药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/01/21 – 2025/01/27
- New acceptances this week
- 558
- Drugs with new generic filings (by drug name, de-duplicated)
- 137
- Accepted this week, now under review
- 30
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
558filings, 195 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 216 |
| Generic | 195 |
| New drug | 116 |
| Import | 19 |
| Unspecified | 6 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 392 |
| 治疗用生物制品 | 82 |
| TCM | 73 |
| 预防用生物制品 | 8 |
| Biologic | 3 |
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
137 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 富马酸伏诺拉生片 | 6 | 3 | 58 |
| 2 | 美阿沙坦钾片 | 6 | 3 | 33 |
| 3 | 磷酸芦可替尼片 | 5 | 3 | 27 |
| 4 | 左氧氟沙星注射液 | 4 | 2 | 1 |
| 5 | 甲苯磺酸艾多沙班片 | 4 | 2 | 9 |
| 6 | 米库氯铵注射液 | 4 | 2 | 3 |
| 7 | 非奈利酮片 | 3 | 2 | 71 |
| 8 | 利奥西呱片 | 3 | 1 | 4 |
| 9 | 布瑞哌唑口崩片 | 3 | 1 | 10 |
| 10 | 布瑞哌唑片 | 3 | 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
354 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | AstraZeneca AB | 7 | 5 | 0 |
| 2 | 齐鲁制药有限公司 | 6 | 5 | 1 |
| 3 | 安徽金马药业股份有限公司 | 5 | 5 | 0 |
| 4 | 湖南先施制药有限公司 | 5 | 3 | 1 |
| 5 | 南京黄龙生物科技有限公司 | 5 | 2 | 5 |
| 6 | 江苏恒瑞医药股份有限公司 | 5 | 2 | 0 |
| 7 | 海南中和药业股份有限公司 | 5 | 2 | 0 |
| 8 | 杭州新元素药业有限公司 | 5 | 1 | 0 |
| 9 | 吉林菲诺制药有限公司 | 4 | 4 | 0 |
| 10 | 贵州恒和制药有限公司 | 4 | 4 | 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
217 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/01/27Import · Class 1 | 普乐司兰钠注射液JXHS2500018 | Arrowhead Pharmaceuticals Inc.; Ajinomoto Althea Inc.; Visirna Therapeutics (Suzhou) Co. Ltd. |
| 2025/01/27Generic · Class 3 | 色甘酸钠滴眼液CYHS2500545 | 武汉新瑞医药科技有限公司; 武汉五景药业有限公司 |
| 2025/01/27Generic · Class 3 | 氯化钾口服溶液CYHS2500535 | 南京恒道医药科技股份有限公司; 南京集萃剂鼎医药有限公司 |
| 2025/01/27Generic · Class 3 | 氯化钾口服溶液CYHS2500533 | 合肥华威药业有限公司 |
| 2025/01/27Generic · Class 3 | 多种微量元素注射液（Ⅳ）CYHS2500521 | 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 |
| 2025/01/27Generic · Class 3 | 琥珀酸多西拉敏片CYHS2500515 | 南京济群医药科技股份有限公司; 远大生命科学（山东）有限公司 |
| 2025/01/27Generic · Class 3 | 琥珀酸多西拉敏片CYHS2500514 | 南京济群医药科技股份有限公司; 远大生命科学（山东）有限公司 |
| 2025/01/27Generic · Class 3 | 布瑞哌唑口崩片CYHS2500513 | 南京海纳制药有限公司 |
| 2025/01/27Generic · Class 3 | 布瑞哌唑口崩片CYHS2500512 | 南京海纳制药有限公司 |
| 2025/01/27Generic · Class 3 | 布瑞哌唑口崩片CYHS2500511 | 南京海纳制药有限公司 |
| 2025/01/27Generic · Class 3 | 秋水仙碱片CYHS2500508 | 浙江浙北药业有限公司 |
| 2025/01/27Generic · Class 3 | 洛索洛芬钠口服溶液CYHS2500506 | 吉林省辉南长龙生化药业股份有限公司 |
| 2025/01/27Generic · Class 3 | 乙酰半胱氨酸片CYHS2500502 | 广东泰来润至医药科技有限公司; 广州玻思韬控释药业有限公司 |
| 2025/01/27Generic · Class 3 | 氨溴特罗口服溶液CYHS2500499 | 吉林省益浦生物科技有限公司 |
| 2025/01/27Generic · Class 3 | 骨化三醇口服溶液CYHS2500498 | 北京仁众药业有限公司; 湖北欣泽霏药业有限公司 |
| 2025/01/27Generic · Class 3 | 盐酸溴己新口服溶液CYHS2500497 | 湖南普道医药技术有限公司; 湖南九典制药股份有限公司 |
| 2025/01/27Generic · Class 3 | 伏环孢素软胶囊CYHL2500031 | 博瑞制药（苏州）有限公司 |
| 2025/01/27Generic · Class 3 | 氟比洛芬贴剂CYHL2500030 | 江西康恩贝中药有限公司 |
| 2025/01/27Generic · Class 3 | 帕立骨化醇软胶囊CYHL2500029 | 青岛国信制药有限公司 |
| 2025/01/27Generic · Class 3 | 帕立骨化醇软胶囊CYHL2500028 | 青岛国信制药有限公司 |
| 2025/01/27Generic · Class 3 | 双氯芬酸钠贴剂CYHL2500027 | 深圳珐玛易药品科技有限公司 |
| 2025/01/27New drug · Class 1.1 | 反流清颗粒CXZL2500005 | 江西银涛药业股份有限公司 |
| 2025/01/27New drug · Class 1 | 古莫奇单抗注射液CXSS2500021 | 中山康方生物医药有限公司; 康方药业有限公司 |
| 2025/01/27New drug · Class 1 | 古莫奇单抗注射液CXSS2500020 | 中山康方生物医药有限公司; 康方药业有限公司 |
| 2025/01/27New drug · Class 3.3 | 地舒单抗注射液CXSS2500019 | 泰州迈博太科药业有限公司 |
| 2025/01/27New drug · Class 3.3 | 地舒单抗注射液CXSS2500018 | 泰州迈博太科药业有限公司 |
| 2025/01/27New drug · Class 2.2 | 冻干人用狂犬病疫苗（无血清Vero细胞）CXSS2500017 | 科兴（成都）生物制品有限公司 |
| 2025/01/27New drug · Class 1 | 人自体多克隆调节性T细胞注射液CXSL2500094 | 上海赛尔欣生物医疗科技有限公司 |
| 2025/01/27New drug · Class 2.2 | 阿得贝利单抗注射液CXSL2500093 | 上海盛迪医药有限公司 |
| 2025/01/27New drug · Class 1 | 注射用ASKG915CXSL2500092 | 江苏奥赛康生物医药有限公司 |
187 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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