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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 175 drug applications between 20 May 2022 and 26 May 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 31, covering 22 drug names.

2022/05/20 – 2022/05/26

Period
2022/05/20 to 2022/05/26, 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
175
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

175filings, 31 of them generic

By application type

Application typeFilings
Supplement73
New drug39
Generic31
Import19
Import re-registration9
Unspecified4

By drug type

Drug typeFilings
Chemical drug134
Therapeutic biologic24
TCM13
Biologic3
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

22 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Piperacillin Sodium for Injection5216
2Palbociclib Capsules310
3Budesonide Nasal Spray213
4Terbutaline Sulfate Injection212
5Mirabegron Extended-release Tablets211
6Candesartan Cilexetil Tablets110
7Doxofylline Injection115
8Levetiracetam Oral Solution113
9Saxagliptin and Metformin Hydrochloride Sustained-release Tablets112
10Saxagliptin and Metformin Hydrochloride Sustained-release Tablets112

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

100 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
6Santen Pharmaceutical Co. Ltd.410
7Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized320
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

66 this week

AcceptedDrugApplicants
2022/05/26Import · Class 1 DS-7300a · No verified English nameJXSL2200065 Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2022/05/26Import · Class 2.2 ACZ885 · No verified English nameJXSL2200064 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/05/26Import · Class 2.2 ACZ885 · No verified English nameJXSL2200063 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/05/26Import · Class 1 Mezagitamab 注射剂 · No verified English nameJXSL2200062 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd.
2022/05/26Generic · Class 3 Terbutaline Sulfate InjectionCYHS2200770 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Anhui Heng Xing Pharmaceutical Co., Ltd. romanized
2022/05/26Generic · Class 3 Terbutaline Sulfate InjectionCYHS2200769 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Anhui Heng Xing Pharmaceutical Co., Ltd. romanized
2022/05/26New drug · Class 2.2 20价肺炎球菌结合疫苗 · No verified English nameCXSL2200224 Suzhou Wei Chao Bio Technology Co., Ltd. romanized; Suzhou Ju Wei Bio Technology Co., Ltd. romanized
2022/05/26New drug · Class 2.3 恒格列净二甲双胍缓释片(Ⅱ) · No verified English nameCXHS2200029 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2022/05/26New drug · Class 2.3 恒格列净二甲双胍缓释片(Ⅰ) · No verified English nameCXHS2200028 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2022/05/26New drug · Class 1 Exd391209注射液 · No verified English nameCXHL2200333 Chengdu Ao Da Bio Technology Co., Ltd. romanized
2022/05/26New drug · Class 1 CG001419片 · No verified English nameCXHL2200332 Shanghai Rui Yue Bio Technology Co., Ltd. romanized
2022/05/26New drug · Class 1 CG001419片 · No verified English nameCXHL2200331 Shanghai Rui Yue Bio Technology Co., Ltd. romanized
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

36 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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