药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/11/12 – 2024/11/18
- New acceptances this week
- 373
- Drugs with new generic filings (by drug name, de-duplicated)
- 79
- Accepted this week, now under review
- 9
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
373filings, 114 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 169 |
| Generic | 114 |
| New drug | 60 |
| Import | 13 |
| Unspecified | 9 |
| Import re-registration | 7 |
| 药械组合 | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 271 |
| TCM | 59 |
| 治疗用生物制品 | 29 |
| 预防用生物制品 | 9 |
| Biologic | 4 |
| 体外诊断试剂 | 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
79 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 盐酸氟西汀口服溶液 | 4 | 1 | 1 |
| 2 | 硫酸氨基葡萄糖胶囊 | 3 | 3 | 50 |
| 3 | 钠钾镁钙注射用浓溶液 | 3 | 3 | 2 |
| 4 | 盐酸氨溴索口服溶液 | 3 | 2 | 45 |
| 5 | 布瑞哌唑片 | 3 | 1 | 31 |
| 6 | 普瑞巴林口服溶液 | 3 | 1 | 5 |
| 7 | 妥布霉素滴眼液 | 2 | 2 | 2 |
| 8 | 比索洛尔氨氯地平片 | 2 | 2 | 8 |
| 9 | 注射用硫酸艾沙康唑 | 2 | 2 | 15 |
| 10 | 碳酸氢钠注射液 | 2 | 2 | 11 |
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
244 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 百济神州(苏州)生物科技有限公司 | 7 | 2 | 0 |
| 2 | 武汉生物制品研究所有限责任公司 | 6 | 4 | 0 |
| 3 | Celgene Corporation | 6 | 1 | 0 |
| 4 | 广州诺金制药有限公司 | 5 | 5 | 0 |
| 5 | 锦州福寿堂医药科技有限公司 | 5 | 5 | 0 |
| 6 | 西洲医药科技(浙江)有限公司 | 5 | 4 | 0 |
| 7 | 安徽杰玺医药有限公司 | 4 | 2 | 4 |
| 8 | Bristol-Myers Squibb Australia Pty Ltd | 4 | 1 | 0 |
| 9 | 安徽四环科宝制药有限公司 | 4 | 1 | 4 |
| 10 | 成都迪康药业股份有限公司 | 3 | 3 | 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
117 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/11/18Generic · Class 3 | 西格列汀二甲双胍缓释片CYHS2403955 | 杭州和泽坤元药业有限公司; 浙江四维医药科技有限公司 |
| 2024/11/18Generic · Class 3 | 碳酸氢钠注射液CYHS2403952 | 湖北多瑞药业有限公司 |
| 2024/11/18Generic · Class 3 | 依帕司他片CYHS2403950 | 广东九明制药有限公司 |
| 2024/11/18Generic · Class 3 | 硝苯地平缓释片(Ⅱ)CYHS2403949 | 四川依科制药有限公司 |
| 2024/11/18New drug · Class 2.2 | 恩朗苏拜单抗注射液CXSL2400782 | 石药集团巨石生物制药有限公司 |
| 2024/11/18New drug · Class 2.4 | 注射用KJ101CXSL2400781 | 上海宝济药业股份有限公司 |
| 2024/11/16Import · Class 1 | JNJ-77242113-AAC片JXHL2400267 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/11/16Generic · Class 3 | 右美沙芬安非他酮缓释片CYHL2400228 | 四川科伦药业股份有限公司 |
| 2024/11/16New drug · Class 1 | 注射用SKB445CXSL2400780 | 四川科伦博泰生物医药股份有限公司 |
| 2024/11/16New drug · Class 1 | 自体天然肿瘤浸润淋巴细胞注射液CXSL2400779 | 上海君赛生物科技有限公司 |
| 2024/11/16New drug · Class 1 | 力胜克拉片CXHS2400114 | 苏州亚盛药业有限公司; 江苏宣泰药业有限公司 |
| 2024/11/16New drug · Class 1 | 力胜克拉片CXHS2400113 | 苏州亚盛药业有限公司; 江苏宣泰药业有限公司 |
| 2024/11/16New drug · Class 1 | 力胜克拉片CXHS2400112 | 苏州亚盛药业有限公司; 江苏宣泰药业有限公司 |
| 2024/11/16New drug · Class 1 | BL0175注射液CXHL2401248 | 上海弼领生物技术有限公司 |
| 2024/11/16New drug · Class 2.2;2.4 | KEM2111凝胶贴膏CXHL2401247 | 深圳珐玛易药品科技有限公司 |
| 2024/11/16New drug · Class 2.2;2.4 | KEM2111凝胶贴膏CXHL2401246 | 深圳珐玛易药品科技有限公司 |
| 2024/11/16New drug · Class 2.2;2.4 | KEM2111凝胶贴膏CXHL2401245 | 深圳珐玛易药品科技有限公司 |
| 2024/11/15Generic · Class 3 | 洛索洛芬钠口服溶液CYHS2403938 | 合肥启旸生物医药科技有限公司; 合肥华威药业有限公司 |
| 2024/11/15Generic · Class 3 | 盐酸甲氧氯普胺注射液CYHS2403936 | 重庆天致药业股份有限公司; 河南天致药业有限公司 |
| 2024/11/15Generic · Class 3 | 注射用哌拉西林钠CYHS2403935 | 江苏睿实生物科技有限公司; 四川制药制剂有限公司 |
| 2024/11/15Generic · Class 3 | 注射用哌拉西林钠CYHS2403934 | 江苏睿实生物科技有限公司; 四川制药制剂有限公司 |
| 2024/11/15Generic · Class 3 | 恩格列净二甲双胍缓释片CYHS2403928 | 江苏谦仁生物科技有限公司 |
| 2024/11/15Generic · Class 3 | 琥珀酸亚铁片CYHS2403926 | 江苏万高药业股份有限公司 |
| 2024/11/15Generic · Class 3 | 钠钾镁钙注射用浓溶液CYHS2403923 | 海西新药创制(福州)有限公司; 福安药业集团宁波天衡制药有限公司 |
| 2024/11/15Generic · Class 3 | 普瑞巴林口服溶液CYHS2403917 | 盖天力医药控股集团制药股份有限公司; 江苏欧歌制药有限公司 |
| 2024/11/15Generic · Class 3 | 普瑞巴林口服溶液CYHS2403916 | 盖天力医药控股集团制药股份有限公司; 江苏欧歌制药有限公司 |
| 2024/11/15Generic · Class 3 | 普瑞巴林口服溶液CYHS2403915 | 盖天力医药控股集团制药股份有限公司; 江苏欧歌制药有限公司 |
| 2024/11/15Generic · Class 3 | 格隆溴铵新斯的明注射液CYHL2400227 | 南京正科医药股份有限公司 |
| 2024/11/15New drug · Class 3.3 | 13价肺炎球菌多糖结合疫苗CXSS2400123 | 艾美坚持生物制药有限公司 |
| 2024/11/15New drug · Class 1.2 | SYS6017(带状疱疹mRNA疫苗)CXSL2400778 | 石药集团巨石生物制药有限公司 |
87 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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