药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/02/08 – 2022/02/14
- New acceptances this week
- 265
- Drugs with new generic filings (by drug name, de-duplicated)
- 36
- 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
265filings, 60 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 141 |
| Generic | 60 |
| New drug | 43 |
| Import | 12 |
| Import re-registration | 7 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 191 |
| 治疗用生物制品 | 45 |
| TCM | 25 |
| 预防用生物制品 | 4 |
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
36 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 奥美沙坦酯氨氯地平氢氯噻嗪片 | 5 | 1 | 5 |
| 2 | 玻璃酸钠滴眼液 | 4 | 4 | 29 |
| 3 | 瑞舒伐他汀钙片 | 4 | 2 | 18 |
| 4 | 氧 | 3 | 3 | 15 |
| 5 | 利伐沙班片 | 3 | 2 | 3 |
| 6 | 乙磺酸尼达尼布软胶囊 | 2 | 1 | 6 |
| 7 | 依托考昔片 | 2 | 1 | 8 |
| 8 | 利奈唑胺干混悬剂 | 2 | 1 | 1 |
| 9 | 奥贝胆酸片 | 2 | 1 | 0 |
| 10 | 左氧氟沙星氯化钠注射液 | 2 | 1 | 14 |
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
160 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 广西壮族自治区花红金瑞药业有限公司 | 10 | 8 | 0 |
| 2 | 长春金赛药业有限责任公司 | 8 | 2 | 0 |
| 3 | AstraZeneca AB | 7 | 2 | 0 |
| 4 | 安徽誉恒生物科技有限公司 | 6 | 3 | 0 |
| 5 | 海南广升誉制药有限公司 | 6 | 3 | 0 |
| 6 | 上海君实生物医药科技股份有限公司 | 6 | 1 | 0 |
| 7 | 百济神州（苏州）生物科技有限公司 | 5 | 2 | 0 |
| 8 | 上海腾瑞制药股份有限公司 | 5 | 1 | 5 |
| 9 | 正大天晴药业集团股份有限公司 | 4 | 3 | 1 |
| 10 | 齐鲁制药有限公司 | 4 | 3 | 3 |
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
67 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/02/14Generic · Class 3 | 利奈唑胺干混悬剂CYHS2200309 | 浙江普利药业有限公司 |
| 2022/02/14Generic · Class 3 | 利奈唑胺干混悬剂CYHS2200308 | 浙江普利药业有限公司 |
| 2022/02/14Generic · Class 3 | 普瑞巴林缓释片CYHL2200017 | 北京泰德制药股份有限公司 |
| 2022/02/14New drug · Class 1 | 异体内皮祖细胞（EPCs）注射液CXSL2200090 | 呈诺再生医学科技（珠海横琴新区）有限公司 |
| 2022/02/14New drug · Class 1 | 注射用重组人源化抗HER2单抗-AS269偶联物（ARX788）CXSL2200080 | 浙江新码生物医药有限公司 |
| 2022/02/14New drug · Class 1 | TT-01488片CXHL2200093 | 药捷安康（南京）科技股份有限公司 |
| 2022/02/14New drug · Class 1 | TT-01488片CXHL2200091 | 药捷安康（南京）科技股份有限公司 |
| 2022/02/14New drug · Class 1 | 注射用聚乙二醇伊立替康CXHL2200081 | 天津键凯科技有限公司 |
| 2022/02/11Import · Class 2.4 | NBTXR3JXHL2200037 | Nanobiotix S.A.; Shanghai LianBio Development Co. Ltd. |
| 2022/02/11Generic · Class 3 | 缩宫素注射液CYHS2200300 | 西安诺达信医药科技有限公司; 西安汉丰药业有限责任公司 |
| 2022/02/11Generic · Class 3 | 缩宫素注射液CYHS2200299 | 西安诺达信医药科技有限公司; 西安汉丰药业有限责任公司 |
| 2022/02/11Generic · Class 3 | 注射用比阿培南CYHS2200297 | 深圳华药南方制药有限公司 |
| 2022/02/11Generic · Class 3 | 劳拉西泮注射液CYHL2200016 | 江苏恩华药业股份有限公司 |
| 2022/02/11New drug · Class 1 | 重组全人抗LAG-3单克隆抗体注射液CXSL2200089 | 广州誉衡生物科技有限公司 |
| 2022/02/11New drug · Class 1 | IBI322CXSL2200088 | 信达生物制药（苏州）有限公司 |
| 2022/02/11New drug · Class 2.2 | 特瑞普利单抗注射液CXSL2200087 | 上海君实生物医药科技股份有限公司 |
| 2022/02/11New drug · Class 2.2 | 特瑞普利单抗注射液CXSL2200086 | 上海君实生物医药科技股份有限公司 |
| 2022/02/11New drug · Class 2.2 | 特瑞普利单抗注射液CXSL2200085 | 上海君实生物医药科技股份有限公司 |
| 2022/02/11New drug · Class 1 | 注射用RC98CXSL2200084 | 荣昌生物制药（烟台）股份有限公司 |
| 2022/02/11New drug · Class 2.2 | 特瑞普利单抗注射液CXSL2200083 | 上海君实生物医药科技股份有限公司 |
| 2022/02/11New drug · Class 2.2 | 特瑞普利单抗注射液CXSL2200082 | 上海君实生物医药科技股份有限公司 |
| 2022/02/11New drug · Class 2.2 | 特瑞普利单抗注射液CXSL2200081 | 上海君实生物医药科技股份有限公司 |
| 2022/02/11New drug · Class 3.3 | 贝伐珠单抗注射液CXSL2200079 | 上海复宏汉霖生物技术股份有限公司 |
| 2022/02/11New drug · Class 1 | 斯鲁利单抗注射液CXSL2200078 | 上海复宏汉霖生物技术股份有限公司 |
| 2022/02/11New drug · Class 1 | 注射用莱古杉醇CXHL2200087 | 上海亲合力生物医药科技股份有限公司 |
| 2022/02/11New drug · Class 1 | MY008211A片CXHL2200085 | 上海美悦生物科技发展有限公司 |
| 2022/02/11New drug · Class 1 | MY008211A片CXHL2200084 | 上海美悦生物科技发展有限公司 |
| 2022/02/11New drug · Class 1 | RGT-419B胶囊CXHL2200077 | 上海齐鲁锐格医药研发有限公司 |
| 2022/02/11New drug · Class 1 | RGT-419B胶囊CXHL2200076 | 上海齐鲁锐格医药研发有限公司 |
| 2022/02/10Generic · Class 3 | 环丝氨酸胶囊CYHS2200291 | 沈阳红旗制药有限公司 |
37 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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