YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 376 drug applications between 5 November 2024 and 11 November 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 113, covering 82 drug names.
2024/11/05 – 2024/11/11
- New acceptances this week
- 376
- Drugs with new generic filings (by drug name, de-duplicated)
- 82
- 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
376filings, 113 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 161 |
| Generic | 113 |
| New drug | 67 |
| Import | 18 |
| Import re-registration | 14 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 296 |
| TCM | 38 |
| Therapeutic biologic | 34 |
| Prophylactic biologic | 6 |
| In vitro diagnostic reagent | 1 |
| 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
82 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 4 | 2 | 60 |
| 2 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 4 | 2 | 23 |
| 3 | Nicergoline Tablets | 3 | 2 | 1 |
| 4 | Methotrexate Injection | 3 | 2 | 11 |
| 5 | Repaglinide Tablets | 3 | 1 | 6 |
| 6 | Crisaborole Ointment | 2 | 2 | 26 |
| 7 | Dydrogesterone Tablets | 2 | 2 | 8 |
| 8 | Sodium sulfate, magnesium sulfate, and potassium chloride Tablets | 2 | 2 | 2 |
| 9 | Iguratimod Tablets | 2 | 2 | 23 |
| 10 | Piracetam Injection | 2 | 1 | 9 |
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
213 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guangdong Sunho Pharmaceutical Co., Ltd. | 17 | 10 | 0 |
| 2 | Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized | 9 | 8 | 0 |
| 3 | Qilu Pharmaceutical Co., Ltd. | 7 | 4 | 2 |
| 4 | Yi Ling Wan Zhou International Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 3 | 0 |
| 6 | GE Healthcare AS | 6 | 1 | 0 |
| 7 | Teva Neuroscience Inc. | 6 | 1 | 0 |
| 8 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized | 6 | 1 | 0 |
| 9 | SANOFI WINTHROP INDUSTRIE | 5 | 3 | 0 |
| 10 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 5 | 2 | 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
125 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/11/11Import · Class 2.2 | 注射用德曲妥珠单抗 · No verified English nameJXSL2400217 | Daiichi Sankyo Inc.; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD. |
| 2024/11/11Generic · Class 3 | Propranolol Hydrochloride InjectionCYHS2403854 | Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2024/11/11Generic · Class 3 | Propranolol Hydrochloride InjectionCYHS2403853 | Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2024/11/11Generic · Class 3 | Pentoxifylline InjectionCYHS2403851 | Shanghai Xian Dai Ha Sen (Shang Qiu) Pharma Co., Ltd. romanized |
| 2024/11/11Generic · Class 3 | Nicergoline TabletsCYHS2403846 | Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/11/11Generic · Class 3 | Nicergoline TabletsCYHS2403845 | Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/11/11Generic · Class 3 | Potassium Aspartate InjectionCYHS2403844 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2024/11/11Generic · Class 3 | Sodium sulfate, magnesium sulfate, and potassium chloride TabletsCYHL2400216 | Shandong Cheng Chuang Lan Hai Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/11/11Generic · Class 3 | Sodium sulfate, magnesium sulfate, and potassium chloride TabletsCYHL2400215 | Bao Ding Tian Hao Pharmaceutical Co., Ltd. romanized |
| 2024/11/11New drug · Class 1 | TAEST16001注射液 · No verified English nameCXSL2400766 | Xiang Xue Sheng Ming Ke Xue Technology (Guangdong) Co., Ltd. romanized |
| 2024/11/11New drug · Class 1 | GenSci120注射液 · No verified English nameCXSL2400765 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2024/11/11New drug · Class 1 | GenSci120注射液 · No verified English nameCXSL2400764 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2024/11/11New drug · Class 1 | GenSci120注射液 · No verified English nameCXSL2400763 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2024/11/11New drug · Class 1.4 | 二价肠道病毒灭活疫苗(Vero细胞) · No verified English nameCXSL2400762 | Beijing Min Hai Bio Technology Co., Ltd. romanized |
| 2024/11/11New drug · Class 1.4 | 四价肠道病毒灭活疫苗(Vero细胞) · No verified English nameCXSL2400761 | Beijing Min Hai Bio Technology Co., Ltd. romanized |
| 2024/11/09Generic · Class 3 | 复方聚乙二醇电解质散(Ⅱ) · No verified English nameCYHS2403839 | Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/11/09Generic · Class 3 | Potassium Chloride GranulesCYHS2403838 | Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized |
| 2024/11/09Generic · Class 3 | Potassium Chloride GranulesCYHS2403837 | Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized |
| 2024/11/09Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2403836 | Changchun Hai Yue Pharma Co., Ltd. romanized |
| 2024/11/09Generic · Class 3 | Eptazocine Hydrobromide InjectionCYHS2403831 | Chengdu Brilliant Pharmaceutical Co., Ltd. |
| 2024/11/09Generic · Class 3 | Nicergoline TabletsCYHS2403829 | Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized |
| 2024/11/09New drug · Class 1 | 注射用AMT-754 · No verified English nameCXSL2400760 | Pu Zhong Fa Xian Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2024/11/09New drug · Class 1 | J-51注射液 · No verified English nameCXSL2400759 | Jin Wei Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/11/09New drug · Class 1 | SAR444656 · No verified English nameCXHL2401212 | Sai Nuo Fei (Zhongguo) Investment Co., Ltd. romanized |
| 2024/11/09New drug · Class 1 | SAR444656 · No verified English nameCXHL2401211 | Sai Nuo Fei (Zhongguo) Investment Co., Ltd. romanized |
| 2024/11/09New drug · Class 1 | NSP-1047A片 · No verified English nameCXHL2401210 | Nuo Wo Si Da Pharma (Shanghai) Co., Ltd. romanized |
| 2024/11/09New drug · Class 1 | NSP-1047A片 · No verified English nameCXHL2401209 | Nuo Wo Si Da Pharma (Shanghai) Co., Ltd. romanized |
| 2024/11/09New drug · Class 1 | GH56胶囊 · No verified English nameCXHL2401208 | Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2024/11/09New drug · Class 1 | GH56胶囊 · No verified English nameCXHL2401207 | Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2024/11/09New drug · Class 1 | GH56胶囊 · No verified English nameCXHL2401206 | Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized |
95 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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