药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/03/11 – 2025/03/17
- New acceptances this week
- 376
- Drugs with new generic filings (by drug name, de-duplicated)
- 64
- Accepted this week, now under review
- 27
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
376filings, 95 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 169 |
| Generic | 95 |
| New drug | 49 |
| Import re-registration | 23 |
| Import | 21 |
| Unspecified | 19 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 286 |
| TCM | 45 |
| 治疗用生物制品 | 41 |
| 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
64 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 地氯雷他定口服溶液 | 4 | 2 | 26 |
| 2 | 沙库巴曲缬沙坦钠片 | 4 | 2 | 72 |
| 3 | 米库氯铵注射液 | 4 | 2 | 3 |
| 4 | 乳果糖口服溶液 | 3 | 2 | 40 |
| 5 | 甲氧氯普胺片 | 3 | 2 | 4 |
| 6 | 利奥西呱片 | 3 | 1 | 4 |
| 7 | 左氧氟沙星氯化钠注射液 | 3 | 1 | 14 |
| 8 | 腺苷钴胺胶囊 | 2 | 2 | 8 |
| 9 | 多种维生素注射液(13) | 2 | 1 | 4 |
| 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
211 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 南阳普康恒旺药业有限公司 | 17 | 16 | 0 |
| 2 | Bracco Imaging S.P.A. | 13 | 1 | 0 |
| 3 | Fresenius Kabi Deutschland GmbH | 12 | 2 | 0 |
| 4 | 北京星昊盈盛药业有限公司 | 6 | 3 | 0 |
| 5 | 百济神州(苏州)生物科技有限公司 | 6 | 3 | 0 |
| 6 | AstraZeneca AB | 5 | 3 | 0 |
| 7 | 华夏生生药业(北京)有限公司 | 5 | 2 | 2 |
| 8 | 知和(山东)大药厂有限公司 | 4 | 4 | 0 |
| 9 | 中国科学院上海药物研究所 | 4 | 3 | 0 |
| 10 | 齐鲁制药有限公司 | 4 | 3 | 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
100 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/03/17Import · Class 1 | [225Ac]Ac-PSMA-617注射液JXHL2500047 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/03/15Import · Class 2.2 | 度普利尤单抗注射液JXSS2500026 | Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd. |
| 2025/03/15Import · Class 2.2 | 度普利尤单抗注射液JXSS2500025 | Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd. |
| 2025/03/15Import · Class 1 | ADI-001JXSL2500038 | Adicet Therapeutics Inc.; Shanghai Adicet Biotechnology Co. Ltd. |
| 2025/03/15Import · Class 1 | VSA001注射液JXHL2500045 | Arrowhead Pharmaceuticals Inc.; Sanofi (China) Investment Co. Ltd. |
| 2025/03/15Generic · Class 3 | 碳酸镧颗粒CYHS2501085 | 江西施美药业股份有限公司 |
| 2025/03/15Generic · Class 3 | 碳酸镧颗粒CYHS2501084 | 江西施美药业股份有限公司 |
| 2025/03/15Generic · Class 3 | 聚乙二醇3350散CYHS2501080 | 嘉实(湖南)医药科技有限公司; 湖南天济草堂制药股份有限公司 |
| 2025/03/15Generic · Class 3 | 腺苷钴胺胶囊CYHS2501078 | 湖南方盛制药股份有限公司 |
| 2025/03/15Generic · Class 3 | 尼莫地平口服溶液CYHS2501074 | 石家庄四药有限公司; 浙江国镜药业有限公司 |
| 2025/03/15New drug · Class 1.2 | SOC201胶囊CXZL2500017 | 中国科学院上海药物研究所; 芷江润甜甜茶生物技术有限公司 |
| 2025/03/15New drug · Class 1.2 | SOC201提取物CXZL2500016 | 中国科学院上海药物研究所; 芷江润甜甜茶生物技术有限公司 |
| 2025/03/15New drug · Class 1.1 | 小儿热立清颗粒CXZL2500015 | 奇正(珠海市横琴)国际医药有限公司; 甘肃奇正藏药有限公司 |
| 2025/03/15New drug · Class 1 | 注射用AK146D1CXSL2500227 | 中山康方生物医药有限公司 |
| 2025/03/15New drug · Class 1 | JWK002注射液CXSL2500225 | 武汉金唯科生物科技有限公司; 成都金唯科生物科技有限公司 |
| 2025/03/15New drug · Class 1 | GLS-W1100胶囊CXSL2500224 | 杭州远大生物制药有限公司 |
| 2025/03/15New drug · Class 1 | 玛氘诺沙韦片CXHS2500022 | 嘉兴安帝康生物科技有限公司; 上海合全医药有限公司 |
| 2025/03/15New drug · Class 1 | 塞拉维诺片CXHL2500291 | 中国科学院上海药物研究所; 首都医科大学附属北京天坛医院 |
| 2025/03/15New drug · Class 1 | 塞拉维诺片CXHL2500290 | 中国科学院上海药物研究所; 首都医科大学附属北京天坛医院 |
| 2025/03/15New drug · Class 2.2 | PDX-04CXHL2500289 | 湖南九典制药股份有限公司 |
| 2025/03/15New drug · Class 2.2 | PDX-04CXHL2500288 | 湖南九典制药股份有限公司 |
| 2025/03/15New drug · Class 1 | 伊匹乌肽散剂CXHL2500287 | 益承康泰(厦门)生物科技有限公司 |
| 2025/03/15New drug · Class 1 | ZYS-1肠溶片CXHL2500286 | 北京科佑爱科技有限责任公司 |
| 2025/03/15New drug · Class 2.2 | KEM2414直服颗粒CXHL2500285 | 深圳珐玛易药品科技有限公司 |
| 2025/03/15New drug · Class 1 | PLB1004胶囊CXHL2500284 | 鞍石药业(宁波)有限责任公司 |
| 2025/03/15New drug · Class 1 | PLB1004胶囊CXHL2500283 | 鞍石药业(宁波)有限责任公司 |
| 2025/03/14Import · Class 1 | TQJ230注射液JXHL2500044 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/03/14Import · Class 1 | ELVN-001胶囊JXHL2500043 | Enliven Therapeutics Inc.; R&G PharmaStudies Co. Ltd. |
| 2025/03/14Generic · Class 3 | 腺苷钴胺胶囊CYHS2501064 | 山东益康药业股份有限公司 |
| 2025/03/14Generic · Class 3 | 法莫替丁注射液CYHS2501060 | 安徽美来药业股份有限公司; 裕松源药业有限公司 |
70 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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