YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 319 drug applications between 18 October 2021 and 24 October 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 51, covering 36 drug names.

2021/10/18 – 2021/10/24

Period
2021/10/18 to 2021/10/24, 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
319
Drugs with new generic filings (by drug name, de-duplicated)
36
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

319filings, 51 of them generic

By application type

Application typeFilings
Supplement180
Generic51
New drug44
Import19
Import re-registration15
Unspecified10

By drug type

Drug typeFilings
Chemical drug214
TCM48
Therapeutic biologic46
Biologic6
Prophylactic biologic5

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

36 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Fluconazole for Oral Suspension410
2阿普米司特片 · No verified English name313
3Valsartan and Amlodipine Tablets(I)222
4Dimethyl Fumarate Delayed-release Capsules210
5Empagliflozin Tablets2118
6Fluconazole and Sodium Chloride Injection211
7Tranexamic Acid Injection2111
8Meropenem for Injection215
9Sodium Hyaluronate Eye Drops2130
10Dopamine Hydrochloride Injection213

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

164 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Gansu Fu Ge Zang Yao Co., Ltd. romanized27250
2Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanized23110
3Changchun Jin Sai Pharma Co., Ltd. romanized820
4Shanxi Wan Hui Pharmaceutical Co., Ltd. romanized750
5Eli Lilly and Company430
6Novartis Pharma Schweiz AG430
7Hui Rui Pharmaceutical Technology Co., Ltd. romanized430
8Shanghai Jia Bao Yao Yin Pharmaceuticals Technology Co., Ltd. romanized420
9Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized420
10NAPP PHARMACEUTICALS LIMITED410

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

76 this week

AcceptedDrugApplicants
2021/10/22Import · Class 2.2 司库奇尤单抗注射液 · No verified English nameJXSL2101119 Novartis Pharma Schweiz AG; Beijing Novartis Pharma Co. Ltd.
2021/10/22Import · Class 1 SAR439859片 · No verified English nameJXHL2101217 Sanofi-aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2021/10/22Import · Class 1 Nemtabrutinib片 · No verified English nameJXHL2101216 Merck Sharp & Dohme Corp.,a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2021/10/22Import · Class 1 Nemtabrutinib片 · No verified English nameJXHL2101215 Merck Sharp & Dohme Corp.,a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2021/10/22Generic · Class 3 Fosaprepitant Dimeglumine for InjectionCYHS2101913 Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized
2021/10/22Generic · Class 3 Peramivir InjectionCYHS2101912 Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized
2021/10/22Generic · Class 3 特利加压素注射液 · No verified English nameCYHS2101870 Shenzhen Han Yu Pharma Co., Ltd. romanized; Gansu Cheng Ji Bio Pharma Co., Ltd. romanized
2021/10/22New drug · Class 3.4 注射用CMAB007 · No verified English nameCXSS2101035 Tai Zhou Mai Bo Tai Ke Pharma Co., Ltd. romanized
2021/10/22New drug · Class 3.4 注射用CMAB007 · No verified English nameCXSS2101034 Tai Zhou Mai Bo Tai Ke Pharma Co., Ltd. romanized
2021/10/22New drug · Class 1 JS019注射液 · No verified English nameCXSL2101382 Suzhou Ke Bo Rui Jun Biopharmaceuticals Technology Co., Ltd. romanized
2021/10/22New drug · Class 1 JDB175片 · No verified English nameCXHL2101598 Shanghai Jia Bao Yao Yin Pharmaceuticals Technology Co., Ltd. romanized
2021/10/22New drug · Class 1 JDB175片 · No verified English nameCXHL2101597 Shanghai Jia Bao Yao Yin Pharmaceuticals Technology Co., Ltd. romanized
2021/10/22New drug · Class 1 JDB153片 · No verified English nameCXHL2101596 Shanghai Jia Bao Yao Yin Pharmaceuticals Technology Co., Ltd. romanized
2021/10/22New drug · Class 1 JDB153片 · No verified English nameCXHL2101595 Shanghai Jia Bao Yao Yin Pharmaceuticals Technology Co., Ltd. romanized
2021/10/22New drug · Class 1 注射用CN-105肽 · No verified English nameCXHL2101594 Name not romanized
2021/10/22New drug · Class 1 HS-10383片 · No verified English nameCXHL2101593 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/10/22New drug · Class 1 HS-10383片 · No verified English nameCXHL2101592 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/10/22New drug · Class 1 注射用XNW4107 · No verified English nameCXHL2101591 Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2021/10/21Import · Class 2.1 OAV101注射液 · No verified English nameJXSL2101118 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd
2021/10/21Import · Class 1 注射用MRX-8 · No verified English nameJXHL2101212 MicuRx Pharmaceuticals Inc.; Name not romanized
2021/10/21Import · Class 1 venglustat · No verified English nameJXHL2101211 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd
2021/10/21Import · Class 1 venglustat · No verified English nameJXHL2101210 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd
2021/10/21Generic · Class 3 Tranexamic Acid InjectionCYHS2101906 Peng Lai Nuo Kang Pharma Co., Ltd. romanized
2021/10/21Generic · Class 3 Tranexamic Acid InjectionCYHS2101905 Peng Lai Nuo Kang Pharma Co., Ltd. romanized
2021/10/21Generic · Class 3 Ibuprofen Lysine InjectionCYHS2101904 Sichuan Wei Ao Pharmaceutical Co., Ltd. romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2021/10/21Generic · Class 3 Amlodipine Besylate and Benazepril Hydrochloride CapsulesCYHS2101902 Yang Zi Jiang Pharma Group Guangzhou Hai Rui Pharma Co., Ltd. romanized
2021/10/21Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2101900 Jilin Zhen Ao Pharmaceutical Co., Ltd. romanized
2021/10/21Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2101899 Jilin Zhen Ao Pharmaceutical Co., Ltd. romanized
2021/10/21Generic · Class 3 Calcium Gluconate InjectionCYHS2101857 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2021/10/21Generic · Class 3 Pregabalin Oral SolutionCYHS2101844 Hefei En Rui Te Pharma Co., Ltd. romanized

46 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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