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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 245 drug applications between 14 June 2023 and 20 June 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 48, covering 38 drug names.

2023/06/14 – 2023/06/20

Period
2023/06/14 to 2023/06/20, 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
245
Drugs with new generic filings (by drug name, de-duplicated)
38
Accepted this week, now under review
2

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

245filings, 48 of them generic

By application type

Application typeFilings
Supplement114
Generic48
New drug47
Import23
Unspecified8
Import re-registration5

By drug type

Drug typeFilings
Chemical drug176
TCM39
Therapeutic biologic28
Prophylactic biologic2

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

38 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Acarbose Tablets323
2Ibuprofen Suspension2214
3Empagliflozin Tablets2218
4Ibrutinib Tablets210
5Vonoprazan Fumarate Tablets2160
6Procaterol Hydrochloride Oral Solution2112
7Esomeprazole Magnesium Enteric-Coated Capsules214
8Ketorolac Tromethamine Injection214
9Trimebutine Maleate Tablets214
10Sodium Valproate Oral Solution111

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

152 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
4Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized550
5Novartis Pharma Schweiz AG540
6Janssen Research & Development LLC440
7Huang Shi Yan Wu Pharma Co., Ltd. romanized440
8Hetero Labs Limited420
9Hangzhou Ji Tai Pharmaceuticals Technology Co., Ltd. romanized410
10Zhejiang Ya Tai Pharma Co., Ltd. romanized410

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

86 this week

AcceptedDrugApplicants
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
2023/06/20Generic · Class 3 Vardenafil Hydrochloride Orally disintegrating TabletsCYHS2301661 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2023/06/20Generic · Class 3 Trimebutine Maleate TabletsCYHS2301659 Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/06/20Generic · Class 3 Trimebutine Maleate TabletsCYHS2301658 Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/06/20New drug · Class 1.2 SZ1108片 · No verified English nameCXZL2300043 Su Zhong Pharma Group Co., Ltd. romanized
2023/06/20New drug · Class 1.2 SZ1108 · No verified English nameCXZL2300042 Su Zhong Pharma Group Co., Ltd. romanized
2023/06/20New drug · Class 1 IHS002人脐带间充质干细胞 · No verified English nameCXSL2300424 Wuxi Hua Tai Innovation Yao Technology Research Institute Co., Ltd. romanized
2023/06/20New drug · Class 1 注射用JS207 · No verified English nameCXSL2300423 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2023/06/20New drug · Class 1 注射用BC001 · No verified English nameCXSL2300422 Sichuan Lu Zhou Bu Zhang Biopharmaceutical Co., Ltd. romanized
2023/06/20New drug · Class 2.4 西格列他钠片 · No verified English nameCXHS2300056 Chengdu Wei Xin Pharma Co., Ltd. romanized
2023/06/20New drug · Class 2.2; 2.4 YN001 · No verified English nameCXHL2300672 Beijing Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized
2023/06/20New drug · Class 1 AND017胶囊 · No verified English nameCXHL2300671 Hangzhou An Dao Pharma Co., Ltd. romanized
2023/06/20New drug · Class 1 AND017胶囊 · No verified English nameCXHL2300670 Hangzhou An Dao Pharma Co., Ltd. romanized
2023/06/20New drug · Class 1 AND017胶囊 · No verified English nameCXHL2300669 Hangzhou An Dao Pharma Co., Ltd. romanized
2023/06/20New drug · Class 1 AND017胶囊 · No verified English nameCXHL2300668 Hangzhou An Dao Pharma Co., Ltd. romanized
2023/06/20New drug · Class 1 AND017胶囊 · No verified English nameCXHL2300667 Hangzhou An Dao Pharma Co., Ltd. romanized
2023/06/20New drug · Class 1 AND017胶囊 · No verified English nameCXHL2300666 Hangzhou An Dao Pharma Co., Ltd. romanized
2023/06/19Generic · Class 3 Ibrutinib TabletsCYHS2301654 Qilu Pharmaceutical (Hainan) Co., Ltd
2023/06/19Generic · Class 3 Ibrutinib TabletsCYHS2301653 Qilu Pharmaceutical (Hainan) Co., Ltd
2023/06/19New drug · Class 1 人肝细胞血浆灌流器 · No verified English nameCXSL2300421 Suzhou Rui Lai Bio Technology Co., Ltd. romanized
2023/06/19New drug · Class 2.2 IBI310 · No verified English nameCXSL2300420 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2023/06/19New drug · Class 1 HSK21542片 · No verified English nameCXHL2300665 Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized
2023/06/19New drug · Class 1 HSK21542片 · No verified English nameCXHL2300664 Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized
2023/06/19New drug · Class 1 TCIC-002颗粒 · No verified English nameCXHL2300663 Tang Chuan Bio Technology (Xiamen) Co., Ltd. romanized

56 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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