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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 228 drug applications between 23 January 2021 and 29 January 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 41, covering 31 drug names.

2021/01/23 – 2021/01/29

Period
2021/01/23 to 2021/01/29, 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
228
Drugs with new generic filings (by drug name, de-duplicated)
31
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

228filings, 41 of them generic

By application type

Application typeFilings
Supplement116
Generic41
New drug34
Import21
Unspecified8
Import re-registration8

By drug type

Drug typeFilings
Chemical drug192
Therapeutic biologic22
TCM11
Prophylactic biologic2
Biologic1

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

31 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tranexamic Acid Injection3111
2Tenofovir alafenamide Fumarate Tablets220
3Delafloxacin for Injection220
4Sodium Valproate Concentrated Solution for Injection210
5Ipratropium Bromide Inhalation Solution212
6Temozolomide Capsules210
7Carfilzomib For Injection210
8Dapagliflozin Tablets2184
9Febuxostat Tablets2112
10Linezolid and Glucose Injection113

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
1Suzhou Kai Tuo Pharma Co., Ltd. romanized920
2Yangtze River Pharmaceutical Group Co., Ltd545
3Hubei Yi Ban Tian Pharmaceutical Co., Ltd. romanized520
4Changzhou Heng Bang Pharma Co., Ltd. romanized430
5Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized420
6Shandong Run Ze Pharmaceutical Co., Ltd. romanized420
7Roche Pharma(Schweiz)AG410
8Jiangsu Xin Yuan Su Pharmaceuticals Technology Co., Ltd. romanized410
9Zhejiang Hai Kang Bio Zhi Pin Co., Ltd. romanized410
10Suzhou Xi Ke Luo Pharmaceutical Co., Ltd. romanized410

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

59 this week

AcceptedDrugApplicants
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
2021/01/29New drug · Class 1 GT20029酊 · No verified English nameCXHL2100064 Suzhou Kai Tuo Pharma Co., Ltd. romanized
2021/01/29New drug · Class 1 GT20029酊 · No verified English nameCXHL2100063 Suzhou Kai Tuo Pharma Co., Ltd. romanized
2021/01/29New drug · Class 1 GT20029酊 · No verified English nameCXHL2100062 Suzhou Kai Tuo Pharma Co., Ltd. romanized
2021/01/28Import · Class 2.4 Oxaliplatin for InjectionJXHS2100012 Sanofi-Aventis France; CENEXI-Laboratoires THISSEN S.A.
2021/01/28Generic · Class 3 Epinastine Hydrochloride Eye DropsCYHS2100125 Zhao Ke (Guangzhou) Yan Ke Drug Co., Ltd. romanized
2021/01/28New drug · Class 3.3 23价肺炎球菌多糖疫苗 · No verified English nameCXSL2100033 Ai Mei Wei Xin Bio Pharma (Zhejiang) Co., Ltd. romanized
2021/01/28New drug · Class 1 注射用SIM1910-09 · No verified English nameCXHL2100061 Hainan Xian Sheng Pharma Co., Ltd. romanized
2021/01/28New drug · Class 2.2 注射用多西他赛聚合物胶束 · No verified English nameCXHL2100029 Jiangsu Vanguard Pharmaceutical Co., Ltd.
2021/01/27Import · Class 2.4 Tofacitinib Citrate TabletsJXHS2100011 Pfizer Europe MA EEIG; Pfizer Manufacturing Deutschland GmbH
2021/01/27Generic · Class 3 Carfilzomib For InjectionCYHL2100010 Yangtze River Pharmaceutical Group Co., Ltd
2021/01/27Generic · Class 3 Carfilzomib For InjectionCYHL2100009 Yangtze River Pharmaceutical Group Co., Ltd
2021/01/27Generic · Class 3 Fosnetupitant and Palonosetron for InjectionCYHL2100007 Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized
2021/01/27New drug · Class 2.2 QP001注射液 · No verified English nameCXHL2100060 Nanjing Qing Pu Bio Technology Co., Ltd. romanized

29 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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