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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 428 drug applications between 22 April 2023 and 28 April 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 85, covering 56 drug names.

2023/04/22 – 2023/04/28

Period
2023/04/22 to 2023/04/28, 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
428
Drugs with new generic filings (by drug name, de-duplicated)
56
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

428filings, 85 of them generic

By application type

Application typeFilings
Supplement226
Generic85
New drug66
Import29
Import re-registration13
Unspecified9

By drug type

Drug typeFilings
Chemical drug289
TCM78
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

56 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
3Duloxetine Hydrochloride Enteric Capsules314
4Sitagliptin and Metformin Hydrochloride Extended-release Tablets3112
5硫酸特布他林雾化吸入用溶液 · No verified English name221
6Sugammadex Sodium Injection226
7Procaterol Hydrochloride Solution for Inhalation212
8复方醋酸钠林格注射液 · No verified English name212
9异氟烷 · No verified English name210
10Topiroxostat Tablets210

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. romanized23180
2Anhui Xian Gui Pharmaceuticals Technology Co., Ltd. romanized14140
3Sichuan He Li Xin Jian Pharma Co., Ltd. romanized14100
4Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized1090
5Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized1070
6Zhejiang Guo Jing Pharma Co., Ltd. romanized920
7Tong Yong Dian Qi Pharma (Shanghai) Co., Ltd. romanized818
8Guo Xin (Heilongjiang) Pharmaceutical Co., Ltd. romanized770
9Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized630
10Roche Pharma (Schweiz) AG620

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

122 this week

AcceptedDrugApplicants
2023/04/28Import · Class 2.2 TV-44749 · No verified English nameJXHL2300099 Teva Branded Pharmaceutical Products R&D Inc.
2023/04/28Generic · Class 3 氢化可的松缓释片 · No verified English nameCYHL2300068 Jin Yao Pharma Co., Ltd. romanized
2023/04/28Generic · Class 3 氢化可的松缓释片 · No verified English nameCYHL2300067 Jin Yao Pharma Co., Ltd. romanized
2023/04/28New drug · Class 3.1 芍药甘草颗粒 · No verified English nameCXZS2300010 Shen Wei Pharma Group Co., Ltd. romanized
2023/04/28New drug · Class 1 SNP201注射液 · No verified English nameCXSL2300297 Sai Shen (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2023/04/28New drug · Class 2.2 注射用重组改构人肿瘤坏死因子 · No verified English nameCXSL2300296 Shanghai Wei Ke Biopharmaceutical Co., Ltd. romanized
2023/04/28New drug · Class 1 JY016注射液 · No verified English nameCXSL2300295 Beijing Dong Fang Bai Tai Bio Technology Co., Ltd. romanized; Beijing Jing Yi Tai Xiang Technology Development Co., Ltd. romanized
2023/04/28New drug · Class 1 VGM-R02b · No verified English nameCXSL2300294 Shanghai Tian Ze Yun Tai Biopharmaceuticals Co., Ltd. romanized
2023/04/28New drug · Class 1 QB0208-1胶囊 · No verified English nameCXHL2300445 Beijing Qing Bo Hui Neng Pharmaceuticals Technology Co., Ltd. romanized
2023/04/28New drug · Class 1 QB0208-1胶囊 · No verified English nameCXHL2300444 Beijing Qing Bo Hui Neng Pharmaceuticals Technology Co., Ltd. romanized
2023/04/28New drug · Class 2.3 HY22017胶囊 · No verified English nameCXHL2300443 Changchun Hai Yue Pharma Co., Ltd. romanized
2023/04/28New drug · Class 1 DZ2002 · No verified English nameCXHL2300442 Ningbo Zi Yuan Pharma Co., Ltd. romanized
2023/04/28New drug · Class 1 DZ2002 · No verified English nameCXHL2300441 Ningbo Zi Yuan Pharma Co., Ltd. romanized
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

92 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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