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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 246 drug applications between 15 June 2023 and 21 June 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 54, covering 42 drug names.

2023/06/15 – 2023/06/21

Period
2023/06/15 to 2023/06/21, 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
246
Drugs with new generic filings (by drug name, de-duplicated)
42
Accepted this week, now under review
1

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

246filings, 54 of them generic

By application type

Application typeFilings
Supplement104
Generic54
New drug52
Import24
Unspecified8
Import re-registration4

By drug type

Drug typeFilings
Chemical drug176
TCM39
Therapeutic biologic31

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

42 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Carfilzomib For Injection320
2Acarbose Tablets323
3Ibuprofen Suspension2214
4Oxacillin Sodium for Injection2213
5Ibrutinib Tablets210
6Vonoprazan Fumarate Tablets2160
7Procaterol Hydrochloride Oral Solution2112
8Nalbuphine Hydrochloride Injection2111
9Esomeprazole Magnesium Enteric-Coated Capsules214
10Trimebutine Maleate Tablets214

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

159 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1An Guo Ya Dong Biopharmaceutical Co., Ltd. romanized660
2Changsha Ai Bei Gao Pharma Co., Ltd. romanized660
3Hangzhou An Dao Pharma Co., Ltd. romanized610
4Huang Shi Yan Wu Pharma Co., Ltd. romanized440
5Novartis Pharma Schweiz AG430
6Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized430
7Hetero Labs Limited420
8Hangzhou Ji Tai Pharmaceuticals Technology Co., Ltd. romanized410
9Janssen Research & Development LLC330
10Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized330

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

95 this week

AcceptedDrugApplicants
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
2023/06/21New drug · Class 1 TLL-041 缓释片 · No verified English nameCXHL2300677 Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized
2023/06/21New drug · Class 1 TLL-041 缓释片 · No verified English nameCXHL2300676 Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized
2023/06/21New drug · Class 1 HTD1801胶囊 · No verified English nameCXHL2300675 Shenzhen Jun Sheng Tai Bio Technology Co., Ltd. romanized
2023/06/21New drug · Class 1 HRS-7085片 · No verified English nameCXHL2300674 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/06/21New drug · Class 1 HRS-7085片 · No verified English nameCXHL2300673 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/06/20Import · Class 2.2 注射用A型肉毒毒素 · No verified English nameJXSS2300048 AbbVie Limited; Allergan Pharmaceuticals Ireland; Allergan Information Consulting (Shanghai) Co. Ltd.
2023/06/20Import · Class 2.2 注射用A型肉毒毒素 · No verified English nameJXSS2300047 AbbVie Limited; Allergan Pharmaceuticals Ireland; Allergan Information Consulting (Shanghai) Co. Ltd.
2023/06/20Import · Class 2.2 注射用A型肉毒毒素 · No verified English nameJXSS2300046 AbbVie Limited; Allergan Pharmaceuticals Ireland; Allergan Information Consulting (Shanghai) Co. Ltd.
2023/06/20Import · Class 1 IcoSema 注射液 · No verified English nameJXSL2300112 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2023/06/20Import · Class 2.2 眼用贝伐珠单抗注射液 · No verified English nameJXSL2300111 Outlook Therapeutics Inc.; Beijing Syntone Biopharma Ltd.
2023/06/20Import · Class 1 Imlunestrant 片 · No verified English nameJXHL2300144 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/06/20Generic · Class 3 Nicergoline TabletsCYHS2301664 Hainan Si Da Pharmaceutical Co., Ltd. romanized; Hainan Sai Li Ke Pharma Co., Ltd. romanized

65 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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