药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/09/30 – 2025/10/06
- New acceptances this week
- 98
- Drugs with new generic filings (by drug name, de-duplicated)
- 13
- Accepted this week, now under review
- 19
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
98filings, 16 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 58 |
| New drug | 17 |
| Generic | 16 |
| Import | 3 |
| Unspecified | 2 |
| Import re-registration | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 53 |
| 治疗用生物制品 | 24 |
| TCM | 20 |
| Unspecified | 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
13 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 依折麦布阿托伐他汀钙片 | 2 | 1 | 4 |
| 2 | 布美他尼注射液 | 2 | 1 | 16 |
| 3 | 瑞舒伐他汀钙片 | 2 | 1 | 18 |
| 4 | 倍氯米松福莫特罗吸入气雾剂 | 1 | 1 | 0 |
| 5 | 双氯芬酸二乙胺乳胶剂 | 1 | 1 | 21 |
| 6 | 来特莫韦片 | 1 | 1 | 6 |
| 7 | 注射用氢化可的松琥珀酸钠 | 1 | 1 | 16 |
| 8 | 盐酸乐卡地平片 | 1 | 1 | 6 |
| 9 | 盐酸利多卡因注射液 | 1 | 1 | 6 |
| 10 | 盐酸氨溴索口服溶液 | 1 | 1 | 45 |
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
62 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 吉林省祈克药业有限公司 | 5 | 3 | 0 |
| 2 | 江苏恒瑞医药股份有限公司 | 5 | 2 | 0 |
| 3 | 湖北睿泽药业有限公司 | 4 | 1 | 0 |
| 4 | 吉林百琦药业有限公司 | 3 | 3 | 0 |
| 5 | Janssen-Cilag AG | 3 | 2 | 0 |
| 6 | 正大天晴药业集团南京顺欣制药有限公司 | 3 | 2 | 0 |
| 7 | 广东九明制药有限公司 | 3 | 1 | 0 |
| 8 | 神州细胞工程有限公司 | 3 | 1 | 0 |
| 9 | 合肥凯华制药有限公司 | 2 | 2 | 0 |
| 10 | 哈尔滨医大药业股份有限公司 | 2 | 2 | 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
23 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/10/01Generic · Class 3 | 盐酸利多卡因注射液CYHS2503595 | 广州瑞尔医药科技有限公司; 太极集团四川太极制药有限公司 |
| 2025/10/01New drug · Class 2.3 | 荆防合剂CXZL2500092 | 鲁南厚普制药有限公司 |
| 2025/10/01New drug · Class 1 | 瑞西奇拜单抗注射液CXSS2500106 | 上海华奥泰生物药业股份有限公司; 浙江华海生物科技有限公司 |
| 2025/10/01New drug · Class 1 | XLS-103注射液CXSL2500857 | 香雪生命科学技术（广东）有限公司 |
| 2025/10/01New drug · Class 1 | XLS-103注射液CXSL2500856 | 香雪生命科学技术（广东）有限公司 |
| 2025/10/01New drug · Class 1 | 注射用YB-01CXSL2500855 | 元本（珠海横琴）生物科技有限公司 |
| 2025/09/30Import · Class 1 | MK-1084片JXHL2500304 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2025/09/30Import · Class 1 | MK-1084片JXHL2500303 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2025/09/30Generic · Class 3 | 注射用氢化可的松琥珀酸钠CYHS2503584 | 海南紫程众投生物科技有限公司; 辽宁海思科制药有限公司 |
| 2025/09/30Generic · Class 3 | 布美他尼注射液CYHS2503579 | 山东益健药业有限公司 |
| 2025/09/30Generic · Class 3 | 布美他尼注射液CYHS2503578 | 山东益健药业有限公司 |
| 2025/09/30New drug · Class 1.1 | 精芪化浊颗粒CXZL2500091 | 黑龙江省济仁药业有限公司 |
| 2025/09/30New drug · Class 3.2 | 尼妥珠单抗注射液CXSS2500105 | 百泰生物药业有限公司 |
| 2025/09/30New drug · Class 2.2 | 注射用卡瑞利珠单抗CXSS2500104 | 苏州盛迪亚生物医药有限公司 |
| 2025/09/30New drug · Class 1 | 伊立芙普α眼内注射液CXSS2500103 | 荣昌生物制药（烟台）股份有限公司 |
| 2025/09/30New drug · Class 1 | HY001N细胞注射液CXSL2500854 | 合源生物科技（天津）有限公司; 广东合源生物医药有限公司 |
| 2025/09/30New drug · Class 1 | 注射用TQB2102CXSL2500853 | 正大天晴药业集团南京顺欣制药有限公司 |
| 2025/09/30New drug · Class 1 | 注射用BG-C137CXSL2500852 | 广州百济神州生物制药有限公司 |
| 2025/09/30New drug · Class 1 | TQB2930注射液CXSL2500851 | 正大天晴药业集团南京顺欣制药有限公司 |
| 2025/09/30New drug · Class 1 | TQB2930注射液CXSL2500850 | 正大天晴药业集团南京顺欣制药有限公司 |
| 2025/09/30New drug · Class 2.4 | 苹果酸法米替尼胶囊CXHS2500122 | 江苏恒瑞医药股份有限公司 |
| 2025/09/30New drug · Class 2.4 | GEN-725片CXHL2501058 | 河南真实生物科技有限公司 |
| 2025/09/30New drug · Class 2.4 | GEN-725片CXHL2501057 | 河南真实生物科技有限公司 |
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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