药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/11/02 – 2021/11/08
- New acceptances this week
- 215
- Drugs with new generic filings (by drug name, de-duplicated)
- 35
- 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
215filings, 41 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 126 |
| Generic | 41 |
| New drug | 20 |
| Import | 17 |
| Import re-registration | 6 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 160 |
| 治疗用生物制品 | 29 |
| TCM | 22 |
| 预防用生物制品 | 4 |
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
35 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 奥扎格雷钠注射液 | 2 | 1 | 3 |
| 2 | 氨氯地平阿托伐他汀钙片 | 2 | 1 | 2 |
| 3 | 注射用盐酸瑞芬太尼 | 2 | 1 | 2 |
| 4 | 玻璃酸钠滴眼液 | 2 | 1 | 29 |
| 5 | 阿普米司特片 | 2 | 1 | 3 |
| 6 | 雷诺嗪缓释片 | 2 | 1 | 3 |
| 7 | ω-3 鱼油中长链脂肪乳/氨基酸（16）/葡萄糖（30%）注射液 | 1 | 1 | 0 |
| 8 | 丙酸氟替卡松吸入粉雾剂 | 1 | 1 | 1 |
| 9 | 去氧孕烯炔雌醇片 | 1 | 1 | 0 |
| 10 | 吸入用异丙托溴铵溶液 | 1 | 1 | 2 |
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
120 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 费森尤斯卡比华瑞制药有限公司 | 8 | 1 | 0 |
| 2 | 华北制药金坦生物技术股份有限公司 | 7 | 1 | 0 |
| 3 | 华夏生生药业（北京）有限公司 | 7 | 1 | 0 |
| 4 | 海南通用三洋药业有限公司 | 6 | 2 | 0 |
| 5 | 广东科伦药业有限公司 | 6 | 1 | 0 |
| 6 | 陕西年青保制药有限公司 | 5 | 5 | 0 |
| 7 | UCB Pharma SA | 5 | 2 | 0 |
| 8 | 柳河长隆制药有限公司 | 4 | 4 | 0 |
| 9 | 浙江赞生药业有限公司 | 4 | 4 | 0 |
| 10 | 重庆多代医药科技有限公司 | 4 | 4 | 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
49 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/11/08Import · Class 1 | PH94B 鼻用喷雾剂JXHL2101235 | VistaGen Therapeutics Inc. |
| 2021/11/08Generic · Class 3 | 雷诺嗪缓释片CYHS2101987 | 海思科制药（眉山）有限公司 |
| 2021/11/08Generic · Class 3 | 雷诺嗪缓释片CYHS2101986 | 海思科制药（眉山）有限公司 |
| 2021/11/08Generic · Class 3 | 左氧氟沙星注射液CYHS2101981 | 四川新斯顿制药股份有限公司 |
| 2021/11/08Generic · Class 3 | 奥美沙坦酯口崩片CYHS2101960 | 江西施美药业股份有限公司 |
| 2021/11/08Generic · Class 3 | 硫酸特布他林口服溶液CYHS2101952 | 杭州上禾健康科技有限公司; 浙江凯润药业股份有限公司 |
| 2021/11/08Generic · Class 3 | 酒石酸阿福特罗吸入溶液CYHL2101037 | 江苏长泰药业有限公司 |
| 2021/11/08Generic · Class 3 | 注射用双羟萘酸奥氮平CYHL2101036 | 浙江圣兆药物科技股份有限公司 |
| 2021/11/08New drug · Class 3.3 | 托珠单抗注射液CXSS2101049 | 百奥泰生物制药股份有限公司 |
| 2021/11/08New drug · Class 3.3 | 托珠单抗注射液CXSS2101048 | 百奥泰生物制药股份有限公司 |
| 2021/11/08New drug · Class 3.3 | 托珠单抗注射液CXSS2101047 | 百奥泰生物制药股份有限公司 |
| 2021/11/08New drug · Class 1 | QX005N注射液CXSL2101411 | 江苏荃信生物医药股份有限公司 |
| 2021/11/08New drug · Class 1 | YH004注射液CXSL2101410 | 祐和医药科技（北京）有限公司 |
| 2021/11/08New drug · Class 1 | BR105注射液CXSL2101409 | 浙江博锐生物制药有限公司; 海正生物制药有限公司 |
| 2021/11/08New drug · Class 1 | DZD8586片CXHL2101631 | 迪哲（江苏）医药股份有限公司 |
| 2021/11/08New drug · Class 1 | DZD8586片CXHL2101630 | 迪哲（江苏）医药股份有限公司 |
| 2021/11/08New drug · Class 1 | DZD8586片CXHL2101629 | 迪哲（江苏）医药股份有限公司 |
| 2021/11/05Import · Class 2.2 | 度伐利尤单抗注射液JXSL2101125 | MedImmune LLC; AstraZeneca Investment (China) Co. Limited |
| 2021/11/05Import · Class 2.2 | 阿普唑仑吸入粉剂JXHL2101234 | UCB Pharma SA; UCB Trading (Shanghai) Co. Ltd. |
| 2021/11/05Import · Class 1 | BBP-398 胶囊JXHL2101233 | Navire Pharma Inc.; Shanghai LianBio Development Co. Ltd. |
| 2021/11/05Import · Class 1 | BBP-398胶囊JXHL2101232 | Navire Pharma Inc.; Shanghai LianBio Development Co. Ltd. |
| 2021/11/05Generic · Class 3 | 甲硫酸新斯的明注射液CYHS2101978 | 广州瑞尔医药科技有限公司; 河北凯威制药有限责任公司 |
| 2021/11/05Generic · Class 3 | 丙酸氟替卡松吸入粉雾剂CYHL2101034 | 润生药业有限公司 |
| 2021/11/04Generic · Class 3 | ω-3 鱼油中长链脂肪乳/氨基酸（16）/葡萄糖（30%）注射液CYHL2101035 | 福建盛迪医药有限公司 |
| 2021/11/04New drug · Class 3.3 | 冻干人用狂犬病疫苗（人二倍体细胞）CXSS2101046 | 北京民海生物科技有限公司 |
| 2021/11/04New drug · Class 2.2 | 信迪利单抗注射液CXSS2101045 | 信达生物制药（苏州）有限公司 |
| 2021/11/04New drug · Class 1 | TWP-103注射液CXSL2101402 | 泰泽惠康生物医药有限责任公司 |
| 2021/11/04New drug · Class 1 | KN056注射液CXSL2101386 | 苏州康宁杰瑞生物科技有限公司 |
| 2021/11/04New drug · Class 1 | WTS-007胶囊CXHL2101624 | 杭州梧桐树药业有限公司 |
| 2021/11/04New drug · Class 1 | WTS-007胶囊CXHL2101623 | 杭州梧桐树药业有限公司 |
19 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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