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
- 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 type | Filings |
|---|---|
| Supplement | 148 |
| Generic | 88 |
| New drug | 64 |
| Import | 14 |
| Unspecified | 7 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 210 |
| TCM | 64 |
| Therapeutic biologic | 43 |
| Prophylactic biologic | 8 |
| Biologic | 1 |
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
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Bumetanide Injection | 6 | 3 | 13 |
| 2 | Rivaroxaban Tablets | 4 | 1 | 3 |
| 3 | Gadobutrol Injection | 3 | 1 | 8 |
| 4 | Nicardipine Hydrochloride Injection | 2 | 2 | 13 |
| 5 | Salbutamol Sulfate injection | 2 | 2 | 1 |
| 6 | 维生素B6注射液 · No verified English name | 2 | 2 | 10 |
| 7 | Lactulose Oral Solution | 2 | 1 | 34 |
| 8 | Empagliflozin Tablets | 2 | 1 | 18 |
| 9 | Sildenafil Citrate Tablets | 2 | 1 | 12 |
| 10 | Nafamostat Mesilate for Injection | 2 | 1 | 38 |
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) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Zhen Yuan Pharmaceutical Co., Ltd. romanized | 6 | 5 | 0 |
| 2 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized | 6 | 3 | 0 |
| 3 | Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized | 6 | 1 | 0 |
| 4 | Shanxi Ren Yuan Tang Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 5 | CISEN PHARMACEUTICAL CO., LTD. | 4 | 4 | 1 |
| 6 | Qingdao Dong Hai Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Jilin Xin Wan Lian Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 8 | Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized | 4 | 2 | 4 |
| 9 | Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized | 4 | 1 | 4 |
| 10 | Haerbin Mei Jun Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
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
| Accepted | Drug | Applicants |
|---|---|---|
| 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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