药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/02/11 – 2025/02/17
- New acceptances this week
- 239
- Drugs with new generic filings (by drug name, de-duplicated)
- 59
- Accepted this week, now under review
- 18
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
239filings, 81 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 87 |
| Generic | 81 |
| New drug | 42 |
| Import | 19 |
| Unspecified | 6 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 161 |
| 治疗用生物制品 | 48 |
| TCM | 26 |
| Biologic | 2 |
| 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
59 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 磷酸芦可替尼片 | 5 | 3 | 27 |
| 2 | 硝酸甘油注射液 | 4 | 2 | 7 |
| 3 | 注射用硫酸多黏菌素B | 2 | 2 | 7 |
| 4 | 双氯芬酸钠缓释片 | 2 | 1 | 10 |
| 5 | 头孢托仑匹酯颗粒 | 2 | 1 | 18 |
| 6 | 奥卡西平片 | 2 | 1 | 4 |
| 7 | 奥硝唑注射液 | 2 | 1 | 0 |
| 8 | 布瑞哌唑片 | 2 | 1 | 31 |
| 9 | 布美他尼注射液 | 2 | 1 | 16 |
| 10 | 托吡司特片 | 2 | 1 | 0 |
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
162 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 石药集团欧意药业有限公司 | 5 | 4 | 0 |
| 2 | 江西人可医药科技有限公司 | 5 | 3 | 5 |
| 3 | Novo Nordisk A/S | 5 | 1 | 0 |
| 4 | 江苏万高药业股份有限公司 | 4 | 2 | 4 |
| 5 | 西安力邦制药有限公司 | 4 | 1 | 0 |
| 6 | 江西普正制药股份有限公司 | 3 | 2 | 0 |
| 7 | 珠海润都制药股份有限公司 | 3 | 2 | 3 |
| 8 | 默沙东研发（中国）有限公司 | 3 | 2 | 0 |
| 9 | Janssen-Cilag International NV | 3 | 1 | 0 |
| 10 | Novartis Pharma AG | 3 | 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
102 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/02/17Import · Class 1 | RO7446603注射液JXSL2500027 | Genentech Inc.; Roche (China) Holding Ltd. |
| 2025/02/17Generic · Class 3 | 小儿复方氨基酸注射液（19AA-Ⅰ）CYHS2500752 | 湖北长联杜勒制药有限公司 |
| 2025/02/17New drug · Class 3.1 | 泻白颗粒CXZS2500008 | 江苏康缘药业股份有限公司 |
| 2025/02/17New drug · Class 1 | 注射用IBB0979CXSL2500150 | 盛禾（中国）生物制药有限公司 |
| 2025/02/17New drug · Class 3.4 | 冻干马抗眼镜蛇毒F(ab′)2抗体CXSL2500149 | 浙江健博生物科技股份有限公司 |
| 2025/02/15Import · Class 3.1 | 呼吸道合胞病毒疫苗JXSL2500026 | Pfizer Inc.; Pfizer Investment CO Ltd. |
| 2025/02/15Generic · Class 3 | 酒石酸美托洛尔注射液CYHS2500749 | 白云山东泰商丘药业有限公司; 上海现代哈森（商丘）药业有限公司 |
| 2025/02/15Generic · Class 3 | 琥珀酸曲格列汀片CYHS2500748 | 南京万融健诚医药科技有限公司; 江苏万禾制药有限公司 |
| 2025/02/15Generic · Class 3 | 琥珀酸曲格列汀片CYHS2500747 | 南京万融健诚医药科技有限公司; 江苏万禾制药有限公司 |
| 2025/02/15New drug · Class 1 | 注射用MK-3120CXSL2500148 | 默沙东研发（中国）有限公司 |
| 2025/02/15New drug · Class 1 | 人脐带间充质干细胞注射液CXSL2500147 | 武汉汉密顿生物科技股份有限公司 |
| 2025/02/15New drug · Class 1 | 人脐带间充质干细胞注射液CXSL2500146 | 武汉汉密顿生物科技股份有限公司 |
| 2025/02/15New drug · Class 1 | 艾玛昔替尼软膏CXHS2500018 | 江苏恒瑞医药股份有限公司 |
| 2025/02/14Generic · Class 3 | 盐酸半胱氨酸注射液CYHS2500743 | 北京柏雅联合药物研究所有限公司; 广东星昊药业有限公司 |
| 2025/02/14Generic · Class 3 | 盐酸曲唑酮片CYHS2500738 | 江苏万高药业股份有限公司 |
| 2025/02/14Generic · Class 3 | 盐酸曲唑酮片CYHS2500737 | 江苏万高药业股份有限公司 |
| 2025/02/14Generic · Class 3 | 米诺地尔泡沫剂（男用）CYHL2500041 | 山东京卫制药有限公司 |
| 2025/02/14New drug · Class 1 | 注射用AS1501CXSL2500145 | 深圳市中科艾深医药有限公司 |
| 2025/02/14New drug · Class 2.2;2.4 | 枸地氯雷他定口服溶液CXHS2500017 | 合肥恩瑞特药业有限公司 |
| 2025/02/13Import · Class 3.1 | 西妥昔单抗注射液JXSS2500012 | Merck Europe B.V.; Merck Healthcare KGaA; Merck Serono Co. Ltd. |
| 2025/02/13Import · Class 2.2 | 艾加莫德α注射液（皮下注射）JXSL2500025 | argenx BV; Zai Lab (Shanghai) Co. Ltd. |
| 2025/02/13Generic · Class 3 | 注射用乳糖酸红霉素CYHS2500734 | 海韬新药研发（江苏）有限公司; 津药和平（天津）制药有限公司 |
| 2025/02/13Generic · Class 3 | 琥珀酸亚铁片CYHS2500733 | 江西泰吉立生物医药科技有限公司; 浙江赛默制药有限公司 |
| 2025/02/13Generic · Class 3 | 盐酸多巴胺注射液CYHS2500732 | 成都恒瑞制药有限公司; 四川美大康佳乐药业有限公司 |
| 2025/02/13Generic · Class 3 | 盐酸多巴胺注射液CYHS2500731 | 成都恒瑞制药有限公司; 四川美大康佳乐药业有限公司 |
| 2025/02/13Generic · Class 3 | 二羟丙茶碱注射液CYHS2500730 | 成都华宇制药有限公司 |
| 2025/02/13Generic · Class 3 | 盐酸奥普力农注射液CYHS2500729 | 山东健滨医药科技有限公司; 西安汉丰药业有限责任公司 |
| 2025/02/13Generic · Class 3 | 复合磷酸氢钾注射液CYHS2500728 | 成都诺和晟鸿生物制药有限公司; 广东星昊药业有限公司 |
| 2025/02/13Generic · Class 3 | 复方聚乙二醇电解质散（儿童型）CYHS2500725 | 山东益康药业股份有限公司 |
| 2025/02/13Generic · Class 3 | 注射用硫酸多黏菌素BCYHS2500724 | 江苏迪赛诺制药有限公司 |
72 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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