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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 382 drug applications between 1 November 2024 and 7 November 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 112, covering 83 drug names.

2024/11/01 – 2024/11/07

Period
2024/11/01 to 2024/11/07, 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
382
Drugs with new generic filings (by drug name, de-duplicated)
83
Accepted this week, now under review
3

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

382filings, 112 of them generic

By application type

Application typeFilings
Supplement171
Generic112
New drug57
Import23
Import re-registration14
Unspecified5

By drug type

Drug typeFilings
Chemical drug292
TCM59
Therapeutic biologic25
Prophylactic biologic3
Biologic2
In vitro diagnostic reagent1

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

83 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution4223
2Methotrexate Injection3211
3Ampicillin Sodium and Sulbactam Sodium for Injection3113
4Repaglinide Tablets316
5Acetylcysteine Solution For Inhalation224
6盐酸纳美芬注射液 · No verified English name221
7Potassium Aspartate And Magnesium Aspartate Injection223
8Ezetimibe and Atorvastatin Calcium Trihydrate Tablets214
9Piracetam Injection219
10Doxofylline Tablets212

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

230 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangdong Sunho Pharmaceutical Co., Ltd.21130
2Yi Ling Wan Zhou International Pharmaceutical Co., Ltd. romanized660
3Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized630
4GE Healthcare AS610
5Teva Neuroscience Inc.610
6Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized610
7Ya Bao Pharma Group Co., Ltd. romanized430
8Jiangsu Yong An Pharmaceutical Co., Ltd. romanized420
9Jiangsu En Hua Pharma Co., Ltd. romanized410
10Jilin Sheng Zhong Cheng Pharmaceutical Co., Ltd. romanized330

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

124 this week

AcceptedDrugApplicants
2024/11/07Import · Class 3.1 艾可瑞妥单抗注射液 · No verified English nameJXSS2400101 AbbVie Deutschland GmbH & Co. KG; Vetter Pharma-Fertigung GmbH & Co. KG; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/11/07Import · Class 2.4 Vorasidenib片 · No verified English nameJXHL2400266 Institut de Recherches Internationales Servier
2024/11/07Import · Class 2.4 Vorasidenib片 · No verified English nameJXHL2400265 Institut de Recherches Internationales Servier
2024/11/07Generic · Class 3 Piracetam InjectionCYHS2403809 Jia Heng (Zhuhai Heng Qin) Pharmaceuticals Technology Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized
2024/11/07Generic · Class 3 Piracetam InjectionCYHS2403808 Jia Heng (Zhuhai Heng Qin) Pharmaceuticals Technology Co., Ltd. romanized; Henan Fu Sen Pharma Co., Ltd. romanized
2024/11/07Generic · Class 3 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2403802 Hebei Zhi Heng Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized
2024/11/07Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2403801 Shandong Long Yang Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jia Heng Pharmaceutical Co., Ltd. romanized
2024/11/07Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2403800 Shandong Long Yang Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jia Heng Pharmaceutical Co., Ltd. romanized
2024/11/07Generic · Class 3 Magnesium Sulfate InjectionCYHS2403798 Hebei Tian Cheng Pharma Co., Ltd. romanized
2024/11/07Generic · Class 3 Magnesium Sulfate InjectionCYHS2403797 Hebei Tian Cheng Pharma Co., Ltd. romanized
2024/11/07Generic · Class 3 布比卡因脂质体注射液 · No verified English nameCYHS2403794 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2024/11/07Generic · Class 3 布比卡因脂质体注射液 · No verified English nameCYHS2403793 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2024/11/07Generic · Class 3 Drotaverine Hydrochloride TabletsCYHS2403792 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2024/11/07Generic · Class 3 Sodium Bicarbonate InjectionCYHS2403788 Hainan Ru Kang Bio Technology Co., Ltd. romanized; Hainan Ai Ke Pharmaceutical Co., Ltd. romanized
2024/11/07Generic · Class 3 Foscarnet Sodium InjectionCYHS2403785 Hainan Ai Ke Pharmaceutical Co., Ltd. romanized
2024/11/07Generic · Class 3 Nafamostat Mesilate for InjectionCYHL2400214 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2024/11/07New drug · Class 1 18F-NYM005注射液 · No verified English nameCXHL2401197 Wuxi Nuo Yu Pharmaceuticals Technology Co., Ltd. romanized
2024/11/07New drug · Class 1 QLS1304片 · No verified English nameCXHL2401196 Qilu Pharmaceutical Co., Ltd.
2024/11/07New drug · Class 1 QLS1304片 · No verified English nameCXHL2401195 Qilu Pharmaceutical Co., Ltd.
2024/11/07New drug · Class 1 QLS1304片 · No verified English nameCXHL2401194 Qilu Pharmaceutical Co., Ltd.
2024/11/06Import · Class 3.1 艾可瑞妥单抗注射用浓溶液 · No verified English nameJXSS2400100 AbbVie Deutschland GmbH & Co. KG; Vetter Pharma-Fertigung GmbH & Co. KG; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/11/06Import · Class 1 Baxdrostat片 · No verified English nameJXHL2400264 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/11/06Import · Class 1 Baxdrostat片 · No verified English nameJXHL2400263 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/11/06Generic · Class 3 Carbocisteine Oral SolutionCYHS2403779 Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized
2024/11/06Generic · Class 3 Cimetidine InjectionCYHS2403778 Hai Tao Xin Yao Research and Development (Jiangsu) Co., Ltd. romanized; Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized
2024/11/06Generic · Class 3 维生素K?注射液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2403776 Hainan Mei Kang Da Pharma Co., Ltd. romanized; Anhui Chang Jiang Pharma Co., Ltd. romanized
2024/11/06Generic · Class 3 MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2403774 Yunnan Xian Shi Pharma Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanized
2024/11/06Generic · Class 3 Pentoxifylline Modified Release TabletsCYHS2403772 HAINAN HUALON PHARMACEUTICAL CO.,LTD
2024/11/06New drug · Class 1 注射用SIBP-A18 · No verified English nameCXSL2400751 Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized
2024/11/06New drug · Class 1 IBR900细胞注射液 · No verified English nameCXSL2400750 Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized

94 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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