药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/01/14 – 2025/01/20
- New acceptances this week
- 347
- Drugs with new generic filings (by drug name, de-duplicated)
- 67
- Accepted this week, now under review
- 9
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
347filings, 96 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 163 |
| Generic | 96 |
| New drug | 60 |
| Import | 21 |
| Import re-registration | 4 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 261 |
| TCM | 50 |
| 治疗用生物制品 | 30 |
| Biologic | 3 |
| 预防用生物制品 | 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
67 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 米库氯铵注射液 | 4 | 2 | 3 |
| 2 | 磷酸芦可替尼片 | 3 | 1 | 27 |
| 3 | 二十碳五烯酸乙酯软胶囊 | 2 | 2 | 25 |
| 4 | 己酮可可碱缓释片 | 2 | 2 | 6 |
| 5 | 枸橼酸西地那非口崩片 | 2 | 2 | 8 |
| 6 | 注射用硫酸艾沙康唑 | 2 | 2 | 15 |
| 7 | 注射用磷酸特地唑胺 | 2 | 2 | 3 |
| 8 | 聚乙二醇钠钾散 | 2 | 2 | 3 |
| 9 | 苯溴马隆片 | 2 | 2 | 3 |
| 10 | 西格列汀二甲双胍缓释片 | 2 | 2 | 14 |
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
206 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 山东威智百科药业有限公司 | 18 | 13 | 0 |
| 2 | 修正药业集团临沂修正制药有限公司 | 12 | 12 | 0 |
| 3 | 百济神州（苏州）生物科技有限公司 | 8 | 3 | 0 |
| 4 | 安徽双鹤药业有限责任公司 | 8 | 2 | 0 |
| 5 | 云南一枝蒿制药有限公司 | 6 | 4 | 0 |
| 6 | 山东盛迪医药有限公司 | 6 | 3 | 0 |
| 7 | Fresenius Kabi AB | 5 | 1 | 0 |
| 8 | 河北广祥医药科技有限公司 | 4 | 3 | 0 |
| 9 | 成都蓉生药业有限责任公司 | 4 | 2 | 0 |
| 10 | 海南倍特药业有限公司 | 4 | 2 | 4 |
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
107 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/01/18Import · Class 3.1 | 艾加莫德α注射液JXSL2500011 | argenx BV; ICON Clinical Research (Beijing No. 2) Co. Ltd. |
| 2025/01/18Import · Class 1 | HCB301注射液JXSL2500010 | FBD Biologics Limited; Shanghai Hanchor Biotech Inc. |
| 2025/01/18Import · Class 1 | 艾曲帕米鼻喷雾剂JXHS2500007 | Milestone Pharmaceuticals Inc.; Catalent Pharma Solutions LLC; Corxel Pharmaceuticals (Shanghai) Co. Ltd |
| 2025/01/18Generic · Class 3 | 盐酸纳美芬注射液CYHS2500353 | 浙江赛默制药有限公司 |
| 2025/01/18Generic · Class 3 | 甲硝唑阴道凝胶CYHS2500352 | 杭州上禾健康科技有限公司; 浙江鼎泰药业股份有限公司 |
| 2025/01/18Generic · Class 3 | 西格列汀二甲双胍缓释片CYHS2500350 | 南京易亨制药有限公司 |
| 2025/01/18Generic · Class 3 | 布立西坦口服溶液CYHL2500019 | 江西科睿药业有限公司 |
| 2025/01/18New drug · Class 2.2 | 注射用重组人TNK组织型纤溶酶原激活剂CXSL2500054 | 石药集团明复乐药业（广州）有限公司 |
| 2025/01/18New 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CXSL2500053 | 上海邦耀生物科技有限公司 |
| 2025/01/18New drug · Class 2.2 | MIRSRT缓释片CXHL2500098 | 吉林天衡药业有限公司 |
| 2025/01/18New drug · Class 2.2 | MIRSRT缓释片CXHL2500097 | 吉林天衡药业有限公司 |
| 2025/01/18New drug · Class 2.2 | MIRSRT缓释片CXHL2500096 | 吉林天衡药业有限公司 |
| 2025/01/18New drug · Class 1 | DNV001注射液CXHL2500095 | 杭州鼎乐新为生物科技有限公司 |
| 2025/01/18New drug · Class 1 | HRS-6719片CXHL2500094 | 山东盛迪医药有限公司; 上海恒瑞医药有限公司 |
| 2025/01/18New drug · Class 1 | 奥格特韦钠胶囊CXHL2500093 | 浙江艾森药业有限公司 |
| 2025/01/18New drug · Class 1 | HRS-6719片CXHL2500092 | 山东盛迪医药有限公司; 上海恒瑞医药有限公司 |
| 2025/01/18New drug · Class 1 | SYH2046片CXHL2500091 | 上海翊石医药科技有限公司 |
| 2025/01/18New drug · Class 1 | SYH2046片CXHL2500090 | 上海翊石医药科技有限公司 |
| 2025/01/17Import · Class 1 | Zasocitinib (TAK-279) 片JXHL2500012 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd. |
| 2025/01/17Import · Class 1 | Zasocitinib (TAK-279) 片JXHL2500011 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd. |
| 2025/01/17Generic · Class 3 | 叶酸片CYHS2500342 | 江苏贝佳制药有限公司 |
| 2025/01/17Generic · Class 3 | 柳氮磺吡啶口服混悬液CYHS2500341 | 上海信谊金朱药业有限公司 |
| 2025/01/17Generic · Class 3 | 盐酸美金刚口服溶液CYHS2500337 | 常州四药制药有限公司 |
| 2025/01/17Generic · Class 3 | 吡拉西坦注射液CYHS2500336 | 石药银湖制药有限公司 |
| 2025/01/17Generic · Class 3 | 布美他尼注射液CYHS2500331 | 浙江赛默制药有限公司 |
| 2025/01/17Generic · Class 3 | 布美他尼注射液CYHS2500330 | 浙江赛默制药有限公司 |
| 2025/01/17Generic · Class 3 | 富马酸酮替芬滴眼液CYHS2500329 | 石家庄格瑞药业有限公司 |
| 2025/01/17Generic · Class 3 | 富马酸酮替芬滴眼液CYHS2500328 | 石家庄格瑞药业有限公司 |
| 2025/01/17Generic · Class 3 | 醋酸地非法林注射液CYHL2500018 | 山东齐都药业有限公司 |
| 2025/01/17New drug · Class 1 | 注射用ZL-1310CXSL2500052 | 再鼎医药（上海）有限公司 |
77 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.