药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/06/08 – 2021/06/14
- New acceptances this week
- 160
- Drugs with new generic filings (by drug name, de-duplicated)
- 19
- 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
160filings, 31 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 82 |
| New drug | 33 |
| Generic | 31 |
| Import re-registration | 7 |
| Import | 5 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 114 |
| 治疗用生物制品 | 23 |
| TCM | 19 |
| 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
19 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 奥卡西平片 | 3 | 1 | 4 |
| 2 | 吸入用异丙托溴铵溶液 | 2 | 1 | 2 |
| 3 | 奥硝唑注射液 | 2 | 1 | 0 |
| 4 | 奥贝胆酸片 | 2 | 1 | 0 |
| 5 | 左氧氟沙星片 | 2 | 1 | 8 |
| 6 | 沙库巴曲缬沙坦钠片 | 2 | 1 | 68 |
| 7 | 注射用头孢美唑钠/氯化钠注射液 | 2 | 1 | 1 |
| 8 | 注射用达托霉素 | 2 | 1 | 1 |
| 9 | 盐酸依匹斯汀颗粒 | 2 | 1 | 0 |
| 10 | 盐酸左沙丁胺醇雾化吸入溶液 | 2 | 1 | 2 |
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
90 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | NAPP PHARMACEUTICALS LIMITED | 9 | 1 | 0 |
| 2 | 通用电气药业（上海）有限公司 | 7 | 1 | 0 |
| 3 | AstraZeneca AB | 6 | 3 | 0 |
| 4 | Bristol-Myers Squibb Pharma EEIG | 5 | 1 | 0 |
| 5 | 石家庄四药有限公司 | 4 | 3 | 3 |
| 6 | 江苏恒瑞医药股份有限公司 | 4 | 2 | 0 |
| 7 | 江苏威凯尔医药科技有限公司 | 4 | 1 | 0 |
| 8 | 扬子江药业集团江苏紫龙药业有限公司 | 3 | 2 | 2 |
| 9 | 芜湖辰优生物医药工程有限公司 | 3 | 2 | 0 |
| 10 | medac Gesellschaft für klinische Spezialpr？parate mbH | 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
46 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/06/11Generic · Class 3 | 盐酸依匹斯汀颗粒CYHS2101293 | 焦作市明仁天然药物有限责任公司 |
| 2021/06/11Generic · Class 3 | 盐酸依匹斯汀颗粒CYHS2101292 | 焦作市明仁天然药物有限责任公司 |
| 2021/06/11Generic · Class 3 | 盐酸右美托咪定注射液CYHS2101291 | 石家庄四药有限公司 |
| 2021/06/11Generic · Class 3 | 注射用头孢美唑钠/氯化钠注射液CYHS2101251 | 北京锐业制药有限公司 |
| 2021/06/11Generic · Class 3 | 注射用头孢美唑钠/氯化钠注射液CYHS2101250 | 北京锐业制药有限公司 |
| 2021/06/11New drug · Class 2.2 | 替雷利珠单抗注射液CXSL2101131 | 百济神州（上海）生物科技有限公司 |
| 2021/06/11New drug · Class 3.4 | 卡介菌纯蛋白衍生物CXSL2101114 | 成都可恩生物科技有限公司 |
| 2021/06/11New drug · Class 1 | 盐酸安舒法辛缓释片CXHS2101024 | 山东绿叶制药有限公司 |
| 2021/06/11New drug · Class 1 | 盐酸安舒法辛缓释片CXHS2101023 | 山东绿叶制药有限公司 |
| 2021/06/11New drug · Class 1 | VC005片CXHL2101199 | 江苏威凯尔医药科技有限公司 |
| 2021/06/11New drug · Class 1 | VC005片CXHL2101198 | 江苏威凯尔医药科技有限公司 |
| 2021/06/11New drug · Class 1 | VC005片CXHL2101197 | 江苏威凯尔医药科技有限公司 |
| 2021/06/11New drug · Class 1 | VC005片CXHL2101196 | 江苏威凯尔医药科技有限公司 |
| 2021/06/10New drug · Class 1 | 注射用IMM01CXSL2101130 | 宜明昂科生物医药技术（上海）有限公司 |
| 2021/06/10New drug · Class 1 | QL1706注射液CXSL2101122 | 齐鲁制药有限公司 |
| 2021/06/10New drug · Class 1.4 | 24价肺炎球菌多糖结合疫苗CXSL2101113 | 江苏坤力生物制药有限责任公司; 山东坤力生物制药有限责任公司 |
| 2021/06/10New drug · Class 2.2 | 小儿水合氯醛糖浆CXHL2101193 | 海南鹏康药业有限公司 |
| 2021/06/10New drug · Class 1 | HEC93077片CXHL2101192 | 广东东阳光药业有限公司 |
| 2021/06/10New drug · Class 1 | HEC93077片CXHL2101191 | 广东东阳光药业有限公司 |
| 2021/06/10New drug · Class 1 | HEC93077片CXHL2101190 | 广东东阳光药业有限公司 |
| 2021/06/10New drug · Class 1 | HRS2300片CXHL2101189 | 江苏恒瑞医药股份有限公司 |
| 2021/06/10New drug · Class 1 | HRS2300片CXHL2101188 | 江苏恒瑞医药股份有限公司 |
| 2021/06/10New drug · Class 1 | LNK01001胶囊CXHL2101186 | 凌科药业（杭州）有限公司 |
| 2021/06/10New drug · Class 1 | LNK01001胶囊CXHL2101185 | 凌科药业（杭州）有限公司 |
| 2021/06/09Import · Class 1 | BI 425809 片JXHL2101086 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2021/06/09Generic · Class 3 | 奥贝胆酸片CYHL2101014 | 扬子江药业集团有限公司 |
| 2021/06/09Generic · Class 3 | 奥贝胆酸片CYHL2101013 | 扬子江药业集团有限公司 |
| 2021/06/09New drug · Class 1 | SHR-1701注射液CXSL2101128 | 苏州盛迪亚生物医药有限公司 |
| 2021/06/09New drug · Class 1 | IBI110CXSL2101127 | 信达生物制药（苏州）有限公司 |
| 2021/06/09New drug · Class 2.2 | HRG2010胶囊CXHL2101178 | 江苏恒瑞医药股份有限公司 |
16 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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