药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/09/16 – 2025/09/22
- New acceptances this week
- 352
- Drugs with new generic filings (by drug name, de-duplicated)
- 69
- Accepted this week, now under review
- 111
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
352filings, 92 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 176 |
| Generic | 92 |
| New drug | 47 |
| Import | 28 |
| Import re-registration | 7 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 182 |
| TCM | 81 |
| 治疗用生物制品 | 80 |
| 预防用生物制品 | 7 |
| 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
69 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 洛索洛芬钠贴剂 | 4 | 2 | 30 |
| 2 | 哌柏西利胶囊 | 3 | 1 | 0 |
| 3 | 注射用泼尼松龙琥珀酸钠 | 3 | 1 | 3 |
| 4 | 盐酸丁螺环酮片 | 3 | 1 | 7 |
| 5 | 利多卡因丁卡因乳膏 | 2 | 2 | 2 |
| 6 | 硫酸氨基葡萄糖胶囊 | 2 | 2 | 50 |
| 7 | 孟鲁司特钠咀嚼片 | 2 | 1 | 4 |
| 8 | 左卡尼汀口服溶液 | 2 | 1 | 9 |
| 9 | 布瑞哌唑口崩片 | 2 | 1 | 10 |
| 10 | 布瑞哌唑片 | 2 | 1 | 31 |
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
218 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 北京四环生物制药有限公司 | 10 | 1 | 0 |
| 2 | AstraZeneca AB | 8 | 5 | 0 |
| 3 | 吉林菲诺制药有限公司 | 7 | 7 | 0 |
| 4 | 甘肃扶正药业科技股份有限公司 | 7 | 6 | 0 |
| 5 | 安徽安科生物工程(集团)股份有限公司 | 7 | 2 | 0 |
| 6 | 沈阳三生制药有限责任公司 | 6 | 2 | 0 |
| 7 | Novartis Pharma AG | 5 | 2 | 0 |
| 8 | 上海联合赛尔生物工程有限公司 | 5 | 2 | 0 |
| 9 | 山东盛迪医药有限公司 | 5 | 2 | 0 |
| 10 | 浙江赛默制药有限公司 | 5 | 2 | 5 |
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
99 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/09/22Import · Class 2.4 | 甲磺酸奥希替尼片JXHS2500108 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2025/09/22Import · Class 2.4 | 甲磺酸奥希替尼片JXHS2500107 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2025/09/22Import · Class 1 | LY3537021注射液JXHL2500295 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd |
| 2025/09/22New drug · Class 3.3 | QL2110注射液CXSL2500812 | 齐鲁制药有限公司 |
| 2025/09/22New drug · Class 3.3 | QL2110注射液CXSL2500811 | 齐鲁制药有限公司 |
| 2025/09/22New drug · Class 1 | 富马酸仑博替尼胶囊CXHS2500120 | 四川科伦博泰生物医药股份有限公司; 湖南科伦制药有限公司 |
| 2025/09/22New drug · Class 1 | 富马酸仑博替尼胶囊CXHS2500119 | 四川科伦博泰生物医药股份有限公司; 湖南科伦制药有限公司 |
| 2025/09/22New drug · Class 1 | 注射用GMDTCCXHL2501019 | 广州健尔圣医药科技有限公司 |
| 2025/09/20Generic · Class 3 | 米诺地尔搽剂CYHS2503477 | 海南钧华医疗科技有限公司; 北京京丰制药(河北)有限公司 |
| 2025/09/20Generic · Class 3 | 注射用泼尼松龙琥珀酸钠CYHL2500173 | 南京恩泰医药科技有限公司 |
| 2025/09/20Generic · Class 3 | 注射用泼尼松龙琥珀酸钠CYHL2500172 | 南京恩泰医药科技有限公司 |
| 2025/09/20Generic · Class 3 | 注射用泼尼松龙琥珀酸钠CYHL2500171 | 南京恩泰医药科技有限公司 |
| 2025/09/20New drug · Class 1.1 | 柴芍解郁颗粒CXZL2500084 | 黑龙江省济仁药业有限公司 |
| 2025/09/20New drug · Class 1 | 靶向CD19基因修饰的异体嵌合抗原受体T细胞注射液CXSL2500810 | 上海邦耀生物科技有限公司 |
| 2025/09/20New drug · Class 3.3 | 重组人促卵泡激素注射液CXSL2500809 | 成都景泽生物制药有限公司 |
| 2025/09/20New drug · Class 3.3 | 重组人促卵泡激素注射液CXSL2500808 | 成都景泽生物制药有限公司 |
| 2025/09/20New drug · Class 2.2 | WGP03CXSL2500807 | 深圳市卫光生物制品股份有限公司; 深圳瑞健生命科学研究院有限公司 |
| 2025/09/19Import · Class 1 | 注射用AZD0292JXSL2500182 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd |
| 2025/09/19Generic · Class 3 | 地氯雷他定口服溶液CYHS2503469 | 广州聚力医药开发有限公司; 广东众生药业股份有限公司 |
| 2025/09/19Generic · Class 3 | 注射用盐酸多西环素CYHS2503467 | 湖北美林药业有限公司 |
| 2025/09/19Generic · Class 3 | 利多卡因丁卡因乳膏CYHS2503466 | 江苏盈科生物制药有限公司 |
| 2025/09/19Generic · Class 3 | 维生素K1注射液CYHS2503464 | 江苏九旭药业有限公司 |
| 2025/09/19New drug · Class 1.1 | 参苏止咳颗粒CXZL2500083 | 玉森(江西)新药研发有限公司 |
| 2025/09/19New drug · Class 3.3 | 阿柏西普眼内注射溶液CXSS2500098 | 迈威(上海)生物科技股份有限公司; 江苏泰康生物医药有限公司 |
| 2025/09/19New drug · Class 1 | 泰卡西单抗注射液CXSS2500097 | 深圳信立泰药业股份有限公司; 信立泰(苏州)药业有限公司 |
| 2025/09/19New drug · Class 1 | 泰卡西单抗注射液CXSS2500096 | 深圳信立泰药业股份有限公司; 信立泰(苏州)药业有限公司 |
| 2025/09/19New drug · Class 1 | 注射用SSGJ-709CXSL2500806 | 沈阳三生制药有限责任公司 |
| 2025/09/19New drug · Class 1.2 | 冻干带状疱疹病毒mRNA疫苗CXSL2500805 | 北京沃森创新生物技术有限公司; 云南疫苗实验室有限公司; 复旦大学; 上海蓝鹊生物医药有限公司; 玉溪沃森生物技术有限公司 |
| 2025/09/19New drug · Class 1.2 | 冻干带状疱疹病毒mRNA疫苗CXSL2500804 | 北京沃森创新生物技术有限公司; 云南疫苗实验室有限公司; 复旦大学; 上海蓝鹊生物医药有限公司; 玉溪沃森生物技术有限公司 |
| 2025/09/19New drug · Class 2.2 | 注射用苏维西塔单抗CXSL2500803 | 江苏先声生物制药有限公司 |
69 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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