YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 154 drug applications between 26 January 2021 and 1 February 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 30, covering 22 drug names.

2021/01/26 – 2021/02/01

Period
2021/01/26 to 2021/02/01, 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
154
Drugs with new generic filings (by drug name, de-duplicated)
22
Accepted this week, now under review
0

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

154filings, 30 of them generic

By application type

Application typeFilings
Supplement76
Generic30
New drug28
Import14
Unspecified4
Import re-registration2

By drug type

Drug typeFilings
Chemical drug127
Therapeutic biologic16
TCM8
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

22 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tranexamic Acid Injection3111
2Peramivir Injection227
3Sodium Valproate Concentrated Solution for Injection210
4Ipratropium Bromide Inhalation Solution212
5Carfilzomib For Injection210
6Pramipexole Dihydrochloride Prolonged-release Tablets210
7Dapagliflozin Tablets2184
8Canagliflozin Tablets118
9Ambroxol Hydrochloride Solution For Inhalation1110
10Tenofovir alafenamide Fumarate Tablets110

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

98 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Suzhou Kai Tuo Pharma Co., Ltd. romanized920
2Hubei Yi Ban Tian Pharmaceutical Co., Ltd. romanized520
3Yangtze River Pharmaceutical Group Co., Ltd434
4Roche Pharma(Schweiz)AG410
5Jiangsu Xin Yuan Su Pharmaceuticals Technology Co., Ltd. romanized410
6Zhejiang Hai Kang Bio Zhi Pin Co., Ltd. romanized410
7Guo Yao Group Wei Qi Da Pharma Co., Ltd. romanized330
8Karyopharm Therapeutics Inc.320
9Genzyme Corporation310
10Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized310

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

47 this week

AcceptedDrugApplicants
2021/01/30Import · Class 1 Tiragolumab注射液 · No verified English nameJXSL2100014 F.Hoffmann-La Roche Ltd
2021/01/30Import · Class 3.3 阿柏西普眼内注射溶液 · No verified English nameJXSL2100013 Affamed Therapeutics (HK) Limited
2021/01/30Import · Class 1 AMG 570 · No verified English nameJXSL2100012 Amgen Inc.
2021/01/30Import · Class 1 ATG-019 片 · No verified English nameJXHL2100031 Karyopharm Therapeutics Inc.
2021/01/30Import · Class 1 ATG-019 片 · No verified English nameJXHL2100030 Karyopharm Therapeutics Inc.
2021/01/30Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2100139 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2021/01/30Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2100138 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2021/01/30Generic · Class 3 Peramivir InjectionCYHS2100136 Yangtze River Pharmaceutical Group Co., Ltd
2021/01/30Generic · Class 3 Peramivir InjectionCYHS2100134 Yang Zi Jiang Pharma Group Sichuan Hai Rong Pharma Co., Ltd. romanized
2021/01/30New drug · Class 1 HH30134片 · No verified English nameCXHL2100079 Shanghai Hai He Drug Research Kai Fa Co., Ltd. romanized
2021/01/30New drug · Class 1 HH30134片 · No verified English nameCXHL2100078 Shanghai Hai He Drug Research Kai Fa Co., Ltd. romanized
2021/01/30New drug · Class 2.4 奥布替尼片 · No verified English nameCXHL2100077 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2021/01/30New drug · Class 2.4 奥布替尼片 · No verified English nameCXHL2100076 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2021/01/29Generic · Class 3 Azelastine hydrochloride Fluticasone Propionate Nasal SprayCYHS2100131 Zhang Feng Pharma Co., Ltd. romanized
2021/01/29Generic · Class 3 Memantine Hydrochloride Oral SolutionCYHS2100130 Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2021/01/29Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHS2100128 Yin Gu Pharmaceutical Co., Ltd. romanized
2021/01/29Generic · Class 3 Enalapril Maleate Oral SolutionCYHS2100127 Sichuan Bai Li Pharma Co., Ltd. romanized
2021/01/29New drug · Class 1.1 雪蟾软坚柔肝片 · No verified English nameCXZL2100001 Shanghai Tian Chan Bio Technology Co., Ltd. romanized
2021/01/29New drug · Class 1 注射用SHR-A1904 · No verified English nameCXSL2100034 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/01/29New drug · Class 1 CN401片 · No verified English nameCXHL2100075 Tong Run Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2021/01/29New drug · Class 1 CN401片 · No verified English nameCXHL2100074 Tong Run Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2021/01/29New drug · Class 1 IBI362注射液 · No verified English nameCXHL2100073 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2021/01/29New drug · Class 1 IBI362注射液 · No verified English nameCXHL2100072 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2021/01/29New drug · Class 1 IBI362注射液 · No verified English nameCXHL2100071 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2021/01/29New drug · Class 1 GT20029凝胶 · No verified English nameCXHL2100070 Suzhou Kai Tuo Pharma Co., Ltd. romanized
2021/01/29New drug · Class 1 GT20029凝胶 · No verified English nameCXHL2100069 Suzhou Kai Tuo Pharma Co., Ltd. romanized
2021/01/29New drug · Class 1 GT20029凝胶 · No verified English nameCXHL2100068 Suzhou Kai Tuo Pharma Co., Ltd. romanized
2021/01/29New drug · Class 1 GT20029凝胶 · No verified English nameCXHL2100067 Suzhou Kai Tuo Pharma Co., Ltd. romanized
2021/01/29New drug · Class 1 GT20029凝胶 · No verified English nameCXHL2100066 Suzhou Kai Tuo Pharma Co., Ltd. romanized
2021/01/29New drug · Class 1 GT20029凝胶 · No verified English nameCXHL2100065 Suzhou Kai Tuo Pharma Co., Ltd. romanized

17 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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