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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 161 drug applications between 19 June 2023 and 25 June 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 32, covering 26 drug names.

2023/06/19 – 2023/06/25

Period
2023/06/19 to 2023/06/25, 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
161
Drugs with new generic filings (by drug name, de-duplicated)
26
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

161filings, 32 of them generic

By application type

Application typeFilings
Supplement59
New drug42
Generic32
Import15
Import re-registration9
Unspecified4

By drug type

Drug typeFilings
Chemical drug119
Therapeutic biologic23
TCM19

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

26 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ibuprofen Suspension2214
2Ibrutinib Tablets210
3Carfilzomib For Injection210
4Nalbuphine Hydrochloride Injection2111
5Rocuronium Bromide Injection211
6Trimebutine Maleate Tablets214
7Acetylcysteine Injection1153
8Lactulose Oral Solution1134
9Tadalafil Tablets1123
10Potassium Phosphates Injection112

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

107 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hangzhou An Dao Pharma Co., Ltd. romanized610
2Dr. Reddy's Laboratories Ltd.520
3Novartis Pharma Schweiz AG430
4Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized410
5Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized330
6AbbVie Inc.310
7AbbVie Limited310
8Hetero Labs Limited310
9Organon Pharma (UK) Limited310
10Kunming Ji Da Pharmaceutical Co., Ltd. romanized310

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

66 this week

AcceptedDrugApplicants
2023/06/22Import · Class 1 MK-0616 片 · No verified English nameJXHL2300146 Merck Sharp & Dohme LLC; Name not romanized
2023/06/22Generic · Class 3 Esmolol Hydrochloride InjectionCYHS2301678 Hainan Brilliant Pharmaceutical Co., Ltd.
2023/06/22New drug · Class 1 注射用D3L-001 · No verified English nameCXSL2300428 Name not romanized
2023/06/22New drug · Class 1 重组抗CD20人源化单克隆抗体皮下注射液 · No verified English nameCXSL2300427 Shanghai Shang Yao Jiao Lian Pharmaceuticals Technology Co., Ltd. romanized
2023/06/22New drug · Class 1 注射用NCB003 · No verified English nameCXSL2300426 Zhejiang Xin Ma Biopharmaceuticals Co., Ltd. romanized
2023/06/22New drug · Class 1 VV119胶囊 · No verified English nameCXHL2300686 Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized
2023/06/22New drug · Class 1 VV119胶囊 · No verified English nameCXHL2300685 Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized
2023/06/22New drug · Class 1 VV119胶囊 · No verified English nameCXHL2300684 Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized
2023/06/22New drug · Class 1 JYP0061片 · No verified English nameCXHL2300683 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2023/06/22New drug · Class 1 JYP0061片 · No verified English nameCXHL2300682 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2023/06/22New drug · Class 1 JYP0061片 · No verified English nameCXHL2300681 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2023/06/22New drug · Class 1 JYP0061片 · No verified English nameCXHL2300680 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2023/06/21Import · Class 1 LEO 138559 注射液 · No verified English nameJXSL2300113 LEO Pharma A/S; LEO Pharma Consultancy (Shanghai) Company Limited
2023/06/21Import · Class 1 Sisunatovir 胶囊 · No verified English nameJXHL2300145 Pfizer Inc.; Pfizer Investment CO. Ltd
2023/06/21Generic · Class 3 Pentoxifylline InjectionCYHS2301677 Hebei Yi Pin Biopharmaceuticals Co., Ltd. romanized; Hebei Yi Pin Pharmaceutical Co., Ltd. romanized
2023/06/21Generic · Class 3 Potassium Phosphates InjectionCYHS2301676 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2023/06/21Generic · Class 3 Formoterol Fumarate Inhalation SolutionCYHS2301674 Shanghai Xin Yi Jin Zhu Pharma Co., Ltd. romanized
2023/06/21Generic · Class 3 Oxacillin Sodium for InjectionCYHS2301673 Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2023/06/21Generic · Class 3 Acetylcysteine InjectionCYHS2301671 Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized
2023/06/21Generic · Class 3 Carbocisteine Oral SolutionCYHS2301670 Beijing Wo Bang Pharmaceuticals Technology Co., Ltd. romanized; Yang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanized
2023/06/21Generic · Class 3 Nalbuphine Hydrochloride InjectionCYHL2300080 Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized
2023/06/21Generic · Class 3 Nalbuphine Hydrochloride InjectionCYHL2300079 Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized
2023/06/21New drug · Class 3.3 注射用奥马珠单抗 · No verified English nameCXSS2300047 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2023/06/21New drug · Class 1 注射用瑞卡西单抗 · No verified English nameCXSS2300046 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized; Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2023/06/21New drug · Class 1 注射用重组人凝血因子Ⅷ-Fc融合蛋白 · No verified English nameCXSS2300045 Jiangsu Cheng Si Biopharmaceutical Co., Ltd. romanized; Ao Si Kang Bio (Nan Tong) Co., Ltd. romanized
2023/06/21New drug · Class 1 注射用重组人凝血因子Ⅷ-Fc融合蛋白 · No verified English nameCXSS2300044 Jiangsu Cheng Si Biopharmaceutical Co., Ltd. romanized; Ao Si Kang Bio (Nan Tong) Co., Ltd. romanized
2023/06/21New drug · Class 1 SHR-2005注射液 · No verified English nameCXSL2300425 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/06/21New drug · Class 2.4 泽布替尼胶囊 · No verified English nameCXHS2300057 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2023/06/21New drug · Class 1 LP-168片 · No verified English nameCXHL2300679 Guangzhou Lu Peng Pharmaceutical Co., Ltd. romanized
2023/06/21New drug · Class 1 LP-168片 · No verified English nameCXHL2300678 Guangzhou Lu Peng Pharmaceutical Co., Ltd. romanized

36 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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