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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 376 drug applications between 5 November 2024 and 11 November 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 113, covering 82 drug names.

2024/11/05 – 2024/11/11

Period
2024/11/05 to 2024/11/11, 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
376
Drugs with new generic filings (by drug name, de-duplicated)
82
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

376filings, 113 of them generic

By application type

Application typeFilings
Supplement161
Generic113
New drug67
Import18
Import re-registration14
Unspecified3

By drug type

Drug typeFilings
Chemical drug296
TCM38
Therapeutic biologic34
Prophylactic biologic6
In vitro diagnostic reagent1
Biologic1

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

82 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets4260
2Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution4223
3Nicergoline Tablets321
4Methotrexate Injection3211
5Repaglinide Tablets316
6Crisaborole Ointment2226
7Dydrogesterone Tablets228
8Sodium sulfate, magnesium sulfate, and potassium chloride Tablets222
9Iguratimod Tablets2223
10Piracetam Injection219

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

213 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangdong Sunho Pharmaceutical Co., Ltd.17100
2Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized980
3Qilu Pharmaceutical Co., Ltd.742
4Yi Ling Wan Zhou International Pharmaceutical Co., Ltd. romanized660
5Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized630
6GE Healthcare AS610
7Teva Neuroscience Inc.610
8Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized610
9SANOFI WINTHROP INDUSTRIE530
10Jiangsu Hao Sen Pharma Group Co., Ltd. romanized520

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

125 this week

AcceptedDrugApplicants
2024/11/11Import · Class 2.2 注射用德曲妥珠单抗 · No verified English nameJXSL2400217 Daiichi Sankyo Inc.; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD.
2024/11/11Generic · Class 3 Propranolol Hydrochloride InjectionCYHS2403854 Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized
2024/11/11Generic · Class 3 Propranolol Hydrochloride InjectionCYHS2403853 Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized
2024/11/11Generic · Class 3 Pentoxifylline InjectionCYHS2403851 Shanghai Xian Dai Ha Sen (Shang Qiu) Pharma Co., Ltd. romanized
2024/11/11Generic · Class 3 Nicergoline TabletsCYHS2403846 Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/11/11Generic · Class 3 Nicergoline TabletsCYHS2403845 Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/11/11Generic · Class 3 Potassium Aspartate InjectionCYHS2403844 Shandong Qidu Pharmaceutical Co., Ltd.
2024/11/11Generic · Class 3 Sodium sulfate, magnesium sulfate, and potassium chloride TabletsCYHL2400216 Shandong Cheng Chuang Lan Hai Pharmaceuticals Technology Co., Ltd. romanized
2024/11/11Generic · Class 3 Sodium sulfate, magnesium sulfate, and potassium chloride TabletsCYHL2400215 Bao Ding Tian Hao Pharmaceutical Co., Ltd. romanized
2024/11/11New drug · Class 1 TAEST16001注射液 · No verified English nameCXSL2400766 Xiang Xue Sheng Ming Ke Xue Technology (Guangdong) Co., Ltd. romanized
2024/11/11New drug · Class 1 GenSci120注射液 · No verified English nameCXSL2400765 Changchun Jin Sai Pharma Co., Ltd. romanized
2024/11/11New drug · Class 1 GenSci120注射液 · No verified English nameCXSL2400764 Changchun Jin Sai Pharma Co., Ltd. romanized
2024/11/11New drug · Class 1 GenSci120注射液 · No verified English nameCXSL2400763 Changchun Jin Sai Pharma Co., Ltd. romanized
2024/11/11New drug · Class 1.4 二价肠道病毒灭活疫苗(Vero细胞) · No verified English nameCXSL2400762 Beijing Min Hai Bio Technology Co., Ltd. romanized
2024/11/11New drug · Class 1.4 四价肠道病毒灭活疫苗(Vero细胞) · No verified English nameCXSL2400761 Beijing Min Hai Bio Technology Co., Ltd. romanized
2024/11/09Generic · Class 3 复方聚乙二醇电解质散(Ⅱ) · No verified English nameCYHS2403839 Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized
2024/11/09Generic · Class 3 Potassium Chloride GranulesCYHS2403838 Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized
2024/11/09Generic · Class 3 Potassium Chloride GranulesCYHS2403837 Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized
2024/11/09Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2403836 Changchun Hai Yue Pharma Co., Ltd. romanized
2024/11/09Generic · Class 3 Eptazocine Hydrobromide InjectionCYHS2403831 Chengdu Brilliant Pharmaceutical Co., Ltd.
2024/11/09Generic · Class 3 Nicergoline TabletsCYHS2403829 Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized
2024/11/09New drug · Class 1 注射用AMT-754 · No verified English nameCXSL2400760 Pu Zhong Fa Xian Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2024/11/09New drug · Class 1 J-51注射液 · No verified English nameCXSL2400759 Jin Wei Biopharmaceuticals Technology Co., Ltd. romanized
2024/11/09New drug · Class 1 SAR444656 · No verified English nameCXHL2401212 Sai Nuo Fei (Zhongguo) Investment Co., Ltd. romanized
2024/11/09New drug · Class 1 SAR444656 · No verified English nameCXHL2401211 Sai Nuo Fei (Zhongguo) Investment Co., Ltd. romanized
2024/11/09New drug · Class 1 NSP-1047A片 · No verified English nameCXHL2401210 Nuo Wo Si Da Pharma (Shanghai) Co., Ltd. romanized
2024/11/09New drug · Class 1 NSP-1047A片 · No verified English nameCXHL2401209 Nuo Wo Si Da Pharma (Shanghai) Co., Ltd. romanized
2024/11/09New drug · Class 1 GH56胶囊 · No verified English nameCXHL2401208 Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized
2024/11/09New drug · Class 1 GH56胶囊 · No verified English nameCXHL2401207 Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized
2024/11/09New drug · Class 1 GH56胶囊 · No verified English nameCXHL2401206 Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized

95 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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