药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/10/31 – 2023/11/06
- New acceptances this week
- 317
- Drugs with new generic filings (by drug name, de-duplicated)
- 57
- Accepted this week, now under review
- 0
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
317filings, 74 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 149 |
| Generic | 74 |
| New drug | 66 |
| Import re-registration | 18 |
| Import | 8 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 204 |
| TCM | 67 |
| 治疗用生物制品 | 43 |
| 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
57 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 玻璃酸钠滴眼液 | 3 | 2 | 29 |
| 2 | 米诺地尔搽剂 | 3 | 2 | 49 |
| 3 | 培哚普利叔丁胺片 | 3 | 1 | 5 |
| 4 | 复合磷酸氢钾注射液 | 2 | 2 | 2 |
| 5 | 卡络磺钠注射液 | 2 | 1 | 1 |
| 6 | 吸入用盐酸丙卡特罗溶液 | 2 | 1 | 2 |
| 7 | 多索茶碱片 | 2 | 1 | 2 |
| 8 | 奥美沙坦酯片 | 2 | 1 | 1 |
| 9 | 富马酸伏诺拉生片 | 2 | 1 | 58 |
| 10 | 布立西坦片 | 2 | 1 | 16 |
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
201 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 江西南昌济生制药有限责任公司 | 9 | 9 | 0 |
| 2 | 广东团力制药有限公司 | 5 | 5 | 0 |
| 3 | 百奥泰生物制药股份有限公司 | 5 | 3 | 0 |
| 4 | Janssen-Cilag International NV | 5 | 2 | 0 |
| 5 | Merck Sharp & Dohme B.V. | 5 | 1 | 0 |
| 6 | 杭州九源基因工程有限公司 | 5 | 1 | 0 |
| 7 | 武汉朗来科技发展有限公司 | 4 | 2 | 0 |
| 8 | 江苏恒瑞医药股份有限公司 | 4 | 2 | 0 |
| 9 | 浙江高跖医药科技股份有限公司 | 4 | 2 | 4 |
| 10 | 商丘市鑫马生物科技有限公司 | 3 | 3 | 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
106 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/11/06Generic · Class 3 | 复合磷酸氢钾注射液CYHS2303010 | 成都米子生物医药科技有限公司; 山东华鲁制药有限公司 |
| 2023/11/06New drug · Class 1 | QR056240CR片CXHL2301223 | 武汉朗来科技发展有限公司 |
| 2023/11/06New drug · Class 1 | QR056240CR片CXHL2301222 | 武汉朗来科技发展有限公司 |
| 2023/11/06New drug · Class 1 | BGB-43395片CXHL2301221 | 百济神州(苏州)生物科技有限公司 |
| 2023/11/06New drug · Class 1 | BGB-43395片CXHL2301220 | 百济神州(苏州)生物科技有限公司 |
| 2023/11/06New drug · Class 1 | BGB-43395片CXHL2301219 | 百济神州(苏州)生物科技有限公司 |
| 2023/11/04Generic · Class 3 | 复合磷酸氢钾注射液CYHS2303008 | 成都欣捷高新技术开发股份有限公司; 山东华鲁制药有限公司 |
| 2023/11/04Generic · Class 3 | 富马酸酮替芬滴眼液CYHS2303005 | 成都慧德医药科技有限公司; 浙江赛默制药有限公司 |
| 2023/11/04Generic · Class 3 | 卡络磺钠注射液CYHS2303003 | 河北创健药业有限公司; 河北仁合益康药业有限公司 |
| 2023/11/04Generic · Class 3 | 卡络磺钠注射液CYHS2303002 | 河北创健药业有限公司; 河北仁合益康药业有限公司 |
| 2023/11/04Generic · Class 3 | 酮咯酸氨丁三醇注射液CYHS2303001 | 广州一品红制药有限公司; 河北凯威制药有限责任公司 |
| 2023/11/04Generic · Class 3 | 小儿复方氨基酸注射液(20AA)CYHS2302930 | 石家庄四药有限公司 |
| 2023/11/04New drug · Class 2.4 | BAT4706注射液CXSL2300764 | 百奥泰生物制药股份有限公司 |
| 2023/11/04New drug · Class 2.4 | BAT4706注射液CXSL2300763 | 百奥泰生物制药股份有限公司 |
| 2023/11/04New drug · Class 1 | BAT7104注射液CXSL2300762 | 百奥泰生物制药股份有限公司 |
| 2023/11/04New drug · Class 1 | GMCN-508B自体造血干祖细胞注射液CXSL2300761 | 中吉智药(南京)生物技术有限公司 |
| 2023/11/04New drug · Class 1 | 注射用间充质干细胞(脐带)CXSL2300760 | 天津昂赛细胞基因工程有限公司 |
| 2023/11/04New drug · Class 1 | SHR0302片CXHS2300097 | 江苏恒瑞医药股份有限公司 |
| 2023/11/04New drug · Class 1 | GH2616片CXHL2301218 | 勤浩医药(苏州)有限公司 |
| 2023/11/04New drug · Class 1 | GH2616片CXHL2301217 | 勤浩医药(苏州)有限公司 |
| 2023/11/04New drug · Class 2.3 | SZJ-208CXHL2301216 | 江西施美药业股份有限公司 |
| 2023/11/04New drug · Class 1 | 注射用双利司他CXHL2301215 | 广州必贝特医药股份有限公司 |
| 2023/11/03Import · Class 1 | 盐酸BAY 3283142片JXHL2300271 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2023/11/03Import · Class 1 | 盐酸BAY 3283142片JXHL2300270 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2023/11/03Generic · Class 3 | 甘油果糖氯化钠注射液CYHS2302989 | 湖北美林药业有限公司; 津药和平(天津)制药有限公司 |
| 2023/11/03Generic · Class 3 | 草酸艾司西酞普兰口服溶液CYHS2302987 | 苏州朗科生物技术股份有限公司; 南京海纳制药有限公司 |
| 2023/11/03Generic · Class 3 | 氯化钾注射液CYHS2302986 | 重庆万霖生物医药科技有限公司; 江苏大红鹰恒顺药业有限公司 |
| 2023/11/03New drug · Class 1 | 伊基奥仑赛注射液CXSL2300759 | 南京驯鹿生物医药有限公司 |
| 2023/11/03New drug · Class 1 | PD-1基因编辑T细胞注射液CXSL2300758 | 美杰赛尔(北京)生物科技有限公司 |
| 2023/11/03New drug · Class 1 | YTS104细胞注射液CXSL2300757 | 华夏英泰(北京)生物技术有限公司 |
76 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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