药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/11/18 – 2025/11/24
- New acceptances this week
- 321
- Drugs with new generic filings (by drug name, de-duplicated)
- 62
- Accepted this week, now under review
- 88
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
321filings, 82 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 141 |
| Generic | 82 |
| New drug | 61 |
| Unspecified | 14 |
| Import re-registration | 12 |
| Import | 11 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 173 |
| TCM | 85 |
| 治疗用生物制品 | 48 |
| Biologic | 10 |
| 预防用生物制品 | 5 |
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
62 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 二甲磺酸利右苯丙胺胶囊 | 4 | 1 | 4 |
| 2 | 聚乙烯醇滴眼液 | 3 | 3 | 21 |
| 3 | 沙库巴曲缬沙坦钠片 | 3 | 2 | 72 |
| 4 | 氧(液态) | 2 | 2 | 14 |
| 5 | 非那雄胺喷雾剂 | 2 | 2 | 3 |
| 6 | 二甲硅油乳剂 | 2 | 1 | 14 |
| 7 | 叶酸片 | 2 | 1 | 12 |
| 8 | 呋塞米口服溶液 | 2 | 1 | 8 |
| 9 | 布洛芬颗粒 | 2 | 1 | 3 |
| 10 | 托伐普坦口崩片 | 2 | 1 | 5 |
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 | 青海久美藏医药科技有限公司 | 8 | 8 | 0 |
| 2 | 齐鲁制药有限公司 | 7 | 6 | 1 |
| 3 | 北京同仁堂股份有限公司同仁堂制药厂 | 5 | 3 | 0 |
| 4 | 广东众生睿创生物科技有限公司 | 5 | 1 | 0 |
| 5 | 四川蜀中药业有限公司 | 4 | 3 | 0 |
| 6 | 四川依科制药有限公司 | 4 | 2 | 4 |
| 7 | 正大天晴药业集团股份有限公司 | 4 | 2 | 0 |
| 8 | Terumo Corporation Kofu Factory | 4 | 1 | 0 |
| 9 | 宜昌人福药业有限责任公司 | 4 | 1 | 4 |
| 10 | 杭州景曜生物科技有限责任公司 | 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
103 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/11/24Import · Class 1 | 注射用IPN10200JXSL2500225 | Ipsen Innovation; Ipsen (Shanghai) Innovation Pharmaceutical Co. Ltd |
| 2025/11/24Generic · Class 3 | 中性腹膜透析液(碳酸氢盐-G2.5%)CYHS2504045 | 石家庄四药有限公司 |
| 2025/11/24Generic · Class 3 | 叶酸片CYHS2504044 | 北京福元医药股份有限公司 |
| 2025/11/24Generic · Class 3 | 叶酸片CYHS2504043 | 北京福元医药股份有限公司 |
| 2025/11/24New drug · Class 1 | EP-0210单抗注射液CXSL2501001 | 成都优洛生物科技有限公司 |
| 2025/11/24New drug · Class 1 | R01注射液CXSL2501000 | 杭州纽安津生物科技有限公司 |
| 2025/11/22Import · Class 1 | Itepekimab注射液JXSL2500224 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2025/11/22Import · Class 1 | Omecamtiv Mecarbil缓释片JXHL2500362 | Cytokinetics Incorporated; PPD Pharmaceutical Development (Beijing) Co. Ltd |
| 2025/11/22Import · Class 1 | Omecamtiv Mecarbil缓释片JXHL2500361 | Cytokinetics Incorporated; PPD Pharmaceutical Development (Beijing) Co. Ltd |
| 2025/11/22Import · Class 1 | Omecamtiv Mecarbil缓释片JXHL2500360 | Cytokinetics, Incorporated; PPD Pharmaceutical Development (Beijing) Co. Ltd |
| 2025/11/22Generic · Class 3 | 右酮洛芬氨丁三醇注射液CYHS2504037 | 山东达冠医药科技有限公司; 山东辉成药业有限公司 |
| 2025/11/22Generic · Class 3 | 地氯雷他定口服溶液CYHS2504035 | 广东南国药业有限公司 |
| 2025/11/22New drug · Class 3.4 | 注射用重组人凝血因子ⅧCXSS2500125 | 远大蜀阳生命科学(成都)有限公司; 南京蓬勃生物科技有限公司 |
| 2025/11/22New drug · Class 1 | 注射用LM-24C5CXSL2500999 | 礼新医药科技(上海)有限公司 |
| 2025/11/22New drug · Class 3.2 | 流感病毒裂解疫苗(高剂量)CXSL2500998 | 成大生物(本溪)有限公司; 辽宁成大生物股份有限公司 |
| 2025/11/22New drug · Class 2.4 | 硫酸艾玛昔替尼片CXHS2500141 | 江苏恒瑞医药股份有限公司 |
| 2025/11/22New drug · Class 1 | HYP-6589片CXHL2501289 | 四川汇宇海玥医药科技有限公司 |
| 2025/11/22New drug · Class 1 | HYP-6589片CXHL2501288 | 四川汇宇海玥医药科技有限公司 |
| 2025/11/21Generic · Class 3 | 注射用氨磷汀CYHS2504020 | 大连美罗中药厂有限公司; 美罗药业股份有限公司 |
| 2025/11/21New drug · Class 2.3 | 湿润烧伤膏CXZL2500117 | 汕头市美宝制药有限公司 |
| 2025/11/21New drug · Class 1 | 注射用BL-B01D1CXSS2500124 | 成都百利多特生物药业有限责任公司 |
| 2025/11/21New drug · Class 1 | 注射用SKB518CXSL2500997 | 四川科伦博泰生物医药股份有限公司 |
| 2025/11/21New drug · Class 1 | 注射用HLX43CXSL2500996 | 上海复宏汉霖生物技术股份有限公司; 上海复宏汉霖生物医药有限公司 |
| 2025/11/21New drug · Class 1 | 重组抗EGFR人源化单克隆抗体注射液CXSL2500995 | 上海复宏瑞霖生物技术有限公司; 上海复宏汉霖生物医药有限公司 |
| 2025/11/21New drug · Class 1 | 注射用JSKN003CXSL2500994 | 江苏康宁杰瑞生物制药有限公司 |
| 2025/11/21New drug · Class 1 | QLP2117注射液CXSL2500993 | 齐鲁制药有限公司 |
| 2025/11/21New drug · Class 2.2 | QL2107注射液CXSL2500992 | 齐鲁制药有限公司 |
| 2025/11/21New drug · Class 3.3 | 水痘减毒活疫苗CXSL2500991 | 云南沃森生物技术股份有限公司; 云南疫苗实验室有限公司; 北京沃森创新生物技术有限公司; 玉溪沃森生物技术有限公司 |
| 2025/11/21New drug · Class 2.2 | 氢溴酸伏硫西汀口崩片CXHS2500138 | 深圳市泛谷药业股份有限公司; 华益泰康药业股份有限公司 |
| 2025/11/21New drug · Class 2.2 | 氢溴酸伏硫西汀口崩片CXHS2500137 | 深圳市泛谷药业股份有限公司; 华益泰康药业股份有限公司 |
73 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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