YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 255 drug applications between 24 August 2021 and 30 August 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 37, covering 25 drug names.

2021/08/24 – 2021/08/30

Period
2021/08/24 to 2021/08/30, 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
255
Drugs with new generic filings (by drug name, de-duplicated)
25
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

255filings, 37 of them generic

By application type

Application typeFilings
Supplement167
Generic37
New drug27
Import13
Import re-registration8
Unspecified3

By drug type

Drug typeFilings
Chemical drug150
TCM65
Therapeutic biologic31
Prophylactic biologic7
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

25 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
3Temozolomide Capsules220
4Acetylcysteine Granules214
5吸入用七氟烷 · No verified English name210
6Ticagrelor Tablets2110
7Sildenafil Citrate Tablets2112
8Desvenlafaxine Extended-release 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

123 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Ye Zhen Tang Pharma Co., Ltd. romanized20200
2Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized16150
3GUERBET1310
4Guangxi Ge Hong Tang Fang Lve Pharmaceutical Co., Ltd. romanized770
5Da Tong Wu Zhou Tong Pharmaceutical Co., Ltd. romanized730
6Qin Huang Dao Da En Pharma Co., Ltd. romanized660
7Merck Sharp & Dohme B.V.610
8Upjohn Manufacturing Ireland Unlimited610
9Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.525
10Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized440

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

43 this week

AcceptedDrugApplicants
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
2021/08/27Generic · Class 3 Desvenlafaxine Extended-release TabletsCYHS2101651 Zhejiang Jian Feng Pharma Co., Ltd. romanized
2021/08/27Generic · Class 3 法维拉韦片 · No verified English nameCYHS2101646 Beijing Si Huan Pharmaceutical Co., Ltd. romanized
2021/08/27New drug · Class 1.1 乳藤胶囊 · No verified English nameCXZL2101023 Zhong Nan Min Zu University romanized
2021/08/27New drug · Class 1 UBP1213sc注射液 · No verified English nameCXSL2101290 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/08/27New drug · Class 3.3 阿柏西普眼内注射溶液 · No verified English nameCXSL2101289 Sichuan San Ye Cao Biopharmaceutical Co., Ltd. romanized
2021/08/27New drug · Class 1 YH001注射液 · No verified English nameCXSL2101288 Name not romanized
2021/08/27New drug · Class 1 LBL-007注射液 · No verified English nameCXSL2101286 Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized
2021/08/27New drug · Class 3.3 长效重组人胰高血糖素样肽-1注射液 · No verified English nameCXSL2101283 Beijing SL Pharmaceutical Co., Ltd.
2021/08/27New drug · Class 3.3 长效重组人胰高血糖素样肽-1注射液 · No verified English nameCXSL2101282 Beijing SL Pharmaceutical Co., Ltd.
2021/08/27New drug · Class 1 重组抗PD-1全人源单克隆抗体注射液 · No verified English nameCXSL2101280 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2021/08/27New drug · Class 1 GH21胶囊 · No verified English nameCXHL2101438 Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized
2021/08/27New drug · Class 1 GH21胶囊 · No verified English nameCXHL2101437 Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized
2021/08/27New drug · Class 1 GH21胶囊 · No verified English nameCXHL2101436 Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized
2021/08/26Import · Class 1 M7824 (MSB0011359C) · No verified English nameJXSL2101104 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd.
2021/08/26Import · Class 3.3 乌司奴单抗注射液 · No verified English nameJXSL2101100 Alvotech Swiss AG; Alvotech & CCHT Biopharmaceutical Co. Ltd.
2021/08/26Generic · Class 3 Doxorubicin Hydrochloride Liposome InjectionCYHS2101637 Zhejiang Zhi Da Pharma Co., Ltd. romanized

13 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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