药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/02/13 – 2024/02/19
- New acceptances this week
- 84
- Drugs with new generic filings (by drug name, de-duplicated)
- 13
- Accepted this week, now under review
- 1
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
84filings, 16 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 47 |
| Generic | 16 |
| New drug | 13 |
| Import | 6 |
| Unspecified | 1 |
| Import re-registration | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 55 |
| TCM | 19 |
| 治疗用生物制品 | 10 |
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
13 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 注射用哌拉西林钠 | 2 | 1 | 16 |
| 2 | 美阿沙坦钾片 | 2 | 1 | 33 |
| 3 | 马来酸氟伏沙明片 | 2 | 1 | 0 |
| 4 | 宝心艾维西木口服液 | 1 | 1 | 0 |
| 5 | 愈创木酚甘油醚双层缓释片 | 1 | 1 | 0 |
| 6 | 氯化钙注射液 | 1 | 1 | 6 |
| 7 | 瑞卢戈利片 | 1 | 1 | 2 |
| 8 | 盐酸咪达普利片 | 1 | 1 | 0 |
| 9 | 盐酸美金刚口服溶液 | 1 | 1 | 0 |
| 10 | 硫酸镁注射液 | 1 | 1 | 7 |
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
54 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 石家庄御泽堂制药有限公司 | 6 | 6 | 0 |
| 2 | 成都华健未来科技有限公司 | 4 | 1 | 0 |
| 3 | 哈尔滨康泽源药业有限公司 | 3 | 3 | 0 |
| 4 | 重庆圣华曦药业股份有限公司 | 3 | 2 | 3 |
| 5 | 中孚药业股份有限公司 | 3 | 1 | 0 |
| 6 | 杭州安道药业有限公司 | 3 | 1 | 0 |
| 7 | 沈阳海思科制药有限公司 | 3 | 1 | 0 |
| 8 | 维眸生物科技（浙江）有限公司 | 3 | 1 | 0 |
| 9 | 齐鲁安替制药有限公司 | 3 | 1 | 0 |
| 10 | 海南海神同洲制药有限公司 | 2 | 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
26 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/02/19Import · Class 1 | Riliprubart注射液JXSL2400046 | Sanofi-aventis Recherche & Développement; Sanofi（China）Investment Co. Ltd. |
| 2024/02/19Import · Class 1 | Riliprubart注射液JXSL2400045 | Sanofi-aventis Recherche & Développement; Sanofi（China）Investment Co. Ltd. |
| 2024/02/19Import · Class 1 | Itepekimab注射液JXSL2400044 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2024/02/19Import · Class 1 | IDRX-42JXHL2400035 | IDRX Inc.; Choice Pharma Medical Information Consultancy（Shanghai）Co. Ltd |
| 2024/02/19Import · Class 1 | IDRX-42JXHL2400034 | IDRX Inc.; Choice Pharma Medical Information Consultancy（Shanghai）Co. Ltd |
| 2024/02/19Generic · Class 3 | 盐酸美金刚口服溶液CYHS2400620 | 河北合渡药业有限公司; 乐声药业石家庄有限公司 |
| 2024/02/19Generic · Class 3 | 硫酸镁注射液CYHS2400619 | 石家庄杏泽医药科技有限公司; 山东华鲁制药有限公司 |
| 2024/02/19Generic · Class 3 | 氯化钙注射液CYHS2400618 | 山东齐都药业有限公司 |
| 2024/02/19Generic · Class 3 | 注射用哌拉西林钠CYHS2400611 | 四川制药制剂有限公司 |
| 2024/02/19Generic · Class 3 | 注射用哌拉西林钠CYHS2400610 | 四川制药制剂有限公司 |
| 2024/02/19Generic · Class 3 | 瑞卢戈利片CYHL2400039 | 齐鲁制药有限公司 |
| 2024/02/19New drug · Class 1.1 | 小儿黄金止咳颗粒CXZS2400008 | 北京东方运嘉药业有限公司; 吉林华康药业股份有限公司 |
| 2024/02/19New drug · Class 1 | VVN1901滴眼液CXSL2400123 | 维眸生物科技（浙江）有限公司 |
| 2024/02/19New drug · Class 1 | VVN1901滴眼液CXSL2400122 | 维眸生物科技（浙江）有限公司 |
| 2024/02/19New drug · Class 1 | VVN1901滴眼液CXSL2400121 | 维眸生物科技（浙江）有限公司 |
| 2024/02/19New drug · Class 1 | BR101注射液CXSL2400120 | 浙江博锐生物制药有限公司; 杭州博之锐生物制药有限公司 |
| 2024/02/19New drug · Class 1 | 混合活化杀伤（MAK）免疫细胞注射液CXSL2400119 | 北京拓华伟业生物科技有限公司 |
| 2024/02/19New drug · Class 2.3 | HY22017胶囊CXHS2400012 | 长春海悦药业股份有限公司 |
| 2024/02/19New drug · Class 1 | HJ787软膏CXHL2400199 | 成都华健未来科技有限公司 |
| 2024/02/19New drug · Class 1 | HJ787软膏CXHL2400198 | 成都华健未来科技有限公司 |
| 2024/02/19New drug · Class 1 | HJ787软膏CXHL2400197 | 成都华健未来科技有限公司 |
| 2024/02/19New drug · Class 1 | HJ787软膏CXHL2400196 | 成都华健未来科技有限公司 |
| 2024/02/19New drug · Class 1 | 177Lu-LNC1008注射液CXHL2400195 | 烟台蓝纳成生物技术有限公司 |
| 2024/02/19New drug · Class 2.2 | 注射用瑞卢戈利CXHL2400194 | 诺桥制药（成都）有限责任公司 |
| 2024/02/18Generic · Class 3 | 愈创木酚甘油醚双层缓释片CYHS2400608 | 北京柏雅联合药物研究所有限公司; 石家庄宇惠制药有限公司 |
| 2024/02/18Generic · Class 3 | 糠酸莫米松富马酸福莫特罗吸入气雾剂CYHL2400038 | 长风药业股份有限公司 |
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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