药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/04/20 – 2021/04/26
- New acceptances this week
- 226
- Drugs with new generic filings (by drug name, de-duplicated)
- 21
- 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
226filings, 31 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 97 |
| New drug | 49 |
| Generic | 31 |
| Import | 22 |
| Import re-registration | 17 |
| Unspecified | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 156 |
| TCM | 36 |
| 治疗用生物制品 | 34 |
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
21 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 他达拉非片 | 4 | 1 | 23 |
| 2 | 利伐沙班片 | 3 | 2 | 3 |
| 3 | 奥硝唑注射液 | 2 | 1 | 0 |
| 4 | 奥贝胆酸片 | 2 | 1 | 0 |
| 5 | 替格瑞洛片 | 2 | 1 | 10 |
| 6 | 维生素K1注射液 | 2 | 1 | 6 |
| 7 | 苹果酸卡博替尼片 | 2 | 1 | 0 |
| 8 | 丙戊酸钠注射用浓溶液 | 1 | 1 | 0 |
| 9 | 多索茶碱注射液 | 1 | 1 | 5 |
| 10 | 富马酸丙酚替诺福韦片 | 1 | 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
122 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 内蒙古孟和制药股份有限公司 | 25 | 25 | 0 |
| 2 | Lilly France | 8 | 2 | 0 |
| 3 | AstraZeneca AB | 6 | 1 | 0 |
| 4 | Novartis Pharma Schweiz AG | 5 | 2 | 0 |
| 5 | 烟台元生药业有限公司 | 4 | 3 | 0 |
| 6 | 上海全宇生物科技（驻马店）药业有限公司 | 4 | 2 | 0 |
| 7 | 凌科药业（杭州）有限公司 | 4 | 2 | 0 |
| 8 | 正大天晴药业集团股份有限公司 | 4 | 2 | 0 |
| 9 | 江苏恒瑞医药股份有限公司 | 4 | 2 | 0 |
| 10 | Astellas pharma Europe B.V. | 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
73 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/04/26Import · Class 1 | IMG-020注射液JXSL2101014 | Affibody AB; Inmagene Biopharmaceuticals (Hangzhou) Co. Ltd. |
| 2021/04/26Import · Class 2.4 | 甲磺酸奥希替尼片JXHL2101016 | AstraZeneca AB; Astrazeneca Investment (China) Co. Ltd. |
| 2021/04/26Import · Class 2.4 | 甲磺酸奥希替尼片JXHL2101015 | AstraZeneca AB; Astrazeneca Investment (China) Co. Ltd. |
| 2021/04/26Import · Class 1 | BBP-398 胶囊JXHL2101014 | Navire Pharma Inc.; Shanghai LianBio Development Co. Ltd. |
| 2021/04/26Import · Class 1 | BBP-398胶囊JXHL2101013 | Navire Pharma Inc.; Shanghai LianBio Development Co. Ltd. |
| 2021/04/26Import · Class 1 | BBP-398胶囊JXHL2101012 | Navire Pharma Inc.; Shanghai LianBio Development Co. Ltd. |
| 2021/04/26Generic · Class 3 | 盐酸氨溴索口服溶液CYHS2101100 | 成都慧德医药科技有限公司; 成都迪康药业股份有限公司 |
| 2021/04/26Generic · Class 3 | 氨溴特罗口服溶液CYHS2101098 | 扬子江药业集团江苏紫龙药业有限公司; 扬子江药业集团江苏制药股份有限公司 |
| 2021/04/26Generic · Class 3 | 醋酸乌利司他片CYHL2101006 | 河南泰丰生物科技有限公司 |
| 2021/04/26New drug · Class 1 | BAT6021注射液CXSL2101040 | 百奥泰生物制药股份有限公司 |
| 2021/04/26New drug · Class 1 | 多扎格列艾汀片CXHS2101004 | 华领医药技术（上海）有限公司; 上海迪赛诺生物医药有限公司 |
| 2021/04/26New drug · Class 1 | CX1440胶囊CXHL2101075 | 杭州邦顺制药有限公司 |
| 2021/04/26New drug · Class 1 | CX1440胶囊CXHL2101074 | 杭州邦顺制药有限公司 |
| 2021/04/26New drug · Class 1 | CX1440胶囊CXHL2101073 | 杭州邦顺制药有限公司 |
| 2021/04/26New drug · Class 1 | CX1440胶囊CXHL2101072 | 杭州邦顺制药有限公司 |
| 2021/04/23Import · Class 1 | 注射用OregovomabJXSL2101013 | OncoQuest Pharmaceuticals Inc.; IQVIA RDS (Shanghai) Co. Ltd. |
| 2021/04/23Import · Class 1 | Tiragolumab注射液JXSL2101012 | F.Hoffmann-La Roche Ltd; Roche（China）Holding Ltd |
| 2021/04/23Generic · Class 3 | 奥硝唑注射液CYHS2101097 | 康普药业股份有限公司 |
| 2021/04/23Generic · Class 3 | 奥硝唑注射液CYHS2101096 | 康普药业股份有限公司 |
| 2021/04/23Generic · Class 3 | 丙戊酸钠注射用浓溶液CYHS2101086 | 四川汇宇制药股份有限公司 |
| 2021/04/23Generic · Class 3 | 盐酸可乐定缓释片CYHS2101084 | 力品药业（厦门）股份有限公司 |
| 2021/04/23Generic · Class 3 | 奥贝胆酸片CYHL2101005 | 泰州复旦张江药业有限公司 |
| 2021/04/23Generic · Class 3 | 奥贝胆酸片CYHL2101004 | 泰州复旦张江药业有限公司 |
| 2021/04/23Generic · Class 3 | 维生素K1注射液CYHL2101002 | 海南倍特药业有限公司 |
| 2021/04/23Generic · Class 3 | 维生素K1注射液CYHL2101001 | 海南倍特药业有限公司 |
| 2021/04/23Generic · Class 3 | 氨酚咖妥胶囊CYHL2101000 | 宜昌人福药业有限责任公司 |
| 2021/04/23New drug · Class 1 | 斯鲁利单抗注射液CXSS2101000 | 上海复宏汉霖生物制药有限公司 |
| 2021/04/23New drug · Class 1 | 重组人源化抗BTLA单克隆抗体注射液CXSL2101039 | 上海君实生物医药科技股份有限公司 |
| 2021/04/23New drug · Class 1 | ES102注射液CXSL2101038 | 科望（苏州）生物医药科技有限公司 |
| 2021/04/23New drug · Class 1 | 注射用LBL-015CXSL2101036 | 南京维立志博生物科技有限公司 |
43 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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