药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/01/05 – 2021/01/11
- New acceptances this week
- 324
- Drugs with new generic filings (by drug name, de-duplicated)
- 43
- Accepted this week, now under review
- 0
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
324filings, 53 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 180 |
| New drug | 54 |
| Generic | 53 |
| Import | 31 |
| Import re-registration | 4 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 214 |
| 治疗用生物制品 | 80 |
| TCM | 24 |
| 预防用生物制品 | 6 |
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
43 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 普瑞巴林胶囊 | 3 | 1 | 12 |
| 2 | 盐酸普拉克索缓释片 | 3 | 1 | 0 |
| 3 | 注射用伏立康唑 | 2 | 2 | 4 |
| 4 | 吸入用异丙托溴铵溶液 | 2 | 1 | 2 |
| 5 | 奥硝唑注射液 | 2 | 1 | 0 |
| 6 | 恩格列净片 | 2 | 1 | 18 |
| 7 | 注射用哌拉西林钠他唑巴坦钠 | 2 | 1 | 5 |
| 8 | 注射用培美曲塞二钠 | 2 | 1 | 2 |
| 9 | 二甲双胍维格列汀片（Ⅲ) | 1 | 1 | 0 |
| 10 | 他达拉非片 | 1 | 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
190 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 齐鲁制药有限公司 | 7 | 6 | 5 |
| 2 | BIOTON S.A. | 7 | 3 | 0 |
| 3 | 长春金赛药业有限责任公司 | 7 | 2 | 0 |
| 4 | 石药集团欧意药业有限公司 | 6 | 4 | 4 |
| 5 | 华兰生物工程股份有限公司 | 6 | 1 | 0 |
| 6 | 安徽安科生物工程（集团）股份有限公司 | 6 | 1 | 0 |
| 7 | 重庆药友制药有限责任公司 | 5 | 3 | 1 |
| 8 | Boehringer Ingelheim International GmbH | 5 | 1 | 0 |
| 9 | 华润双鹤利民药业（济南）有限公司 | 4 | 4 | 0 |
| 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
85 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/01/11Generic · Class 3 | 磷酸奥司他韦干混悬剂CYHS2100038 | 苏州二叶制药有限公司 |
| 2021/01/11Generic · Class 3 | 氨溴特罗口服溶液CYHS2100033 | 北京诚济制药股份有限公司 |
| 2021/01/11Generic · Class 3 | 硫酸沙丁胺醇注射液CYHS2100032 | 成都倍特药业股份有限公司 |
| 2021/01/11Generic · Class 3 | 注射用兰索拉唑CYHS2100030 | 湖南恒生制药股份有限公司 |
| 2021/01/11New drug · Class 1 | YP01001胶囊CXHL2100016 | 重庆药友制药有限责任公司 |
| 2021/01/11New drug · Class 1 | YP01001胶囊CXHL2100015 | 重庆药友制药有限责任公司 |
| 2021/01/11New drug · Class 1 | YP01001胶囊CXHL2100014 | 重庆药友制药有限责任公司 |
| 2021/01/11New drug · Class 1 | 50561片CXHL2000687 | 北京卓凯生物技术有限公司 |
| 2021/01/11New drug · Class 1 | 50561片CXHL2000686 | 北京卓凯生物技术有限公司 |
| 2021/01/09Import · Class 1 | Relatlimab/Nivolumab固定剂量复方注射液JXSL2100005 | Bristol-Myers Squibb Company |
| 2021/01/09Import · Class 2.4 | 阿贝西利片JXHL2100011 | Eli Lilly and Company |
| 2021/01/09Import · Class 2.4 | 马昔腾坦片JXHL2100010 | Actelion Pharmaceuticals Ltd |
| 2021/01/09Import · Class 2.4 | 马昔腾坦片JXHL2100009 | Actelion Pharmaceuticals Ltd |
| 2021/01/09Import · Class 1 | PF-06882961片JXHL2100008 | Pfizer Inc. |
| 2021/01/09Import · Class 1 | PF-06882961片JXHL2100007 | Pfizer Inc. |
| 2021/01/09Import · Class 1 | PF-06882961片JXHL2100006 | Pfizer Inc. |
| 2021/01/09Generic · Class 3 | 阿瑞匹坦注射液CYHS2100023 | 齐鲁制药有限公司 |
| 2021/01/09New drug · Class 3.2 | 注射用重组人生长激素CXSS2100006 | 安徽安科生物工程（集团）股份有限公司 |
| 2021/01/09New drug · Class 3.2 | 注射用重组人生长激素CXSS2100005 | 安徽安科生物工程（集团）股份有限公司 |
| 2021/01/09New drug · Class 3.2 | 注射用重组人生长激素CXSS2100004 | 安徽安科生物工程（集团）股份有限公司 |
| 2021/01/09New drug · Class 3.2 | 注射用重组人生长激素CXSS2100003 | 安徽安科生物工程（集团）股份有限公司 |
| 2021/01/09New drug · Class 3.2 | 注射用重组人生长激素CXSS2100002 | 安徽安科生物工程（集团）股份有限公司 |
| 2021/01/09New drug · Class 3.2 | 注射用重组人生长激素CXSS2100001 | 安徽安科生物工程（集团）股份有限公司 |
| 2021/01/09New drug · Class 1 | 注射用QLS31901CXSL2100012 | 齐鲁制药有限公司 |
| 2021/01/09New drug · Class 1 | MCLA-129注射液CXSL2100011 | 贝达药业股份有限公司 |
| 2021/01/09New drug · Class 1 | SMR7694注射液CXSL2100010 | 未名生物医药有限公司 |
| 2021/01/09New drug · Class 1 | 重组人源化抗IL-17A单克隆抗体注射液CXSL2100009 | 上海君实生物医药科技股份有限公司 |
| 2021/01/09New drug · Class 2.2 | 重组人血管内皮抑制素注射液CXSL2100008 | 山东先声生物制药有限公司 |
| 2021/01/09New drug · Class 1 | 注射用IMM2505CXSL2100007 | 盛禾（中国）生物制药有限公司 |
| 2021/01/09New drug · Class 2.2 | 注射用右兰索拉唑CXHS2100001 | 江苏奥赛康药业有限公司 |
55 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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