YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 190 drug applications between 29 January 2021 and 4 February 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 33, covering 24 drug names.

2021/01/29 – 2021/02/04

Period
2021/01/29 to 2021/02/04, 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
190
Drugs with new generic filings (by drug name, de-duplicated)
24
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

190filings, 33 of them generic

By application type

Application typeFilings
Supplement66
Import39
New drug38
Generic33
Unspecified11
Import re-registration3

By drug type

Drug typeFilings
Chemical drug156
Therapeutic biologic17
TCM10
Prophylactic biologic4
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

24 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Duloxetine Hydrochloride Enteric Capsules314
2Tenofovir alafenamide Fumarate Tablets220
3Peramivir Injection227
4Sodium Valproate Concentrated Solution for Injection210
5Irbesartan Tablets214
6Pramipexole Dihydrochloride Prolonged-release Tablets210
7Tirofiban Hydrochloride And Sodium Chloride Injection212
8莫米松福莫特罗吸入气雾剂 · No verified English name210
9Edaravone Injection110
10Canagliflozin Tablets118

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

120 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Suzhou Kai Tuo Pharma Co., Ltd. romanized920
2AbbVie Inc.420
3Amgen Inc.420
4AstraZeneca AB420
5Dr. Reddy's Laboratories Limited410
6Guo Yao Group Wei Qi Da Pharma Co., Ltd. romanized330
7Boehringer Ingelheim International GmbH320
8Guangdong Dong Yang Guang Pharma Co., Ltd. romanized320
9Pfizer Europe MA EEIG310
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

77 this week

AcceptedDrugApplicants
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
2021/02/03Generic · Class 3 Tirofiban Hydrochloride And Sodium Chloride InjectionCYHS2100150 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2021/02/03Generic · Class 3 盐酸肾上腺素注射液 · No verified English nameCYHS2100148 Wuhan Wu Yao Pharmaceutical Co., Ltd. romanized; Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized
2021/02/03Generic · Class 3 莫米松福莫特罗吸入气雾剂 · No verified English nameCYHL2100012 Health Yuan Pharma Group Co., Ltd. romanized
2021/02/03Generic · Class 3 莫米松福莫特罗吸入气雾剂 · No verified English nameCYHL2100011 Health Yuan Pharma Group Co., Ltd. romanized
2021/02/03New drug · Class 1.1 T89(Compound Danshen Dripping Pill) · No verified English nameCXZL2100002 Tian Shi Li Pharmaceuticals Group Co., Ltd. romanized
2021/02/03New drug · Class 2.2 注射用重组人尿激酶原 · No verified English nameCXSS2100013 Tian Shi Li Biopharmaceuticals Co., Ltd. romanized
2021/02/03New drug · Class 1 MG-K10人源化单抗注射液 · No verified English nameCXSL2100043 Shanghai Mai Ji Bio Technology Co., Ltd. romanized
2021/02/03New drug · Class 1 SHR-1314注射液 · No verified English nameCXSL2100042 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/02/03New drug · Class 1 HLX26单抗注射液 · No verified English nameCXSL2100041 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized
2021/02/03New drug · Class 1 注射用NVS451融合蛋白 · No verified English nameCXSL2100040 Guo Yao Zhong Sheng Bio Technology Research Institute Co., Ltd. romanized
2021/02/03New drug · Class 1 NBL-012注射液 · No verified English nameCXSL2100039 Shanghai Xin Shi Biopharmaceuticals Co., Ltd. romanized
2021/02/03New drug · Class 1 EX101注射液 · No verified English nameCXSL2100036 Guangzhou Ai Si Mai Biopharmaceuticals Technology Co., Ltd. romanized

47 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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