药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/01/12 – 2021/01/18
- New acceptances this week
- 149
- Drugs with new generic filings (by drug name, de-duplicated)
- 18
- Accepted this week, now under review
- 2
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
149filings, 24 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 83 |
| Generic | 24 |
| New drug | 22 |
| Import | 15 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 127 |
| 治疗用生物制品 | 19 |
| TCM | 2 |
| 体外诊断试剂 | 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
18 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 拉考沙胺口服溶液 | 2 | 2 | 0 |
| 2 | 克唑替尼胶囊 | 2 | 1 | 7 |
| 3 | 注射用塞替派 | 2 | 1 | 0 |
| 4 | 盐酸度洛西汀肠溶胶囊 | 2 | 1 | 5 |
| 5 | 胞磷胆碱钠注射液 | 2 | 1 | 3 |
| 6 | 达比加群酯胶囊 | 2 | 1 | 2 |
| 7 | 地夸磷索钠滴眼液 | 1 | 1 | 5 |
| 8 | 地奈德乳膏 | 1 | 1 | 0 |
| 9 | 塞来昔布胶囊 | 1 | 1 | 5 |
| 10 | 左西孟旦注射液 | 1 | 1 | 1 |
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
98 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Novartis Pharma Schweiz AG | 7 | 4 | 0 |
| 2 | 湖南科伦制药有限公司 | 6 | 1 | 0 |
| 3 | GUERBET | 5 | 1 | 0 |
| 4 | 深圳信立泰药业股份有限公司 | 4 | 1 | 0 |
| 5 | 西安杨森制药有限公司 | 4 | 1 | 0 |
| 6 | AstraZeneca AB | 3 | 2 | 0 |
| 7 | 信达生物制药（苏州）有限公司 | 3 | 2 | 0 |
| 8 | 四川科伦药业股份有限公司 | 3 | 2 | 2 |
| 9 | 正大天晴药业集团股份有限公司 | 3 | 2 | 0 |
| 10 | 上海上药第一生化药业有限公司 | 2 | 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
36 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/01/18New drug · Class 1 | 西奥罗尼胶囊CXHL2100009 | 深圳微芯生物科技股份有限公司 |
| 2021/01/16Import · Class 1 | JDQ443片JXHL2100017 | Novartis Pharma AG |
| 2021/01/16Import · Class 1 | JDQ443片JXHL2100016 | Novartis Pharma AG |
| 2021/01/16Import · Class 1 | BI 425809 片JXHL2100015 | Boehringer Ingelheim International GmbH |
| 2021/01/16New drug · Class 2 | 乙型肝炎病毒丙型肝炎病毒人类免疫缺陷病毒（1+2型）核酸检测试剂盒（PCR-荧光法）CXSS2100010 | 苏州新波生物技术有限公司 |
| 2021/01/16New drug · Class 2.4 | 重组抗EGFR人鼠嵌合单克隆抗体注射液CXSL2100015 | 宝船生物医药科技（上海）有限公司 |
| 2021/01/16New drug · Class 2.4 | 泊沙康唑肠溶片CXHL2100031 | 上海宣泰医药科技股份有限公司 |
| 2021/01/16New drug · Class 2.4 | 泊沙康唑肠溶片CXHL2100030 | 上海宣泰医药科技股份有限公司 |
| 2021/01/16New drug · Class 1 | SAL0104胶囊CXHL2100022 | 深圳信立泰药业股份有限公司 |
| 2021/01/15Generic · Class 3 | 注射用塞替派CYHS2100063 | 江苏恒瑞医药股份有限公司 |
| 2021/01/15Generic · Class 3 | 注射用塞替派CYHS2100062 | 江苏恒瑞医药股份有限公司 |
| 2021/01/15Generic · Class 3 | 胞磷胆碱钠注射液CYHS2100061 | 山东玉满坤生物科技有限公司; 江苏九旭药业有限公司 |
| 2021/01/15Generic · Class 3 | 胞磷胆碱钠注射液CYHS2100060 | 山东玉满坤生物科技有限公司; 江苏九旭药业有限公司 |
| 2021/01/15New drug · Class 1 | SY-5007片CXHL2100028 | 首药控股（北京）股份有限公司 |
| 2021/01/15New drug · Class 1 | SY-5007片CXHL2100027 | 首药控股（北京）股份有限公司 |
| 2021/01/15New drug · Class 2.2 | TTYP01片CXHL2100026 | 苏州澳宗生物科技有限公司 |
| 2021/01/15New drug · Class 2.2 | 富马酸福莫特罗吸入气雾剂CXHL2100025 | 健康元药业集团股份有限公司 |
| 2021/01/15New drug · Class 2.2 | 富马酸福莫特罗吸入气雾剂CXHL2100024 | 健康元药业集团股份有限公司 |
| 2021/01/14Import · Class 3.1 | 注射用奥马珠单抗JXSS2100003 | Novartis Europharm Limited; Novartis Pharma Stein AG |
| 2021/01/14Generic · Class 3 | 硫酸镁注射液CYHS2100057 | 上海禾丰制药有限公司 |
| 2021/01/14New drug · Class 1 | 替戈拉生片CXHS2000047 | 山东罗欣药业集团股份有限公司 |
| 2021/01/14New drug · Class 1 | SAL0104胶囊CXHL2100023 | 深圳信立泰药业股份有限公司 |
| 2021/01/13Import · Class 2.2 | sacituzumab govitecanJXSL2100007 | Everest Medicines II (HK) Limited |
| 2021/01/13Import · Class 2.4 | 乌帕替尼缓释片JXHS2100004 | AbbVie Deutschland GmbH & Co.KG; AbbVie Ireland NL B.V. |
| 2021/01/13Generic · Class 3 | 地奈德乳膏CYHS2100046 | 福元药业有限公司 |
| 2021/01/13New drug · Class 2.2 | 信迪利单抗注射液CXSS2100009 | 信达生物制药（苏州）有限公司 |
| 2021/01/13New drug · Class 2.2 | 贝伐珠单抗注射液CXSS2100008 | 信达生物制药（苏州）有限公司 |
| 2021/01/13New drug · Class 2.2 | 信迪利单抗注射液CXSS2100007 | 信达生物制药（苏州）有限公司 |
| 2021/01/13New drug · Class 3.3 | 重组GLP-1受体激动剂注射液CXSL2100013 | 北京乐普医药科技有限公司 |
| 2021/01/13New drug · Class 1 | SAL0104胶囊CXHL2100021 | 深圳信立泰药业股份有限公司 |
6 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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