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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 326 drug applications between 24 August 2024 and 30 August 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 88, covering 66 drug names.

2024/08/24 – 2024/08/30

Period
2024/08/24 to 2024/08/30, 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
326
Drugs with new generic filings (by drug name, de-duplicated)
66
Accepted this week, now under review
1

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

326filings, 88 of them generic

By application type

Application typeFilings
Supplement148
Generic88
New drug64
Import14
Unspecified7
Import re-registration5

By drug type

Drug typeFilings
Chemical drug210
TCM64
Therapeutic biologic43
Prophylactic biologic8
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

66 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Bumetanide Injection6313
2Rivaroxaban Tablets413
3Gadobutrol Injection318
4Nicardipine Hydrochloride Injection2213
5Salbutamol Sulfate injection221
6维生素B6注射液 · No verified English name2210
7Lactulose Oral Solution2134
8Empagliflozin Tablets2118
9Sildenafil Citrate Tablets2112
10Nafamostat Mesilate for Injection2138

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

214 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Zhen Yuan Pharmaceutical Co., Ltd. romanized650
2Jiangsu Kang Yuan Pharma Co., Ltd. romanized630
3Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized610
4Shanxi Ren Yuan Tang Pharma Co., Ltd. romanized440
5CISEN PHARMACEUTICAL CO., LTD.441
6Qingdao Dong Hai Pharma Co., Ltd. romanized440
7Jilin Xin Wan Lian Pharmaceuticals Co., Ltd. romanized420
8Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized424
9Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized414
10Haerbin Mei Jun 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

108 this week

AcceptedDrugApplicants
2024/08/30Generic · Class 3 阿瑞匹坦注射液 · No verified English nameCYHS2402842 Jiangsu Kang He Biopharmaceutical Co., Ltd. romanized
2024/08/30Generic · Class 3 Labetalol Hydrochloride InjectionCYHS2402839 Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized
2024/08/30Generic · Class 3 Labetalol Hydrochloride InjectionCYHS2402838 Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized
2024/08/30Generic · Class 3 Sodium Nitroprusside InjectionCYHS2402836 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2024/08/30Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2402833 Guo Ren Health Pharmaceutical (Beijing) Co., Ltd. romanized; Xian Han Feng Pharma Co., Ltd. romanized
2024/08/30Generic · Class 3 Pentoxifylline Modified Release TabletsCYHS2402832 Ben Xi Jiang Cheng Pharmaceuticals Technology Co., Ltd. romanized; Jilin Si Huan Pharmaceutical Co., Ltd. romanized
2024/08/30Generic · Class 3 Trazodone Hydrochloride TabletsCYHS2402827 Zhejiang Jiang Bei Pharma Co., Ltd. romanized
2024/08/30Generic · Class 3 Fat-Soluble Vitamin Injection(Ⅰ)CYHS2402823 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2024/08/30Generic · Class 3 Pioglitazone and Metformin Hydrochloride TabletsCYHS2402822 Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/08/30Generic · Class 3 Nafamostat Mesilate for InjectionCYHL2400181 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized
2024/08/30Generic · Class 3 Nafamostat Mesilate for InjectionCYHL2400180 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized
2024/08/30Generic · Class 3 Brivaracetam Solution for InjectionCYHL2400179 Beijing Ren Zhong Pharma Co., Ltd. romanized
2024/08/30New drug · Class 2.2 重组人血小板生成素注射液 · No verified English nameCXSS2400091 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2024/08/30New drug · Class 2.2 重组人血小板生成素注射液 · No verified English nameCXSS2400090 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2024/08/30New drug · Class 1 PC-0003吸入溶液 · No verified English nameCXHL2400891 Jiangsu Zhang Tai Pharma Co., Ltd. romanized
2024/08/30New drug · Class 1 PC-0003吸入溶液 · No verified English nameCXHL2400890 Jiangsu Zhang Tai Pharma Co., Ltd. romanized
2024/08/30New drug · Class 1 PC-0003吸入溶液 · No verified English nameCXHL2400889 Jiangsu Zhang Tai Pharma Co., Ltd. romanized
2024/08/30New drug · Class 1 ICP-332片 · No verified English nameCXHL2400888 Guangzhou Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2024/08/30New drug · Class 1 KYHY2302乳膏 · No verified English nameCXHL2400887 Jiangsu Kang Yuan Pharma Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized
2024/08/30New drug · Class 1 KYHY2302乳膏 · No verified English nameCXHL2400886 Jiangsu Kang Yuan Pharma Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized
2024/08/30New drug · Class 2.2 HDM7005 · No verified English nameCXHL2400885 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2024/08/30New drug · Class 1 KYHY2303片 · No verified English nameCXHL2400884 Jiangsu Kang Yuan Pharma Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized; Zhong Ke Zhong Shan Drug Innovation Research Institute romanized; Zhong Ke Huan Bo Hai (Yan Tai) Drug Gao Deng Research Institute romanized
2024/08/30New drug · Class 1 KYHY2303片 · No verified English nameCXHL2400883 Jiangsu Kang Yuan Pharma Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized; Zhong Ke Zhong Shan Drug Innovation Research Institute romanized; Zhong Ke Huan Bo Hai (Yan Tai) Drug Gao Deng Research Institute romanized
2024/08/30New drug · Class 1 KYHY2303片 · No verified English nameCXHL2400882 Jiangsu Kang Yuan Pharma Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized; Zhong Ke Zhong Shan Drug Innovation Research Institute romanized; Zhong Ke Huan Bo Hai (Yan Tai) Drug Gao Deng Research Institute romanized
2024/08/29Generic · Class 3 Fludeoxyglucose[18F] InjectionCYHS2402816 Guangzhou Shi Yuan Zi Gao Ke Tong Wei Su Pharmaceuticals Co., Ltd. romanized
2024/08/29Generic · Class 3 Diprophylline InjectionCYHS2402813 Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized
2024/08/29Generic · Class 3 Pregabalin Oral SolutionCYHS2402812 Guangdong He Wei Pharmaceutical Co., Ltd. romanized
2024/08/29Generic · Class 3 Magnesium Sulfate InjectionCYHS2402809 Shijiazhuang Xing Ze Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2024/08/29Generic · Class 3 Bumetanide InjectionCYHS2402806 Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized
2024/08/29Generic · Class 3 Bumetanide InjectionCYHS2402805 Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized

78 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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