药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/04/11 – 2023/04/17
- New acceptances this week
- 287
- Drugs with new generic filings (by drug name, de-duplicated)
- 40
- 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
287filings, 51 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 156 |
| Generic | 51 |
| New drug | 40 |
| Import | 18 |
| Import re-registration | 15 |
| Unspecified | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 212 |
| TCM | 37 |
| 治疗用生物制品 | 34 |
| Biologic | 2 |
| 预防用生物制品 | 2 |
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
40 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 二羟丙茶碱注射液 | 3 | 3 | 7 |
| 2 | 吸入用乙酰半胱氨酸溶液 | 2 | 2 | 4 |
| 3 | 氨溴特罗口服溶液 | 2 | 2 | 23 |
| 4 | 厄贝沙坦氨氯地平片 | 2 | 1 | 1 |
| 5 | 咪达唑仑口服溶液 | 2 | 1 | 0 |
| 6 | 注射用尼可地尔 | 2 | 1 | 1 |
| 7 | 盐酸布比卡因注射液 | 2 | 1 | 4 |
| 8 | 盐酸特比萘芬喷雾剂 | 2 | 1 | 7 |
| 9 | 盐酸鲁拉西酮片 | 2 | 1 | 2 |
| 10 | 美阿沙坦钾片 | 2 | 1 | 33 |
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
154 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 海南恒诚三叶制药有限公司 | 36 | 31 | 0 |
| 2 | 江西南昌济生制药有限责任公司 | 14 | 14 | 0 |
| 3 | 江西仁齐制药有限公司 | 7 | 7 | 1 |
| 4 | McNeil Sweden AB | 6 | 1 | 0 |
| 5 | Janssen Research & Development LLC | 5 | 2 | 0 |
| 6 | Eli Lilly and Company | 5 | 1 | 0 |
| 7 | 北京硕佰医药科技有限责任公司 | 5 | 1 | 0 |
| 8 | 河南蓝天药业有限公司 | 4 | 4 | 0 |
| 9 | Novartis Pharma Schweiz AG | 4 | 2 | 0 |
| 10 | 上海君实生物医药科技股份有限公司 | 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
78 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/04/17Generic · Class 3 | 盐酸溴己新口服溶液CYHS2301068 | 安徽新世纪药业有限公司 |
| 2023/04/17Generic · Class 3 | 氨溴特罗口服溶液CYHS2301066 | 江西仁齐制药有限公司; 湖南九典制药股份有限公司 |
| 2023/04/17Generic · Class 3 | 盐酸丙美卡因滴眼液CYHS2301065 | 合肥立方制药股份有限公司; 安徽省双科药业有限公司 |
| 2023/04/17Generic · Class 3 | 尼麦角林片CYHS2301063 | 北京福元医药股份有限公司 |
| 2023/04/17New drug · Class 3.1 | 桃红四物汤颗粒CXZS2300009 | 瑞阳制药股份有限公司 |
| 2023/04/17New drug · Class 1 | BAT1308注射液CXSL2300263 | 百奥泰生物制药股份有限公司 |
| 2023/04/17New drug · Class 1 | HBW-3220胶囊CXHL2300382 | 成都海博为药业有限公司 |
| 2023/04/17New drug · Class 1 | 注射用MT1002CXHL2300381 | 陕西麦科奥特科技有限公司 |
| 2023/04/17New drug · Class 1 | 注射用MT1002CXHL2300380 | 陕西麦科奥特科技有限公司 |
| 2023/04/17New drug · Class 1 | WD-890片CXHL2300379 | 浙江文达医药科技有限公司 |
| 2023/04/17New drug · Class 1 | WD-890片CXHL2300378 | 浙江文达医药科技有限公司 |
| 2023/04/17New drug · Class 1 | WD-890片CXHL2300377 | 浙江文达医药科技有限公司 |
| 2023/04/17New drug · Class 1 | WD-890片CXHL2300376 | 浙江文达医药科技有限公司 |
| 2023/04/17New drug · Class 1 | CPU-118片CXHL2300375 | 南京芩领医药科技有限公司 |
| 2023/04/15Import · Class 1 | Monalizumab 注射液JXSL2300068 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/04/15Generic · Class 3 | 马来酸氯苯那敏注射液CYHS2301060 | 南京丰恺思药物研发有限公司; 成都市海通药业有限公司 |
| 2023/04/15Generic · Class 3 | 二羟丙茶碱注射液CYHS2301059 | 南京康发生物科技有限公司; 金陵药业股份有限公司南京金陵制药厂 |
| 2023/04/15Generic · Class 3 | 氨溴特罗口服溶液CYHS2301056 | 山东京卫制药有限公司 |
| 2023/04/15New drug · Class 2.2 | 冻干人用狂犬病疫苗（人二倍体细胞）CXSL2300262 | 中逸安科生物技术股份有限公司; 辽宁茂康源生物科技有限公司 |
| 2023/04/15New drug · Class 1 | RC198注射液CXSL2300261 | 荣昌生物制药（烟台）股份有限公司 |
| 2023/04/15New drug · Class 1 | HS-10365胶囊CXHL2300374 | 江苏豪森药业集团有限公司; 上海翰森生物医药科技有限公司 |
| 2023/04/15New drug · Class 1 | HEC53856片CXHL2300373 | 广东东阳光药业有限公司 |
| 2023/04/15New drug · Class 1 | HEC53856片CXHL2300372 | 广东东阳光药业有限公司 |
| 2023/04/14Import · Class 1 | LY3437943注射液JXHL2300084 | Eli Lilly and Company |
| 2023/04/14Import · Class 1 | LY3437943注射液JXHL2300083 | Eli Lilly and Company |
| 2023/04/14Import · Class 1 | LY3437943注射液JXHL2300082 | Eli Lilly and Company |
| 2023/04/14Import · Class 1 | LY3437943注射液JXHL2300081 | Eli Lilly and Company |
| 2023/04/14Import · Class 1 | LY3437943注射液JXHL2300080 | Eli Lilly and Company |
| 2023/04/14Generic · Class 3 | 异烟肼注射液CYHS2301054 | 嘉实（湖南）医药科技有限公司; 湖南五洲通药业股份有限公司 |
| 2023/04/14Generic · Class 3 | 恩替卡韦口服溶液CYHS2301053 | 贵州阜康仁制药有限公司; 湖北唯森制药有限公司 |
48 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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