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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 239 drug applications between 11 November 2021 and 17 November 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 39, covering 25 drug names.

2021/11/11 – 2021/11/17

Period
2021/11/11 to 2021/11/17, 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
239
Drugs with new generic filings (by drug name, de-duplicated)
25
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

239filings, 39 of them generic

By application type

Application typeFilings
Supplement116
New drug44
Generic39
Import20
Import re-registration14
Unspecified6

By drug type

Drug typeFilings
Chemical drug179
TCM29
Therapeutic biologic27
Biologic2
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

25 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dexmedetomidine Hydrochloride Injection320
2阿普米司特片 · No verified English name313
3Sildenafil Citrate Oral Disintegrating Tablets228
4Sodium Valproate Concentrated Solution for Injection210
5Tacrolimus Capsules212
6Ozagrel Sodium Injection213
7Obeticholic Acid Tablets210
8Vonoprazan Fumarate Tablets2160
9Bisoprolol Fumarate Tablets216
10Pregabalin Capsules2112

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

143 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangxi Ge Hong Tang Fang Lve Pharmaceutical Co., Ltd. romanized980
2Da Lian Tian Shan Pharma Co., Ltd. romanized660
3Hunan Wei Er Qiang Pharmaceutical Co., Ltd. romanized640
4Upjohn Manufacturing Ireland Unlimited610
5Shijiazhuang Yu He Tang Pharma Co., Ltd. romanized440
6Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized420
7Fujian Sheng Fu Kang Pharma Co., Ltd. romanized420
8Sanofi-aventis groupe410
9Upjohn US 2 LLC410
10Hainan Wei Kang Pharmaceutical (Qian Shan) 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

68 this week

AcceptedDrugApplicants
2021/11/17Import · Class 1 elranatamab · No verified English nameJXSL2101133 Pfizer Inc; Pfizer Investment CO. Ltd.
2021/11/17Import · Class 3.1 甘精胰岛素利司那肽注射液2:1 · No verified English nameJXSL2101132 Sanofi-Aventis Groupe; Sanofi (China) Investment Co. Ltd.
2021/11/17Import · Class 3.1 甘精胰岛素利司那肽注射液1:1 · No verified English nameJXSL2101131 Sanofi K. K.; Sanofi (China) Investment Co. Ltd.
2021/11/17Import · Class 1 注射用Bempegaldesleukin · No verified English nameJXSL2101129 Nektar Therapeutics; PPD Pharmaceutical Development (Beijing) Co. Ltd
2021/11/17Import · Class 1 注射用Bempegaldesleukin · No verified English nameJXSL2101128 Nektar Therapeutics; PPD Pharmaceutical Development (Beijing) Co. Ltd
2021/11/17Import · Class 2.4 Empagliflozin TabletsJXHS2101074 Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/11/17Import · Class 1 CK-3773274片 · No verified English nameJXHL2101242 Cytokinetics Incorporated; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd
2021/11/17New drug · Class 2.4 Remimazolam Besylate For InjectionCXHS2101053 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2021/11/17New drug · Class 1 TQH3821片 · No verified English nameCXHL2101673 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/11/17New drug · Class 1 TQH3821片 · No verified English nameCXHL2101672 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/11/17New drug · Class 1 GD-N1702胶囊 · No verified English nameCXHL2101671 Hao Yi Sheng Pharma Group Co., Ltd. romanized
2021/11/17New drug · Class 1 GD-N1702胶囊 · No verified English nameCXHL2101670 Hao Yi Sheng Pharma Group Co., Ltd. romanized
2021/11/16Import · Class 2.2 奥妥珠单抗注射液 · No verified English nameJXSL2101130 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2021/11/16Generic · Class 3 Ozagrel Sodium InjectionCYHS2102031 Hubei Shen Zhou Hua Rui Pharmaceuticals Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2021/11/16Generic · Class 3 Ozagrel Sodium InjectionCYHS2102030 Hubei Shen Zhou Hua Rui Pharmaceuticals Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2021/11/16Generic · Class 3 Pentoxifylline InjectionCYHS2102029 Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized
2021/11/16Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2102025 Ji Chuan Pharma Group Co., Ltd. romanized
2021/11/16Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2102024 Ji Chuan Pharma Group Co., Ltd. romanized
2021/11/16Generic · Class 3 Obeticholic Acid TabletsCYHL2101040 Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized
2021/11/16Generic · Class 3 Obeticholic Acid TabletsCYHL2101039 Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized
2021/11/16New drug · Class 1 AK104注射液 · No verified English nameCXSL2101425 Kang Fang Pharma Co., Ltd. romanized
2021/11/16New drug · Class 1 注射用DR30303 · No verified English nameCXSL2101424 Zhejiang Dao Er Bio Technology Co., Ltd. romanized
2021/11/16New drug · Class 1 ASK120067片 · No verified English nameCXHS2101052 Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized
2021/11/16New drug · Class 1 BIOS-0618片 · No verified English nameCXHL2101665 Hangzhou Bai Cheng Pharmaceuticals Technology Co., Ltd. romanized
2021/11/16New drug · Class 1 BIOS-0618片 · No verified English nameCXHL2101664 Hangzhou Bai Cheng Pharmaceuticals Technology Co., Ltd. romanized
2021/11/16New drug · Class 1 JAB-3312胶囊 · No verified English nameCXHL2101663 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2021/11/16New drug · Class 1 JAB-3312胶囊 · No verified English nameCXHL2101662 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2021/11/16New drug · Class 1 JAB-21822片 · No verified English nameCXHL2101661 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2021/11/16New drug · Class 1 JAB-21822片 · No verified English nameCXHL2101660 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2021/11/16New drug · Class 1 TSN084片 · No verified English nameCXHL2101659 Tai Li Bio Technology (Shanghai) Co., Ltd. romanized

38 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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