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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 419 drug applications between 20 April 2023 and 26 April 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 86, covering 60 drug names.

2023/04/20 – 2023/04/26

Period
2023/04/20 to 2023/04/26, 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
419
Drugs with new generic filings (by drug name, de-duplicated)
60
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

419filings, 86 of them generic

By application type

Application typeFilings
Supplement211
Generic86
New drug68
Import28
Import re-registration16
Unspecified10

By drug type

Drug typeFilings
Chemical drug303
TCM57
Therapeutic biologic53
Biologic2
Prophylactic biologic2
In vitro diagnostic reagent1
Drug-device combination1

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

60 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Iodixanol Injection810
2恩那度司他片 · No verified English name310
3Sitagliptin and Metformin Hydrochloride Extended-release Tablets3112
4氧 · No verified English name2215
5Lornoxicam for Injection222
6Isosorbide Dinitrate Injection220
7硫酸特布他林雾化吸入用溶液 · No verified English name221
8Sugammadex Sodium Injection226
9Procaterol Hydrochloride Solution for Inhalation212
10复方醋酸钠林格注射液 · No verified English name212

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

222 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Changsha Ai Bei Gao Pharma Co., Ltd. romanized22170
2Anhui Xian Gui Pharmaceuticals Technology Co., Ltd. romanized14140
3Heilongjiang Hua Xi Biopharmaceuticals Technology Co., Ltd. romanized990
4Zhejiang Guo Jing Pharma Co., Ltd. romanized920
5Sichuan He Li Xin Jian Pharma Co., Ltd. romanized860
6Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized830
7Tong Yong Dian Qi Pharma (Shanghai) Co., Ltd. romanized818
8Roche Pharma (Schweiz) AG620
9Celgene Corporation610
10Yan Tai Chuang He Bio Technology Co., Ltd. romanized610

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

133 this week

AcceptedDrugApplicants
2023/04/26Import · Class 2.2 比吉利珠单抗注射液 · No verified English nameJXSS2300033 UCB Pharma S.A.; UCB Trading (Shanghai) Co. Ltd
2023/04/26Import · Class 2.2 比吉利珠单抗注射液 · No verified English nameJXSS2300032 UCB Pharma S.A.; UCB Trading (Shanghai) Co. Ltd
2023/04/26Import · Class 2.1 阿柏西普眼内注射溶液 · No verified English nameJXSL2300080 Bayer AG; Bayer Healthcare Company Ltd.
2023/04/26Import · Class 1 RO7434656注射液 · No verified English nameJXHL2300098 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2023/04/26Import · Class 1 BLU-5937片 · No verified English nameJXHL2300097 Bellus Health Cough Inc.; George (Beijing) Clinical Research Co. Ltd.
2023/04/26Import · Class 1 BLU-5937片 · No verified English nameJXHL2300096 Bellus Health Cough Inc.; George (Beijing) Clinical Research Co. Ltd.
2023/04/26Generic · Class 3 Diazepam Rectal GelCYHS2301173 Te Feng Pharmaceutical Co., Ltd. romanized
2023/04/26Generic · Class 3 Procaterol Hydrochloride Oral SolutionCYHS2301170 Nanjing Ai De Jia Biopharmaceutical Technology Co., Ltd. romanized; Shanxi Tong Da Pharma Co., Ltd. romanized
2023/04/26Generic · Class 3 Procaterol Hydrochloride Oral SolutionCYHS2301169 Nanjing Ai De Jia Biopharmaceutical Technology Co., Ltd. romanized; Shanxi Tong Da Pharma Co., Ltd. romanized
2023/04/26Generic · Class 3 磷酸奥司他韦颗粒 · No verified English nameCYHS2301164 Hubei Kang Yuan Pharma Co., Ltd. romanized; Hubei Zhong Gu Biopharmaceutical Co., Ltd. romanized
2023/04/26New drug · Class 1 重组人源化抗PCSK9单克隆抗体注射液 · No verified English nameCXSS2300025 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized
2023/04/26New drug · Class 1 重组人源化抗PCSK9单克隆抗体注射液 · No verified English nameCXSS2300024 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized
2023/04/26New drug · Class 1 重组人源化抗PCSK9单克隆抗体注射液 · No verified English nameCXSS2300023 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized
2023/04/26New drug · Class 1 重组人源化抗PCSK9单克隆抗体注射液 · No verified English nameCXSS2300022 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized
2023/04/26New drug · Class 1 重组抗BCMA和CD3双特异性抗体注射液 · No verified English nameCXSL2300287 Hua Lan Ji Yin Gong Cheng (Henan) Co., Ltd. romanized
2023/04/26New drug · Class 1 普卢格列汀片 · No verified English nameCXHS2300048 CSPC OUYI PHARMACEUTICAL CO., LTD.
2023/04/26New drug · Class 2.4 奥雷巴替尼片 · No verified English nameCXHL2300435 Guangzhou Shun Jian Biopharmaceuticals Technology Co., Ltd. romanized
2023/04/26New drug · Class 2.2; 2.4 盐酸伊立替康脂质体注射液 · No verified English nameCXHL2300434 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/04/25Import · Class 1 Epcoritamab注射用浓溶液 · No verified English nameJXSL2300079 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2023/04/25Import · Class 1 GSK3858279 注射液 · No verified English nameJXSL2300078 GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Company Limited
2023/04/25Import · Class 1 GSK3858279 注射液 · No verified English nameJXSL2300077 GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Company Limited
2023/04/25Import · Class 1 ARV-471(PF-07850327)片 · No verified English nameJXHL2300095 Pfizer Inc; Pfizer Investment CO. Ltd.
2023/04/25Import · Class 1 注射用Nacubactam · No verified English nameJXHL2300094 Meiji Seika Pharma Co. Ltd.; Shanghai Fosun Pharmaceutical Industrial Development Company Limited
2023/04/25Import · Class 1 Vamorolone口服混悬液 · No verified English nameJXHL2300093 Santhera Pharmaceuticals (Switzerland) Ltd; Sperogenix (Shanghai)Med Tech Co. Ltd.
2023/04/25Generic · Class 3 Aztreonam For InjectionCYHS2301158 Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized
2023/04/25Generic · Class 3 Acetylcysteine InjectionCYHS2301154 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2023/04/25Generic · Class 3 Famotidine InjectionCYHS2301153 Nanjing Feng Kai Si Drug Research and Development Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2023/04/25Generic · Class 3 Methocarbamol InjectionCYHS2301150 Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized
2023/04/25Generic · Class 3 利多卡因丙胺卡因气雾剂 · No verified English nameCYHL2300063 Ze Zheng (Shanghai) Bio Technology Co., Ltd. romanized
2023/04/25New drug · Class 2.1 重组人胰岛素肠溶胶囊 · No verified English nameCXSS2300021 Hefei Tian Hui Bio Technology Co., Ltd. romanized

103 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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