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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 347 drug applications between 22 November 2023 and 28 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 90, covering 65 drug names.

2023/11/22 – 2023/11/28

Period
2023/11/22 to 2023/11/28, 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
347
Drugs with new generic filings (by drug name, de-duplicated)
65
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

347filings, 90 of them generic

By application type

Application typeFilings
Supplement166
Generic90
New drug54
Import24
Unspecified7
Import re-registration6

By drug type

Drug typeFilings
Chemical drug235
TCM53
Therapeutic biologic50
Prophylactic biologic6
Biologic3

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

65 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Potassium Chloride Granules424
2Roxadustat Capsules4217
3Tadalafil Tablets3123
4Latamoxef Sodium for Injection311
5Iohexol Injection315
6Tafluprost Eye Drops223
7Torsemide Injection211
8Sildenafil Citrate Tablets2112
9Flumazenil Injection212
10Amisulpride Injection211

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

226 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Sichuan Jin Xin Kang Da Pharmaceuticals Technology Co., Ltd. romanized1090
2Jiangsu Hao Sen Pharma Group Co., Ltd. romanized720
3CSL Behring GmbH710
4Suzhou Erye Pharmaceutical Co., Ltd620
5GUERBET510
6Merck Sharp & Dohme LLC510
7Novo Nordisk A/S510
8Hebei Wan Bang Fu Lin Pharma Co., Ltd. romanized440
9Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized440
10Shandong Jing Hui Bio Technology Co., Ltd. romanized424

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

118 this week

AcceptedDrugApplicants
2023/11/28Import · Class 3.1 注射用重组单链人凝血因子VIII · No verified English nameJXSL2300214 CSL Behring GmbH; PAREXEL China Co. Ltd.
2023/11/28Import · Class 3.1 注射用重组单链人凝血因子VIII · No verified English nameJXSL2300213 CSL Behring GmbH; PAREXEL China Co. Ltd.
2023/11/28Import · Class 3.1 注射用重组单链人凝血因子VIII · No verified English nameJXSL2300212 CSL Behring GmbH; PAREXEL China Co. Ltd.
2023/11/28Import · Class 3.1 注射用重组单链人凝血因子VIII · No verified English nameJXSL2300211 CSL Behring GmbH; PAREXEL China Co. Ltd.
2023/11/28Import · Class 3.1 注射用重组单链人凝血因子VIII · No verified English nameJXSL2300210 CSL Behring GmbH; PAREXEL China Co. Ltd.
2023/11/28Import · Class 3.1 注射用重组单链人凝血因子VIII · No verified English nameJXSL2300209 CSL Behring GmbH; PAREXEL China Co. Ltd.
2023/11/28Import · Class 3.1 注射用重组单链人凝血因子VIII · No verified English nameJXSL2300208 CSL Behring GmbH; PAREXEL China Co. Ltd.
2023/11/28Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHS2303288 Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Guo Yao Group Guo Rui Pharma Co., Ltd. romanized
2023/11/28Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2303287 Chengdu Nuo He Cheng Hong Biopharmaceutical Co., Ltd. romanized; Sichuan Xian Tong Pharma Co., Ltd. romanized
2023/11/28Generic · Class 3 Biapenem For InjectionCYHS2303286 Jiangsu Rui Shi Bio Technology Co., Ltd. romanized; Shandong Luo Xin Pharma Group Co., Ltd. romanized
2023/11/28Generic · Class 3 Acetylcysteine InjectionCYHS2303285 Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/11/28Generic · Class 3 Diprophylline InjectionCYHS2303282 Wuhan Hua Er Bio Technology Co., Ltd. romanized; Lang Tian Pharma (Hubei) Co., Ltd. romanized
2023/11/28Generic · Class 3 吗替麦考酚酯干混悬剂 · No verified English nameCYHS2303280 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2023/11/28Generic · Class 3 Acetylcysteine Oral SolutionCYHS2303279 Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2023/11/28Generic · Class 3 Magnesium Sulfate InjectionCYHS2303278 Jiangxi Bo Tai Pharma Co., Ltd. romanized; Jiangxi Dong Fu Pharmaceutical Co., Ltd. romanized
2023/11/28Generic · Class 3 Ketotifen Fumarate Oral SolutionCYHS2303277 Zhejiang Yi Ze Da Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/11/28Generic · Class 3 Amisulpride InjectionCYHS2303270 Qilu Pharmaceutical (Hainan) Co., Ltd
2023/11/28Generic · Class 3 Amisulpride InjectionCYHS2303269 Qilu Pharmaceutical (Hainan) Co., Ltd
2023/11/28Generic · Class 3 Relugolix TabletsCYHL2300144 Jiangxi Shan Xiang Pharma Co., Ltd. romanized
2023/11/28New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2300820 Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized
2023/11/28New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2300819 Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized
2023/11/28New drug · Class 1.3 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2300818 Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized
2023/11/28New drug · Class 1.3 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2300817 Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized
2023/11/28New drug · Class 1 重组人源抗狂犬病病毒单克隆抗体注射液 · No verified English nameCXSL2300816 Lanzhou Bio Zhi Pin Research Institute Co., Ltd. romanized
2023/11/28New drug · Class 1 PT199 · No verified English nameCXSL2300815 Fan En Shi Pharmaceutical (Beijing) Co., Ltd. romanized
2023/11/28New drug · Class 1 IBI389 · No verified English nameCXSL2300814 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2023/11/28New drug · Class 1 ZL-1218注射液 · No verified English nameCXSL2300813 Zai Ding Pharmaceuticals (Shanghai) Co., Ltd. romanized
2023/11/28New drug · Class 1 注射用MK-2870 · No verified English nameCXSL2300812 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2023/11/28New drug · Class 1 ADG126注射液 · No verified English nameCXSL2300811 Tian Yan Pharma (Suzhou) Co., Ltd. romanized
2023/11/28New drug · Class 1 TY751注射液 · No verified English nameCXHL2301314 Tianjin Drug Research Institute Co., Ltd. romanized

88 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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