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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 326 drug applications between 6 March 2023 and 12 March 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 73, covering 54 drug names.

2023/03/06 – 2023/03/12

Period
2023/03/06 to 2023/03/12, 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
326
Drugs with new generic filings (by drug name, de-duplicated)
54
Accepted this week, now under review
9

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

326filings, 73 of them generic

By application type

Application typeFilings
Supplement174
Generic73
New drug46
Import13
Import re-registration12
Unspecified8

By drug type

Drug typeFilings
Chemical drug242
TCM44
Therapeutic biologic35
Biologic3
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

54 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Famotidine Injection338
2Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution3223
3Minoxidil Topical Solution320
4Palbociclib Capsules310
5Risperidone Orally Disintegrating Tablets210
6吸入用布地奈德混悬液 · No verified English name217
7Dimethyl Fumarate Delayed-release Capsules210
8Empagliflozin And Linagliptin Tablets210
9Torsemide Injection211
10Dexrazoxane for 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

188 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Tianjin He Zhi Pharma Group Co., Ltd. romanized880
2Shanghai Qing Ping Pharma Co., Ltd. romanized850
3Actelion Pharmaceuticals Ltd810
4Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized760
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
10Guangzhou Bai Yun Shan Tian Xin Pharmaceutical Co., Ltd. romanized530

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

90 this week

AcceptedDrugApplicants
2023/03/11Import · Class 3.1 度伐利尤单抗注射液 · No verified English nameJXSS2300025 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca Investment (China) Co. Ltd.
2023/03/11Import · Class 3.1 度伐利尤单抗注射液 · No verified English nameJXSS2300024 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca Investment (China) Co. Ltd.
2023/03/11Import · Class 1 elranatamab · No verified English nameJXSL2300049 Pfizer Inc; Pfizer Investment CO. Ltd.
2023/03/11Import · Class 1 Zavegepant鼻喷雾剂 · No verified English nameJXHL2300044 Pfizer Inc.; Pfizer Investment CO. Ltd
2023/03/11Generic · Class 3 Empagliflozin And Linagliptin TabletsCYHS2300770 Qilu Pharmaceutical (Hainan) Co., Ltd
2023/03/11Generic · Class 3 Empagliflozin And Linagliptin TabletsCYHS2300769 Qilu Pharmaceutical (Hainan) Co., Ltd
2023/03/11Generic · Class 3 Famotidine InjectionCYHS2300763 Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Jiu Xu Pharma Co., Ltd. romanized
2023/03/11New drug · Class 1 HH-012注射液 · No verified English nameCXSL2300182 Hua Hui An Jian (Beijing) Bio Technology Co., Ltd. romanized
2023/03/11New drug · Class 2.4 Fulvestrant InjectionCXHL2300302 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/03/11New drug · Class 2.4 Fulvestrant InjectionCXHL2300301 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/03/11New drug · Class 1 替拉扎明注射液 · No verified English nameCXHL2300300 Hangzhou Rui Zhen Pharmaceuticals Co., Ltd. romanized
2023/03/11New drug · Class 1 VC004凝胶 · No verified English nameCXHL2300299 Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized
2023/03/11New drug · Class 1 VC004凝胶 · No verified English nameCXHL2300298 Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized
2023/03/11New drug · Class 1 VC004凝胶 · No verified English nameCXHL2300297 Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized
2023/03/11New drug · Class 1 VC004凝胶 · No verified English nameCXHL2300296 Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized
2023/03/11New drug · Class 1 NRT6008注射液 · No verified English nameCXHL2300295 Chengdu Niu Rui Te Medical Technology Co., Ltd. romanized
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

60 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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