药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/03/04 – 2025/03/10
- New acceptances this week
- 356
- Drugs with new generic filings (by drug name, de-duplicated)
- 72
- 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
356filings, 96 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 165 |
| Generic | 96 |
| New drug | 56 |
| Import | 19 |
| Import re-registration | 13 |
| Unspecified | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 270 |
| 治疗用生物制品 | 42 |
| TCM | 37 |
| 预防用生物制品 | 7 |
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
72 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 | 5 | 2 | 72 |
| 2 | 聚多卡醇注射液 | 5 | 2 | 21 |
| 3 | 布瑞哌唑片 | 3 | 1 | 31 |
| 4 | 比索洛尔氨氯地平片 | 2 | 2 | 8 |
| 5 | 洛索洛芬钠凝胶贴膏 | 2 | 2 | 8 |
| 6 | 洛索洛芬钠口服溶液 | 2 | 2 | 6 |
| 7 | 硫酸氨基葡萄糖胶囊 | 2 | 2 | 50 |
| 8 | 乙酰半胱氨酸颗粒 | 2 | 1 | 4 |
| 9 | 左乙拉西坦片 | 2 | 1 | 6 |
| 10 | 巴瑞替尼片 | 2 | 1 | 32 |
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
212 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 黑龙江深行生物医药科技有限公司 | 17 | 17 | 0 |
| 2 | Bayer AG | 14 | 4 | 0 |
| 3 | 上海民为生物技术有限公司 | 8 | 1 | 0 |
| 4 | Merck Sharp & Dohme B.V. | 7 | 5 | 0 |
| 5 | 吉林菲诺制药有限公司 | 5 | 5 | 0 |
| 6 | Pfizer Inc. | 5 | 3 | 0 |
| 7 | Novo Nordisk A/S | 5 | 1 | 0 |
| 8 | 南京三迭纪医药科技有限公司 | 5 | 1 | 0 |
| 9 | 广东众生睿创生物科技有限公司 | 5 | 1 | 0 |
| 10 | 四川普锐特药业有限公司 | 4 | 2 | 1 |
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
101 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/03/10Import · Class 2.4 | 钇[90Y]微球注射液JXHL2500037 | Sirtex Medical Pty Ltd |
| 2025/03/10Generic · Class 3 | 硫糖铝口服混悬液CYHS2500989 | 安徽瑞旗药业有限公司; 安徽永生堂药业有限责任公司 |
| 2025/03/10Generic · Class 3 | 氨茶碱片CYHS2500988 | 哈尔滨三联药业股份有限公司; 兰西哈三联制药有限公司 |
| 2025/03/10Generic · Class 3 | 奥泽沙星洗剂CYHL2500058 | 杭州中美华东制药有限公司 |
| 2025/03/10New drug · Class 1 | XH001注射液CXSL2500215 | 北京新合睿恩生物医疗科技有限公司 |
| 2025/03/09New drug · Class 1 | JMT106注射液CXSL2500214 | 上海津曼特生物科技有限公司 |
| 2025/03/08Import · Class 1 | BMS-986365胶囊JXHL2500036 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/03/08Generic · Class 3 | 盐酸丁螺环酮片CYHS2500983 | 河北龙海药业股份有限公司 |
| 2025/03/08Generic · Class 3 | 盐酸多沙普仑注射液CYHS2500976 | 成都瑞尔医药科技有限公司; 成都市海通药业有限公司 |
| 2025/03/08Generic · Class 3 | 盐酸普罗帕酮注射液CYHS2500968 | 南阳普康恒旺药业有限公司; 南阳普康药业有限公司 |
| 2025/03/08Generic · Class 3 | 盐酸异丙肾上腺素注射液CYHS2500967 | 绪必迪药业（沧州）有限公司; 河北凯威制药有限责任公司 |
| 2025/03/08Generic · Class 3 | 维生素K滴剂CYHS2500965 | 四川海梦智森生物制药有限公司; 天津市中央药业有限公司 |
| 2025/03/08Generic · Class 3 | 盐酸多巴酚丁胺注射液CYHS2500964 | 武汉市金恒泰药业有限公司; 河南普瑞药业有限公司 |
| 2025/03/08New drug · Class 1.3 | 重组带状疱疹疫苗（CHO细胞）CXSL2500213 | 长春百克生物科技股份公司 |
| 2025/03/08New drug · Class 1 | 注射用JS203CXSL2500212 | 上海君实生物医药科技股份有限公司 |
| 2025/03/08New drug · Class 1 | DZD8586片CXHL2500261 | 迪哲（江苏）医药股份有限公司 |
| 2025/03/08New drug · Class 1 | HRS9531注射液CXHL2500260 | 福建盛迪医药有限公司 |
| 2025/03/08New drug · Class 1 | HRS9531注射液CXHL2500259 | 福建盛迪医药有限公司 |
| 2025/03/08New drug · Class 2.1 | KEM2403注射液CXHL2500258 | 深圳珐玛易药品科技有限公司 |
| 2025/03/07Generic · Class 3 | 盐酸美金刚口崩片CYHS2500954 | 合肥恩瑞特药业有限公司 |
| 2025/03/07Generic · Class 3 | 盐酸美金刚口崩片CYHS2500953 | 合肥恩瑞特药业有限公司 |
| 2025/03/07Generic · Class 3 | 溴吡斯的明片CYHS2500951 | 吉林省博大伟业制药有限公司 |
| 2025/03/07New drug · Class 1 | SH006注射液CXSL2500211 | 南京圣和药业股份有限公司 |
| 2025/03/07New drug · Class 1 | BPR-102胶囊CXSL2500210 | 成都倍特益康恩生物医药科技有限公司 |
| 2025/03/07New drug · Class 1 | BPR-102胶囊CXSL2500209 | 成都倍特益康恩生物医药科技有限公司 |
| 2025/03/07New drug · Class 1.2 | LVRNA015CXSL2500208 | 珠海丽凡达生物技术有限公司 |
| 2025/03/07New drug · Class 1 | SHR-4712注射液CXSL2500207 | 广东恒瑞医药有限公司; 上海盛迪医药有限公司 |
| 2025/03/07New drug · Class 1 | SHR-4712注射液CXSL2500206 | 广东恒瑞医药有限公司; 上海盛迪医药有限公司 |
| 2025/03/07New drug · Class 1 | 注射用CS2009CXSL2500205 | 申石生物医药（上海）有限公司; 基石药业（苏州）有限公司 |
| 2025/03/07New drug · Class 1 | PRT-064040鼻喷雾剂CXHL2500257 | 四川普锐特药业有限公司 |
71 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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