药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/10/19 – 2021/10/25
- New acceptances this week
- 319
- Drugs with new generic filings (by drug name, de-duplicated)
- 36
- Accepted this week, now under review
- 0
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.
Drug and company names link to detail pages; sign in to view them.
New acceptances this week
By application type and drug type
319filings, 51 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 180 |
| Generic | 51 |
| New drug | 44 |
| Import | 19 |
| Import re-registration | 15 |
| Unspecified | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 214 |
| TCM | 48 |
| 治疗用生物制品 | 46 |
| Biologic | 6 |
| 预防用生物制品 | 5 |
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
36 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 氟康唑干混悬剂 | 4 | 1 | 0 |
| 2 | 阿普米司特片 | 3 | 1 | 3 |
| 3 | 缬沙坦氨氯地平片（I） | 2 | 2 | 2 |
| 4 | 富马酸二甲酯肠溶胶囊 | 2 | 1 | 0 |
| 5 | 恩格列净片 | 2 | 1 | 18 |
| 6 | 氟康唑氯化钠注射液 | 2 | 1 | 1 |
| 7 | 氨甲环酸注射液 | 2 | 1 | 11 |
| 8 | 注射用美罗培南 | 2 | 1 | 5 |
| 9 | 玻璃酸钠滴眼液 | 2 | 1 | 29 |
| 10 | 盐酸多巴胺注射液 | 2 | 1 | 3 |
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
164 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 甘肃佛阁藏药有限公司 | 27 | 25 | 0 |
| 2 | 浙江医药股份有限公司新昌制药厂 | 23 | 11 | 0 |
| 3 | 长春金赛药业有限责任公司 | 8 | 2 | 0 |
| 4 | 山西万辉制药有限公司 | 7 | 5 | 0 |
| 5 | Eli Lilly and Company | 4 | 3 | 0 |
| 6 | Novartis Pharma Schweiz AG | 4 | 3 | 0 |
| 7 | 辉瑞制药科技有限公司 | 4 | 3 | 0 |
| 8 | 上海嘉葆药银医药科技有限公司 | 4 | 2 | 0 |
| 9 | 江苏恒瑞医药股份有限公司 | 4 | 2 | 0 |
| 10 | NAPP PHARMACEUTICALS LIMITED | 4 | 1 | 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
76 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/10/22Import · Class 2.2 | 司库奇尤单抗注射液JXSL2101119 | Novartis Pharma Schweiz AG; Beijing Novartis Pharma Co. Ltd. |
| 2021/10/22Import · Class 1 | SAR439859片JXHL2101217 | Sanofi-aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2021/10/22Import · Class 1 | Nemtabrutinib片JXHL2101216 | Merck Sharp & Dohme Corp.，a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2021/10/22Import · Class 1 | Nemtabrutinib片JXHL2101215 | Merck Sharp & Dohme Corp.，a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2021/10/22Generic · Class 3 | 注射用福沙匹坦双葡甲胺CYHS2101913 | 杭州九源基因工程有限公司 |
| 2021/10/22Generic · Class 3 | 帕拉米韦注射液CYHS2101912 | 成都百裕制药股份有限公司 |
| 2021/10/22Generic · Class 3 | 特利加压素注射液CYHS2101870 | 深圳翰宇药业股份有限公司; 甘肃成纪生物药业有限公司 |
| 2021/10/22New drug · Class 3.4 | 注射用CMAB007CXSS2101035 | 泰州迈博太科药业有限公司 |
| 2021/10/22New drug · Class 3.4 | 注射用CMAB007CXSS2101034 | 泰州迈博太科药业有限公司 |
| 2021/10/22New drug · Class 1 | JS019注射液CXSL2101382 | 苏州科博瑞君生物医药科技有限公司 |
| 2021/10/22New drug · Class 1 | JDB175片CXHL2101598 | 上海嘉葆药银医药科技有限公司 |
| 2021/10/22New drug · Class 1 | JDB175片CXHL2101597 | 上海嘉葆药银医药科技有限公司 |
| 2021/10/22New drug · Class 1 | JDB153片CXHL2101596 | 上海嘉葆药银医药科技有限公司 |
| 2021/10/22New drug · Class 1 | JDB153片CXHL2101595 | 上海嘉葆药银医药科技有限公司 |
| 2021/10/22New drug · Class 1 | 注射用CN-105肽CXHL2101594 | 广东鹍鹏肽灵生物科技有限公司 |
| 2021/10/22New drug · Class 1 | HS-10383片CXHL2101593 | 江苏豪森药业集团有限公司 |
| 2021/10/22New drug · Class 1 | HS-10383片CXHL2101592 | 江苏豪森药业集团有限公司 |
| 2021/10/22New drug · Class 1 | 注射用XNW4107CXHL2101591 | 苏州信诺维医药科技股份有限公司 |
| 2021/10/21Import · Class 2.1 | OAV101注射液JXSL2101118 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd |
| 2021/10/21Import · Class 1 | 注射用MRX-8JXHL2101212 | MicuRx Pharmaceuticals Inc.; 不适用 |
| 2021/10/21Import · Class 1 | venglustatJXHL2101211 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd |
| 2021/10/21Import · Class 1 | venglustatJXHL2101210 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd |
| 2021/10/21Generic · Class 3 | 氨甲环酸注射液CYHS2101906 | 蓬莱诺康药业有限公司 |
| 2021/10/21Generic · Class 3 | 氨甲环酸注射液CYHS2101905 | 蓬莱诺康药业有限公司 |
| 2021/10/21Generic · Class 3 | 赖氨洛芬注射液CYHS2101904 | 四川维奥制药有限公司; 四川汇宇制药股份有限公司 |
| 2021/10/21Generic · Class 3 | 氨氯地平贝那普利胶囊CYHS2101902 | 扬子江药业集团广州海瑞药业有限公司 |
| 2021/10/21Generic · Class 3 | 盐酸多巴胺注射液CYHS2101900 | 吉林振澳制药有限公司 |
| 2021/10/21Generic · Class 3 | 盐酸多巴胺注射液CYHS2101899 | 吉林振澳制药有限公司 |
| 2021/10/21Generic · Class 3 | 葡萄糖酸钙注射液CYHS2101857 | 仁合益康集团有限公司; 河北仁合益康药业有限公司 |
| 2021/10/21Generic · Class 3 | 普瑞巴林口服溶液CYHS2101844 | 合肥恩瑞特药业有限公司 |
46 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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