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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 410 drug applications between 18 April 2023 and 24 April 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 90, covering 68 drug names.

2023/04/18 – 2023/04/24

Period
2023/04/18 to 2023/04/24, 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
410
Drugs with new generic filings (by drug name, de-duplicated)
68
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

410filings, 90 of them generic

By application type

Application typeFilings
Supplement214
Generic90
New drug72
Import18
Unspecified9
Import re-registration6
Drug-device combination product1

By drug type

Drug typeFilings
Chemical drug299
TCM59
Therapeutic biologic44
Prophylactic biologic3
Biologic2
In vitro diagnostic reagent1
Drug-device combination1
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

68 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Lactulose Oral Solution3234
2恩那度司他片 · No verified English name310
3Sitagliptin and Metformin Hydrochloride Extended-release Tablets3112
4Diprophylline Injection227
5Pregabalin Oral Solution225
6氧 · No verified English name2215
7Lornoxicam for Injection222
8Isosorbide Dinitrate Injection220
9Progesterone Injection225
10Procaterol Hydrochloride Solution for Inhalation212

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

221 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Changsha Ai Bei Gao Pharma Co., Ltd. romanized31260
2Jiangxi Nanchang Ji Sheng Pharmaceutical Co., Ltd. romanized14120
3Heilongjiang Hua Xi Biopharmaceuticals Technology Co., Ltd. romanized990
4Zhejiang Guo Jing Pharma Co., Ltd. romanized920
5Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized730
6Celgene Corporation610
7Yan Tai Chuang He Bio Technology Co., Ltd. romanized610
8Shijiazhuang No.4 Pharmaceutical Co., Ltd.545
9Shandong Luo Xin Pharma Group Co., Ltd. romanized520
10Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized510

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

136 this week

AcceptedDrugApplicants
2023/04/24Generic · Class 3 复方醋酸钠林格注射液 · No verified English nameCYHS2301149 Chi Feng Yuan Sheng Pharma Co., Ltd. romanized
2023/04/24Generic · Class 3 复方醋酸钠林格注射液 · No verified English nameCYHS2301148 Chi Feng Yuan Sheng Pharma Co., Ltd. romanized
2023/04/24Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2301143 Nan Tong Lian Ya Pharma Co., Ltd. romanized
2023/04/24Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2301142 Nan Tong Lian Ya Pharma Co., Ltd. romanized
2023/04/24Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2301141 Nan Tong Lian Ya Pharma Co., Ltd. romanized
2023/04/24Generic · Class 3 Procaterol Hydrochloride Solution for InhalationCYHS2301140 Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/04/24Generic · Class 3 Procaterol Hydrochloride Solution for InhalationCYHS2301139 Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/04/24Generic · Class 3 Dobutamine Hydrochloride InjectionCYHS2301138 Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Jiangsu Shen Long Pharma Co., Ltd. romanized
2023/04/24Generic · Class 3 Foscarnet Sodium InjectionCYHS2301137 Hua Ren Pharma Co., Ltd. romanized
2023/04/24Generic · Class 3 Potassium Chloride InjectionCYHS2301136 Chongqing Yao Gu Pharmaceutical Co., Ltd. romanized; HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2023/04/24Generic · Class 3 Potassium Chloride InjectionCYHS2301135 Chongqing Yao Gu Pharmaceutical Co., Ltd. romanized; HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2023/04/24New drug · Class 1.1 HYZ2001胶囊 · No verified English nameCXZL2300030 Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized
2023/04/24New drug · Class 3.3 冻干人用狂犬病疫苗(Vero细胞) · No verified English nameCXSS2300020 Changchun Zhuo Yi Bio Co., Ltd. romanized
2023/04/24New drug · Class 1 IN10018片 · No verified English nameCXHL2300424 Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized
2023/04/24New drug · Class 1 IN10018片 · No verified English nameCXHL2300423 Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized
2023/04/24New drug · Class 1 LPM7100328胶囊 · No verified English nameCXHL2300422 Yan Tai Chuang He Bio Technology Co., Ltd. romanized
2023/04/24New drug · Class 1 LPM7100328胶囊 · No verified English nameCXHL2300421 Yan Tai Chuang He Bio Technology Co., Ltd. romanized
2023/04/24New drug · Class 1 LPM7100328胶囊 · No verified English nameCXHL2300420 Yan Tai Chuang He Bio Technology Co., Ltd. romanized
2023/04/24New drug · Class 1 LPM7100328胶囊 · No verified English nameCXHL2300419 Yan Tai Chuang He Bio Technology Co., Ltd. romanized
2023/04/24New drug · Class 1 LPM7100328胶囊 · No verified English nameCXHL2300418 Yan Tai Chuang He Bio Technology Co., Ltd. romanized
2023/04/24New drug · Class 1 LPM7100328胶囊 · No verified English nameCXHL2300417 Yan Tai Chuang He Bio Technology Co., Ltd. romanized
2023/04/22Import · Class 1 IMG-020注射液 · No verified English nameJXSL2300076 INMAGENE PTE. LTD.; Inmagene Biopharmaceuticals (Hangzhou) Co. Ltd.
2023/04/22Import · Class 1 MEDI5752 · No verified English nameJXSL2300075 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/04/22Import · Class 1 AZD2936 · No verified English nameJXSL2300074 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/04/22Import · Class 1 ASP2138 注射液 · No verified English nameJXSL2300073 Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd.
2023/04/22Generic · Class 3 Diprophylline InjectionCYHS2301131 Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized
2023/04/22Generic · Class 3 Desmopressin Acetate Oral SolutionCYHS2301129 Hefei En Rui Te Pharma Co., Ltd. romanized
2023/04/22Generic · Class 3 Salbutamol Sulfate injectionCYHS2301128 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2023/04/22Generic · Class 3 Potassium Chloride GranulesCYHS2301126 Shanxi Pu De Pharma Co., Ltd. romanized
2023/04/22Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2301124 Beijing Han Mei Bio Technology Co., Ltd. romanized; Beijing Han Mei Medicines Co., Ltd. romanized

106 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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