YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 230 drug applications between 26 February 2021 and 4 March 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 22, covering 17 drug names.

2021/02/26 – 2021/03/04

Period
2021/02/26 to 2021/03/04, 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
230
Drugs with new generic filings (by drug name, de-duplicated)
17
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

230filings, 22 of them generic

By application type

Application typeFilings
Supplement102
New drug50
Import27
Generic22
Unspecified19
Import re-registration10

By drug type

Drug typeFilings
Chemical drug182
Therapeutic biologic34
TCM9
Biologic3
Prophylactic biologic2

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

17 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Apremilast Tablets310
2Dexmedetomidine Hydrochloride Injection220
3Quetiapine Fumarate Extended-release Tablets210
4Memantine Hydrochloride Tablets212
5Compound Ipratropium Bromide Solution For Inhalation114
6Cefdinir Capsules110
7Olmesartan Medoxomil and Amlodipine Besylate Tablets112
8注射用奥美拉唑钠(静脉滴注) · No verified English name110
9Metformin Hydrochloride Extended-release Tablets1110
10Moxifloxacin Hydrochloride Eye Drops114

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

130 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized810
2Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized630
3Bayer Inc.610
4Xian Jing Xi Shuang He Pharma Co., Ltd. romanized610
5Da Lian Tian Shan Pharma Co., Ltd. romanized550
6Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized520
7Aligos Therapeutics Inc.420
8Guo Yao Group Guo Rui Pharma Co., Ltd. romanized420
9Qilu Pharmaceutical (Hainan) Co., Ltd420
10Shanghai Kai Mao Biopharmaceuticals 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

79 this week

AcceptedDrugApplicants
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
2021/03/04Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2100252 Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2021/03/04New drug · Class 1 AK104注射液 · No verified English nameCXSL2100082 Kang Fang Pharma Co., Ltd. romanized
2021/03/04New drug · Class 1 IBI321 · No verified English nameCXSL2100081 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2021/03/04New drug · Class 1 甲磺酸贝福替尼胶囊 · No verified English nameCXHS2100009 Bei Da Pharma Co., Ltd. romanized
2021/03/04New drug · Class 1 甲磺酸贝福替尼胶囊 · No verified English nameCXHS2100008 Bei Da Pharma Co., Ltd. romanized
2021/03/04New drug · Class 1 YY-20394片 · No verified English nameCXHL2100169 Shanghai Ying Li Pharma Co., Ltd. romanized
2021/03/04New drug · Class 1 GW117胶囊 · No verified English nameCXHL2100168 Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized
2021/03/04New drug · Class 1 GW117胶囊 · No verified English nameCXHL2100167 Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized
2021/03/04New drug · Class 1 GW117胶囊 · No verified English nameCXHL2100166 Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized
2021/03/04New drug · Class 1 GW117胶囊 · No verified English nameCXHL2100165 Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized
2021/03/04New drug · Class 1 GW117胶囊 · No verified English nameCXHL2100164 Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized
2021/03/04New drug · Class 1 GW117胶囊 · No verified English nameCXHL2100163 Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized
2021/03/04New drug · Class 1 GW117胶囊 · No verified English nameCXHL2100162 Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized
2021/03/04New drug · Class 1 GW117胶囊 · No verified English nameCXHL2100161 Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized
2021/03/04New drug · Class 1 SHR0302片 · No verified English nameCXHL2100160 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/03/04New drug · Class 1 SHR0302片 · No verified English nameCXHL2100159 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/03/03Import · Class 2.4 Osimertinib Mesylate TabletsJXHL2100068 AstraZeneca AB
2021/03/03Import · Class 2.4 Osimertinib Mesylate TabletsJXHL2100067 AstraZeneca AB
2021/03/03Generic · Class 3 Apremilast TabletsCYHS2101013 Hangzhou Zhu Yang Xin Pharma Co., Ltd. romanized
2021/03/03Generic · Class 3 Apremilast TabletsCYHS2101012 Hangzhou Zhu Yang Xin Pharma Co., Ltd. romanized

49 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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