药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/04/26 – 2022/05/02
- New acceptances this week
- 187
- Drugs with new generic filings (by drug name, de-duplicated)
- 27
- 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
187filings, 38 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 108 |
| Generic | 38 |
| New drug | 24 |
| Unspecified | 9 |
| Import | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 142 |
| TCM | 20 |
| 治疗用生物制品 | 20 |
| Biologic | 4 |
| 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
27 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 硝苯地平控释片 | 3 | 3 | 8 |
| 2 | 布洛芬混悬液 | 2 | 2 | 14 |
| 3 | 丙戊酸钠注射用浓溶液 | 2 | 1 | 0 |
| 4 | 乙磺酸尼达尼布软胶囊 | 2 | 1 | 6 |
| 5 | 地高辛注射液 | 2 | 1 | 3 |
| 6 | 奥硝唑注射液 | 2 | 1 | 0 |
| 7 | 富马酸二甲酯肠溶胶囊 | 2 | 1 | 0 |
| 8 | 左氧氟沙星氯化钠注射液 | 2 | 1 | 14 |
| 9 | 布地奈德鼻喷雾剂 | 2 | 1 | 3 |
| 10 | 碘普罗胺注射液 | 2 | 1 | 27 |
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
117 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 黑龙江中桂制药有限公司 | 6 | 1 | 0 |
| 2 | 河南太龙药业股份有限公司 | 5 | 5 | 0 |
| 3 | 成都青山利康药业股份有限公司 | 5 | 1 | 0 |
| 4 | 芜湖道润药业有限责任公司 | 4 | 4 | 0 |
| 5 | 乐普药业股份有限公司 | 4 | 2 | 1 |
| 6 | MINGHUI PHARMACEUTICAL PTY LTD | 4 | 1 | 0 |
| 7 | 厦门特宝生物工程股份有限公司 | 4 | 1 | 0 |
| 8 | 哈尔滨君安堂医药有限公司 | 3 | 2 | 0 |
| 9 | 四川太平洋药业有限责任公司 | 3 | 2 | 0 |
| 10 | Eli Lilly Nederland B.V. | 3 | 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
41 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/04/29Import · Class 1 | MH080乳膏JXHL2200094 | MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd |
| 2022/04/29Import · Class 1 | MH080乳膏JXHL2200093 | MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd |
| 2022/04/29Import · Class 1 | MH080乳膏JXHL2200092 | MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd |
| 2022/04/29Import · Class 1 | MH080乳膏JXHL2200091 | MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd |
| 2022/04/29Generic · Class 3 | 注射用哌拉西林钠CYHS2200694 | 山东道齐生物医药科技有限公司; 中孚药业股份有限公司 |
| 2022/04/29Generic · Class 3 | 盐酸多柔比星脂质体注射液CYHS2200689 | 浙江圣兆药物科技股份有限公司; 浙江海正药业股份有限公司 |
| 2022/04/29Generic · Class 3 | 布洛芬注射液CYHS2200644 | 成都苑东生物制药股份有限公司 |
| 2022/04/29New drug · Class 1.2 | 甘草总查耳酮胶囊CXZL2200021 | 北京慧宝源生物技术股份有限公司 |
| 2022/04/29New drug · Class 1.2 | 甘草总查耳酮CXZL2200020 | 北京慧宝源生物技术股份有限公司 |
| 2022/04/29New drug · Class 3.4 | 人凝血酶原复合物CXSS2200049 | 四川远大蜀阳药业有限责任公司 |
| 2022/04/29New drug · Class 1 | 拓培非格司亭注射液CXSS2200048 | 厦门特宝生物工程股份有限公司 |
| 2022/04/29New drug · Class 1 | 拓培非格司亭注射液CXSS2200047 | 厦门特宝生物工程股份有限公司 |
| 2022/04/29New drug · Class 1 | 拓培非格司亭注射液CXSS2200046 | 厦门特宝生物工程股份有限公司 |
| 2022/04/29New drug · Class 1 | 拓培非格司亭注射液CXSS2200045 | 厦门特宝生物工程股份有限公司 |
| 2022/04/29New drug · Class 1 | 注射用LB4330CXSL2200187 | 上海健信生物医药科技有限公司 |
| 2022/04/29New drug · Class 1 | 注射用K11CXSL2200186 | 江苏康禾生物制药有限公司 |
| 2022/04/29New drug · Class 1 | DZD1516片CXHL2200270 | 迪哲(江苏)医药股份有限公司 |
| 2022/04/29New drug · Class 1 | DZD1516片CXHL2200269 | 迪哲(江苏)医药股份有限公司 |
| 2022/04/29New drug · Class 1 | ICP-490片CXHL2200267 | 北京诺诚健华医药科技有限公司 |
| 2022/04/29New drug · Class 1 | ICP-490片CXHL2200266 | 北京诺诚健华医药科技有限公司 |
| 2022/04/29New drug · Class 2.2 | 黄体酮长效注射液CXHL2200265 | 四川科伦药业股份有限公司 |
| 2022/04/29New drug · Class 2.2 | 黄体酮长效注射液CXHL2200264 | 四川科伦药业股份有限公司 |
| 2022/04/29New drug · Class 1 | WS015干混悬剂CXHL2200255 | 中美华世通生物医药科技(武汉)股份有限公司 |
| 2022/04/28Generic · Class 3 | 磷酸奥司他韦干混悬剂CYHS2200687 | 四川子仁制药有限公司 |
| 2022/04/28Generic · Class 3 | 奥扎格雷钠注射液CYHS2200686 | 华夏生生药业(北京)有限公司 |
| 2022/04/28Generic · Class 3 | 布洛芬混悬滴剂CYHS2200685 | 广西维威制药有限公司 |
| 2022/04/28Generic · Class 3 | 地高辛注射液CYHS2200680 | 成都倍特药业股份有限公司 |
| 2022/04/28Generic · Class 3 | 地高辛注射液CYHS2200679 | 成都倍特药业股份有限公司 |
| 2022/04/28Generic · Class 3 | 奥硝唑注射液CYHS2200678 | 山东海雅医药科技有限公司; 河南润弘制药股份有限公司 |
| 2022/04/28Generic · Class 3 | 奥硝唑注射液CYHS2200677 | 山东海雅医药科技有限公司; 河南润弘制药股份有限公司 |
11 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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