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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 377 drug applications between 16 April 2023 and 22 April 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 79, covering 64 drug names.

2023/04/16 – 2023/04/22

Period
2023/04/16 to 2023/04/22, 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
377
Drugs with new generic filings (by drug name, de-duplicated)
64
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

377filings, 79 of them generic

By application type

Application typeFilings
Supplement193
Generic79
New drug72
Import18
Unspecified8
Import re-registration6
Drug-device combination product1

By drug type

Drug typeFilings
Chemical drug270
TCM56
Therapeutic biologic45
Prophylactic biologic2
In vitro diagnostic reagent1
Biologic1
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

64 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
3Diprophylline Injection227
4Pregabalin Oral Solution225
5Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution2223
6Isosorbide Dinitrate Injection220
7Progesterone Injection225
8Lacosamide Injection210
9注射用头孢唑肟钠 · No verified English name214
10Neostigmine Methylsulfate Injection214

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

216 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jiangxi Nanchang Ji Sheng Pharmaceutical Co., Ltd. romanized20180
2Changsha Ai Bei Gao Pharma Co., Ltd. romanized15150
3Heilongjiang Hua Xi Biopharmaceuticals Technology Co., Ltd. romanized990
4Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized730
5Celgene Corporation610
6Shandong Luo Xin Pharma Group Co., Ltd. romanized520
7Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized510
8Sichuan Kelun Pharmaceutical Co., Ltd.431
9Da Lian Tian Shan Pharma Co., Ltd. romanized430
10Shijiazhuang No.4 Pharmaceutical Co., Ltd.434

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

129 this week

AcceptedDrugApplicants
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
2023/04/22Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2301121 Jiangsu Jiu Xu Pharma Co., Ltd. romanized
2023/04/22Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2301120 Jiangsu Jiu Xu Pharma Co., Ltd. romanized
2023/04/22Generic · Class 3 Sumatriptan and Naproxen Sodium TabletsCYHS2301119 Kang Yuan Hua Wei Pharmaceuticals Co., Ltd. romanized; Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2023/04/22Generic · Class 3 恩那度司他片 · No verified English nameCYHL2300062 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2023/04/22Generic · Class 3 恩那度司他片 · No verified English nameCYHL2300061 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2023/04/22Generic · Class 3 恩那度司他片 · No verified English nameCYHL2300060 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2023/04/22New drug · Class 2.3 脑心清片 · No verified English nameCXZL2300029 Guangzhou Bai Yun Shan He Ji Huang Pu Zhong Yao Co., Ltd. romanized
2023/04/22New drug · Class 2.3 杏贝止咳颗粒 · No verified English nameCXZL2300028 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2023/04/22New drug · Class 1 SG301 SC注射液 · No verified English nameCXSL2300283 Hangzhou Shang Jian Bio Technology Co., Ltd. romanized
2023/04/22New drug · Class 1 注射用AST-006 · No verified English nameCXHL2300416 Shenzhen Ai Xin Da Wei Pharmaceuticals Technology Co., Ltd. romanized
2023/04/22New drug · Class 1 BPHY-08胶囊 · No verified English nameCXHL2300415 Bai Ji Hong Ye (Nan Tong) Pharmaceuticals Technology Co., Ltd. romanized
2023/04/22New drug · Class 1 BPHY-08胶囊 · No verified English nameCXHL2300414 Bai Ji Hong Ye (Nan Tong) Pharmaceuticals Technology Co., Ltd. romanized
2023/04/22New drug · Class 1 吡罗西尼片 · No verified English nameCXHL2300413 Xuan Zhu Bio Technology Co., Ltd. romanized
2023/04/22New drug · Class 1 WS635片 · No verified English nameCXHL2300412 Zhong Mei Hua Shi Tong Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized
2023/04/22New drug · Class 2.2 盐酸鲁拉西酮口溶膜 · No verified English nameCXHL2300411 Sichuan Kelun Pharmaceutical Co., Ltd.
2023/04/22New drug · Class 2.4 布比卡因脂质体注射液 · No verified English nameCXHL2300410 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/04/22New drug · Class 2.4 布比卡因脂质体注射液 · No verified English nameCXHL2300409 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/04/21Import · Class 3.4 达雷妥尤单抗注射液 · No verified English nameJXSL2300072 Janssen-Cilag AG; Johnson & Johnson (China) Investment Ltd.
2023/04/21Generic · Class 3 Fudosteine oral solutionCYHS2301118 Sichuan Yi Sheng Zhi Tong Pharmaceuticals Bio Technology Development Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2023/04/21Generic · Class 3 Pentoxifylline InjectionCYHS2301115 Anhui Mei Lai Pharma Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized
2023/04/21Generic · Class 3 Temozolomide For InjectionCYHS2301114 Beijing SL Pharmaceutical Co., Ltd.

99 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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