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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 377 drug applications between 17 November 2023 and 23 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 97, covering 70 drug names.

2023/11/17 – 2023/11/23

Period
2023/11/17 to 2023/11/23, 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
377
Drugs with new generic filings (by drug name, de-duplicated)
70
Accepted this week, now under review
4

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

377filings, 97 of them generic

By application type

Application typeFilings
Supplement187
Generic97
New drug59
Import16
Unspecified10
Import re-registration8

By drug type

Drug typeFilings
Chemical drug265
TCM65
Therapeutic biologic39
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
1Brivaracetam Tablets4119
2Latamoxef Sodium for Injection311
3Iohexol Injection315
4Dabigatran Etexilate Capsules312
5Metoclopramide Hydrochloride Injection226
6Esmolol Hydrochloride Injection223
7Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution228
8Tacrolimus Sustained-release Capsules216
9Gabapentin Capsules210
10Perindopril arginine and amlodipine besylate tablets213

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

239 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S1020
2Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized880
3Jiangsu Hao Sen Pharma Group Co., Ltd. romanized720
4Shandong Er Ye Pharmaceutical Co., Ltd. romanized520
5Eli Lilly and Company510
6GUERBET510
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

106 this week

AcceptedDrugApplicants
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
2023/11/23New drug · Class 1 重组人源化抗BTLA单克隆抗体注射液 · No verified English nameCXSL2300803 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2023/11/23New drug · Class 1 重组柯萨奇病毒B3注射液 · No verified English nameCXSL2300802 Wuhan Bo Wei De Bio Technology Co., Ltd. romanized
2023/11/23New drug · Class 1 注射用ACR246 · No verified English nameCXSL2300801 Hangzhou Ai Ke Rui Si Biopharmaceuticals Co., Ltd. romanized
2023/11/23New drug · Class 1 EMB-01注射液 · No verified English nameCXSL2300800 Shanghai An Mai Bio Technology Co., Ltd. romanized; An Mai Bio Technology (Suzhou) Co., Ltd. romanized
2023/11/23New drug · Class 1 HS-10398胶囊 · No verified English nameCXHL2301308 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2023/11/23New drug · Class 1 HS-10398胶囊 · No verified English nameCXHL2301307 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2023/11/23New drug · Class 1 HS-10398胶囊 · No verified English nameCXHL2301306 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2023/11/23New drug · Class 1 HS-10398胶囊 · No verified English nameCXHL2301305 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2023/11/23New drug · Class 1 HS-10398胶囊 · No verified English nameCXHL2301304 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2023/11/23New drug · Class 1 HS-10398胶囊 · No verified English nameCXHL2301303 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2023/11/23New drug · Class 1 GST-HG141片 · No verified English nameCXHL2301302 Fujian Guang Sheng Zhong Lin Bio Technology Co., Ltd. romanized
2023/11/23New drug · Class 1 GST-HG141片 · No verified English nameCXHL2301301 Fujian Guang Sheng Zhong Lin Bio Technology Co., Ltd. romanized
2023/11/23New drug · Class 1 盐酸希美替尼片 · No verified English nameCXHL2301298 Zhongguo Ke College Shanghai Drug Research Institute romanized; Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized
2023/11/23New drug · Class 1 CG-7321胶囊 · No verified English nameCXHL2301297 Name not romanized
2023/11/23New drug · Class 1 CG-7321胶囊 · No verified English nameCXHL2301296 Name not romanized
2023/11/22Import · Class 1 HRO761 · No verified English nameJXHL2300295 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.

76 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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