药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/01/02 – 2024/01/08
- New acceptances this week
- 326
- Drugs with new generic filings (by drug name, de-duplicated)
- 73
- Accepted this week, now under review
- 3
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
326filings, 98 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 152 |
| Generic | 98 |
| New drug | 48 |
| Import | 16 |
| Unspecified | 6 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 248 |
| 治疗用生物制品 | 39 |
| TCM | 36 |
| 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
73 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 富马酸伏诺拉生片 | 4 | 2 | 58 |
| 2 | 米诺地尔搽剂 | 4 | 2 | 49 |
| 3 | 胞磷胆碱注射液 | 3 | 1 | 0 |
| 4 | 氯化钙注射液 | 2 | 2 | 6 |
| 5 | 腺苷钴胺胶囊 | 2 | 2 | 8 |
| 6 | 中/长链脂肪乳注射液(C6~24) | 2 | 1 | 0 |
| 7 | 乙酰半胱氨酸口服溶液 | 2 | 1 | 11 |
| 8 | 乳果糖口服溶液 | 2 | 1 | 40 |
| 9 | 双丙戊酸钠缓释片 | 2 | 1 | 0 |
| 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
197 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 内蒙古孟和制药股份有限公司 | 8 | 8 | 0 |
| 2 | 武汉滨湖双鹤药业有限责任公司 | 8 | 1 | 0 |
| 3 | 石家庄四药有限公司 | 6 | 5 | 4 |
| 4 | 绿叶嘉奥制药石家庄有限公司 | 6 | 1 | 0 |
| 5 | 宜昌人福药业有限责任公司 | 5 | 3 | 3 |
| 6 | 贝达药业股份有限公司 | 5 | 2 | 0 |
| 7 | 黑龙江宋慈制药有限责任公司 | 4 | 4 | 0 |
| 8 | 南京海纳医药科技股份有限公司 | 4 | 3 | 0 |
| 9 | 浙江花园药业有限公司 | 4 | 3 | 2 |
| 10 | AstraZeneca AB | 4 | 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
104 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/01/08Generic · Class 3 | 硫酸特布他林口服溶液CYHS2400090 | 合肥国药诺和药业有限公司; 华益药业科技(安徽)有限公司 |
| 2024/01/08Generic · Class 3 | 硫酸特布他林口服溶液CYHS2400089 | 合肥国药诺和药业有限公司; 华益药业科技(安徽)有限公司 |
| 2024/01/08Generic · Class 3 | 西格列汀二甲双胍缓释片CYHS2400088 | 广东东阳光药业股份有限公司; 宜昌东阳光长江药业股份有限公司 |
| 2024/01/08Generic · Class 3 | 西格列汀二甲双胍缓释片CYHS2400087 | 广东东阳光药业股份有限公司; 宜昌东阳光长江药业股份有限公司 |
| 2024/01/08Generic · Class 3 | 卡络磺钠片CYHS2400086 | 成都倍特药业股份有限公司 |
| 2024/01/08New drug · Class 1 | SYS6023CXSL2400013 | 石药集团巨石生物制药有限公司 |
| 2024/01/08New drug · Class 1 | 注射用NC18CXSL2400012 | 诺灵生物医药科技(杭州)有限公司 |
| 2024/01/08New drug · Class 1 | SYH2039片CXHL2400030 | 石药集团中奇制药技术(石家庄)有限公司 |
| 2024/01/08New drug · Class 1 | SYH2039片CXHL2400029 | 石药集团中奇制药技术(石家庄)有限公司 |
| 2024/01/06Import · Class 1 | Itepekimab注射液JXSL2400008 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2024/01/06Import · Class 1 | ABBV-383输注用溶液JXSL2400007 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2024/01/06Import · Class 1 | TAK-279胶囊JXHL2400004 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd |
| 2024/01/06Import · Class 1 | TAK-279胶囊JXHL2400003 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd |
| 2024/01/06Generic · Class 3 | 乙酰半胱氨酸注射液CYHS2400081 | 杭州云柏医药科技有限公司; 浙江赛默制药有限公司 |
| 2024/01/06Generic · Class 3 | 呋塞米口服溶液CYHS2400080 | 江苏康缘药业股份有限公司 |
| 2024/01/06Generic · Class 3 | 己酮可可碱注射液CYHS2400077 | 广东迈恒医药研发有限公司; 中孚药业股份有限公司 |
| 2024/01/06Generic · Class 3 | 氨甲环酸氯化钠注射液CYHS2400076 | 石家庄四药有限公司 |
| 2024/01/06Generic · Class 3 | 马来酸噻吗洛尔滴眼液CYHS2400075 | 石家庄四药有限公司 |
| 2024/01/06Generic · Class 3 | 氨氯地平贝那普利胶囊CYHS2400074 | 北京万辉双鹤药业有限责任公司; 华润双鹤药业股份有限公司 |
| 2024/01/06Generic · Class 3 | 盐酸苯海拉明注射液CYHS2400071 | 海南秋实医药科技有限公司; 河南润弘制药股份有限公司 |
| 2024/01/06Generic · Class 3 | 盐酸多巴酚丁胺注射液CYHS2400068 | 山西德元堂药业有限公司 |
| 2024/01/06Generic · Class 3 | 复方枸橼酸铋钾胶囊CYHL2400007 | 湖北荆江源制药股份有限公司 |
| 2024/01/06New drug · Class 3.3 | QL2109注射液CXSL2400011 | 齐鲁制药有限公司 |
| 2024/01/06New drug · Class 1 | 注射用VDJ010CXSL2400010 | 北京伟德杰生物科技有限公司 |
| 2024/01/06New drug · Class 2.4;2.2 | LY102片CXHL2400028 | 青岛海洋生物医药研究院; 青岛海济生物医药有限公司; 中国海洋大学 |
| 2024/01/06New drug · Class 2.4;2.2 | LY102片CXHL2400027 | 青岛海洋生物医药研究院; 青岛海济生物医药有限公司; 中国海洋大学 |
| 2024/01/06New drug · Class 1 | LPM526000133富马酸盐胶囊CXHL2400026 | 绿叶嘉奥制药石家庄有限公司 |
| 2024/01/06New drug · Class 1 | LPM526000133富马酸盐胶囊CXHL2400025 | 绿叶嘉奥制药石家庄有限公司 |
| 2024/01/06New drug · Class 1 | LPM526000133富马酸盐胶囊CXHL2400024 | 绿叶嘉奥制药石家庄有限公司 |
| 2024/01/06New drug · Class 1 | LPM526000133富马酸盐胶囊CXHL2400023 | 绿叶嘉奥制药石家庄有限公司 |
74 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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