药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/06/06 – 2023/06/12
- New acceptances this week
- 255
- Drugs with new generic filings (by drug name, de-duplicated)
- 46
- 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
255filings, 69 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 104 |
| Generic | 69 |
| New drug | 53 |
| Import | 13 |
| Unspecified | 11 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 181 |
| 治疗用生物制品 | 40 |
| TCM | 26 |
| Biologic | 4 |
| 预防用生物制品 | 4 |
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
46 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 氯化钾注射液 | 3 | 3 | 10 |
| 2 | 米诺地尔外用溶液 | 3 | 2 | 0 |
| 3 | 乳果糖口服溶液 | 3 | 1 | 36 |
| 4 | 注射用头孢哌酮钠舒巴坦钠（2:1） | 3 | 1 | 2 |
| 5 | 甲硫酸新斯的明注射液 | 3 | 1 | 4 |
| 6 | 硝酸甘油舌下片 | 3 | 1 | 3 |
| 7 | 间苯三酚注射液 | 2 | 2 | 2 |
| 8 | 吸入用盐酸丙卡特罗溶液 | 2 | 1 | 2 |
| 9 | 地氯雷他定口服溶液 | 2 | 1 | 26 |
| 10 | 氯化钾颗粒 | 2 | 1 | 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
165 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 江苏众红生物工程创药研究院有限公司 | 6 | 1 | 0 |
| 2 | 东莞市阳之康医药有限责任公司 | 4 | 4 | 0 |
| 3 | 信东生技股份有限公司 | 4 | 1 | 0 |
| 4 | 安徽九洲方圆制药有限公司 | 3 | 3 | 0 |
| 5 | 广西泰诺制药有限公司 | 3 | 3 | 0 |
| 6 | AstraZeneca AB | 3 | 2 | 0 |
| 7 | Merck Healthcare KGaA | 3 | 2 | 0 |
| 8 | 江苏恩华药业股份有限公司 | 3 | 2 | 0 |
| 9 | 江西科睿药业有限公司 | 3 | 2 | 0 |
| 10 | 齐鲁制药有限公司 | 3 | 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
93 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/06/12New drug · Class 1.3 | 冻干人用CpG佐剂狂犬病疫苗（Vero细胞）CXSL2300409 | 长春卓谊生物股份有限公司 |
| 2023/06/12New drug · Class 2.2;2.4 | 注射用醋酸丙氨瑞林微球CXHL2300637 | 上海丽珠制药有限公司 |
| 2023/06/10Generic · Class 3 | 盐酸多巴胺注射液CYHS2301598 | 圣嘉（滨海）生物医药科技有限公司; 浙江赛默制药有限公司 |
| 2023/06/10Generic · Class 3 | 盐酸多巴胺注射液CYHS2301597 | 圣嘉（滨海）生物医药科技有限公司; 浙江赛默制药有限公司 |
| 2023/06/10Generic · Class 3 | 氯化钾注射液CYHS2301596 | 成都米子生物医药科技有限公司; 山东华鲁制药有限公司 |
| 2023/06/10Generic · Class 3 | 盐酸哌罗匹隆片CYHS2301594 | 四川科瑞德制药股份有限公司 |
| 2023/06/10Generic · Class 3 | 盐酸哌罗匹隆片CYHS2301593 | 四川科瑞德制药股份有限公司 |
| 2023/06/10Generic · Class 3 | 硝酸甘油注射液CYHS2301592 | 仁合益康集团有限公司; 河北仁合益康药业有限公司 |
| 2023/06/10Generic · Class 3 | 硝酸甘油注射液CYHS2301591 | 仁合益康集团有限公司; 河北仁合益康药业有限公司 |
| 2023/06/10Generic · Class 3 | 西格列汀二甲双胍缓释片CYHS2301590 | 齐鲁制药（海南）有限公司 |
| 2023/06/10Generic · Class 3 | 氯化钾颗粒CYHS2301588 | 济川药业集团有限公司 |
| 2023/06/10Generic · Class 3 | 氯化钾颗粒CYHS2301587 | 济川药业集团有限公司 |
| 2023/06/10Generic · Class 3 | 布美他尼注射液CYHS2301586 | 成都苑东生物制药股份有限公司 |
| 2023/06/10Generic · Class 3 | 尼麦角林片CYHS2301585 | 北京九能天远科技有限公司; 山东齐都药业有限公司 |
| 2023/06/10New drug · Class 1 | TAVO412注射液CXSL2300408 | 拓创生物科技（江苏）有限公司 |
| 2023/06/10New drug · Class 1.2 | 人用狂犬病mRNA疫苗CXSL2300407 | 珠海丽凡达生物技术有限公司; 艾美疫苗股份有限公司 |
| 2023/06/10New drug · Class 1 | SGN1注射液CXSL2300406 | 广州华津医药科技有限公司 |
| 2023/06/10New drug · Class 1 | SGN1注射液CXSL2300405 | 广州华津医药科技有限公司 |
| 2023/06/10New drug · Class 1 | SM17单克隆抗体注射液CXSL2300404 | 杏联药业（苏州）有限公司 |
| 2023/06/10New drug · Class 1 | ZX-7101A片CXHL2300636 | 南京征祥医药有限公司 |
| 2023/06/10New drug · Class 1 | ZX-7101A片CXHL2300635 | 南京征祥医药有限公司 |
| 2023/06/10New drug · Class 2.4;2.1 | ASC10片CXHL2300634 | 歌礼生物科技（杭州）有限公司 |
| 2023/06/10New drug · Class 1 | HRS-7450注射液CXHL2300633 | 福建盛迪医药有限公司 |
| 2023/06/10New drug · Class 1 | PG-011凝胶（Ⅱ）CXHL2300632 | 北京普祺医药科技股份有限公司 |
| 2023/06/10New drug · Class 1 | PG-011凝胶（Ⅱ）CXHL2300631 | 北京普祺医药科技股份有限公司 |
| 2023/06/10New drug · Class 1 | ISM4808胶囊CXHL2300630 | 英矽智能科技（上海）有限公司 |
| 2023/06/10New drug · Class 1 | ISM4808胶囊CXHL2300629 | 英矽智能科技（上海）有限公司 |
| 2023/06/10New drug · Class 2.3 | HMK-JST-080CXHL2300628 | 浙江和沐康医药科技有限公司 |
| 2023/06/10New drug · Class 1 | APL-1401胶囊CXHL2300627 | 江苏亚虹医药科技股份有限公司 |
| 2023/06/10New drug · Class 1 | APL-1401胶囊CXHL2300626 | 江苏亚虹医药科技股份有限公司 |
63 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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