YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 207 drug applications between 30 January 2021 and 5 February 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 38, covering 26 drug names.

2021/01/30 – 2021/02/05

Period
2021/01/30 to 2021/02/05, 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
207
Drugs with new generic filings (by drug name, de-duplicated)
26
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

207filings, 38 of them generic

By application type

Application typeFilings
Supplement70
Import40
Generic38
New drug25
Unspecified23
Import re-registration11

By drug type

Drug typeFilings
Chemical drug170
Therapeutic biologic16
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

26 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Peramivir Injection337
2Duloxetine Hydrochloride Enteric Capsules314
3Metaraminol Tartrate Injection222
4Sodium Valproate Concentrated Solution for Injection210
5Irbesartan Tablets214
6Vortioxetine Hydrobromide Tablets2110
7Tranexamic Acid Injection2111
8Pramipexole Dihydrochloride Prolonged-release Tablets210
9Tirofiban Hydrochloride And Sodium Chloride Injection212
10莫米松福莫特罗吸入气雾剂 · No verified English name210

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

135 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1AstraZeneca AB530
2AbbVie Inc.420
3Actelion Pharmaceuticals Ltd420
4Amgen Inc.420
5Dr. Reddy's Laboratories Limited410
6Boehringer Ingelheim International GmbH320
7Yangtze River Pharmaceutical Group Co., Ltd323
8Aspen Pharma Trading Limited310
9GLAXOSMITHKLINE S.A.310
10Laboratoire GlaxoSmithKline310

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

69 this week

AcceptedDrugApplicants
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
2021/02/03Import · Class 1 注射用Trilaciclib · No verified English nameJXHL2100040 G1 THERAPEUTICS INC.
2021/02/03Import · Class 2.4 Olaparib TabletsJXHL2100039 AstraZeneca AB
2021/02/03Import · Class 2.4 Olaparib TabletsJXHL2100038 AstraZeneca AB
2021/02/03Import · Class 1 Navitoclax片 · No verified English nameJXHL2100037 AbbVie Inc.
2021/02/03Import · Class 1 Navitoclax片 · No verified English nameJXHL2100036 AbbVie Inc.
2021/02/03Import · Class 1 ABBV-744片 · No verified English nameJXHL2100035 AbbVie Inc.
2021/02/03Import · Class 1 ABBV-744片 · No verified English nameJXHL2100034 AbbVie Inc.
2021/02/03Generic · Class 3 Metaraminol Tartrate InjectionCYHS2100153 Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized
2021/02/03Generic · Class 3 Tofacitinib Citrate Extended Release tabletsCYHS2100152 CSPC OUYI PHARMACEUTICAL CO., LTD.
2021/02/03Generic · Class 3 Tirofiban Hydrochloride And Sodium Chloride InjectionCYHS2100151 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized

39 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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