药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/12/28 – 2022/01/03
- New acceptances this week
- 236
- Drugs with new generic filings (by drug name, de-duplicated)
- 41
- 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
236filings, 60 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 92 |
| Generic | 60 |
| New drug | 60 |
| Import | 11 |
| Import re-registration | 8 |
| Unspecified | 4 |
| 药械组合产品 | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 181 |
| 治疗用生物制品 | 38 |
| TCM | 16 |
| 药械组合 | 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
41 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 盐酸文拉法辛缓释胶囊 | 3 | 2 | 0 |
| 2 | 枸橼酸西地那非片 | 3 | 1 | 12 |
| 3 | 氯沙坦钾氢氯噻嗪片 | 3 | 1 | 1 |
| 4 | 阿普米司特片 | 3 | 1 | 3 |
| 5 | 硫酸氨基葡萄糖胶囊 | 2 | 2 | 51 |
| 6 | 奥氮平口崩片 | 2 | 1 | 0 |
| 7 | 替格瑞洛片 | 2 | 1 | 10 |
| 8 | 氨甲环酸注射液 | 2 | 1 | 11 |
| 9 | 沙库巴曲缬沙坦钠片 | 2 | 1 | 68 |
| 10 | 注射用盐酸头孢吡肟/氯化钠注射液 | 2 | 1 | 0 |
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
137 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 华润双鹤药业股份有限公司 | 7 | 5 | 3 |
| 2 | 扬子江药业集团江苏制药股份有限公司 | 6 | 6 | 0 |
| 3 | 浙江诺得药业有限公司 | 6 | 3 | 6 |
| 4 | 山东润泽制药有限公司 | 6 | 1 | 0 |
| 5 | 广东科伦药业有限公司 | 5 | 1 | 0 |
| 6 | 广州润尔眼科生物科技有限公司 | 5 | 1 | 0 |
| 7 | 宜昌人福药业有限责任公司 | 4 | 4 | 3 |
| 8 | AstraZeneca AB | 4 | 2 | 0 |
| 9 | 北京锐业制药有限公司 | 4 | 2 | 2 |
| 10 | 山东罗欣药业集团股份有限公司 | 4 | 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
84 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/12/31Generic · Class 3 | 盐酸多巴酚丁胺注射液CYHS2102338 | 上海旭东海普药业有限公司 |
| 2021/12/31Generic · Class 3 | 盐酸多巴酚丁胺注射液CYHS2102337 | 上海旭东海普药业有限公司 |
| 2021/12/31Generic · Class 3 | 地高辛注射液CYHS2102336 | 中润药业有限公司; 成都市海通药业有限公司 |
| 2021/12/31Generic · Class 3 | 盐酸氨溴索口服溶液CYHS2102335 | 黑龙江珍宝岛药业股份有限公司 |
| 2021/12/31Generic · Class 3 | 氟比洛芬酯注射液CYHL2101059 | 宜昌人福药业有限责任公司 |
| 2021/12/31New drug · Class 2.4 | 注射用重组A型肉毒毒素CXSL2101534 | 重庆誉颜制药有限公司 |
| 2021/12/31New drug · Class 1 | GC304腺相关病毒注射液CXSL2101532 | 北京锦篮基因科技有限公司 |
| 2021/12/31New drug · Class 1 | 靶向HLA-A*02:01/NY-ESO-1的TCR-T细胞注射液CXSL2101531 | 深圳普瑞金生物药业有限公司 |
| 2021/12/31New drug · Class 1 | 靶向Survivin DC细胞注射液CXSL2101530 | 启辰生生物科技（珠海）有限公司 |
| 2021/12/31New drug · Class 1 | JMKX000623片CXHL2101856 | 上海济煜医药科技有限公司 |
| 2021/12/31New drug · Class 1 | JMKX000623片CXHL2101855 | 上海济煜医药科技有限公司 |
| 2021/12/31New drug · Class 2.2;2.4 | 孟鲁司特钠凝胶CXHL2101854 | 江阴贝瑞森制药有限公司 |
| 2021/12/31New drug · Class 2.2 | 孟鲁司特钠凝胶CXHL2101853 | 江阴贝瑞森制药有限公司 |
| 2021/12/31New drug · Class 1 | KL130008胶囊CXHL2101852 | 四川科伦博泰生物医药股份有限公司 |
| 2021/12/31New drug · Class 1 | KL130008胶囊CXHL2101851 | 四川科伦博泰生物医药股份有限公司 |
| 2021/12/31New drug · Class 1 | KL130008胶囊CXHL2101850 | 四川科伦博泰生物医药股份有限公司 |
| 2021/12/31New drug · Class 2.2 | BCM235缓释干混悬剂CXHL2101825 | 上海博志研新药物技术有限公司 |
| 2021/12/30Import · Class 3.1 | 注射用维博妥珠单抗JXSS2101037 | Roche Pharma （Schweiz）AG; F. Hoffmann-La Roche AG |
| 2021/12/30Import · Class 3.1 | 注射用维博妥珠单抗JXSS2101036 | Roche Pharma （Schweiz）AG; BSP Pharmaceuticals S.p.A. |
| 2021/12/30Import · Class 1 | Sepantronium Bromide注射液JXHL2101289 | Cothera Bioscience Inc.; Beijing Percans Oncology Co. Ltd. |
| 2021/12/30Generic · Class 3 | 硫辛酸片CYHS2102326 | 亚宝药业集团股份有限公司 |
| 2021/12/30Generic · Class 3 | 硫辛酸片CYHS2102325 | 亚宝药业集团股份有限公司 |
| 2021/12/30Generic · Class 3 | 奥硝唑注射液CYHS2102322 | 华夏生生药业（北京）有限公司 |
| 2021/12/30Generic · Class 3 | 注射用盐酸头孢吡肟/氯化钠注射液CYHS2102321 | 北京锐业制药有限公司 |
| 2021/12/30Generic · Class 3 | 注射用盐酸头孢吡肟/氯化钠注射液CYHS2102318 | 北京锐业制药有限公司 |
| 2021/12/30Generic · Class 3 | 氨甲环酸注射液CYHS2102317 | 锦州奥鸿药业有限责任公司 |
| 2021/12/30Generic · Class 3 | 氨甲环酸注射液CYHS2102316 | 锦州奥鸿药业有限责任公司 |
| 2021/12/30New drug · Class 1.1 | 秦苓颗粒CXZL2101043 | 北京纽维珀奥医药科技有限公司 |
| 2021/12/30New drug · Class 1.1 | 驹藿片CXZL2101042 | 北京纽维珀奥医药科技有限公司 |
| 2021/12/30New drug · Class 1.1 | 牛贝消核颗粒CXZL2101041 | 广东奇方药业有限公司 |
54 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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