YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 226 drug applications between 20 April 2021 and 26 April 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 31, covering 21 drug names.

2021/04/20 – 2021/04/26

Period
2021/04/20 to 2021/04/26, 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
226
Drugs with new generic filings (by drug name, de-duplicated)
21
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

226filings, 31 of them generic

By application type

Application typeFilings
Supplement97
New drug49
Generic31
Import22
Import re-registration17
Unspecified10

By drug type

Drug typeFilings
Chemical drug156
TCM36
Therapeutic biologic34

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

21 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets4123
2Rivaroxaban Tablets323
3Ornidazole Injection210
4Obeticholic Acid Tablets210
5Ticagrelor Tablets2110
6Vitamin K1 Injection216
7Cabozantinib Tablets210
8Sodium Valproate Concentrated Solution for Injection110
9Doxofylline Injection115
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

122 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Nei Menggu Meng He Pharmaceutical Co., Ltd. romanized25250
2Lilly France820
3AstraZeneca AB610
4Novartis Pharma Schweiz AG520
5Yan Tai Yuan Sheng Pharma Co., Ltd. romanized430
6Shanghai Quan Yu Bio Technology (Zhu Ma Dian) Pharma Co., Ltd. romanized420
7Ling Ke Pharma (Hangzhou) Co., Ltd. romanized420
8CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD420
9Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized420
10Astellas pharma Europe B.V.410

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

73 this week

AcceptedDrugApplicants
2021/04/26Import · Class 1 IMG-020注射液 · No verified English nameJXSL2101014 Affibody AB; Inmagene Biopharmaceuticals (Hangzhou) Co. Ltd.
2021/04/26Import · Class 2.4 Osimertinib Mesylate TabletsJXHL2101016 AstraZeneca AB; Astrazeneca Investment (China) Co. Ltd.
2021/04/26Import · Class 2.4 Osimertinib Mesylate TabletsJXHL2101015 AstraZeneca AB; Astrazeneca Investment (China) Co. Ltd.
2021/04/26Import · Class 1 BBP-398 胶囊 · No verified English nameJXHL2101014 Navire Pharma Inc.; Shanghai LianBio Development Co. Ltd.
2021/04/26Import · Class 1 BBP-398胶囊 · No verified English nameJXHL2101013 Navire Pharma Inc.; Shanghai LianBio Development Co. Ltd.
2021/04/26Import · Class 1 BBP-398胶囊 · No verified English nameJXHL2101012 Navire Pharma Inc.; Shanghai LianBio Development Co. Ltd.
2021/04/26Generic · Class 3 Ambroxol Hydrochloride Oral SolutionCYHS2101100 Chengdu Hui De Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Di Kang Pharma Co., Ltd. romanized
2021/04/26Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2101098 Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized; Yang Zi Jiang Pharma Group Jiangsu Pharmaceutical Co., Ltd. romanized
2021/04/26Generic · Class 3 Ulipristal Acetate TabletsCYHL2101006 Henan Tai Feng Bio Technology Co., Ltd. romanized
2021/04/26New drug · Class 1 BAT6021注射液 · No verified English nameCXSL2101040 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2021/04/26New drug · Class 1 多扎格列艾汀片 · No verified English nameCXHS2101004 Hua Ling Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized; Shanghai Di Sai Nuo Biopharmaceuticals Co., Ltd. romanized
2021/04/26New drug · Class 1 CX1440胶囊 · No verified English nameCXHL2101075 Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized
2021/04/26New drug · Class 1 CX1440胶囊 · No verified English nameCXHL2101074 Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized
2021/04/26New drug · Class 1 CX1440胶囊 · No verified English nameCXHL2101073 Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized
2021/04/26New drug · Class 1 CX1440胶囊 · No verified English nameCXHL2101072 Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized
2021/04/23Import · Class 1 注射用Oregovomab · No verified English nameJXSL2101013 OncoQuest Pharmaceuticals Inc.; IQVIA RDS (Shanghai) Co. Ltd.
2021/04/23Import · Class 1 Tiragolumab注射液 · No verified English nameJXSL2101012 F.Hoffmann-La Roche Ltd; Roche(China)Holding Ltd
2021/04/23Generic · Class 3 Ornidazole InjectionCYHS2101097 Kang Pu Pharma Co., Ltd. romanized
2021/04/23Generic · Class 3 Ornidazole InjectionCYHS2101096 Kang Pu Pharma Co., Ltd. romanized
2021/04/23Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2101086 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2021/04/23Generic · Class 3 Clonidine hydrochloride extended-release tabletsCYHS2101084 Li Pin Pharma (Xiamen) Co., Ltd. romanized
2021/04/23Generic · Class 3 Obeticholic Acid TabletsCYHL2101005 Tai Zhou Fu Dan Zhang Jiang Pharma Co., Ltd. romanized
2021/04/23Generic · Class 3 Obeticholic Acid TabletsCYHL2101004 Tai Zhou Fu Dan Zhang Jiang Pharma Co., Ltd. romanized
2021/04/23Generic · Class 3 Vitamin K1 InjectionCYHL2101002 Hainan Brilliant Pharmaceutical Co., Ltd.
2021/04/23Generic · Class 3 Vitamin K1 InjectionCYHL2101001 Hainan Brilliant Pharmaceutical Co., Ltd.
2021/04/23Generic · Class 3 Butalbital, Acetaminophen, and Caffeine CapsulesCYHL2101000 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2021/04/23New drug · Class 1 斯鲁利单抗注射液 · No verified English nameCXSS2101000 Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized
2021/04/23New drug · Class 1 重组人源化抗BTLA单克隆抗体注射液 · No verified English nameCXSL2101039 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/04/23New drug · Class 1 ES102注射液 · No verified English nameCXSL2101038 Ke Wang (Suzhou) Biopharmaceuticals Technology Co., Ltd. romanized
2021/04/23New drug · Class 1 注射用LBL-015 · No verified English nameCXSL2101036 Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized

43 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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