药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/05/07 – 2024/05/13
- New acceptances this week
- 417
- Drugs with new generic filings (by drug name, de-duplicated)
- 89
- Accepted this week, now under review
- 4
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
417filings, 120 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 172 |
| Generic | 120 |
| New drug | 79 |
| Import | 30 |
| Import re-registration | 11 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 297 |
| TCM | 61 |
| 治疗用生物制品 | 57 |
| 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
89 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 | 4 | 2 | 58 |
| 2 | 沙库巴曲缬沙坦钠片 | 3 | 2 | 72 |
| 3 | 盐酸贝尼地平片 | 3 | 2 | 4 |
| 4 | 马来酸氟伏沙明片 | 3 | 2 | 0 |
| 5 | 替米沙坦片 | 3 | 1 | 4 |
| 6 | 枸橼酸西地那非片 | 3 | 1 | 12 |
| 7 | 氘丁苯那嗪片 | 3 | 1 | 0 |
| 8 | 注射用尼可地尔 | 3 | 1 | 1 |
| 9 | 聚乙二醇钠钾散 | 2 | 2 | 3 |
| 10 | 二甲硅油乳剂 | 2 | 1 | 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
239 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 吉林恒星科技制药有限公司 | 19 | 17 | 0 |
| 2 | 安徽丰原药业股份有限公司淮海药厂 | 10 | 2 | 0 |
| 3 | 湖北第六制药有限公司 | 7 | 5 | 0 |
| 4 | Janssen Research & Development LLC | 7 | 3 | 0 |
| 5 | 重庆赛维药业有限公司 | 7 | 2 | 2 |
| 6 | 浙江赛默制药有限公司 | 6 | 5 | 6 |
| 7 | 百奥泰生物制药股份有限公司 | 6 | 3 | 0 |
| 8 | 南京正大天晴制药有限公司 | 6 | 2 | 3 |
| 9 | 山东盛迪医药有限公司 | 6 | 2 | 0 |
| 10 | 江苏恒瑞医药股份有限公司 | 6 | 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
149 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/05/13Import · Class 2.4 | Upadacitinib片JXHL2400112 | AbbVie Inc. |
| 2024/05/13Import · Class 2.4 | Upadacitinib片JXHL2400111 | AbbVie Inc. |
| 2024/05/13Import · Class 2.4 | Upadacitinib片JXHL2400110 | AbbVie Inc. |
| 2024/05/13Import · Class 2.4 | 镥(177Lu)vipivotide tetraxetan注射液JXHL2400109 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2024/05/13Import · Class 2.4 | 镥(177Lu)vipivotide tetraxetan注射液JXHL2400108 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2024/05/13Generic · Class 3 | 法莫替丁注射液CYHS2401441 | 成都倍特药业股份有限公司 |
| 2024/05/13Generic · Class 3 | 坎地氢噻片CYHS2401435 | 北京福元医药股份有限公司 |
| 2024/05/13Generic · Class 3 | 甘露醇山梨醇注射液CYHL2400092 | 湖北欣泽霏药业有限公司 |
| 2024/05/13New drug · Class 1 | APH01727片CXHL2400473 | 广州一品红制药有限公司 |
| 2024/05/13New drug · Class 1 | D3S-001胶囊CXHL2400472 | 德昇济医药(无锡)有限公司 |
| 2024/05/13New drug · Class 1 | D3S-001胶囊CXHL2400471 | 德昇济医药(无锡)有限公司 |
| 2024/05/12Import · Class 2.2 | 马昔腾坦分散片JXHL2400107 | Actelion Pharmaceuticals Ltd; Johnson & Johnson (China) Investment Ltd. |
| 2024/05/12Generic · Class 3 | 盐酸多巴胺注射液CYHS2401431 | 海南普利制药股份有限公司 |
| 2024/05/12New drug · Class 1 | 塔戈利单抗注射液CXSS2400049 | 四川科伦博泰生物医药股份有限公司 |
| 2024/05/12New drug · Class 1 | CM512注射液CXSL2400309 | 康诺亚生物医药科技(成都)有限公司 |
| 2024/05/12New drug · Class 1 | 重组I型单纯疱疹病毒R130注射液(Vero细胞)CXSL2400308 | 上海允英生物医药科技有限公司 |
| 2024/05/12New drug · Class 2.4 | 枸橼酸舒芬太尼注射液CXHL2400470 | 宜昌人福药业有限责任公司 |
| 2024/05/12New drug · Class 2.4 | 枸橼酸舒芬太尼注射液CXHL2400469 | 宜昌人福药业有限责任公司 |
| 2024/05/12New drug · Class 2.4 | 枸橼酸舒芬太尼注射液CXHL2400468 | 宜昌人福药业有限责任公司 |
| 2024/05/12New drug · Class 2.4 | 枸橼酸舒芬太尼注射液CXHL2400467 | 宜昌人福药业有限责任公司 |
| 2024/05/12New drug · Class 2.4 | 枸橼酸舒芬太尼注射液CXHL2400466 | 宜昌人福药业有限责任公司 |
| 2024/05/12New drug · Class 1 | HRS-4508片CXHL2400465 | 江苏恒瑞医药股份有限公司 |
| 2024/05/12New drug · Class 1 | HRS-4508片CXHL2400464 | 江苏恒瑞医药股份有限公司 |
| 2024/05/11Import · Class 2.2 | 古塞奇尤单抗注射液JXSL2400091 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/05/11Import · Class 2.2 | 古塞奇尤单抗注射液JXSL2400090 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/05/11Import · Class 2.2 | 古塞奇尤单抗注射液JXSL2400089 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/05/11Import · Class 2.2;2.4 | 盐酸氨酮戊酸己酯软膏光动力治疗系统JXHS2400035 | ASIERIS MEDITECH (Hong Kong) CO. LIMITED; Bioglan AB; Jiangsu Yahong Meditech Co. Ltd. |
| 2024/05/11Import · Class 1 | BI 690517片JXHL2400106 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2024/05/11Generic · Class 3 | 盐酸多西环素片CYHS2401422 | 浙江赛默制药有限公司 |
| 2024/05/11Generic · Class 3 | 盐酸多西环素片CYHS2401421 | 浙江赛默制药有限公司 |
119 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.