

Application typeFilings
Supplement86
Generic42
New drug41
Import40
Unspecified23
Import re-registration12

By drug type

Drug typeFilings
Chemical drug190
Therapeutic biologic30
TCM15
Biologic6
Prophylactic 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

33 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Duloxetine Hydrochloride Enteric Capsules314
2Metaraminol Tartrate Injection222
3Irbesartan Tablets214
4Vortioxetine Hydrobromide Tablets2110
5Tranexamic Acid Injection2111
6Tirofiban Hydrochloride And Sodium Chloride Injection212
7Eldecalcitol Soft Capsules218
8莫米松福莫特罗吸入气雾剂 · No verified English name210
9Tadalafil Tablets1123
10Edaravone Injection110

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

156 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1AstraZeneca AB530
2Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized510
3AbbVie Inc.420
4Actelion Pharmaceuticals Ltd420
5Pfizer Europe MA EEIG420
6ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.424
7Dr. Reddy's Laboratories Limited410
8Amgen Inc.310
9Aspen Pharma Trading Limited310
10Ferring Pharmaceuticals A/S310

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

84 this week

AcceptedDrugApplicants
2021/02/08Import · Class 3.1 重组人促卵泡激素δ注射液 · No verified English nameJXSS2100014 Ferring Pharmaceuticals A/S; Vetter Pharma-Fertigung GmbH & Co.KG
2021/02/08Import · Class 3.1 重组人促卵泡激素δ注射液 · No verified English nameJXSS2100013 Ferring Pharmaceuticals A/S; Vetter Pharma-Fertigung GmbH & Co.KG
2021/02/08Import · Class 3.1 重组人促卵泡激素δ注射液 · No verified English nameJXSS2100012 Ferring Pharmaceuticals A/S; Vetter Pharma-Fertigung GmbH & Co.KG
2021/02/08Generic · Class 3 Terbutaline Sulfate InjectionCYHS2100174 Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized
2021/02/08Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2100173 Sichuan Pu Rui Te Pharma Co., Ltd. romanized
2021/02/08Generic · Class 3 Benzbromarone TabletsCYHS2100172 Chengdu Brilliant Pharmaceutical Co., Ltd.
2021/02/08New drug · Class 1.1 天杏咳喘贴 · No verified English nameCXZS2100003 Hubei You Er Sheng Pharma Co., Ltd. romanized
2021/02/08New drug · Class 1.1 天杏咳喘贴 · No verified English nameCXZS2100002 Hubei You Er Sheng Pharma Co., Ltd. romanized
2021/02/08New drug · Class 1.1 天杏咳喘贴 · No verified English nameCXZS2100001 Hubei You Er Sheng Pharma Co., Ltd. romanized
2021/02/08New drug · Class 1 注射用SG12473 · No verified English nameCXSL2101000 Hangzhou Shang Jian Bio Technology Co., Ltd. romanized
2021/02/08New drug · Class 1 GR1802注射液 · No verified English nameCXSL2100048 Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2021/02/08New drug · Class 1 西奥罗尼胶囊 · No verified English nameCXHL2101001 Shenzhen Wei Xin Bio Technology Co., Ltd. romanized
2021/02/08New drug · Class 1 西奥罗尼胶囊 · No verified English nameCXHL2101000 Shenzhen Wei Xin Bio Technology Co., Ltd. romanized
2021/02/08New drug · Class 1 HY1770乳膏 · No verified English nameCXHL2100099 Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized
2021/02/08New drug · Class 1 HY1770乳膏 · No verified English nameCXHL2100098 Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized
2021/02/08New drug · Class 1 HY1770乳膏 · No verified English nameCXHL2100097 Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized
2021/02/08New drug · Class 1 HY1770乳膏 · No verified English nameCXHL2100096 Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized
2021/02/08New drug · Class 1 HY1770乳膏 · No verified English nameCXHL2100095 Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized
2021/02/06Import · Class 3.1 注射用罗特西普 · No verified English nameJXSS2100011 Celgene Corporation; Patheon Italia S.p.A.
2021/02/06Import · Class 3.1 注射用罗特西普 · No verified English nameJXSS2100010 Celgene Corporation; Patheon Italia S.p.A.
2021/02/06New drug · Class 1 EMB-02注射液 · No verified English nameCXSL2100047 Shanghai An Mai Bio Technology Co., Ltd. romanized
2021/02/06New drug · Class 1 GR1802注射液 · No verified English nameCXSL2100045 Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2021/02/06New drug · Class 1 GR1802注射液 · No verified English nameCXSL2100044 Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2021/02/06New drug · Class 2.4 环泊酚注射液 · No verified English nameCXHS2100003 Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized
2021/02/06New drug · Class 1 SHR1459片 · No verified English nameCXHL2100094 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/02/06New drug · Class 1 SHR1459片 · No verified English nameCXHL2100093 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/02/06New drug · Class 1 SHR1459片 · No verified English nameCXHL2100092 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/02/06New drug · Class 1 YY-20394片 · No verified English nameCXHL2100091 Shanghai Ying Li Pharma Co., Ltd. romanized
2021/02/05Import · Class 2.2 Benralizumab注射液 · No verified English nameJXSL2100018 AstraZeneca AB
2021/02/05Import · Class 1 TK216注射液 · No verified English nameJXHL2100045 Shanghai Pharmaceutical (USA) Inc.

54 more not listed (at most 30 rows).

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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