YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 250 drug applications between 25 August 2021 and 31 August 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 35, covering 23 drug names.

2021/08/25 – 2021/08/31

Period
2021/08/25 to 2021/08/31, 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
250
Drugs with new generic filings (by drug name, de-duplicated)
23
Accepted this week, now under review
3

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

250filings, 35 of them generic

By application type

Application typeFilings
Supplement158
Generic35
New drug32
Import14
Unspecified7
Import re-registration4

By drug type

Drug typeFilings
Chemical drug138
TCM66
Therapeutic biologic41
Prophylactic biologic5

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

23 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation3112
2Edoxaban Tosilate Tablets319
3Acetylcysteine Granules214
4吸入用七氟烷 · No verified English name210
5Ticagrelor Tablets2110
6Sildenafil Citrate Tablets2112
7Desvenlafaxine Extended-release Tablets210
8Milrinone Injection210
9Polidocanol Injection2123
10Febuxostat Tablets2112

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

122 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Ye Zhen Tang Pharma Co., Ltd. romanized20200
2Qin Huang Dao Da En Pharma Co., Ltd. romanized14140
3Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized14130
4Guangxi Ge Hong Tang Fang Lve Pharmaceutical Co., Ltd. romanized770
5Da Tong Wu Zhou Tong Pharmaceutical Co., Ltd. romanized730
6Merck Sharp & Dohme B.V.610
7Upjohn Manufacturing Ireland Unlimited610
8Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.525
9AstraZeneca Pharmaceuticals LP510
10Health Yuan Pharma Group Co., Ltd. romanized423

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

49 this week

AcceptedDrugApplicants
2021/08/31Import · Class 1 GSK3511294注射液 · No verified English nameJXSL2101107 GlaxoSmithKline (Ireland) Limited; GlaxoSmithKline(China) Investment Co. Ltd
2021/08/31Import · Class 1 Etripamil 鼻喷雾剂 · No verified English nameJXHL2101171 Milestone Pharmaceuticals Inc.; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd
2021/08/31Generic · Class 3 Bromhexine Hydrochloride Solution For InhalationCYHL2101026 Jiangxi Yi You Pharma Co., Ltd. romanized
2021/08/31New drug · Class 1 IMM27M注射液 · No verified English nameCXSL2101298 Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2021/08/31New drug · Class 1 异体人源脂肪间充质干细胞注射液 · No verified English nameCXSL2101297 Jiangsu De Kang Bio Technology Co., Ltd. romanized
2021/08/31New drug · Class 1 SHR-1701注射液 · No verified English nameCXSL2101295 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/08/31New drug · Class 1 CM326注射液 · No verified English nameCXSL2101294 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2021/08/31New drug · Class 1 FCN-342片 · No verified English nameCXHL2101446 Chongqing Fu Chuang Pharmaceuticals Research Co., Ltd. romanized
2021/08/31New drug · Class 1 FCN-342片 · No verified English nameCXHL2101445 Chongqing Fu Chuang Pharmaceuticals Research Co., Ltd. romanized
2021/08/31New drug · Class 1 FCN-342片 · No verified English nameCXHL2101444 Chongqing Fu Chuang Pharmaceuticals Research Co., Ltd. romanized
2021/08/31New drug · Class 1 FCN-342片 · No verified English nameCXHL2101443 Chongqing Fu Chuang Pharmaceuticals Research Co., Ltd. romanized
2021/08/31New drug · Class 1 LNK01001胶囊 · No verified English nameCXHL2101442 Ling Ke Pharma (Hangzhou) Co., Ltd. romanized
2021/08/31New drug · Class 1 LNK01001胶囊 · No verified English nameCXHL2101441 Ling Ke Pharma (Hangzhou) Co., Ltd. romanized
2021/08/31New drug · Class 1 LH-1802胶囊 · No verified English nameCXHL2101435 Jiangsu Lianhuan Pharmaceutical Co.,Ltd.
2021/08/31New drug · Class 1 LH-1802胶囊 · No verified English nameCXHL2101434 Jiangsu Lianhuan Pharmaceutical Co.,Ltd.
2021/08/31New drug · Class 1 LH-1802胶囊 · No verified English nameCXHL2101433 Jiangsu Lianhuan Pharmaceutical Co.,Ltd.
2021/08/30Import · Class 1 CG0070注射液 · No verified English nameJXSL2101105 CG Oncology Inc.; Lepu Biopharma Co. Ltd.
2021/08/30Generic · Class 3 Milrinone InjectionCYHS2101658 Hua Run San Jiu (Ya An) Pharma Co., Ltd. romanized
2021/08/30Generic · Class 3 Milrinone InjectionCYHS2101657 Hua Run San Jiu (Ya An) Pharma Co., Ltd. romanized
2021/08/30Generic · Class 3 Prasugrel Hydrochloride TabletsCYHS2101653 Chongqing Pharmaceuticals (Group) Co., Ltd. romanized; Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized
2021/08/30Generic · Class 3 Pregabalin Oral SolutionCYHS2101642 Chengdu Hui De Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Di Kang Pharma Co., Ltd. romanized
2021/08/30New drug · Class 3.3 地舒单抗注射液 · No verified English nameCXSS2101023 Qilu Pharmaceutical Co., Ltd.
2021/08/30New drug · Class 3.3 四价流感病毒裂解疫苗 · No verified English nameCXSL2101293 Jiangsu Kang Run Bio Technology Co., Ltd. romanized
2021/08/30New drug · Class 3.2 四价流感病毒裂解疫苗 · No verified English nameCXSL2101292 Jiangsu Kang Run Bio Technology Co., Ltd. romanized
2021/08/30New drug · Class 1 注射用CN202 · No verified English nameCXSL2101291 Tong Run Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2021/08/30New drug · Class 1 PZ-1片 · No verified English nameCXHL2101440 Chongqing Wen Li College romanized
2021/08/30New drug · Class 1 PZ-1片 · No verified English nameCXHL2101439 Chongqing Wen Li College romanized
2021/08/27Import · Class 1 Rozanolixizumab注射液 · No verified English nameJXSL2101103 UCB Pharma SA; UCB Trading (Shanghai) Co. Ltd
2021/08/27Import · Class 1 HBM9161(HL161BKN)注射液 · No verified English nameJXSL2101102 Harbour BioMed Therapeutics Limited; He Bo Pharmaceuticals (Suzhou) Co., Ltd. romanized
2021/08/27Generic · Class 3 Desvenlafaxine Extended-release TabletsCYHS2101652 Zhejiang Jian Feng Pharma Co., Ltd. romanized

19 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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