药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/05/09 – 2023/05/15
- New acceptances this week
- 421
- Drugs with new generic filings (by drug name, de-duplicated)
- 50
- Accepted this week, now under review
- 2
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
421filings, 70 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 246 |
| Generic | 70 |
| New drug | 63 |
| Import | 20 |
| Import re-registration | 13 |
| Unspecified | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 276 |
| TCM | 107 |
| 治疗用生物制品 | 38 |
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
50 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 硝普钠氯化钠注射液 | 4 | 1 | 3 |
| 2 | 达沙替尼片 | 4 | 1 | 0 |
| 3 | 吸入用七氟烷 | 3 | 1 | 0 |
| 4 | 左氧氟沙星滴眼液 | 2 | 2 | 16 |
| 5 | 氨溴特罗口服溶液 | 2 | 2 | 23 |
| 6 | 法莫替丁注射液 | 2 | 2 | 8 |
| 7 | 克立硼罗软膏 | 2 | 1 | 28 |
| 8 | 卡络磺钠注射液 | 2 | 1 | 1 |
| 9 | 吸入用异丙托溴铵溶液 | 2 | 1 | 2 |
| 10 | 富马酸伏诺拉生片 | 2 | 1 | 58 |
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
191 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 安阳广盛恒制药有限公司 | 62 | 50 | 0 |
| 2 | 河北凯威恒诚制药有限公司 | 19 | 15 | 0 |
| 3 | 江西人可医药科技有限公司 | 15 | 14 | 0 |
| 4 | 南京艾美斐生物医药科技有限公司 | 12 | 1 | 0 |
| 5 | Bard Pharmaceuticals Limited | 7 | 3 | 0 |
| 6 | 齐鲁制药（海南）有限公司 | 6 | 2 | 4 |
| 7 | Eli Lilly and Company | 6 | 1 | 0 |
| 8 | 长沙爱贝高药业有限公司 | 5 | 5 | 0 |
| 9 | 华北制药集团先泰药业有限公司 | 5 | 2 | 0 |
| 10 | 江苏博创园生物医药科技有限公司 | 5 | 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
105 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/05/15Generic · Class 3 | 复方磷酸盐颗粒CYHS2301310 | 嘉实（湖南）医药科技有限公司; 湖南天济草堂制药股份有限公司 |
| 2023/05/13Generic · Class 3 | 盐酸普萘洛尔注射液CYHS2301309 | 华夏生生药业（北京）有限公司 |
| 2023/05/13Generic · Class 3 | 氨溴特罗口服溶液CYHS2301308 | 广州仁恒医药科技股份有限公司; 湖南九典制药股份有限公司 |
| 2023/05/13Generic · Class 3 | 盐酸替罗非班氯化钠注射液CYHS2301307 | 河南润弘制药股份有限公司; 山东华鲁制药有限公司 |
| 2023/05/13Generic · Class 3 | 盐酸替罗非班氯化钠注射液CYHS2301306 | 河南润弘制药股份有限公司; 山东华鲁制药有限公司 |
| 2023/05/13New drug · Class 1.1 | 参蓉颗粒CXZL2300034 | 石家庄以岭药业股份有限公司 |
| 2023/05/13New drug · Class 1 | BAT1308注射液CXSL2300336 | 百奥泰生物制药股份有限公司 |
| 2023/05/13New drug · Class 2.4 | BAT4706注射液CXSL2300335 | 百奥泰生物制药股份有限公司 |
| 2023/05/13New drug · Class 2.4 | BAT4706注射液CXSL2300334 | 百奥泰生物制药股份有限公司 |
| 2023/05/13New drug · Class 1 | SIM0278注射液CXSL2300333 | 江苏先声药业有限公司 |
| 2023/05/13New drug · Class 1 | XH-5102片CXHL2300516 | 上海勋和医药科技有限公司 |
| 2023/05/13New drug · Class 1 | XH-5102片CXHL2300515 | 上海勋和医药科技有限公司 |
| 2023/05/12Import · Class 3.1 | Nirsevimab注射液JXSS2300038 | AstraZeneca AB; Patheon Manufacturing Services LLC; - |
| 2023/05/12Import · Class 3.1 | Nirsevimab注射液JXSS2300037 | AstraZeneca AB; Patheon Manufacturing Services LLC; - |
| 2023/05/12Import · Class 2.2 | Anifrolumab注射液JXSL2300092 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2023/05/12Generic · Class 3 | 氨氯地平贝那普利胶囊CYHS2301300 | 浙江高跖医药科技股份有限公司; 江苏和晨药业有限公司 |
| 2023/05/12Generic · Class 3 | 富马酸福莫特罗吸入溶液CYHS2301297 | 山东京卫制药有限公司 |
| 2023/05/12Generic · Class 3 | 硝普钠氯化钠注射液CYHS2301295 | 海南普利制药股份有限公司 |
| 2023/05/12Generic · Class 3 | 硝普钠氯化钠注射液CYHS2301294 | 海南普利制药股份有限公司 |
| 2023/05/12Generic · Class 3 | 硝普钠氯化钠注射液CYHS2301293 | 海南普利制药股份有限公司 |
| 2023/05/12Generic · Class 3 | 硝普钠氯化钠注射液CYHS2301292 | 海南普利制药股份有限公司 |
| 2023/05/12New drug · Class 3.3 | SAL023注射液CXSL2300332 | 信立泰（成都）生物技术有限公司; 信立泰（苏州）药业有限公司; 深圳信立泰药业股份有限公司 |
| 2023/05/12New drug · Class 1 | 注射用QLS31905CXSL2300331 | 齐鲁制药有限公司 |
| 2023/05/12New drug · Class 1 | 镥[177Lu]JH020002注射液CXHL2300514 | 晶核生物医药科技（南京）有限公司; 晶核生物医药科技（上海）有限公司 |
| 2023/05/12New drug · Class 1 | KH607片CXHL2300513 | 成都康弘药业集团股份有限公司 |
| 2023/05/12New drug · Class 1 | KH607片CXHL2300512 | 成都康弘药业集团股份有限公司 |
| 2023/05/12New drug · Class 1 | KH607片CXHL2300511 | 成都康弘药业集团股份有限公司 |
| 2023/05/12New drug · Class 2.3 | 海博麦布阿托伐他汀钙片CXHL2300510 | 瀚晖制药有限公司 |
| 2023/05/12New drug · Class 2.3 | 海博麦布阿托伐他汀钙片CXHL2300509 | 瀚晖制药有限公司 |
| 2023/05/11Import · Class 1 | EYP-1901玻璃体内植入剂JXHL2300114 | EyePoint Pharmaceuticals Inc.; Betta Pharmaceuticals Co. Ltd. |
75 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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