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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 154 drug applications between 19 May 2022 and 25 May 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 24, covering 18 drug names.

2022/05/19 – 2022/05/25

Period
2022/05/19 to 2022/05/25, 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
154
Drugs with new generic filings (by drug name, de-duplicated)
18
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

154filings, 24 of them generic

By application type

Application typeFilings
Supplement69
New drug33
Generic24
Import15
Import re-registration9
Unspecified4

By drug type

Drug typeFilings
Chemical drug118
Therapeutic biologic21
TCM12
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

18 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Piperacillin Sodium for Injection5216
2Budesonide Nasal Spray213
3Mirabegron Extended-release Tablets211
4Candesartan Cilexetil Tablets110
5Levetiracetam Oral Solution113
6Saxagliptin and Metformin Hydrochloride Sustained-release Tablets112
7Saxagliptin and Metformin Hydrochloride Sustained-release Tablets112
8Lopinavir and Ritonavir Tablets110
9Phentolamine Mesilate Injection113
10Urapidil Hydrochloride Injection116

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

87 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bo Zhou Ya Ying Pharmaceuticals Technology Co., Ltd. romanized660
2Qilu Pharmaceutical Co., Ltd.630
3ASPEN PHARMA TRADING LIMITED510
4Jilin Sheng Dou Bang Pharma Co., Ltd. romanized510
5Ren He Yi Kang Group Co., Ltd. romanized431
6Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized420
7Santen Pharmaceutical Co. Ltd.410
8Karuna Therapeutics Inc.310
9Kyowa Kirin Co. Ltd.310
10Merck Serono S.p.A310

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

54 this week

AcceptedDrugApplicants
2022/05/25Import · Class 3.1 Netakimab注射液 · No verified English nameJXSL2200061 Joint Stock Company “BIOCAD”,(JSC “BIOCAD”); SPH-Biocad Biopharmaceuticals (SH) Co. Ltd.
2022/05/25Import · Class 1 SQZ-AAC-HPV · No verified English nameJXSL2200060 SQZ Biotechnologies Company; ICON Clinical Research (Beijing No.2) Co. Ltd.
2022/05/25Import · Class 1 ALXN2050片 · No verified English nameJXHL2200120 Alexion Pharmaceuticals Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd
2022/05/25Generic · Class 3 维氟醌乳膏 · No verified English nameCYHS2200748 Zhejiang Fu Nuo Pharmaceuticals Co., Ltd. romanized
2022/05/25New drug · Class 2.2 注射用右兰索拉唑 · No verified English nameCXHS2200027 Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized
2022/05/25New drug · Class 2.2 盐酸美金刚颗粒 · No verified English nameCXHL2200330 Zhejiang Pu Li Pharma Co., Ltd. romanized
2022/05/25New drug · Class 2.2 盐酸美金刚颗粒 · No verified English nameCXHL2200329 Zhejiang Pu Li Pharma Co., Ltd. romanized
2022/05/25New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2200326 Qilu Pharmaceutical Co., Ltd.
2022/05/25New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2200325 Qilu Pharmaceutical Co., Ltd.
2022/05/25New drug · Class 1 BB102片 · No verified English nameCXHL2200324 Beijing Bo Hui Bio Technology Co., Ltd. romanized
2022/05/25New drug · Class 1 BB102片 · No verified English nameCXHL2200323 Beijing Bo Hui Bio Technology Co., Ltd. romanized
2022/05/25New drug · Class 1 注射用MT1011 · No verified English nameCXHL2200322 Shaanxi Mai Ke Ao Te Technology Co., Ltd. romanized
2022/05/24Import · Class 1 AZD7789 · No verified English nameJXSL2200059 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2022/05/24Import · Class 1 Relatlimab注射液 · No verified English nameJXSL2200058 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2022/05/24Import · Class 1 CAN1012注射液 · No verified English nameJXHL2200119 CanWell Pharma Inc.
2022/05/24Import · Class 2.4 Rimegepant口崩片 · No verified English nameJXHL2200115 Biohaven Pharmaceutical Ireland Designated Activity Company; BioShin (Shanghai) Co. Ltd.
2022/05/24Import · Class 2.4 Rimegepant口崩片 · No verified English nameJXHL2200114 Biohaven Pharmaceutical Ireland Designated Activity Company; BioShin (Shanghai) Co. Ltd.
2022/05/24Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2200757 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2022/05/24Generic · Class 3 Piperacillin Sodium for InjectionCYHS2200756 Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized
2022/05/24Generic · Class 3 Piperacillin Sodium for InjectionCYHS2200755 Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized
2022/05/24Generic · Class 3 Piperacillin Sodium for InjectionCYHS2200754 Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized
2022/05/24Generic · Class 3 Piperacillin Sodium for InjectionCYHS2200750 Nanjing Feng Kai Si Drug Research and Development Co., Ltd. romanized; Jiangsu Hai Hong Pharmaceutical Co., Ltd. romanized
2022/05/24Generic · Class 3 Piperacillin Sodium for InjectionCYHS2200749 Nanjing Feng Kai Si Drug Research and Development Co., Ltd. romanized; Jiangsu Hai Hong Pharmaceutical Co., Ltd. romanized
2022/05/24Generic · Class 3 Magnesium Sulfate InjectionCYHS2200746 Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanized
2022/05/24Generic · Class 3 硫酸沙丁胺醇口服溶液 · No verified English nameCYHS2200744 Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized
2022/05/24Generic · Class 3 Memantine Hydrochloride Oral SolutionCYHS2200742 Anhui Xin Shi Ji Pharma Co., Ltd. romanized
2022/05/24New drug · Class 1.1 柴芩通淋片 · No verified English nameCXZL2200024 Shijiazhuang Yi Ling Pharma Co., Ltd. romanized
2022/05/24New drug · Class 1 Domvanalimab注射液 · No verified English nameCXSL2200221 Shanghai Bai Li Jia Sheng Pharmaceuticals Technology Co., Ltd. romanized
2022/05/24New drug · Class 3.3 CMAB015注射液 · No verified English nameCXSL2200220 Tai Zhou Mai Bo Tai Ke Pharma Co., Ltd. romanized
2022/05/24New drug · Class 1 MG-ZG122人源化单抗注射液 · No verified English nameCXSL2200219 Shanghai Mai Ji Bio Technology Co., Ltd. romanized

24 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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