YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 216 drug applications between 31 January 2021 and 6 February 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 36, covering 27 drug names.

2021/01/31 – 2021/02/06

Period
2021/01/31 to 2021/02/06, 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
216
Drugs with new generic filings (by drug name, de-duplicated)
27
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

216filings, 36 of them generic

By application type

Application typeFilings
Supplement80
Generic36
Import36
New drug29
Unspecified23
Import re-registration12

By drug type

Drug typeFilings
Chemical drug172
Therapeutic biologic23
TCM12
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

27 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
9Edaravone Injection110
10Lidocaine and Prilocaine Cream1124

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

141 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1AstraZeneca AB530
2AbbVie Inc.420
3Actelion Pharmaceuticals Ltd420
4Pfizer Europe MA EEIG420
5Dr. Reddy's Laboratories Limited410
6Amgen Inc.310
7Aspen Pharma Trading Limited310
8GLAXOSMITHKLINE S.A.310
9Laboratoire GlaxoSmithKline310
10Sandoz Private Limited310

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

66 this week

AcceptedDrugApplicants
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.
2021/02/05Generic · Class 3 Tranexamic Acid InjectionCYHS2100168 Guangdong Sunho Pharmaceutical Co., Ltd.
2021/02/05Generic · Class 3 Tranexamic Acid InjectionCYHS2100167 Guangdong Sunho Pharmaceutical Co., Ltd.
2021/02/05Generic · Class 3 对乙酰氨基酚泡腾片 · No verified English nameCYHS2100164 Shenyang Ao Ji Na Pharma Co., Ltd. romanized
2021/02/05Generic · Class 3 Compound Paracetamol and Vitamin C Effervescent TabletsCYHS2100162 Hainan Tao Sheng Pharmaceuticals Technology Research Institute Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2021/02/05Generic · Class 3 Peramivir InjectionCYHS2100161 Zhong Run Pharma Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2021/02/05Generic · Class 3 Metaraminol Tartrate InjectionCYHS2100160 Chengdu Giantech Hi-technology Development Co., Ltd.; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2021/02/05Generic · Class 3 醋酸艾司利卡西平片 · No verified English nameCYHS2100147 Yang Zi Jiang Pharma Group Beijing Hai Yan Pharma Co., Ltd. romanized; Yangtze River Pharmaceutical Group Co., Ltd
2021/02/05New drug · Class 2.2 注射用利培酮微球(4W) · No verified English nameCXHL2100090 Guangzhou Di Qi Pharmaceuticals Technology Co., Ltd. romanized
2021/02/05New drug · Class 2.2 注射用利培酮微球(4W) · No verified English nameCXHL2100089 Guangzhou Di Qi Pharmaceuticals Technology Co., Ltd. romanized
2021/02/05New drug · Class 2.2 注射用利培酮微球(4W) · No verified English nameCXHL2100088 Guangzhou Di Qi Pharmaceuticals Technology Co., Ltd. romanized
2021/02/03Import · Class 1 PF-06480605注射液 · No verified English nameJXSL2100017 Pfizer Inc.
2021/02/03Import · Class 1 RO7030816 · No verified English nameJXSL2100016 F. Hoffmann-La Roche Ltd
2021/02/03Import · Class 1 RO7030816 · No verified English nameJXSL2100015 F. Hoffmann-La Roche Ltd
2021/02/03Import · Class 1 Finerenone薄膜衣片 · No verified English nameJXHS2100018 Bayer AG
2021/02/03Import · Class 1 Finerenone薄膜衣片 · No verified English nameJXHS2100017 Bayer AG
2021/02/03Import · Class 2.4 阿贝西利片 · No verified English nameJXHL2100044 Eli Lilly and Company
2021/02/03Import · Class 2.4 环硅酸锆钠散 · No verified English nameJXHL2100042 AstraZeneca AB
2021/02/03Import · Class 2.4 环硅酸锆钠散 · No verified English nameJXHL2100041 AstraZeneca AB

36 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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