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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 284 drug applications between 22 May 2022 and 28 May 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 57, covering 40 drug names.

2022/05/22 – 2022/05/28

Period
2022/05/22 to 2022/05/28, 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
284
Drugs with new generic filings (by drug name, de-duplicated)
40
Accepted this week, now under review
1

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

284filings, 57 of them generic

By application type

Application typeFilings
Supplement129
Generic57
New drug47
Import27
Unspecified13
Import re-registration11

By drug type

Drug typeFilings
Chemical drug201
Therapeutic biologic45
TCM30
Biologic7
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

40 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Piperacillin Sodium for Injection5216
2Palbociclib Capsules310
3阿普米司特片 · No verified English name313
4Epalrestat Tablets221
5Irbesartan and Amlodipine Tablets211
6Budesonide Nasal Spray213
7Lamotrigine Dispersible Tablets212
8Dopamine Hydrochloride Injection213
9Terbutaline Sulfate Injection212
10Mirabegron Extended-release Tablets211

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

161 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bo Zhou Ya Ying Pharmaceuticals Technology Co., Ltd. romanized660
2Jiangxi Yuan Dong Pharma Co., Ltd. romanized660
3Qilu Pharmaceutical Co., Ltd.630
4Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized540
5Novartis Pharma AG530
6Novartis Pharma Schweiz AG520
7Hainan Zan Bang Pharmaceutical Co., Ltd. romanized520
8ASPEN PHARMA TRADING LIMITED510
9Jilin Sheng Dou Bang Pharma Co., Ltd. romanized510
10Ren He Yi Kang Group Co., Ltd. romanized431

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

87 this week

AcceptedDrugApplicants
2022/05/28Import · Class 3.1 Netakimab注射液 · No verified English nameJXSL2200066 Joint Stock Company “BIOCAD”,(JSC “BIOCAD”); SPH-Biocad Biopharmaceuticals (SH) Co. Ltd.
2022/05/28Import · Class 2.2 二氟泼尼酯滴眼液 · No verified English nameJXHL2200123 SUN PHARMACEUTICAL INDUSTRIES LTD.
2022/05/28Import · Class 1 Enpatoran · No verified English nameJXHL2200122 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd.
2022/05/28Import · Class 1 Enpatoran · No verified English nameJXHL2200121 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd.
2022/05/28Generic · Class 3 Epalrestat TabletsCYHS2200799 Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/05/28New drug · Class 1 伊基仑赛注射液 · No verified English nameCXSL2200234 Nanjing Xun Lu Biopharmaceuticals Co., Ltd. romanized
2022/05/28New drug · Class 1 伊基仑赛注射液 · No verified English nameCXSL2200233 Nanjing Xun Lu Biopharmaceuticals Co., Ltd. romanized
2022/05/28New drug · Class 1 EOC202注射液 · No verified English nameCXSL2200232 Tai Zhou Yi Teng Jing Ang Pharma Co., Ltd. romanized
2022/05/28New drug · Class 2.2 盐酸多奈哌齐口溶膜 · No verified English nameCXHL2200341 Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized
2022/05/28New drug · Class 2.2 Enzalutamide TabletsCXHL2200339 Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized
2022/05/27Import · Class 3.1 司美格鲁肽片 · No verified English nameJXSS2200018 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2022/05/27Import · Class 3.1 司美格鲁肽片 · No verified English nameJXSS2200017 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2022/05/27Import · Class 3.1 司美格鲁肽片 · No verified English nameJXSS2200016 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2022/05/27Import · Class 1 VAY736注射液 · No verified English nameJXSL2200067 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/05/27Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2200790 Fu Ou Pharmaceuticals Technology (Hu Zhou) Co., Ltd. romanized; Anhui Chang Jiang Pharma Co., Ltd. romanized
2022/05/27Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2200789 Fu Ou Pharmaceuticals Technology (Hu Zhou) Co., Ltd. romanized; Anhui Chang Jiang Pharma Co., Ltd. romanized
2022/05/27Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2200783 Chengdu Li Er Pharma Co., Ltd. romanized
2022/05/27Generic · Class 3 Epalrestat TabletsCYHS2200777 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2022/05/27Generic · Class 3 Aripiprazole Oral SolutionCYHS2200776 Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/05/27Generic · Class 3 Irbesartan and Amlodipine TabletsCYHL2200045 Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized
2022/05/27Generic · Class 3 Irbesartan and Amlodipine TabletsCYHL2200044 Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized
2022/05/27New drug · Class 3.4 人凝血因子Ⅷ · No verified English nameCXSS2200054 Shenzhen Shi Wei Guang Bio Zhi Pin Co., Ltd. romanized
2022/05/27New drug · Class 1 泽美洛韦玛佐瑞韦单抗注射液 · No verified English nameCXSS2200053 Xing Meng Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2022/05/27New drug · Class 1 泽美洛韦玛佐瑞韦单抗注射液 · No verified English nameCXSS2200052 Xing Meng Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2022/05/27New drug · Class 3.2 外用重组人凝血酶 · No verified English nameCXSS2200051 Name not romanized
2022/05/27New drug · Class 1 赫基仑赛注射液 · No verified English nameCXSL2200231 He Yuan Bio Technology (Tianjin) Co., Ltd. romanized
2022/05/27New drug · Class 3.2 静注人免疫球蛋白 · No verified English nameCXSL2200230 Shenzhen Shi Wei Guang Bio Zhi Pin Co., Ltd. romanized
2022/05/27New drug · Class 3.2 静注人免疫球蛋白 · No verified English nameCXSL2200229 Shenzhen Shi Wei Guang Bio Zhi Pin Co., Ltd. romanized
2022/05/27New drug · Class 1 B1962注射液 · No verified English nameCXSL2200226 Tian Shi Li Biopharmaceuticals Co., Ltd. romanized
2022/05/27New drug · Class 1 HR20014注射液 · No verified English nameCXSL2200225 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized

57 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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