药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/12/05 – 2023/12/11
- New acceptances this week
- 378
- Drugs with new generic filings (by drug name, de-duplicated)
- 64
- Accepted this week, now under review
- 1
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
378filings, 91 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 180 |
| Generic | 91 |
| New drug | 57 |
| Import | 25 |
| Unspecified | 13 |
| Import re-registration | 12 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 233 |
| TCM | 76 |
| 治疗用生物制品 | 56 |
| Biologic | 10 |
| 预防用生物制品 | 2 |
| 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
64 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 阿戈美拉汀片 | 3 | 3 | 8 |
| 2 | 左卡尼汀口服溶液 | 3 | 2 | 9 |
| 3 | 米诺地尔搽剂 | 3 | 2 | 49 |
| 4 | 盐酸左沙丁胺醇雾化吸入溶液 | 3 | 1 | 2 |
| 5 | 阿普米司特片 | 3 | 1 | 3 |
| 6 | 二羟丙茶碱注射液 | 2 | 2 | 7 |
| 7 | 吗啉硝唑氯化钠注射液 | 2 | 2 | 10 |
| 8 | 地氯雷他定口服溶液 | 2 | 2 | 26 |
| 9 | 注射用盐酸罗沙替丁醋酸酯 | 2 | 2 | 5 |
| 10 | 美索巴莫注射液 | 2 | 2 | 4 |
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
218 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 蓝耘智合生物科技有限责任公司 | 39 | 30 | 0 |
| 2 | 太极集团四川天诚制药有限公司 | 8 | 8 | 0 |
| 3 | Novo Nordisk A/S | 7 | 2 | 0 |
| 4 | 浙江华海药业股份有限公司 | 5 | 4 | 3 |
| 5 | Sanofi-Aventis Recherche & Développement | 5 | 2 | 0 |
| 6 | 百济神州（苏州）生物科技有限公司 | 5 | 2 | 0 |
| 7 | Karuna Therapeutics Inc. | 5 | 1 | 0 |
| 8 | 华夏生生药业（北京）有限公司 | 4 | 3 | 4 |
| 9 | Janssen Research & Development LLC | 4 | 2 | 0 |
| 10 | Novartis Pharma AG | 4 | 1 | 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
115 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/12/10New drug · Class 1 | YZJ-5799磷酸盐胶囊CXHL2301368 | 上海海雁医药科技有限公司 |
| 2023/12/10New drug · Class 1 | YZJ-5799磷酸盐胶囊CXHL2301367 | 上海海雁医药科技有限公司 |
| 2023/12/09Import · Class 1 | MK-7240注射用浓溶液JXSL2300220 | Merck Sharp & Dohme LLC; 不适用 |
| 2023/12/09Import · Class 1 | MK-7240注射液JXSL2300219 | Merck Sharp & Dohme LLC; 不适用 |
| 2023/12/09Import · Class 1 | SAR441566JXHL2300311 | Sanofi-Aventis Recherche & Développement; Sanofi（China）Investment Co. Ltd. |
| 2023/12/09Import · Class 1 | SAR441566JXHL2300310 | Sanofi-Aventis Recherche & Développement; Sanofi（China）Investment Co. Ltd. |
| 2023/12/09Import · Class 1 | SAR441566JXHL2300309 | Sanofi-Aventis Recherche & Développement; Sanofi（China）Investment Co. Ltd. |
| 2023/12/09Import · Class 1 | SAR441566JXHL2300308 | Sanofi-Aventis Recherche & Développement; Sanofi（China）Investment Co. Ltd. |
| 2023/12/09Generic · Class 3 | 盐酸多巴酚丁胺注射液CYHS2303423 | 江苏联环药业股份有限公司 |
| 2023/12/09Generic · Class 3 | 复方聚乙二醇（3350）电解质散CYHS2303422 | 华益泰康药业股份有限公司 |
| 2023/12/09Generic · Class 3 | 间苯三酚口崩片CYHS2303414 | 寿光富康制药有限公司 |
| 2023/12/09Generic · Class 3 | 吲哚布芬片CYHS2303413 | 浙江百代医药科技有限公司; 浙江赛默制药有限公司 |
| 2023/12/09Generic · Class 3 | 硫酸镁注射液CYHS2303410 | 成都百裕制药股份有限公司 |
| 2023/12/09Generic · Class 3 | 坎地沙坦酯氢氯噻嗪片CYHS2303409 | 浙江华海药业股份有限公司 |
| 2023/12/09Generic · Class 3 | 米诺地尔搽剂CYHS2303407 | 辽宁新高制药有限公司 |
| 2023/12/09Generic · Class 3 | 普瑞巴林缓释片CYHS2303406 | 浙江诺得药业有限公司 |
| 2023/12/09Generic · Class 3 | 普瑞巴林缓释片CYHS2303405 | 浙江诺得药业有限公司 |
| 2023/12/09Generic · Class 3 | 地氯雷他定口服溶液CYHS2303404 | 江苏万高药业股份有限公司 |
| 2023/12/09Generic · Class 3 | 米诺地尔外用溶液CYHS2303403 | 北京诚济制药股份有限公司; 浙江赛默制药有限公司 |
| 2023/12/09Generic · Class 3 | 米诺地尔外用溶液CYHS2303402 | 北京诚济制药股份有限公司; 浙江赛默制药有限公司 |
| 2023/12/09Generic · Class 3 | 美索巴莫注射液CYHS2303401 | 江苏正大清江制药有限公司 |
| 2023/12/09Generic · Class 3 | 盐酸毛果芸香碱滴眼液CYHL2300149 | 山东华铂凯盛生物科技有限公司 |
| 2023/12/09New drug · Class 2.3 | 克感利咽口服液CXZL2300073 | 广州王老吉药业股份有限公司 |
| 2023/12/09New drug · Class 1 | 注射用SKB264CXSS2300093 | 四川科伦博泰生物医药股份有限公司 |
| 2023/12/09New drug · Class 1 | 注射用SIBP-A17CXSL2300851 | 上海生物制品研究所有限责任公司 |
| 2023/12/09New drug · Class 2.4 | 艾诺米替片CXHS2300112 | 江苏艾迪药业股份有限公司 |
| 2023/12/09New drug · Class 2.4 | 艾诺韦林片CXHS2300111 | 江苏艾迪药业股份有限公司 |
| 2023/12/09New drug · Class 1 | BY101298胶囊CXHL2301366 | 成都百裕制药股份有限公司 |
| 2023/12/09New drug · Class 1 | BY101298胶囊CXHL2301365 | 成都百裕制药股份有限公司 |
| 2023/12/09New drug · Class 1 | BEBT-109胶囊CXHL2301364 | 广州必贝特医药股份有限公司 |
85 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.