药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/01/23 – 2024/01/29
- New acceptances this week
- 290
- Drugs with new generic filings (by drug name, de-duplicated)
- 72
- 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
290filings, 94 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 108 |
| Generic | 94 |
| New drug | 50 |
| Import re-registration | 19 |
| Import | 16 |
| Unspecified | 2 |
| 药械组合产品 | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 206 |
| TCM | 45 |
| 治疗用生物制品 | 33 |
| 预防用生物制品 | 5 |
| Biologic | 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
72 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 利奥西呱片 | 3 | 1 | 4 |
| 2 | 左氧氟沙星滴眼液 | 2 | 2 | 16 |
| 3 | 比索洛尔氨氯地平片 | 2 | 2 | 8 |
| 4 | 氧(液态) | 2 | 2 | 14 |
| 5 | 法莫替丁注射液 | 2 | 2 | 8 |
| 6 | 盐酸戊乙奎醚注射液 | 2 | 2 | 2 |
| 7 | 罗沙司他胶囊 | 2 | 2 | 17 |
| 8 | 乙磺酸尼达尼布软胶囊 | 2 | 1 | 6 |
| 9 | 乳果糖口服溶液 | 2 | 1 | 40 |
| 10 | 他达拉非片 | 2 | 1 | 23 |
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
199 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 湖北福人金身药业有限公司 | 7 | 7 | 0 |
| 2 | 金诃藏药股份有限公司 | 7 | 7 | 0 |
| 3 | Sanofi -aventis France | 7 | 1 | 0 |
| 4 | Amgen Inc. | 6 | 2 | 0 |
| 5 | AstraZeneca AB | 4 | 2 | 0 |
| 6 | 正大天晴药业集团股份有限公司 | 4 | 2 | 2 |
| 7 | 昆明南疆制药有限公司 | 4 | 1 | 0 |
| 8 | Janssen-Cilag International NV | 3 | 3 | 0 |
| 9 | Merck Sharp & Dohme LLC | 3 | 2 | 0 |
| 10 | 四川科瑞德制药股份有限公司 | 3 | 2 | 1 |
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
101 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/01/29Generic · Class 3 | 帕拉米韦注射液CYHS2400380 | 河南润弘制药股份有限公司 |
| 2024/01/29New drug · Class 1.1 | 喉喑清胶囊CXZS2400007 | 贵州瑞和制药有限公司 |
| 2024/01/28New drug · Class 1 | FHND6091胶囊CXHL2400119 | 江苏正大丰海制药有限公司 |
| 2024/01/28New drug · Class 1 | FHND6091胶囊CXHL2400118 | 江苏正大丰海制药有限公司 |
| 2024/01/27Generic · Class 3 | 盐酸甲氧氯普胺注射液CYHS2400373 | 河北凯威制药有限责任公司 |
| 2024/01/27Generic · Class 3 | 硫酸阿托品注射液CYHS2400371 | 河南普瑞药业有限公司 |
| 2024/01/27Generic · Class 3 | 氯化钾颗粒CYHS2400365 | 广州森荣医药科技有限公司; 金鸿药业股份有限公司 |
| 2024/01/27Generic · Class 3 | 氯化钾颗粒CYHS2400364 | 广州森荣医药科技有限公司; 金鸿药业股份有限公司 |
| 2024/01/27Generic · Class 3 | 氨基己酸注射液CYHS2400362 | 四环医药(郑州)有限公司 |
| 2024/01/27New drug · Class 3.3 | 利妥昔单抗注射液CXSS2400015 | 山东新时代药业有限公司 |
| 2024/01/26Import · Class 2.2 | 埃万妥单抗注射液JXSS2400004 | Janssen-Cilag International NV; Cilag AG; Johnson & Johnson Pharmaceutical Ltd. |
| 2024/01/26Import · Class 2.4 | 甲磺酸兰泽替尼片JXHS2400009 | Janssen-Cilag International NV; JANSSEN CILAG S.P.A.; Johnson & Johnson Pharmaceutical Ltd. |
| 2024/01/26Generic · Class 3 | 盐酸氢吗啡酮注射液CYHS2400358 | 国药集团工业有限公司廊坊分公司 |
| 2024/01/26Generic · Class 3 | 聚乙二醇3350散CYHS2400355 | 南京明生医药有限公司; 南京白敬宇制药有限责任公司 |
| 2024/01/26Generic · Class 3 | 复方匹可硫酸钠颗粒CYHS2400354 | 成都倍特得诺药业有限公司 |
| 2024/01/26Generic · Class 3 | 特利加压素注射液CYHS2400353 | 辰欣药业股份有限公司 |
| 2024/01/26New drug · Class 1.1 | 牛黄小儿退热贴CXZS2400006 | 健民药业集团股份有限公司 |
| 2024/01/26New drug · Class 1 | IBR822细胞注射液CXSL2400067 | 英百瑞(杭州)生物医药有限公司 |
| 2024/01/26New drug · Class 3.3 | ACYW135群脑膜炎球菌多糖结合疫苗(CRM197载体)CXSL2400066 | 辽宁成大生物股份有限公司; 北京成大天和生物科技有限公司; 成大生物(本溪)有限公司 |
| 2024/01/26New drug · Class 1 | TQC3927吸入粉雾剂CXHL2400117 | 正大天晴药业集团股份有限公司 |
| 2024/01/26New drug · Class 1 | TQC3927吸入粉雾剂CXHL2400116 | 正大天晴药业集团股份有限公司 |
| 2024/01/26New drug · Class 2.2 | 司美格鲁肽注射液CXHL2400115 | 华润双鹤药业股份有限公司 |
| 2024/01/26New drug · Class 2.2 | 司美格鲁肽注射液CXHL2400114 | 华润双鹤药业股份有限公司 |
| 2024/01/26New drug · Class 1 | HJ-002-03片CXHL2400113 | 和径医药科技(上海)有限公司 |
| 2024/01/26New drug · Class 1 | HJ-002-03片CXHL2400112 | 和径医药科技(上海)有限公司 |
| 2024/01/25Import · Class 2.2 | 度普利尤单抗注射液JXSS2400003 | Sanofi-aventis groupe; Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd. |
| 2024/01/25Import · Class 2.2 | 度普利尤单抗注射液JXSS2400002 | Sanofi-aventis groupe; Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd. |
| 2024/01/25Generic · Class 3 | 复合磷酸氢钾注射液CYHS2400350 | 北京民康百草医药科技有限公司; 山东华鲁制药有限公司 |
| 2024/01/25Generic · Class 3 | 盐酸美金刚口崩片CYHS2400349 | 合肥恩瑞特药业有限公司 |
| 2024/01/25Generic · Class 3 | 阿伐那非片CYHS2400348 | 扬州市三药制药有限公司 |
71 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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