YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 113 drug applications between 18 May 2022 and 24 May 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 23, covering 16 drug names.

2022/05/18 – 2022/05/24

Period
2022/05/18 to 2022/05/24, 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
113
Drugs with new generic filings (by drug name, de-duplicated)
16
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

113filings, 23 of them generic

By application type

Application typeFilings
Supplement43
New drug26
Generic23
Import12
Import re-registration9

By drug type

Drug typeFilings
Chemical drug80
Therapeutic biologic21
TCM11
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

16 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Piperacillin Sodium for Injection5216
2Vonoprazan Fumarate Tablets2160
3Budesonide Nasal Spray213
4Mirabegron Extended-release Tablets211
5Levetiracetam Oral Solution113
6Saxagliptin and Metformin Hydrochloride Sustained-release Tablets112
7Saxagliptin and Metformin Hydrochloride Sustained-release Tablets112
8Phentolamine Mesilate Injection113
9Urapidil Hydrochloride Injection116
10Memantine Hydrochloride Oral Solution110

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

64 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bo Zhou Ya Ying Pharmaceuticals Technology Co., Ltd. romanized660
2Jilin Sheng Dou Bang Pharma Co., Ltd. romanized510
3Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized420
4Qilu Pharmaceutical Co., Ltd.420
5Santen Pharmaceutical Co. Ltd.410
6Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized330
7Karuna Therapeutics Inc.310
8Kyowa Kirin Co. Ltd.310
9Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized310
10Zhejiang Dou Bang Pharma Co., Ltd. romanized310

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
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
2022/05/24New drug · Class 1 APG-2575片 · No verified English nameCXHL2200321 Suzhou Ya Sheng Pharma Co., Ltd. romanized
2022/05/24New drug · Class 1 APG-2575片 · No verified English nameCXHL2200320 Suzhou Ya Sheng Pharma Co., Ltd. romanized
2022/05/24New drug · Class 1 APG-2575片 · No verified English nameCXHL2200319 Suzhou Ya Sheng Pharma Co., Ltd. romanized
2022/05/24New drug · Class 2.4 硫酸阿托品滴眼液 · No verified English nameCXHL2200318 Qilu Pharmaceutical Co., Ltd.
2022/05/24New drug · Class 2.4 硫酸阿托品滴眼液 · No verified English nameCXHL2200317 Qilu Pharmaceutical Co., Ltd.
2022/05/24New drug · Class 2.4 硫酸阿托品滴眼液 · No verified English nameCXHL2200316 Qilu Pharmaceutical Co., Ltd.
2022/05/24New drug · Class 2.2 注射用CZ1S · No verified English nameCXHL2200315 Zhejiang Xian Ju Cui Ze Pharmaceuticals Technology Co., Ltd. romanized
2022/05/24New drug · Class 2.2 QP002凝胶 · No verified English nameCXHL2200314 Nanjing Qing Pu Bio Technology Co., Ltd. romanized
2022/05/20Import · Class 1 KarXT胶囊 · No verified English nameJXHL2200118 Karuna Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd.
2022/05/20Import · Class 1 KarXT胶囊 · No verified English nameJXHL2200117 Karuna Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd.
2022/05/20Import · Class 1 KarXT胶囊 · No verified English nameJXHL2200116 Karuna Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd.
2022/05/20New drug · Class 1.1 黄酯胶囊 · No verified English nameCXZL2200023 Sichuan Sheng Zhong Pharmaceuticals Ke College (Sichuan Sheng Zhong Yao Research Institute) 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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