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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 339 drug applications between 18 November 2023 and 24 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 98, covering 70 drug names.

2023/11/18 – 2023/11/24

Period
2023/11/18 to 2023/11/24, 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
339
Drugs with new generic filings (by drug name, de-duplicated)
70
Accepted this week, now under review
1

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

339filings, 98 of them generic

By application type

Application typeFilings
Supplement158
Generic98
New drug52
Import15
Unspecified10
Import re-registration6

By drug type

Drug typeFilings
Chemical drug243
TCM57
Therapeutic biologic31
Biologic6
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

70 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Potassium Chloride Granules424
2Brivaracetam Tablets4119
3Latamoxef Sodium for Injection311
4Iohexol Injection315
5Dabigatran Etexilate Capsules312
6Esmolol Hydrochloride Injection223
7Tacrolimus Sustained-release Capsules216
8Gabapentin Capsules210
9Vonoprazan Fumarate Tablets2160
10Flumazenil Injection212

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

219 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Sichuan Jin Xin Kang Da Pharmaceuticals Technology Co., Ltd. romanized1090
2Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized770
3Jiangsu Hao Sen Pharma Group Co., Ltd. romanized610
4Eli Lilly and Company510
5GUERBET510
6Novo Nordisk A/S510
7Shandong Jing Hui Bio Technology Co., Ltd. romanized424
8Fresenius Kabi Austria GmbH410
9ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.414
10Ferring GmbH330

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

103 this week

AcceptedDrugApplicants
2023/11/24Generic · Class 3 Fudosteine oral solutionCYHS2303253 Jiangsu Kai Yuan Pharma Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2023/11/24Generic · Class 3 Potassium Chloride InjectionCYHS2303251 Beijing Bu Lin Bio Technology Co., Ltd. romanized; Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/11/24Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2303246 Hebei Dong Sheng Ke Yu Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized
2023/11/24Generic · Class 3 Potassium Chloride GranulesCYHS2303245 Guizhou Rui He Pharmaceutical Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized
2023/11/24Generic · Class 3 Potassium Chloride GranulesCYHS2303244 Guizhou Rui He Pharmaceutical Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized
2023/11/24Generic · Class 3 复方匹可硫酸钠颗粒 · No verified English nameCYHS2303242 Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Shijiazhuang Yu Hui Pharmaceutical Co., Ltd. romanized
2023/11/24Generic · Class 3 Flumazenil InjectionCYHS2303241 Shanghai Xu Dong Hai Pu Pharma Co., Ltd. romanized
2023/11/24Generic · Class 3 Flumazenil InjectionCYHS2303240 Shanghai Xu Dong Hai Pu Pharma Co., Ltd. romanized
2023/11/24Generic · Class 3 聚乙二醇3350散 · No verified English nameCYHS2303239 Shu Tai Shen (Beijing) Biopharmaceutical Co., Ltd. romanized
2023/11/24New drug · Class 1.1 辛芪通鼻片 · No verified English nameCXZS2300024 Beijing Yi Ling Pharma Co., Ltd. romanized; Shijiazhuang Yi Ling Pharma Co., Ltd. romanized
2023/11/24New drug · Class 1 B013注射液 · No verified English nameCXSL2300807 Shanghai Shang Yao Jiao Lian Pharmaceuticals Technology Co., Ltd. romanized
2023/11/24New drug · Class 1 GR2102注射液 · No verified English nameCXSL2300806 Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized; Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized
2023/11/24New drug · Class 1 GR1802注射液 · No verified English nameCXSL2300805 Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized
2023/11/24New drug · Class 1 福泽雷塞片 · No verified English nameCXHS2300105 Xin Da Bio Technology Co., Ltd. romanized; Kang Long Hua Cheng (Ningbo) Technology Development Co., Ltd. romanized
2023/11/24New drug · Class 1 注射用CEND-1 · No verified English nameCXHL2301310 Qilu Pharmaceutical Co., Ltd.
2023/11/24New drug · Class 2.4; 2.2 BH011注射液 · No verified English nameCXHL2301309 Zhuhai Bei Hai Bio Technology Co., Ltd. romanized
2023/11/23Import · Class 1 CagriSema注射液 · No verified English nameJXSL2300201 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2023/11/23Import · Class 1 CagriSema注射液 · No verified English nameJXSL2300200 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2023/11/23Import · Class 1 CagriSema注射液 · No verified English nameJXSL2300199 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2023/11/23Import · Class 1 CagriSema注射液 · No verified English nameJXSL2300198 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2023/11/23Import · Class 1 CagriSema注射液 · No verified English nameJXSL2300197 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2023/11/23Generic · Class 3 Ferrous Succinate TabletsCYHS2303234 Rui Yang Pharmaceutical Co., Ltd. romanized
2023/11/23Generic · Class 3 Potassium Chloride GranulesCYHS2303232 Zhejiang Bai Ao Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2023/11/23Generic · Class 3 Potassium Chloride GranulesCYHS2303231 Zhejiang Bai Ao Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2023/11/23Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2303224 Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized
2023/11/23Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2303223 Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized
2023/11/23Generic · Class 3 Latamoxef Sodium for InjectionCYHS2303221 Shandong Jing Hui Bio Technology Co., Ltd. romanized; Shandong Run Ze Pharmaceutical Co., Ltd. romanized
2023/11/23Generic · Class 3 Latamoxef Sodium for InjectionCYHS2303220 Shandong Jing Hui Bio Technology Co., Ltd. romanized; Shandong Run Ze Pharmaceutical Co., Ltd. romanized
2023/11/23Generic · Class 3 Latamoxef Sodium for InjectionCYHS2303219 Shandong Jing Hui Bio Technology Co., Ltd. romanized; Shandong Run Ze Pharmaceutical Co., Ltd. romanized
2023/11/23New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2300804 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized

73 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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