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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 340 drug applications between 4 March 2023 and 10 March 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 81, covering 59 drug names.

2023/03/04 – 2023/03/10

Period
2023/03/04 to 2023/03/10, 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
340
Drugs with new generic filings (by drug name, de-duplicated)
59
Accepted this week, now under review
7

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

340filings, 81 of them generic

By application type

Application typeFilings
Supplement185
Generic81
New drug42
Import re-registration14
Unspecified9
Import9

By drug type

Drug typeFilings
Chemical drug251
TCM49
Therapeutic biologic36
Biologic3
Prophylactic biologic1

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

59 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dapagliflozin Tablets4284
2Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution3223
3Minoxidil Topical Solution320
4Palbociclib Capsules310
5Lidocaine and Prilocaine Cream2224
6Famotidine Injection228
7Lactulose Oral Solution2134
8Risperidone Orally Disintegrating Tablets210
9吸入用布地奈德混悬液 · No verified English name217
10Torsemide Injection211

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

197 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized11100
2Shanghai Qing Ping Pharma Co., Ltd. romanized850
3Actelion Pharmaceuticals Ltd810
4Tianjin He Zhi Pharma Group Co., Ltd. romanized660
5Hong Xiang (Heilongjiang) Pharmaceutical Co., Ltd. romanized660
6Shandong Run Ze Pharmaceutical Co., Ltd. romanized610
7Eurofins Analytical Science Laboratories Inc.550
8Bo Zhou Ya Ying Pharmaceuticals Technology Co., Ltd. romanized550
9Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized551
10Shijiazhuang No.4 Pharmaceutical Co., Ltd.542

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

84 this week

AcceptedDrugApplicants
2023/03/10Import · Class 3.1 注射用维恩妥尤单抗 · No verified English nameJXSS2300023 Astellas Pharma Europe B.V.; Baxter Oncology GmbH; Astellas (China) Investment Co. Ltd.
2023/03/10Import · Class 3.1 注射用维恩妥尤单抗 · No verified English nameJXSS2300022 Astellas Pharma Europe B.V.; Baxter Oncology GmbH; Astellas (China) Investment Co Ltd.
2023/03/10Generic · Class 3 Famotidine InjectionCYHS2300762 Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized
2023/03/10Generic · Class 3 Dobutamine Hydrochloride InjectionCYHS2300761 Shenyang Shuang Ding Pharmaceutical Co., Ltd. romanized
2023/03/10Generic · Class 3 Dobutamine Hydrochloride InjectionCYHS2300760 Shenyang Shuang Ding Pharmaceutical Co., Ltd. romanized
2023/03/10Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2300759 Tong Hua Wan Tong Pharma Co., Ltd. romanized
2023/03/10Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2300758 Tong Hua Wan Tong Pharma Co., Ltd. romanized
2023/03/10Generic · Class 3 Oxaliplatin InjectionCYHS2300754 Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized
2023/03/10Generic · Class 3 Rivastigmine Hydrogen Tartrate Oral SolutionCYHS2300753 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2023/03/10New drug · Class 1 恩朗苏拜单抗注射液 · No verified English nameCXSS2300010 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2023/03/10New drug · Class 1 EA5注射液 · No verified English nameCXSL2300180 Suzhou Bo Wei Bio Technology Co., Ltd. romanized; Shanghai Lan Yi Pharmaceuticals Technology Co., Ltd. romanized
2023/03/10New drug · Class 1 HS-20117注射液 · No verified English nameCXSL2300179 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2023/03/10New drug · Class 2.2 他达拉非口腔速溶膜 · No verified English nameCXHS2300037 Sichuan Bai Li Pharma Co., Ltd. romanized
2023/03/10New drug · Class 1 WT-1108片 · No verified English nameCXHL2300294 Hangzhou Wei Tan Pharmaceuticals Technology Co., Ltd. romanized
2023/03/10New drug · Class 1 WT-1108片 · No verified English nameCXHL2300293 Hangzhou Wei Tan Pharmaceuticals Technology Co., Ltd. romanized
2023/03/10New drug · Class 1 QLS1103片 · No verified English nameCXHL2300292 Qilu Pharmaceutical Co., Ltd.
2023/03/10New drug · Class 1 QLS1103片 · No verified English nameCXHL2300291 Qilu Pharmaceutical Co., Ltd.
2023/03/09Import · Class 1 AZD9592 · No verified English nameJXSL2300048 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/03/09Generic · Class 3 Ibuprofen InjectionCYHS2300749 Xian Han Feng Pharma Co., Ltd. romanized
2023/03/09Generic · Class 3 Baclofen Oral SolutionCYHL2300034 Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized
2023/03/09New drug · Class 1 EXG102-031眼用注射液 · No verified English nameCXSL2300178 Hangzhou Jia Yin Bio Technology Co., Ltd. romanized
2023/03/09New drug · Class 1 盐酸阿司匹林胺喷雾剂 · No verified English nameCXHL2300290 Tai Fei Er Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2023/03/09New drug · Class 1 AXT-1003胶囊 · No verified English nameCXHL2300289 Ai Si Tuo Kang Pharmaceuticals Technology (Beijing) Co., Ltd. romanized
2023/03/09New drug · Class 1 AXT-1003胶囊 · No verified English nameCXHL2300288 Ai Si Tuo Kang Pharmaceuticals Technology (Beijing) Co., Ltd. romanized
2023/03/08Import · Class 1 Lanifibranor片 · No verified English nameJXHL2300043 Inventiva S.A.; Chia Tai Tianqing Pharmaceutical Group Co. Ltd.
2023/03/08Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300746 Hainan Tian Sheng Bao He Bio Technology Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized
2023/03/08Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300745 Hainan Tian Sheng Bao He Bio Technology Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized
2023/03/08Generic · Class 3 Calcium Acetate Oral SolutionCYHS2300744 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Sui Cheng Pharma Co., Ltd. romanized
2023/03/08Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2300741 Beijing Bu Lin Bio Technology Co., Ltd. romanized; Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/03/08Generic · Class 3 Minoxidil Topical SolutionCYHS2300740 Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized

54 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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