药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/09/19 – 2023/09/25
- New acceptances this week
- 349
- Drugs with new generic filings (by drug name, de-duplicated)
- 75
- Accepted this week, now under review
- 4
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
349filings, 89 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 174 |
| Generic | 89 |
| New drug | 55 |
| Import | 22 |
| Unspecified | 5 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 255 |
| TCM | 55 |
| 治疗用生物制品 | 33 |
| 预防用生物制品 | 4 |
| Biologic | 2 |
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
75 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 盐酸他喷他多片 | 3 | 1 | 0 |
| 2 | 丙戊酸钠缓释片(Ⅰ) | 2 | 2 | 4 |
| 3 | 二羟丙茶碱注射液 | 2 | 2 | 7 |
| 4 | 美索巴莫注射液 | 2 | 2 | 3 |
| 5 | 他克莫司软膏 | 2 | 1 | 8 |
| 6 | 地高辛注射液 | 2 | 1 | 3 |
| 7 | 塞来昔布片 | 2 | 1 | 3 |
| 8 | 奥卡西平片 | 2 | 1 | 4 |
| 9 | 生理氯化钠溶液 | 2 | 1 | 17 |
| 10 | 甲硫酸新斯的明注射液 | 2 | 1 | 4 |
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
215 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Boehringer Ingelheim International GmbH | 10 | 1 | 0 |
| 2 | 黑龙江宋慈制药有限责任公司 | 7 | 6 | 0 |
| 3 | 山西黄河中药有限公司 | 5 | 4 | 0 |
| 4 | 江西施美药业股份有限公司 | 5 | 4 | 4 |
| 5 | Novartis Europharm Limited | 5 | 3 | 0 |
| 6 | 哈尔滨三联药业股份有限公司 | 5 | 2 | 0 |
| 7 | 陕西丽彩药业有限公司 | 5 | 2 | 2 |
| 8 | 宜昌人福药业有限责任公司 | 4 | 2 | 4 |
| 9 | 江苏恒瑞医药股份有限公司 | 4 | 2 | 0 |
| 10 | Sanofi Winthrop Industrie | 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
106 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/09/25Generic · Class 3 | 甲硫酸新斯的明注射液CYHS2302585 | 上海旭东海普药业有限公司 |
| 2023/09/25Generic · Class 3 | 甲硫酸新斯的明注射液CYHS2302584 | 上海旭东海普药业有限公司 |
| 2023/09/25New drug · Class 1.1 | 五味益心颗粒CXZL2300064 | 江苏康缘药业股份有限公司 |
| 2023/09/25New drug · Class 1 | 重组抗 Claudin18.2 全人源单克隆抗体注射液CXSL2300651 | 华兰基因工程(河南)有限公司 |
| 2023/09/25New drug · Class 1 | SCT650C注射液CXSL2300650 | 神州细胞工程有限公司 |
| 2023/09/25New drug · Class 1 | HS-10516胶囊CXHL2301032 | 江苏豪森药业集团有限公司; 上海翰森生物医药科技有限公司 |
| 2023/09/25New drug · Class 1 | HS-10516胶囊CXHL2301031 | 江苏豪森药业集团有限公司; 上海翰森生物医药科技有限公司 |
| 2023/09/23Generic · Class 3 | 氨氯地平贝那普利胶囊CYHS2302581 | 地奥集团成都药业股份有限公司 |
| 2023/09/23Generic · Class 3 | 硫酸镁注射液CYHS2302580 | 云南药科院生物医药股份有限公司; 楚雄和创药业有限责任公司 |
| 2023/09/23Generic · Class 3 | 倍他米松磷酸钠注射液CYHS2302577 | 辰欣药业股份有限公司 |
| 2023/09/23Generic · Class 3 | 奥美拉唑碳酸氢钠胶囊(Ⅱ)CYHS2302576 | 宁波美诺华天康药业有限公司 |
| 2023/09/23Generic · Class 3 | 奥美拉唑碳酸氢钠胶囊CYHS2302575 | 宁波美诺华天康药业有限公司 |
| 2023/09/23Generic · Class 3 | 地高辛注射液CYHS2302574 | 安徽长江药业有限公司; 浙江赛默制药有限公司 |
| 2023/09/23Generic · Class 3 | 地高辛注射液CYHS2302573 | 安徽长江药业有限公司; 浙江赛默制药有限公司 |
| 2023/09/23New drug · Class 1 | Xs02注射液CXSL2300649 | 北京先声祥瑞生物制品股份有限公司 |
| 2023/09/23New drug · Class 1 | Xs02注射液CXSL2300648 | 北京先声祥瑞生物制品股份有限公司 |
| 2023/09/23New drug · Class 1 | Xs02注射液CXSL2300647 | 北京先声祥瑞生物制品股份有限公司 |
| 2023/09/23New drug · Class 2.2 | SHR-8068注射液CXSL2300646 | 苏州盛迪亚生物医药有限公司 |
| 2023/09/23New drug · Class 1 | BPAb002注射液CXSL2300645 | 博品泽荣(深圳)生物医药科技有限公司 |
| 2023/09/23New drug · Class 1 | 斯美瑞非片CXHS2300087 | 苏州旺山旺水生物医药股份有限公司; 苏州特瑞药业股份有限公司 |
| 2023/09/23New drug · Class 1 | 斯美瑞非片CXHS2300086 | 苏州旺山旺水生物医药股份有限公司; 苏州特瑞药业股份有限公司 |
| 2023/09/23New drug · Class 1 | 斯美瑞非片CXHS2300085 | 苏州旺山旺水生物医药股份有限公司; 苏州特瑞药业股份有限公司 |
| 2023/09/23New drug · Class 1 | KC1036片CXHL2301030 | 北京康辰药业股份有限公司 |
| 2023/09/23New drug · Class 1 | KC1036片CXHL2301029 | 北京康辰药业股份有限公司 |
| 2023/09/23New drug · Class 2.1;2.2;2.4 | 盐酸(R)氯胺酮鼻用喷雾剂CXHL2301028 | 江苏恩华药业股份有限公司 |
| 2023/09/22Import · Class 1 | BI 456906 注射液JXHL2300244 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/22Import · Class 1 | BI 456906 注射液JXHL2300243 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/22Import · Class 1 | BI 456906 注射液JXHL2300242 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/22Import · Class 1 | BI 456906 注射液JXHL2300241 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/22Import · Class 1 | BI 456906 注射液JXHL2300240 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
76 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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