药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/08/05 – 2025/08/11
- New acceptances this week
- 377
- Drugs with new generic filings (by drug name, de-duplicated)
- 75
- Accepted this week, now under review
- 107
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
377filings, 107 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 159 |
| Generic | 107 |
| New drug | 77 |
| Import | 16 |
| Import re-registration | 15 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 234 |
| TCM | 78 |
| 治疗用生物制品 | 63 |
| 预防用生物制品 | 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 | 沙库巴曲缬沙坦钠片 | 4 | 2 | 72 |
| 2 | 替尔泊肽注射液 | 4 | 1 | 26 |
| 3 | 乙酰半胱氨酸注射液 | 3 | 3 | 53 |
| 4 | 非奈利酮片 | 3 | 2 | 71 |
| 5 | 中性低钙腹膜透析液(碳酸氢盐-G1.5%) | 3 | 1 | 7 |
| 6 | 左乙拉西坦片 | 3 | 1 | 6 |
| 7 | 乳果糖口服溶液 | 2 | 1 | 40 |
| 8 | 他克莫司软膏 | 2 | 1 | 8 |
| 9 | 吡拉西坦注射液 | 2 | 1 | 9 |
| 10 | 吸入用盐酸丙卡特罗溶液 | 2 | 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
210 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 沈药合泽药业(山东)有限公司 | 15 | 6 | 0 |
| 2 | 江苏恒瑞医药股份有限公司 | 10 | 6 | 0 |
| 3 | 山西华康药业股份有限公司 | 9 | 8 | 0 |
| 4 | 苏州盛迪亚生物医药有限公司 | 9 | 8 | 0 |
| 5 | 湖南科伦制药有限公司 | 7 | 5 | 6 |
| 6 | Bayer Inc. | 6 | 1 | 0 |
| 7 | 贵州浩诚药业有限公司 | 5 | 5 | 0 |
| 8 | 贵州益佰制药股份有限公司 | 5 | 5 | 0 |
| 9 | 华润紫竹药业有限公司 | 5 | 4 | 2 |
| 10 | 山西正来制药有限公司 | 5 | 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
126 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/08/11Import · Class 1 | Icotrokinra片JXHL2500213 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2025/08/11Import · Class 2.4;2.2 | 马立巴韦干混悬剂JXHL2500212 | Takeda Pharmaceuticals U.S.A. Inc; Takeda(China) International Company Ltd. |
| 2025/08/11Import · Class 2.4;2.2 | 马立巴韦干混悬剂JXHL2500211 | Takeda Pharmaceuticals U.S.A. Inc.; Takeda(China) International Company Ltd. |
| 2025/08/11New drug · Class 2.4 | 海曲泊帕乙醇胺片CXHS2500094 | 江苏恒瑞医药股份有限公司 |
| 2025/08/11New drug · Class 2.4 | 海曲泊帕乙醇胺片CXHS2500093 | 江苏恒瑞医药股份有限公司 |
| 2025/08/11New drug · Class 2.4 | 海曲泊帕乙醇胺片CXHS2500092 | 江苏恒瑞医药股份有限公司 |
| 2025/08/09Generic · Class 3 | 格隆溴铵注射液CYHS2502894 | 河南普瑞药业有限公司 |
| 2025/08/09Generic · Class 3 | 格隆溴铵注射液CYHS2502893 | 河南普瑞药业有限公司 |
| 2025/08/09Generic · Class 3 | 艾拉戈克钠片CYHS2502892 | 南京正大天晴制药有限公司 |
| 2025/08/09Generic · Class 3 | 艾拉戈克钠片CYHS2502891 | 南京正大天晴制药有限公司 |
| 2025/08/09Generic · Class 3 | 盐酸纳洛酮注射液CYHS2502890 | 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 |
| 2025/08/09Generic · Class 3 | 注射用多黏菌素E甲磺酸钠CYHL2500139 | 南京正科医药股份有限公司 |
| 2025/08/09Generic · Class 3 | 普瑞巴林缓释片CYHL2500138 | 宜昌人福药业有限责任公司 |
| 2025/08/09Generic · Class 3 | 普瑞巴林缓释片CYHL2500137 | 宜昌人福药业有限责任公司 |
| 2025/08/09New drug · Class 3.3 | 西妥昔单抗注射液CXSS2500081 | 广东安普泽生物医药股份有限公司; 澳斯康生物(南通)股份有限公司 |
| 2025/08/09New drug · Class 2.2 | 特瑞普利单抗注射液CXSS2500080 | 上海君实生物医药科技股份有限公司; 上海君实生物工程有限公司; 苏州众合生物医药科技有限公司 |
| 2025/08/09New drug · Class 2.2 | 特瑞普利单抗注射液CXSS2500079 | 上海君实生物医药科技股份有限公司; 上海君实生物工程有限公司; 苏州众合生物医药科技有限公司 |
| 2025/08/09New drug · Class 1 | 注射用SHR-1826CXSL2500689 | 苏州盛迪亚生物医药有限公司 |
| 2025/08/09New drug · Class 1 | 注射用SHR-A2009CXSL2500688 | 苏州盛迪亚生物医药有限公司 |
| 2025/08/09New drug · Class 1 | 注射用FH-006CXSL2500687 | 上海甫弘生物医药有限公司; 江苏恒瑞医药股份有限公司 |
| 2025/08/09New drug · Class 1 | SHR-4610注射液CXSL2500686 | 上海盛迪医药有限公司 |
| 2025/08/09New drug · Class 1 | 注射用SHR-9839 (sc)CXSL2500685 | 苏州盛迪亚生物医药有限公司; 上海恒瑞医药有限公司 |
| 2025/08/09New drug · Class 2.2 | 注射用瑞康曲妥珠单抗CXSL2500684 | 苏州盛迪亚生物医药有限公司 |
| 2025/08/09New drug · Class 1 | 注射用SHR-A2102CXSL2500683 | 苏州盛迪亚生物医药有限公司; 上海恒瑞医药有限公司 |
| 2025/08/09New drug · Class 1 | 注射用SHR-A2102CXSL2500682 | 苏州盛迪亚生物医药有限公司; 上海恒瑞医药有限公司 |
| 2025/08/09New drug · Class 2.2 | 阿得贝利单抗注射液CXSL2500681 | 上海盛迪医药有限公司 |
| 2025/08/09New drug · Class 1 | 注射用BL-M24D1CXSL2500680 | 成都百利多特生物药业有限责任公司; 四川百利药业有限责任公司 |
| 2025/08/09New drug · Class 1 | QX029N注射液CXSL2500679 | 江苏荃信生物医药股份有限公司; 杭州中美华东制药有限公司 |
| 2025/08/09New drug · Class 1 | HRS-7058片CXHL2500832 | 山东盛迪医药有限公司 |
| 2025/08/09New drug · Class 1 | HRS-7058片CXHL2500831 | 山东盛迪医药有限公司 |
96 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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