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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 408 drug applications between 21 April 2023 and 27 April 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 86, covering 59 drug names.

2023/04/21 – 2023/04/27

Period
2023/04/21 to 2023/04/27, 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
408
Drugs with new generic filings (by drug name, de-duplicated)
59
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

408filings, 86 of them generic

By application type

Application typeFilings
Supplement200
Generic86
New drug69
Import27
Import re-registration14
Unspecified12

By drug type

Drug typeFilings
Chemical drug285
TCM62
Therapeutic biologic52
Biologic4
Prophylactic biologic4
In vitro diagnostic reagent1

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

59 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
5Isosorbide Dinitrate Injection220
6硫酸特布他林雾化吸入用溶液 · No verified English name221
7Sugammadex Sodium Injection226
8Procaterol Hydrochloride Solution for Inhalation212
9复方醋酸钠林格注射液 · No verified English name212
10异氟烷 · No verified English name210

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

225 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Changsha Ai Bei Gao Pharma Co., Ltd. romanized23180
2Anhui Xian Gui Pharmaceuticals Technology Co., Ltd. romanized14140
3Zhejiang Guo Jing Pharma Co., Ltd. romanized920
4Sichuan He Li Xin Jian Pharma Co., Ltd. romanized860
5Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized830
6Tong Yong Dian Qi Pharma (Shanghai) Co., Ltd. romanized818
7Roche Pharma (Schweiz) AG620
8Celgene Corporation610
9Yan Tai Chuang He Bio Technology Co., Ltd. romanized610
10Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized550

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

130 this week

AcceptedDrugApplicants
2023/04/27Import · Class 1 注射用SAR444200 · No verified English nameJXSL2300081 Sanofi-Aventis Recherche & Développement; Sanofi(China)Investment Co. Ltd.
2023/04/27Generic · Class 3 Minodronic acid TabletsCYHS2301180 Anhui Bo Nuo Mei Ke Biopharmaceuticals Co., Ltd. romanized; Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized
2023/04/27Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2301179 Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Guo Yao Group Guo Rui Pharma Co., Ltd. romanized
2023/04/27Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2301178 Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Guo Yao Group Guo Rui Pharma Co., Ltd. romanized
2023/04/27Generic · Class 3 Topiroxostat TabletsCYHL2300066 Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized
2023/04/27Generic · Class 3 Topiroxostat TabletsCYHL2300065 Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized
2023/04/27New drug · Class 2.1 双黄连吸入溶液 · No verified English nameCXZL2300031 Shen Wei Pharma Group Co., Ltd. romanized; Beijing Ying Ke Rui Innovation Pharmaceuticals Co., Ltd. romanized
2023/04/27New drug · Class 3.3 注射用曲妥珠单抗 · No verified English nameCXSS2300027 Qilu Pharmaceutical Co., Ltd.
2023/04/27New drug · Class 1 夫那奇珠单抗注射液 · No verified English nameCXSS2300026 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2023/04/27New drug · Class 1.4 二价肠道病毒灭活疫苗(Vero细胞) · No verified English nameCXSL2300293 Beijing Ke Xing Bio Zhi Pin Co., Ltd. romanized
2023/04/27New drug · Class 1.4 二价肠道病毒灭活疫苗(Vero细胞) · No verified English nameCXSL2300292 Beijing Ke Xing Bio Zhi Pin Co., Ltd. romanized
2023/04/27New drug · Class 1.4 二价肠道病毒灭活疫苗(Vero细胞) · No verified English nameCXSL2300291 Beijing Ke Xing Bio Zhi Pin Co., Ltd. romanized
2023/04/27New drug · Class 1 GT201注射液 · No verified English nameCXSL2300290 Suzhou Sha Li Bio Technology Co., Ltd. romanized
2023/04/27New drug · Class 1 GB002重组多肽吸入溶液 · No verified English nameCXSL2300289 Nanning Ji Rui Biopharmaceuticals Co., Ltd. romanized; Zhejiang Ying Kang Biopharmaceuticals Co., Ltd. romanized
2023/04/27New drug · Class 1 注射用SKB264 · No verified English nameCXSL2300288 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2023/04/27New drug · Class 1 FWD1802片 · No verified English nameCXHL2300440 Shenzhen Fu Wo Pharma Co., Ltd. romanized
2023/04/27New drug · Class 1 FWD1802片 · No verified English nameCXHL2300439 Shenzhen Fu Wo Pharma Co., Ltd. romanized
2023/04/27New drug · Class 1 FWD1802片 · No verified English nameCXHL2300438 Shenzhen Fu Wo Pharma Co., Ltd. romanized
2023/04/27New drug · Class 1 HRS-9815注射液制备用药盒 · No verified English nameCXHL2300437 Tianjin Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/04/27New drug · Class 1 HRS-9815注射液 · No verified English nameCXHL2300436 Tianjin Heng Rui Pharmaceuticals Co., Ltd. romanized
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

100 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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