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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 274 drug applications between 2 November 2022 and 8 November 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 44, covering 36 drug names.

2022/11/02 – 2022/11/08

Period
2022/11/02 to 2022/11/08, 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
274
Drugs with new generic filings (by drug name, de-duplicated)
36
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

274filings, 44 of them generic

By application type

Application typeFilings
Supplement149
Generic44
New drug35
Import29
Import re-registration9
Unspecified8

By drug type

Drug typeFilings
Chemical drug183
TCM52
Therapeutic biologic37
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

36 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Pentoxifylline Injection223
2Piracetam Injection219
3Empagliflozin Tablets2118
4Sacubitril Valsartan Sodium Tablets2170
5Rocuronium Bromide Injection211
6羟乙基淀粉130/0.4氯化钠注射液 · No verified English name210
7Sugammadex Sodium Injection216
8Dapagliflozin Tablets2184
9Fluticasone Propionate Nebuliser Suspension118
10Canagliflozin Tablets118

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

149 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Gansu Xin Min Hai Pharmaceutical Co., Ltd. romanized14140
2Bo Zhou Ya Ying Pharmaceuticals Technology Co., Ltd. romanized1090
3Guangdong Dong Yang Guang Pharma Co., Ltd. romanized910
4Hainan Mei Lan Shi Ke Pharmaceutical Co., Ltd. romanized810
5Jilin Sheng Yi Pu Bio Technology Co., Ltd. romanized550
6Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized535
7Annora Pharma Private Limited520
8Guangxi Lian He Sheng Sheng Pharma Co., Ltd. romanized440
9Sanofi-Aventis Recherche & Développement420
10Tianjin Jin Yao Pharma Co., Ltd. romanized420

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

63 this week

AcceptedDrugApplicants
2022/11/08Import · Class 1 Tiragolumab注射液 · No verified English nameJXSL2200197 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd
2022/11/08Import · Class 1 RO7247669注射液 · No verified English nameJXSL2200196 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd
2022/11/08Generic · Class 3 Pentoxifylline InjectionCYHS2201903 Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2022/11/08New drug · Class 1 欧司珀利单抗注射液 · No verified English nameCXSL2200564 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2022/11/08New drug · Class 1 舒非尼酮(SC1011)片 · No verified English nameCXHL2200876 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2022/11/08New drug · Class 1 HZ-A-018胶囊 · No verified English nameCXHL2200875 Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized
2022/11/08New drug · Class 1 HZ-A-018胶囊 · No verified English nameCXHL2200874 Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized
2022/11/08New drug · Class 1 HZ-A-018胶囊 · No verified English nameCXHL2200873 Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized
2022/11/08New drug · Class 1 HZ-A-018胶囊 · No verified English nameCXHL2200872 Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized
2022/11/08New drug · Class 1 ZXBT-1158胶囊 · No verified English nameCXHL2200871 Shenzhen Shi Zhen Xing Bei Te Pharmaceuticals Technology Co., Ltd. romanized
2022/11/08New drug · Class 1 ZXBT-1158胶囊 · No verified English nameCXHL2200870 Shenzhen Shi Zhen Xing Bei Te Pharmaceuticals Technology Co., Ltd. romanized
2022/11/08New drug · Class 1 APG-5918片 · No verified English nameCXHL2200869 Suzhou Ya Sheng Pharma Co., Ltd. romanized; Guangzhou Shun Jian Biopharmaceuticals Technology Co., Ltd. romanized
2022/11/08New drug · Class 1 APG-5918片 · No verified English nameCXHL2200868 Suzhou Ya Sheng Pharma Co., Ltd. romanized; Guangzhou Shun Jian Biopharmaceuticals Technology Co., Ltd. romanized
2022/11/07New drug · Class 1 EMB-07注射液 · No verified English nameCXSL2200562 An Mai Bio Technology (Suzhou) Co., Ltd. romanized
2022/11/07New drug · Class 1 HLX23 · No verified English nameCXSL2200561 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized
2022/11/07New drug · Class 1 重组抗PD-1全人源单克隆抗体注射液 · No verified English nameCXSL2200560 Shanghai Yun Yi Health Technology Development Co., Ltd. romanized
2022/11/06Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2201901 Jiangxi Yi You Pharma Co., Ltd. romanized; Jing Cheng Hui Yao Pharma Co., Ltd. romanized
2022/11/05Import · Class 1 注射用SAR443216 · No verified English nameJXSL2200195 Sanofi-Aventis Recherche & Développement; SANOFI (CHINA) INVESTMENT CO. LTD
2022/11/05Import · Class 1 注射用SAR443216 · No verified English nameJXSL2200194 Sanofi-Aventis Recherche & Développement; SANOFI (CHINA) INVESTMENT CO. LTD
2022/11/05Import · Class 1 AZD2936 · No verified English nameJXSL2200193 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2022/11/05Import · Class 1 VAY736注射液 · No verified English nameJXSL2200192 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/11/05Import · Class 1 MEDI5752 · No verified English nameJXSL2200191 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2022/11/05Generic · Class 3 Pentoxifylline InjectionCYHS2201898 Anhui Heng Xing Pharmaceutical Co., Ltd. romanized
2022/11/05Generic · Class 3 Cetirizine Hydrochloride InjectionCYHS2201895 Beijing Si Huan Ke Bao Pharma Co., Ltd. romanized; Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2022/11/05New drug · Class 2.2 注射用维迪西妥单抗 · No verified English nameCXSL2200559 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2022/11/04Import · Class 1 Omecamtiv Mecarbil缓释片 · No verified English nameJXHS2200102 Cytokinetics Incorporated; Patheon Inc.; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd
2022/11/04Import · Class 1 Omecamtiv Mecarbil缓释片 · No verified English nameJXHS2200101 Cytokinetics Incorporated; Patheon Inc.; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd
2022/11/04Import · Class 1 Omecamtiv Mecarbil缓释片 · No verified English nameJXHS2200100 Cytokinetics Incorporated; Patheon Inc.; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd
2022/11/04Import · Class 2.2 诺西那生钠注射液 · No verified English nameJXHL2200330 Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd
2022/11/04Import · Class 2.2 诺西那生钠注射液 · No verified English nameJXHL2200329 Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd

33 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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