YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 232 drug applications between 11 August 2021 and 17 August 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 49, covering 35 drug names.

2021/08/11 – 2021/08/17

Period
2021/08/11 to 2021/08/17, 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
232
Drugs with new generic filings (by drug name, de-duplicated)
35
Accepted this week, now under review
1

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

232filings, 49 of them generic

By application type

Application typeFilings
Supplement117
Generic49
New drug36
Import14
Unspecified8
Import re-registration8

By drug type

Drug typeFilings
Chemical drug162
Therapeutic biologic47
TCM21
In vitro diagnostic reagent1
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

35 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ornidazole Injection420
2Rivaroxaban Tablets323
3Omeprazole and Sodium Bicarbonate Capsules320
4草酸艾司西酞普兰口服溶液 · No verified English name3211
5Meropenem for Injection315
6Gemcitabine Hydrochloride for Injection211
7Iopamidol Injection210
8Sugammadex Sodium Injection216
9Tadalafil Tablets1123
10Olmesartan Medoxomil and Hydrochlorothiazide Tablets113

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

143 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Janssen Research & Development LLC640
2Upjohn EESV630
3AstraZeneca AB620
4Novartis Pharma Schweiz AG620
5Jilin Hua Kang Pharma Co., Ltd. romanized550
6Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized530
7Boehringer Ingelheim International GmbH510
8Haerbin Han Bang Medical Technology Co., Ltd. romanized510
9Shandong Er Ye Pharmaceutical Co., Ltd. romanized510
10Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized421

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
2021/08/17Import · Class 1 Relatlimab/Nivolumab固定剂量复方注射液 · No verified English nameJXSL2101097 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2021/08/17Import · Class 1 JNJ-63733657注射液 · No verified English nameJXSL2101091 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2021/08/17Import · Class 1 注射用普那布林浓溶液 · No verified English nameJXHS2101041 BeyondSpring Pharmaceuticals Inc.; Pharmaceutics International Incorporated(Pii); Dalian Wanchun Bulin Pharmaceutical Co. Ltd.
2021/08/17Import · Class 1 Difelikefalin注射液 · No verified English nameJXHL2101166 Vifor Fresenius Medical Care Renal Pharma Ltd.; Hangzhou Tigermed Consulting Co. Ltd.
2021/08/17Generic · Class 3 Paracetamol and Caffeine TabletsCYHS2101600 Jiangsu Vanguard Pharmaceutical Co., Ltd.
2021/08/17Generic · Class 3 Ornidazole InjectionCYHS2101599 Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2021/08/17Generic · Class 3 Ornidazole InjectionCYHS2101598 Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2021/08/17Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2101595 Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized
2021/08/17Generic · Class 3 Iopamidol InjectionCYHS2101594 Hainan Pu Li Pharmaceutical Co., Ltd. romanized
2021/08/17Generic · Class 3 Iopamidol InjectionCYHS2101593 Hainan Pu Li Pharmaceutical Co., Ltd. romanized
2021/08/17Generic · Class 3 Omeprazole and Sodium Bicarbonate CapsulesCYHS2101590 Hebei Xin Rui Wei Lai Technology Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2021/08/17Generic · Class 3 Trelagliptin Succinate TabletsCYHS2101573 CSPC OUYI PHARMACEUTICAL CO., LTD.
2021/08/17Generic · Class 3 Ambroxol Hydrochloride Oral SolutionCYHS2101561 Jiangsu Vanguard Pharmaceutical Co., Ltd.
2021/08/17New drug · Class 1 CM326注射液 · No verified English nameCXSL2101271 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2021/08/17New drug · Class 1 TQB2928注射液 · No verified English nameCXSL2101269 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2021/08/17New drug · Class 1 AK119注射液 · No verified English nameCXSL2101265 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2021/08/17New drug · Class 1 AK104注射液 · No verified English nameCXSL2101264 Kang Fang Pharma Co., Ltd. romanized
2021/08/17New drug · Class 1 HRS-8080片 · No verified English nameCXHL2101409 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2021/08/17New drug · Class 1 HRS-8080片 · No verified English nameCXHL2101408 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2021/08/17New drug · Class 1 HS-10342片 · No verified English nameCXHL2101407 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/08/16Import · Class 1 Teclistamab 注射液 · No verified English nameJXSL2101096 Janssen Research & Development, LLC; Johnson & Johnson (China) Investment Ltd.
2021/08/16Import · Class 1 Teclistamab 注射液 · No verified English nameJXSL2101095 Janssen Research & Development, LLC; Johnson & Johnson (China) Investment Ltd.
2021/08/16Import · Class 1 Tiragolumab注射液 · No verified English nameJXSL2101094 F.Hoffmann-La Roche Ltd.; Roche(China)Holding Ltd.
2021/08/16Import · Class 1 MHV370胶囊 · No verified English nameJXHL2101164 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2021/08/16Generic · Class 3 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2101584 Chengdu Kang Hong Pharma Group Co., Ltd. romanized; Chengdu Di Kang Pharma Co., Ltd. romanized
2021/08/16Generic · Class 3 Ornidazole InjectionCYHS2101578 Shandong Zhi Tai Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2021/08/16Generic · Class 3 Ornidazole InjectionCYHS2101577 Shandong Zhi Tai Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2021/08/16New drug · Class 1 冻干GT90008抗体蛋白 · No verified English nameCXSL2101268 Kai Tuo Pharma (Guangdong) Co., Ltd. romanized
2021/08/16New drug · Class 1 靶向间皮素嵌合抗原受体NK细胞注射液 · No verified English nameCXSL2101267 Guo Jian Cheng Nuo Bio Technology (Beijing) Co., Ltd. romanized
2021/08/16New drug · Class 1 注射用SHR-A1921 · No verified English nameCXSL2101266 Suzhou Sheng Di Ya Biopharmaceuticals 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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