药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/02/20 – 2024/02/26
- New acceptances this week
- 292
- Drugs with new generic filings (by drug name, de-duplicated)
- 67
- Accepted this week, now under review
- 6
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
292filings, 87 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 133 |
| Generic | 87 |
| New drug | 56 |
| Import | 13 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 197 |
| TCM | 49 |
| 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
67 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 复合磷酸氢钾注射液 | 3 | 3 | 2 |
| 2 | 恩格列净二甲双胍缓释片 | 3 | 1 | 12 |
| 3 | 托吡司特片 | 3 | 1 | 0 |
| 4 | 注射用拉氧头孢钠 | 3 | 1 | 4 |
| 5 | 二羟丙茶碱注射液 | 2 | 2 | 7 |
| 6 | 比索洛尔氨氯地平片 | 2 | 2 | 8 |
| 7 | 重酒石酸间羟胺注射液 | 2 | 2 | 2 |
| 8 | 丙泊酚乳状注射液 | 2 | 1 | 2 |
| 9 | 乙酰半胱氨酸颗粒 | 2 | 1 | 4 |
| 10 | 布洛芬混悬液 | 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
170 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 石家庄御泽堂制药有限公司 | 21 | 19 | 0 |
| 2 | 甘肃新岷海制药有限公司 | 10 | 10 | 0 |
| 3 | 石药集团中诺药业(石家庄)有限公司 | 10 | 3 | 0 |
| 4 | 成都百利多特生物药业有限责任公司 | 7 | 1 | 0 |
| 5 | 四川医颗草药业有限公司 | 6 | 6 | 0 |
| 6 | AstraZeneca AB | 6 | 3 | 0 |
| 7 | 山东齐都药业有限公司 | 5 | 4 | 2 |
| 8 | Myokardia Inc. | 5 | 1 | 0 |
| 9 | 石家庄四药有限公司 | 4 | 4 | 2 |
| 10 | 上海领泰生物医药科技有限公司 | 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
113 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/02/26Import · Class 1 | 注射用JR8603JXHL2400043 | JiaRay Pharmaceuticals Inc. |
| 2024/02/26Generic · Class 3 | 盐酸多巴胺注射液CYHS2400700 | 上海灵桐医药科技有限公司; 浙江赛默制药有限公司 |
| 2024/02/26Generic · Class 3 | 腺苷钴胺胶囊CYHS2400699 | 福建古田药业有限公司 |
| 2024/02/26New drug · Class 1 | 注射用YKST02CXSL2400158 | 益科思特(北京)医药科技发展有限公司 |
| 2024/02/26New drug · Class 1 | SCM-181注射液CXSL2400157 | 云南舜喜再生医学工程有限公司 |
| 2024/02/26New drug · Class 1 | 宫血间充质干细胞注射液CXSL2400156 | 浙江生创精准医疗科技有限公司 |
| 2024/02/26New drug · Class 1 | YK-051乳状注射液CXHL2400217 | 南京优科制药有限公司 |
| 2024/02/24Import · Class 2.2 | 纳武利尤单抗注射液JXSS2400015 | Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2024/02/24Import · Class 2.2 | 纳武利尤单抗注射液JXSS2400014 | Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2024/02/24Import · Class 2.4 | 拉索昔芬片JXHL2400042 | Sermonix Pharmaceuticals Inc.; Shanghai Henlius Biotech Inc. |
| 2024/02/24Generic · Class 3 | 二羟丙茶碱注射液CYHS2400692 | 广东鼎信医药科技有限公司; 广东星昊药业有限公司 |
| 2024/02/24Generic · Class 3 | 二羟丙茶碱注射液CYHS2400690 | 河北龙海药业有限公司; 石家庄凯达生物工程有限公司 |
| 2024/02/24New drug · Class 1 | LAE102注射液CXSL2400155 | 来凯医药科技(上海)有限公司 |
| 2024/02/24New drug · Class 1 | ENN0403胶囊CXHL2400216 | 轶诺(浙江)药业有限公司 |
| 2024/02/24New drug · Class 1 | ENN0403胶囊CXHL2400215 | 轶诺(浙江)药业有限公司 |
| 2024/02/24New drug · Class 1 | 注射用YN17CXHL2400214 | 浙江永宁药业股份有限公司 |
| 2024/02/24New drug · Class 1 | VB15010片CXHL2400213 | 深圳扬厉医药技术有限公司 |
| 2024/02/24New drug · Class 1 | VB15010片CXHL2400212 | 深圳扬厉医药技术有限公司 |
| 2024/02/24New drug · Class 1 | SR1375胶囊CXHL2400211 | 上海赛默罗生物科技有限公司 |
| 2024/02/24New drug · Class 1 | SR1375胶囊CXHL2400210 | 上海赛默罗生物科技有限公司 |
| 2024/02/24New drug · Class 1 | SR1375胶囊CXHL2400209 | 上海赛默罗生物科技有限公司 |
| 2024/02/23Generic · Class 3 | 美索巴莫注射液CYHS2400686 | 西洲医药科技(浙江)有限公司; 浙江北生药业汉生制药有限公司 |
| 2024/02/23Generic · Class 3 | 复合磷酸氢钾注射液CYHS2400685 | 广州合和医药有限公司; 扬州中宝药业股份有限公司 |
| 2024/02/23Generic · Class 3 | 马来酸氯苯那敏注射液CYHS2400684 | 辽宁海神联盛制药有限公司; 山东简道制药有限公司 |
| 2024/02/23Generic · Class 3 | 复合磷酸氢钾注射液CYHS2400682 | 仁合益康汇泽药业河北有限公司; 河北仁合益康药业有限公司 |
| 2024/02/23Generic · Class 3 | 复合磷酸氢钾注射液CYHS2400681 | 重庆赛维药业有限公司; 山东华鲁制药有限公司 |
| 2024/02/23Generic · Class 3 | 氯化钾缓释片CYHS2400678 | 天津力生制药股份有限公司 |
| 2024/02/23Generic · Class 3 | 氯化钾缓释片CYHS2400677 | 天津力生制药股份有限公司 |
| 2024/02/23Generic · Class 3 | 法莫替丁注射液CYHS2400674 | 海南全星制药有限公司 |
| 2024/02/23New drug · Class 1 | CM383注射液CXSL2400154 | 康诺亚生物医药科技(成都)有限公司 |
83 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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