YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 279 drug applications between 15 October 2021 and 21 October 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 47, covering 32 drug names.

2021/10/15 – 2021/10/21

Period
2021/10/15 to 2021/10/21, 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
279
Drugs with new generic filings (by drug name, de-duplicated)
32
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

279filings, 47 of them generic

By application type

Application typeFilings
Supplement155
Generic47
New drug46
Import14
Import re-registration9
Unspecified8

By drug type

Drug typeFilings
Chemical drug206
Therapeutic biologic35
TCM29
Prophylactic biologic5
Biologic4

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

32 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

149 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanized23110
2Gansu Fu Ge Zang Yao Co., Ltd. romanized990
3Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized950
4Shanxi Wan Hui Pharmaceutical Co., Ltd. romanized750
5Fo Shan De Rui Ke Pharmaceutical Co., Ltd. romanized510
6Eli Lilly and Company430
7Hui Rui Pharmaceutical Technology Co., Ltd. romanized430
8Bioverativ Therapeutics Inc410
9NAPP PHARMACEUTICALS LIMITED410
10Takeda Pharmaceutical Company 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

72 this week

AcceptedDrugApplicants
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
2021/10/21New drug · Class 2.2 注射用重组人尿激酶原 · No verified English nameCXSS2101040 Tian Shi Li Biopharmaceuticals Co., Ltd. romanized
2021/10/21New drug · Class 1 重组人源化抗表皮生长因子受体单克隆抗体注射液 · No verified English nameCXSL2101379 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2021/10/21New drug · Class 1 重组抗PD-1全人源单克隆抗体注射液 · No verified English nameCXSL2101378 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2021/10/21New drug · Class 1 TQB2450注射液 · No verified English nameCXSL2101363 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/10/21New drug · Class 1 安纳拉唑钠肠溶片 · No verified English nameCXHS2101049 Xuan Zhu (Beijing) Pharmaceuticals Technology Co., Ltd. romanized; Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized
2021/10/21New drug · Class 2.4 甲苯磺酸多纳非尼片 · No verified English nameCXHS2101048 Name not romanized
2021/10/21New drug · Class 1 注射用TB001 · No verified English nameCXHL2101590 Qing Yuan Shi Tu Wei An Chuang Technology Kai Fa Co., Ltd. romanized
2021/10/21New drug · Class 1 JYP0322片 · No verified English nameCXHL2101589 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2021/10/21New drug · Class 1 JYP0322片 · No verified English nameCXHL2101588 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2021/10/21New drug · Class 1 注射用TB001 · No verified English nameCXHL2101587 Qing Yuan Shi Tu Wei An Chuang Technology Kai Fa Co., Ltd. romanized
2021/10/21New drug · Class 2.4 注射用多西他赛(白蛋白结合型) · No verified English nameCXHL2101586 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2021/10/21New drug · Class 1 SCR-6852胶囊 · No verified English nameCXHL2101584 Xian Sheng Pharma Co., Ltd. romanized
2021/10/21New drug · Class 1 SCR-6852胶囊 · No verified English nameCXHL2101583 Xian Sheng Pharma Co., Ltd. romanized
2021/10/21New drug · Class 2.2 SYHX2011 · No verified English nameCXHL2101581 CSPC OUYI PHARMACEUTICAL CO., LTD.
2021/10/21New drug · Class 2.2; 2.4 注射用醋酸丙氨瑞林微球 · No verified English nameCXHL2101573 Shanghai Li Zhu Pharmaceutical Co., Ltd. romanized
2021/10/20New drug · Class 1 注射用RS2102 · No verified English nameCXSL2101376 Rui Shi Biopharmaceuticals Co., Ltd. romanized
2021/10/19Import · Class 3.1 替拉珠单抗注射液 · No verified English nameJXSS2101026 Sun Pharma Global FZE; Vetter Pharma-Fertigung GmbH & Co. KG; Shenzhen Kangzhe Biotechnology Co. Ltd.
2021/10/19Import · Class 1 SAR442168 · No verified English nameJXHL2101209 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.

42 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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