YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 184 drug applications between 3 March 2021 and 9 March 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 21, covering 15 drug names.

2021/03/03 – 2021/03/09

Period
2021/03/03 to 2021/03/09, 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
184
Drugs with new generic filings (by drug name, de-duplicated)
15
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

184filings, 21 of them generic

By application type

Application typeFilings
Supplement96
New drug33
Import22
Generic21
Unspecified9
Import re-registration3

By drug type

Drug typeFilings
Chemical drug134
Therapeutic biologic25
TCM21
Biologic2
In vitro diagnostic reagent1
Prophylactic 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

15 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Apremilast Tablets310
2Levofloxacin Injection211
3Atomoxetine Hydrochloride Capsules216
4Memantine Hydrochloride Tablets212
5Esomeprazole Magnesium Enteric-Coated Capsules214
6Tadalafil Tablets1123
7Cefdinir Capsules110
8Tofacitinib Citrate Tablets111
9注射用奥美拉唑钠(静脉滴注) · No verified English name110
10Parecoxib Sodium for Injection112

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

103 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized1020
2Zhong Yu Pharmaceutical (Haikou) Co., Ltd. romanized850
3Fresenius Kabi Austria GmbH720
4Gansu Qi Zheng Zang Yao Co., Ltd. romanized660
5Da Lian Tian Shan Pharma Co., Ltd. romanized550
6Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized520
7CISEN PHARMACEUTICAL CO., LTD.431
8Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized420
9Jilin Si Huan Ao Kang Pharma Co., Ltd. romanized410
10Karyopharm Therapeutics Inc.320

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
2021/03/09Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2100264 Chongqing Lai Mei Pharma Co., Ltd. romanized
2021/03/09Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2100263 Chongqing Lai Mei Pharma Co., Ltd. romanized
2021/03/09New drug · Class 2.2 重组抗EGFR人鼠嵌合单克隆抗体注射液 · No verified English nameCXSL2100086 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2021/03/09New drug · Class 3.3 水痘减毒活疫苗 · No verified English nameCXSL2100085 Ke Xing (Da Lian) Yi Miao Technology Co., Ltd. romanized
2021/03/09New drug · Class 1 GW117口崩片 · No verified English nameCXHL2100158 Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized
2021/03/09New drug · Class 1 GW117口崩片 · No verified English nameCXHL2100157 Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized
2021/03/09New drug · Class 1 BR790片 · No verified English nameCXHL2100156 Jiangxi Qing Feng Pharma Co., Ltd. romanized
2021/03/09New drug · Class 1 BR790片 · No verified English nameCXHL2100155 Jiangxi Qing Feng Pharma Co., Ltd. romanized
2021/03/08Generic · Class 3 Levofloxacin InjectionCYHS2101016 Shandong Qidu Pharmaceutical Co., Ltd.
2021/03/08Generic · Class 3 Levofloxacin InjectionCYHS2101015 Shandong Qidu Pharmaceutical Co., Ltd.
2021/03/06New drug · Class 1 YH003注射液 · No verified English nameCXSL2101002 Name not romanized
2021/03/05Import · Class 1 Tanezumab注射液 · No verified English nameJXSL2100037 Pfizer Inc.
2021/03/05Import · Class 2.2 注射用Luspatercept · No verified English nameJXSL2100036 Celgene Corporation
2021/03/05Import · Class 2.2 注射用Luspatercept · No verified English nameJXSL2100035 Celgene Corporation
2021/03/05Import · Class 1 ATG-016片 · No verified English nameJXHL2100082 Karyopharm Therapeutics Inc.
2021/03/05Import · Class 1 ATG-016片 · No verified English nameJXHL2100081 Karyopharm Therapeutics Inc.
2021/03/05Import · Class 1 注射用EC-DG · No verified English nameJXHL2100080 Name not romanized
2021/03/05New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSS2100030 Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized; Bo Lin Ge Yin Ge Han Bio Pharma (Zhongguo) Co., Ltd. romanized
2021/03/05New drug · Class 1 JS103注射液 · No verified English nameCXSL2100083 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/03/05New drug · Class 2.2 盐酸罗哌卡因脂质体混悬注射液 · No verified English nameCXHL2100170 Nanjing Lv Ye Pharmaceutical Co., Ltd. romanized
2021/03/04Import · Class 1 CG0070注射液 · No verified English nameJXSL2100029 CG Oncology Inc.
2021/03/04Import · Class 1 MB-102注射液 · No verified English nameJXHL2100079 MediBeacon Inc.
2021/03/04Import · Class 1 ALG-010133注射液 · No verified English nameJXHL2100075 Aligos Therapeutics Inc.
2021/03/04Import · Class 1 JNJ-67856633 硬胶囊 · No verified English nameJXHL2100074 Janssen Research & Development LLC
2021/03/04Import · Class 1 JNJ-67856633 硬胶囊 · No verified English nameJXHL2100073 Janssen Research & Development LLC
2021/03/04Import · Class 2.4 ATG-010片 · No verified English nameJXHL2100072 Karyopharm Therapeutics Inc.
2021/03/04Import · Class 1 ZN-c3片 · No verified English nameJXHL2100071 Zentera Therapeutics HK Limited
2021/03/04Import · Class 1 ZN-c3片 · No verified English nameJXHL2100070 Zentera Therapeutics HK Limited
2021/03/04Import · Class 1 注射用LY3437943 · No verified English nameJXHL2100069 Eli Lilly and Company
2021/03/04Generic · Class 3 Carbocisteine Oral SolutionCYHS2100254 Guangdong Pin Cheng Pharmaceuticals Technology Co., Ltd. romanized; Guangzhou Yi Pin Hong Pharmaceutical 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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