药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/11/05 – 2024/11/11
- New acceptances this week
- 376
- Drugs with new generic filings (by drug name, de-duplicated)
- 82
- 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
376filings, 113 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 161 |
| Generic | 113 |
| New drug | 67 |
| Import | 18 |
| Import re-registration | 14 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 296 |
| TCM | 38 |
| 治疗用生物制品 | 34 |
| 预防用生物制品 | 6 |
| 体外诊断试剂 | 1 |
| Biologic | 1 |
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
82 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 富马酸伏诺拉生片 | 4 | 2 | 58 |
| 2 | 氨溴特罗口服溶液 | 4 | 2 | 23 |
| 3 | 尼麦角林片 | 3 | 2 | 1 |
| 4 | 甲氨蝶呤注射液 | 3 | 2 | 12 |
| 5 | 瑞格列奈片 | 3 | 1 | 8 |
| 6 | 克立硼罗软膏 | 2 | 2 | 28 |
| 7 | 地屈孕酮片 | 2 | 2 | 9 |
| 8 | 复方硫酸钠片 | 2 | 2 | 2 |
| 9 | 艾拉莫德片 | 2 | 2 | 24 |
| 10 | 吡拉西坦注射液 | 2 | 1 | 9 |
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
213 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 广东星昊药业有限公司 | 17 | 10 | 0 |
| 2 | 锦州福寿堂医药科技有限公司 | 9 | 8 | 0 |
| 3 | 齐鲁制药有限公司 | 7 | 4 | 2 |
| 4 | 以岭万洲国际制药有限公司 | 6 | 6 | 0 |
| 5 | 百济神州(苏州)生物科技有限公司 | 6 | 3 | 0 |
| 6 | GE Healthcare AS | 6 | 1 | 0 |
| 7 | Teva Neuroscience Inc. | 6 | 1 | 0 |
| 8 | 福建盛迪医药有限公司 | 6 | 1 | 0 |
| 9 | SANOFI WINTHROP INDUSTRIE | 5 | 3 | 0 |
| 10 | 江苏豪森药业集团有限公司 | 5 | 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
125 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/11/11Import · Class 2.2 | 注射用德曲妥珠单抗JXSL2400217 | Daiichi Sankyo Inc.; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD. |
| 2024/11/11Generic · Class 3 | 盐酸普萘洛尔注射液CYHS2403854 | 江西人可医药科技有限公司; 津药和平(天津)制药有限公司 |
| 2024/11/11Generic · Class 3 | 盐酸普萘洛尔注射液CYHS2403853 | 江西人可医药科技有限公司; 津药和平(天津)制药有限公司 |
| 2024/11/11Generic · Class 3 | 己酮可可碱注射液CYHS2403851 | 上海现代哈森(商丘)药业有限公司 |
| 2024/11/11Generic · Class 3 | 尼麦角林片CYHS2403846 | 浙江恒研医药科技有限公司; 浙江赛默制药有限公司 |
| 2024/11/11Generic · Class 3 | 尼麦角林片CYHS2403845 | 浙江恒研医药科技有限公司; 浙江赛默制药有限公司 |
| 2024/11/11Generic · Class 3 | 门冬氨酸钾注射液CYHS2403844 | 山东齐都药业有限公司 |
| 2024/11/11Generic · Class 3 | 复方硫酸钠片CYHL2400216 | 山东诚创蓝海医药科技有限公司 |
| 2024/11/11Generic · Class 3 | 复方硫酸钠片CYHL2400215 | 保定天浩制药有限公司 |
| 2024/11/11New drug · Class 1 | TAEST16001注射液CXSL2400766 | 香雪生命科学技术(广东)有限公司 |
| 2024/11/11New drug · Class 1 | GenSci120注射液CXSL2400765 | 长春金赛药业有限责任公司 |
| 2024/11/11New drug · Class 1 | GenSci120注射液CXSL2400764 | 长春金赛药业有限责任公司 |
| 2024/11/11New drug · Class 1 | GenSci120注射液CXSL2400763 | 长春金赛药业有限责任公司 |
| 2024/11/11New drug · Class 1.4 | 二价肠道病毒灭活疫苗(Vero细胞)CXSL2400762 | 北京民海生物科技有限公司 |
| 2024/11/11New drug · Class 1.4 | 四价肠道病毒灭活疫苗(Vero细胞)CXSL2400761 | 北京民海生物科技有限公司 |
| 2024/11/09Generic · Class 3 | 复方聚乙二醇电解质散(Ⅱ)CYHS2403839 | 福州基石医药科技有限公司 |
| 2024/11/09Generic · Class 3 | 氯化钾颗粒CYHS2403838 | 湖南千金湘江药业股份有限公司 |
| 2024/11/09Generic · Class 3 | 氯化钾颗粒CYHS2403837 | 湖南千金湘江药业股份有限公司 |
| 2024/11/09Generic · Class 3 | 盐酸甲氧氯普胺注射液CYHS2403836 | 长春海悦药业股份有限公司 |
| 2024/11/09Generic · Class 3 | 氢溴酸依他佐辛注射液CYHS2403831 | 成都倍特药业股份有限公司 |
| 2024/11/09Generic · Class 3 | 尼麦角林片CYHS2403829 | 华润双鹤利民药业(济南)有限公司 |
| 2024/11/09New drug · Class 1 | 注射用AMT-754CXSL2400760 | 普众发现医药科技(上海)有限公司 |
| 2024/11/09New drug · Class 1 | J-51注射液CXSL2400759 | 劲威生物医药科技有限公司 |
| 2024/11/09New drug · Class 1 | SAR444656CXHL2401212 | 赛诺菲(中国)投资有限公司 |
| 2024/11/09New drug · Class 1 | SAR444656CXHL2401211 | 赛诺菲(中国)投资有限公司 |
| 2024/11/09New drug · Class 1 | NSP-1047A片CXHL2401210 | 诺沃斯达药业(上海)有限公司 |
| 2024/11/09New drug · Class 1 | NSP-1047A片CXHL2401209 | 诺沃斯达药业(上海)有限公司 |
| 2024/11/09New drug · Class 1 | GH56胶囊CXHL2401208 | 勤浩医药(苏州)有限公司 |
| 2024/11/09New drug · Class 1 | GH56胶囊CXHL2401207 | 勤浩医药(苏州)有限公司 |
| 2024/11/09New drug · Class 1 | GH56胶囊CXHL2401206 | 勤浩医药(苏州)有限公司 |
95 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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