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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 356 drug applications between 2 November 2024 and 8 November 2024 (data as of 14 November 2026 06:00). Of these, generic applications numbered 97, covering 72 drug names.

2024/11/02 – 2024/11/08

Period
2024/11/02 to 2024/11/08, 7 days inclusive
Data as of
2026/11/14 06:00
Cached records
94,880 acceptance records, 11,632 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
356
Drugs with new generic filings (by drug name, de-duplicated)
72
Accepted this week, now under review
4

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

356filings, 97 of them generic

By application type

Application typeFilings
Supplement159
Generic97
New drug65
Import17
Import re-registration15
Unspecified3

By drug type

Drug typeFilings
Chemical drug273
TCM49
Therapeutic biologic28
Prophylactic biologic4
In vitro diagnostic reagent1
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

72 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets4258
2Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution4223
3Methotrexate Injection3211
4Repaglinide Tablets316
5Ezetimibe and Atorvastatin Calcium Trihydrate Tablets214
6Piracetam Injection219
7Doxofylline Tablets212
8布比卡因脂质体注射液 · No verified English name217
9Sacubitril Valsartan Sodium Tablets2170
10Ursodeoxycholic acid oral suspension214

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

207 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangdong Sunho Pharmaceutical Co., Ltd.20120
2Jiangsu Hao Sen Pharma Group Co., Ltd. romanized730
3Yi Ling Wan Zhou International Pharmaceutical Co., Ltd. romanized660
4Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized630
5Qilu Pharmaceutical Co., Ltd.631
6GE Healthcare AS610
7Teva Neuroscience Inc.610
8Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized610
9Ya Bao Pharma Group Co., Ltd. romanized430
10AstraZeneca AB420

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
2024/11/08Generic · Class 3 盐酸纳美芬注射液 · No verified English nameCYHS2403823 Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized; Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized
2024/11/08New drug · Class 1.1 苓仙颗粒 · No verified English nameCXZL2400077 Suzhou Yu Sen Xin Yao Kai Fa Co., Ltd. romanized
2024/11/08New drug · Class 1 IBI3010 · No verified English nameCXSL2400758 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2024/11/08New drug · Class 1 注射用SIBP-A19 · No verified English nameCXSL2400757 Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized
2024/11/08New drug · Class 1 RGL-2201注射液 · No verified English nameCXSL2400756 Shanghai Rui Hong Di Pharmaceuticals Co., Ltd. romanized
2024/11/08New drug · Class 1 注射用YK012 · No verified English nameCXSL2400755 Yi Ke Si Te (Beijing) Pharmaceuticals Technology Development Co., Ltd. romanized
2024/11/08New drug · Class 3.3 重组人促卵泡激素注射液 · No verified English nameCXSL2400754 Qilu Pharmaceutical Co., Ltd.
2024/11/08New drug · Class 3.3 重组人促卵泡激素注射液 · No verified English nameCXSL2400753 Qilu Pharmaceutical Co., Ltd.
2024/11/08New drug · Class 1.2 呼吸道合胞病毒mRNA疫苗 · No verified English nameCXSL2400752 Da Mian Yi Miao (Guangzhou) Co., Ltd. romanized; Hua Lan Bio Yi Miao Co., Ltd. romanized
2024/11/08New drug · Class 1 ASN-3186胶囊 · No verified English nameCXHL2401204 Shanghai Ya Hong Pharmaceuticals Technology Co., Ltd. romanized
2024/11/08New drug · Class 2.2 HXHTT024 · No verified English nameCXHL2401203 Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized
2024/11/08New drug · Class 1 HS-10518胶囊 · No verified English nameCXHL2401202 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2024/11/08New drug · Class 1 HS-10518胶囊 · No verified English nameCXHL2401201 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2024/11/08New drug · Class 1 HS-10518胶囊 · No verified English nameCXHL2401200 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2024/11/08New drug · Class 1 NTQ5082胶囊 · No verified English nameCXHL2401199 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2024/11/08New drug · Class 1 NTQ5082胶囊 · No verified English nameCXHL2401198 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
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

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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