药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2026/02/24 – 2026/03/02
- New acceptances this week
- 517
- Drugs with new generic filings (by drug name, de-duplicated)
- 90
- Accepted this week, now under review
- 191
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
517filings, 120 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 216 |
| New drug | 128 |
| Generic | 120 |
| Import | 32 |
| Unspecified | 16 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 334 |
| 治疗用生物制品 | 106 |
| TCM | 66 |
| 预防用生物制品 | 7 |
| Biologic | 3 |
| 体外诊断试剂 | 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
90 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 瑞舒伐他汀钙片 | 4 | 2 | 18 |
| 2 | 盐酸卡利拉嗪胶囊 | 3 | 1 | 3 |
| 3 | 氟轻松氢醌维A酸乳膏 | 2 | 2 | 0 |
| 4 | 注射用甲苯磺酸奥马环素 | 2 | 2 | 9 |
| 5 | 盐酸氮？斯汀滴眼液 | 2 | 2 | 7 |
| 6 | 艾拉莫德片 | 2 | 2 | 24 |
| 7 | 他达拉非片 | 2 | 1 | 23 |
| 8 | 依普利酮片 | 2 | 1 | 4 |
| 9 | 双氯芬酸钠缓释片 | 2 | 1 | 10 |
| 10 | 多替诺雷片 | 2 | 1 | 49 |
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
306 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 山东盛迪医药有限公司 | 9 | 6 | 0 |
| 2 | 上海恒瑞医药有限公司 | 7 | 4 | 0 |
| 3 | Novartis Pharma AG | 7 | 3 | 0 |
| 4 | The Wellcome Foundation Limited | 7 | 2 | 0 |
| 5 | 苏州盛迪亚生物医药有限公司 | 6 | 6 | 0 |
| 6 | 齐鲁制药有限公司 | 6 | 4 | 0 |
| 7 | Takeda Development Center Americas Inc. | 6 | 2 | 0 |
| 8 | 成都盛迪医药有限公司 | 6 | 2 | 0 |
| 9 | 洛阳顺势药业有限公司 | 5 | 5 | 0 |
| 10 | 上海翰森生物医药科技有限公司 | 5 | 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
202 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/03/02Import · Class 3.1 | 尘螨变应原舌下片 (Actair)JXSL2600061 | STALLERGENES; Nuance Pharma(Beijing)Co. Ltd |
| 2026/03/02Import · Class 3.1 | 尘螨变应原舌下片 (Actair)JXSL2600060 | STALLERGENES; Nuance Pharma(Beijing)Co. Ltd |
| 2026/03/02Generic · Class 3 | 铝碳酸镁混悬液CYHS2600606 | 安徽康融药业有限公司 |
| 2026/03/02Generic · Class 3 | 马尿酸乌洛托品片CYHS2600602 | 成都恒瑞制药有限公司 |
| 2026/03/02Generic · Class 3 | 氨磺必利口服溶液CYHS2600599 | 四川森科制药有限公司 |
| 2026/03/02Generic · Class 3 | 洛度沙胺氨丁三醇滴眼液CYHS2600598 | 石家庄四药有限公司; 江西科伦药业有限公司 |
| 2026/03/02New drug · Class 3.3 | 德谷胰岛素注射液CXSS2600034 | 重庆宸安生物制药有限公司 |
| 2026/03/02New drug · Class 2 | 乙型肝炎病毒、丙型肝炎病毒、人类免疫缺陷病毒（1+2型）核酸检测试剂盒（PCR-荧光法）CXSS2600033 | 山东见微生物科技有限公司 |
| 2026/03/02New drug · Class 1 | SKB118注射液CXSL2600292 | 四川科伦博泰生物医药股份有限公司 |
| 2026/03/02New drug · Class 1 | 注射用BG-C0979CXSL2600291 | 广州百济神州生物制药有限公司 |
| 2026/03/02New drug · Class 2.2 | 三价流感病毒裂解疫苗（MDCK细胞）CXSL2600289 | 北京科兴生物制品有限公司 |
| 2026/03/02New drug · Class 1 | 注射用RC288CXSL2600288 | 荣昌生物制药（烟台）股份有限公司 |
| 2026/03/02New drug · Class 2.1;2.2 | 伏欣奇拜单抗注射液CXSL2600285 | 长春金赛药业有限责任公司 |
| 2026/03/02New drug · Class 2.1;2.2 | 伏欣奇拜单抗注射液CXSL2600284 | 长春金赛药业有限责任公司 |
| 2026/03/02New drug · Class 1 | JYP0061片CXHL2600259 | 广州嘉越医药科技股份有限公司 |
| 2026/03/02New drug · Class 1 | DSC158A片CXHL2600258 | 太极集团重庆涪陵制药厂有限公司; 广州呼吸健康研究院 |
| 2026/03/02New drug · Class 1 | DSC158A片CXHL2600257 | 太极集团重庆涪陵制药厂有限公司; 广州呼吸健康研究院 |
| 2026/03/02New drug · Class 1 | DSC158A片CXHL2600256 | 太极集团重庆涪陵制药厂有限公司; 广州呼吸健康研究院 |
| 2026/03/02New drug · Class 2.2 | 阿莫西林伏诺拉生胃漂浮片CXHL2600255 | 南京三迭纪医药科技有限公司 |
| 2026/03/02New drug · Class 1 | YKYY018雾化吸入剂CXHL2600254 | 北京悦康科创医药科技股份有限公司 |
| 2026/03/02New drug · Class 1 | 注射用LPM5260558CXHL2600253 | 山东全重生物医药科技有限公司 |
| 2026/03/02New drug · Class 1 | YKYY018雾化吸入剂CXHL2600252 | 北京悦康科创医药科技股份有限公司 |
| 2026/03/01Import · Class 3.1 | 埃万妥单抗注射液（皮下注射）JXSS2600013 | Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd. |
| 2026/03/01Import · Class 3.1 | 埃万妥单抗注射液（皮下注射）JXSS2600012 | Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd. |
| 2026/03/01New drug · Class 3.1 | 温胆汤颗粒CXZS2600015 | 北京同仁堂股份有限公司同仁堂制药厂 |
| 2026/03/01New drug · Class 1 | GenSci161注射液CXSL2600283 | 长春金赛药业有限责任公司 |
| 2026/03/01New drug · Class 1 | GenSci161注射液CXSL2600282 | 长春金赛药业有限责任公司 |
| 2026/03/01New drug · Class 1 | 注射用IMM0306CXSL2600281 | 宜明昂科生物医药技术（上海）股份有限公司 |
| 2026/03/01New drug · Class 1 | ICP-054片CXHL2600251 | 北京诺诚健华医药科技有限公司 |
| 2026/03/01New drug · Class 1 | ICP-054片CXHL2600250 | 北京诺诚健华医药科技有限公司 |
172 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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