YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 254 drug applications between 26 August 2021 and 1 September 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 33, covering 22 drug names.

2021/08/26 – 2021/09/01

Period
2021/08/26 to 2021/09/01, 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
254
Drugs with new generic filings (by drug name, de-duplicated)
22
Accepted this week, now under review
0

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

254filings, 33 of them generic

By application type

Application typeFilings
Supplement162
New drug35
Generic33
Import13
Unspecified7
Import re-registration4

By drug type

Drug typeFilings
Chemical drug152
TCM63
Therapeutic biologic36
Prophylactic biologic3

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

22 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Acetylcysteine Granules214
2Tadalafil Tablets2123
3吸入用七氟烷 · No verified English name210
4Ticagrelor Tablets2110
5Sildenafil Citrate Tablets2112
6Latamoxef Sodium for Injection211
7Desvenlafaxine Extended-release Tablets210
8Prasugrel Hydrochloride Tablets210
9Milrinone Injection210
10Polidocanol Injection2123

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
1Qin Huang Dao Da En Pharma Co., Ltd. romanized19190
2Hubei Ye Zhen Tang Pharma Co., Ltd. romanized15150
3Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized13130
4Dr. Falk Pharma GmbH830
5Guangxi Ge Hong Tang Fang Lve Pharmaceutical Co., Ltd. romanized770
6Da Tong Wu Zhou Tong Pharmaceutical Co., Ltd. romanized730
7Merck Sharp & Dohme B.V.610
8Upjohn Manufacturing Ireland Unlimited610
9AstraZeneca Pharmaceuticals LP510
10Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized420

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

55 this week

AcceptedDrugApplicants
2021/09/01Generic · Class 3 Fudosteine oral solutionCYHS2101672 Suzhou Hua Jian Rui Da Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized
2021/09/01Generic · Class 3 Latamoxef Sodium for InjectionCYHS2101669 Chongqing Ji Si Rui Pharmaceutical Co., Ltd. romanized
2021/09/01Generic · Class 3 Latamoxef Sodium for InjectionCYHS2101668 Chongqing Ji Si Rui Pharmaceutical Co., Ltd. romanized
2021/09/01Generic · Class 3 Prasugrel Hydrochloride TabletsCYHS2101654 Chongqing Pharmaceuticals (Group) Co., Ltd. romanized; Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized
2021/09/01New drug · Class 1.1 和胃解毒胶囊 · No verified English nameCXZL2101024 Hunan Xin Hui Pharmaceutical Co., Ltd. romanized
2021/09/01New drug · Class 2.4 Tobramycin Inhalation SolutionCXHS2101036 Health Yuan Pharma Group Co., Ltd. romanized; Health Yuan Hai Bin Pharma Co., Ltd. romanized
2021/09/01New drug · Class 1 LP-168片 · No verified English nameCXHL2101448 Guangzhou Lu Peng Pharmaceutical Co., Ltd. romanized
2021/09/01New drug · Class 1 LP-168片 · No verified English nameCXHL2101447 Guangzhou Lu Peng Pharmaceutical Co., Ltd. romanized
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.

25 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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