药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/03/19 – 2024/03/25
- New acceptances this week
- 176
- Drugs with new generic filings (by drug name, de-duplicated)
- 36
- Accepted this week, now under review
- 1
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
176filings, 45 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 88 |
| Generic | 45 |
| New drug | 28 |
| Import | 8 |
| Unspecified | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 103 |
| TCM | 47 |
| 治疗用生物制品 | 24 |
| Biologic | 1 |
| 预防用生物制品 | 1 |
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
36 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 他达拉非片 | 3 | 1 | 23 |
| 2 | 吗啉硝唑氯化钠注射液 | 2 | 2 | 10 |
| 3 | 复合磷酸氢钾注射液 | 2 | 2 | 2 |
| 4 | 注射用尼可地尔 | 2 | 2 | 1 |
| 5 | 吸入用盐酸溴己新溶液 | 2 | 1 | 1 |
| 6 | 盐酸氨溴索口服溶液 | 2 | 1 | 45 |
| 7 | 盐酸艾司洛尔氯化钠注射液 | 2 | 1 | 0 |
| 8 | 舒更葡糖钠注射液 | 2 | 1 | 6 |
| 9 | 利多卡因丁卡因乳膏 | 1 | 1 | 2 |
| 10 | 呋塞米注射液 | 1 | 1 | 6 |
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
111 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 国大(吉林)制药集团有限公司 | 22 | 22 | 0 |
| 2 | 宜昌诺安制药有限公司 | 4 | 4 | 0 |
| 3 | 石家庄四药有限公司 | 4 | 4 | 4 |
| 4 | 百奥泰生物制药股份有限公司 | 4 | 3 | 0 |
| 5 | Albireo AB | 4 | 1 | 0 |
| 6 | 昆明南疆制药有限公司 | 4 | 1 | 0 |
| 7 | 沈阳红旗制药有限公司 | 3 | 2 | 1 |
| 8 | 辉瑞制药科技有限公司 | 3 | 2 | 0 |
| 9 | 正大天晴药业集团股份有限公司 | 3 | 1 | 0 |
| 10 | 江苏润邦药业有限公司 | 3 | 1 | 3 |
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
52 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/03/25Generic · Class 3 | 氨磺必利口服溶液CYHS2400906 | 仁合益康集团有限公司; 河北仁合益康药业有限公司 |
| 2024/03/25Generic · Class 3 | 呋塞米注射液CYHS2400905 | 酒泉大得利制药股份有限公司 |
| 2024/03/23Import · Class 1 | MK-7240注射用浓溶液JXSL2400063 | Merck Sharp & Dohme LLC; 不适用 |
| 2024/03/23Import · Class 1 | MK-7240注射液JXSL2400062 | Merck Sharp & Dohme LLC; 不适用 |
| 2024/03/23Import · Class 1 | BudigalimabJXSL2400061 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2024/03/23Generic · Class 3 | 复方醋酸钠林格注射液CYHS2400900 | 石家庄四药有限公司 |
| 2024/03/23Generic · Class 3 | 注射用尼可地尔CYHS2400899 | 广东海赫生物医药科技有限公司; 山西振东泰盛制药有限公司 |
| 2024/03/23Generic · Class 3 | 复合磷酸氢钾注射液CYHS2400897 | 哈尔滨誉衡制药有限公司; 浙江赛默制药有限公司 |
| 2024/03/23Generic · Class 3 | 盐酸尼卡地平氯化钠注射液CYHS2400895 | 石家庄四药有限公司 |
| 2024/03/23Generic · Class 3 | 利多卡因丁卡因乳膏CYHL2400063 | 江苏万高药业股份有限公司 |
| 2024/03/23New drug · Class 2.2 | 贝伐珠单抗注射液CXSL2400202 | 百奥泰生物制药股份有限公司 |
| 2024/03/23New drug · Class 2.2 | 贝伐珠单抗注射液CXSL2400201 | 百奥泰生物制药股份有限公司 |
| 2024/03/23New drug · Class 1 | HCB101注射液CXSL2400200 | 广州汉科生物有限公司 |
| 2024/03/22Generic · Class 3 | 盐酸多巴胺注射液CYHS2400892 | 上海现代哈森(商丘)药业有限公司 |
| 2024/03/22Generic · Class 3 | 盐酸肾上腺素注射液CYHS2400890 | 南京臣功制药股份有限公司; 合肥亿帆生物制药有限公司 |
| 2024/03/22Generic · Class 3 | 注射用尼可地尔CYHS2400889 | 福州华为医药技术开发有限公司; 四川宏明博思药业有限公司 |
| 2024/03/22New drug · Class 3.3 | 四价流感病毒裂解疫苗CXSS2400027 | 江苏康润生物科技股份有限公司 |
| 2024/03/22New drug · Class 1 | 盐酸杰克替尼片CXHL2400298 | 苏州泽璟生物制药股份有限公司 |
| 2024/03/22New drug · Class 1 | 盐酸杰克替尼片CXHL2400297 | 苏州泽璟生物制药股份有限公司 |
| 2024/03/22New drug · Class 1 | YK-051CXHL2400296 | 南京优科制药有限公司 |
| 2024/03/21Generic · Class 3 | 复合磷酸氢钾注射液CYHS2400885 | 苏州朗科生物技术股份有限公司; 扬州中宝药业股份有限公司 |
| 2024/03/21Generic · Class 3 | 氨氯地平贝那普利胶囊CYHS2400884 | 北京福元医药股份有限公司 |
| 2024/03/21Generic · Class 3 | 注射用雷替曲塞CYHS2400880 | 山东百诺医药股份有限公司; 哈尔滨三联药业股份有限公司 |
| 2024/03/21Generic · Class 3 | 盐酸异丙肾上腺素注射液CYHS2400879 | 远大医药(中国)有限公司 |
| 2024/03/21New drug · Class 1 | GCB-001CXSL2400199 | 上海金珂博生物技术有限公司 |
| 2024/03/21New drug · Class 1 | BAT7104注射液CXSL2400198 | 百奥泰生物制药股份有限公司 |
| 2024/03/21New drug · Class 1 | 注射用BAT8008CXSL2400197 | 百奥泰生物制药股份有限公司 |
| 2024/03/20Import · Class 1 | LY3819469注射液JXHL2400066 | Eli Lilly and Company |
| 2024/03/20New drug · Class 1.1 | 柴桂解感颗粒CXZL2400016 | 山东中医药大学; 山东古金中医药科技有限公司 |
| 2024/03/20New drug · Class 1 | 注射用DB-1305CXSL2400196 | 映恩生物制药(苏州)有限公司 |
22 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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