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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 435 drug applications between 31 December 2022 and 6 January 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 65, covering 49 drug names.

2022/12/31 – 2023/01/06

Period
2022/12/31 to 2023/01/06, 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
435
Drugs with new generic filings (by drug name, de-duplicated)
49
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

435filings, 65 of them generic

By application type

Application typeFilings
Supplement261
Generic65
New drug64
Import23
Import re-registration16
Unspecified6

By drug type

Drug typeFilings
Chemical drug274
TCM100
Therapeutic biologic55
Prophylactic biologic5
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

49 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Penicillin G Sodium For Injection312
2Dopamine Hydrochloride Injection313
3Ritonavir Tablets220
4Famotidine Injection228
5Phloroglucinol Injection222
6Perampanel Tablets212
7Fesoterodine Fumarate Prolonged-Release Tablets210
8Empagliflozin Tablets2118
9Torasemide Tablets210
10Lacosamide Injection210

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

205 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized44440
2Hubei Lang De Pharma Co., Ltd. romanized32160
3Guo Da (Heilongjiang) Pharmaceutical Technology Co., Ltd. romanized24240
4Jiangxi Xin Zheng Pharma Co., Ltd. romanized12110
5Guangzhou Bai Te Medical Yong Pin Co., Ltd. romanized960
6Novo Nordisk A/S620
7Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized550
8Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized552
9Novartis Pharma Schweiz AG530
10Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized530

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

114 this week

AcceptedDrugApplicants
2023/01/06Import · Class 1 Ziltivekimab 注射液 · No verified English nameJXSL2300017 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2023/01/06Import · Class 1 MK-3475A注射液 · No verified English nameJXSL2300016 Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2023/01/06Import · Class 1 Bemarituzumab注射液 · No verified English nameJXSL2300015 Amgen Inc.; Zai Lab (Shanghai) CO. Ltd.
2023/01/06Import · Class 1 BIIB059 · No verified English nameJXSL2300014 Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd
2023/01/06Import · Class 2.2 司美格鲁肽注射液 · No verified English nameJXSL2300013 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2023/01/06Import · Class 2.2 司美格鲁肽注射液 · No verified English nameJXSL2300012 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2023/01/06Import · Class 2.2 司美格鲁肽注射液 · No verified English nameJXSL2300011 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2023/01/06Import · Class 2.2 司美格鲁肽注射液 · No verified English nameJXSL2300010 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2023/01/06Import · Class 2.2 司美格鲁肽注射液 · No verified English nameJXSL2300009 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2023/01/06Import · Class 1 帕萨利司片 · No verified English nameJXHS2300004 Incyte Corporation; Quotient Sciences Philadephia LLC; Innovent Biologics (Suzhou) Co. Ltd
2023/01/06Import · Class 1 帕萨利司片 · No verified English nameJXHS2300003 Incyte Corporation; Quotient Sciences Philadephia LLC; Innovent Biologics (Suzhou) Co. Ltd
2023/01/06Import · Class 1 帕萨利司片 · No verified English nameJXHS2300002 Incyte Corporation; Quotient Sciences Philadephia LLC; Innovent Biologics (Suzhou) Co. Ltd
2023/01/06Generic · Class 3 Calcium Gluconate InjectionCYHS2300045 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2023/01/06Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2300044 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2023/01/06Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2300040 Hefei Shi Wei Lai Drug Kai Fa Co., Ltd. romanized; Bai Zheng Pharma Co., Ltd. romanized
2023/01/06Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2300039 Hefei Shi Wei Lai Drug Kai Fa Co., Ltd. romanized; Bai Zheng Pharma Co., Ltd. romanized
2023/01/06Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2300038 Hefei Shi Wei Lai Drug Kai Fa Co., Ltd. romanized; Bai Zheng Pharma Co., Ltd. romanized
2023/01/06Generic · Class 3 Citicoline Sodium InjectionCYHS2300036 Shanxi De Yuan Tang Pharma Co., Ltd. romanized
2023/01/06Generic · Class 3 Citicoline Sodium InjectionCYHS2300035 Shanxi De Yuan Tang Pharma Co., Ltd. romanized
2023/01/06Generic · Class 3 Indobufen TabletsCYHS2300034 Kunming Yuan Rui Pharmaceutical Co., Ltd. romanized
2023/01/06New drug · Class 2.2 注射用维迪西妥单抗 · No verified English nameCXSL2300017 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2023/01/06New drug · Class 1 QX007N注射液 · No verified English nameCXSL2300016 Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized
2023/01/06New drug · Class 3.3 艾美赛珠单抗注射液 · No verified English nameCXSL2300015 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2023/01/06New drug · Class 1 IMM27M注射液 · No verified English nameCXSL2300014 Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/01/06New drug · Class 1 GC301腺相关病毒注射液 · No verified English nameCXSL2300013 Beijing Jin Lan Ji Yin Technology Co., Ltd. romanized
2023/01/06New drug · Class 1 FB1001重组人源化单克隆抗体注射液 · No verified English nameCXSL2300012 Fu Bei Bio Technology (Suzhou) Co., Ltd. romanized
2023/01/06New drug · Class 3.4 治疗用卡介苗 · No verified English nameCXSL2300011 Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized
2023/01/06New drug · Class 3.2 ACYW135群脑膜炎球菌多糖结合疫苗 · No verified English nameCXSL2300010 Beijing Ke Xing Zhong Wei Bio Technology Co., Ltd. romanized
2023/01/06New drug · Class 1 注射用RC88 · No verified English nameCXSL2300009 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2023/01/06New drug · Class 3.2 注射用A型肉毒毒素 · No verified English nameCXSL2300008 Lanzhou Bio Technology Kai Fa Co., Ltd. romanized

84 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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