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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 380 drug applications between 6 November 2023 and 12 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 97, covering 66 drug names.

2023/11/06 – 2023/11/12

Period
2023/11/06 to 2023/11/12, 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
380
Drugs with new generic filings (by drug name, de-duplicated)
66
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

380filings, 97 of them generic

By application type

Application typeFilings
Supplement192
Generic97
New drug59
Import14
Unspecified11
Import re-registration7

By drug type

Drug typeFilings
Chemical drug265
TCM86
Therapeutic biologic27
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

66 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Norepinephrine Bitartrate Injection639
2Potassium Chloride Granules424
3Ibuprofen Injection328
4Potassium Chloride Oral Solution3211
5中/长链脂肪乳注射液(C6~24) · No verified English name310
6Piracetam Injection319
7Famotidine Injection228
8Oseltamivir Phosphate For Oral Suspension222
9Ethyl Iosapentate Capsules2127
10Etoricoxib Tablets218

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

215 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanxi Shuang Yan Pharma Co., Ltd. romanized14140
2Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized1140
3Jiangxi Nanchang Ji Sheng Pharmaceutical Co., Ltd. romanized10100
4Jiangsu Hao Sen Pharma Group Co., Ltd. romanized1030
5Sanofi Winthrop Industrie730
6Shijiazhuang No.4 Pharmaceutical Co., Ltd.721
7ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.545
8Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized530
9Merck Sharp & Dohme LLC520
10Jilin Sheng Shen Lu Pharmaceutical Co., Ltd. romanized440

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

119 this week

AcceptedDrugApplicants
2023/11/11Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2300192 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2023/11/11Generic · Class 3 Potassium Chloride GranulesCYHS2303100 Shanxi Huang Cheng Xiang Fu Pharma Co., Ltd. romanized
2023/11/11Generic · Class 3 Potassium Chloride GranulesCYHS2303099 Shanxi Huang Cheng Xiang Fu Pharma Co., Ltd. romanized
2023/11/11New drug · Class 1 ZS805注射液 · No verified English nameCXSL2300775 Sichuan Zhi Shan Wei Xin Bio Technology Co., Ltd. romanized
2023/11/11New drug · Class 1 注射用MK-2870 · No verified English nameCXSL2300774 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2023/11/11New drug · Class 2.4; 2.2 硫酸阿托品滴眼液 · No verified English nameCXHL2301262 Le Pu Pharma Co., Ltd. romanized
2023/11/11New drug · Class 2.4; 2.2 硫酸阿托品滴眼液 · No verified English nameCXHL2301261 Le Pu Pharma Co., Ltd. romanized
2023/11/11New drug · Class 2.4 盐酸氨酮戊酸颗粒剂 · No verified English nameCXHL2301260 Shanghai Fu Dan Zhang Jiang Biopharmaceuticals Co., Ltd. romanized
2023/11/11New drug · Class 1 FCN-338片 · No verified English nameCXHL2301259 Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized
2023/11/11New drug · Class 1 FCN-338片 · No verified English nameCXHL2301258 Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized
2023/11/11New drug · Class 2.4 硫酸阿托品滴眼液 · No verified English nameCXHL2301257 Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized
2023/11/11New drug · Class 2.4 硫酸阿托品滴眼液 · No verified English nameCXHL2301256 Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized
2023/11/10Import · Class 2.3 马昔腾坦他达拉非片 · No verified English nameJXHL2300281 Actelion Pharmaceuticals Ltd; Johnson & Johnson (China) Investment Ltd.
2023/11/10Import · Class 1 LNP023胶囊 · No verified English nameJXHL2300280 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2023/11/10Generic · Class 3 Potassium Chloride Oral SolutionCYHS2303094 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2023/11/10Generic · Class 3 Sodium Acetate Ringer's InjectionCYHS2303093 Zhejiang Kang Ji Er Pharma Co., Ltd. romanized
2023/11/10Generic · Class 3 Paracetamol and Ibuprofen TabletsCYHS2303092 Changchun Lan Jiang Pharmaceuticals Technology Co., Ltd. romanized; Zhi En Bio Technology Co., Ltd. romanized
2023/11/10Generic · Class 3 Vitamin K1 InjectionCYHS2303088 Hainan Brilliant Pharmaceutical Co., Ltd.
2023/11/10Generic · Class 3 Vitamin K1 InjectionCYHS2303087 Hainan Brilliant Pharmaceutical Co., Ltd.
2023/11/10Generic · Class 3 Pioglitazone and Metformin Hydrochloride TabletsCYHS2303085 Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized
2023/11/10Generic · Class 3 Ibuprofen InjectionCYHL2300136 SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED
2023/11/10New drug · Class 3.4 人凝血酶原复合物 · No verified English nameCXSS2300087 Guo Yao Group Lanzhou Biopharmaceutical Co., Ltd. romanized
2023/11/10New drug · Class 1 重组抗IL-1β人源化单克隆抗体注射液 · No verified English nameCXSL2300773 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2023/11/10New drug · Class 1 BR115注射液 · No verified English nameCXSL2300772 Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized; Hai Zheng Biopharmaceutical Co., Ltd. romanized; Chengdu En Mu Bio Technology Co., Ltd. romanized
2023/11/10New drug · Class 1 注射用AMT-116 · No verified English nameCXSL2300771 Pu Zhong Fa Xian Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/11/10New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2300770 Shenzhen Shi Yin Guan Bio Technology Co., Ltd. romanized
2023/11/10New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2300769 Guangzhou Da Bo Bio Zhi Pin Co., Ltd. romanized
2023/11/10New drug · Class 2.3 HR20031片(Ⅱ) · No verified English nameCXHS2300100 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/11/10New drug · Class 2.3 HR20031片(Ⅰ) · No verified English nameCXHS2300099 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/11/10New drug · Class 2.4 盐酸右美托咪定鼻喷剂 · No verified English nameCXHL2301255 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized

89 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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