药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/11/30 – 2021/12/06
- New acceptances this week
- 230
- Drugs with new generic filings (by drug name, de-duplicated)
- 43
- Accepted this week, now under review
- 1
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
230filings, 57 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 112 |
| Generic | 57 |
| New drug | 25 |
| Import | 15 |
| Unspecified | 11 |
| Import re-registration | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 158 |
| TCM | 46 |
| 治疗用生物制品 | 23 |
| Biologic | 3 |
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 | 雷贝拉唑钠肠溶片 | 3 | 2 | 0 |
| 2 | 乳果糖口服溶液 | 3 | 1 | 36 |
| 3 | 胞磷胆碱钠注射液 | 3 | 1 | 3 |
| 4 | 培哚普利叔丁胺片 | 2 | 1 | 5 |
| 5 | 普瑞巴林胶囊 | 2 | 1 | 12 |
| 6 | 注射用利福平 | 2 | 1 | 2 |
| 7 | 注射用头孢米诺钠 | 2 | 1 | 0 |
| 8 | 注射用帕瑞昔布钠 | 2 | 1 | 2 |
| 9 | 盐酸帕洛诺司琼注射液 | 2 | 1 | 1 |
| 10 | 盐酸胍法辛缓释片 | 2 | 1 | 4 |
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
141 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 武汉爱民制药股份有限公司 | 12 | 10 | 0 |
| 2 | 吉林敖东延边药业股份有限公司 | 10 | 10 | 0 |
| 3 | 石家庄御和堂药业股份有限公司 | 8 | 8 | 0 |
| 4 | 华润双鹤药业股份有限公司 | 7 | 4 | 0 |
| 5 | Novartis Pharma AG | 6 | 3 | 0 |
| 6 | 南京恩泰医药科技有限公司 | 5 | 3 | 0 |
| 7 | 江苏恩华药业股份有限公司 | 5 | 3 | 0 |
| 8 | 山东新时代药业有限公司 | 3 | 3 | 2 |
| 9 | 海南涛生医药科技研究院有限公司 | 3 | 3 | 0 |
| 10 | 四川百利药业有限责任公司 | 3 | 2 | 2 |
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
55 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/12/06Import · Class 1 | Enavogliflozin 片JXHL2101266 | Daewoong Pharmaceutical Co. Ltd.; Beijing Daewoong Pharmaceutical R&D Center Co. Ltd. |
| 2021/12/06Generic · Class 3 | 盐酸奥洛他定颗粒CYHS2102147 | 北京四环科宝制药股份有限公司 |
| 2021/12/06Generic · Class 3 | 奥硝唑注射液CYHS2102143 | 北京阜康仁生物制药科技有限公司; 山西诺成制药有限公司 |
| 2021/12/06Generic · Class 3 | 盐酸胍法辛缓释片CYHS2102139 | 四川百利药业有限责任公司 |
| 2021/12/06Generic · Class 3 | 盐酸胍法辛缓释片CYHS2102138 | 四川百利药业有限责任公司 |
| 2021/12/06Generic · Class 3 | 盐酸普萘洛尔口服溶液CYHS2102137 | 陕西步长制药有限公司; 山东步长制药股份有限公司 |
| 2021/12/06Generic · Class 3 | 醋酸去氨加压素口服溶液CYHS2102129 | 南京海纳医药科技股份有限公司; 南京海纳制药有限公司 |
| 2021/12/06Generic · Class 3 | 咪达那新片CYHL2101047 | 南京制药厂有限公司 |
| 2021/12/06New drug · Class 1 | SH006注射液CXSL2101463 | 南京圣和药业股份有限公司 |
| 2021/12/06New drug · Class 1 | SI-B001双特异性抗体注射液CXSL2101461 | 四川百利药业有限责任公司 |
| 2021/12/06New drug · Class 2.2 | 注射用伊尼妥单抗CXSL2101459 | 三生国健药业（上海）股份有限公司 |
| 2021/12/06New drug · Class 1 | GZR4CXSL2101457 | 甘李药业股份有限公司 |
| 2021/12/06New drug · Class 2.4 | 奥布替尼片CXHL2101710 | 北京诺诚健华医药科技有限公司 |
| 2021/12/03Import · Class 1 | OMS721注射液JXSL2101144 | Omeros Corporation; George (Beijing) Clinical Research Co. Ltd. |
| 2021/12/03Generic · Class 3 | 盐酸米那普仑片CYHS2102131 | 四川科瑞德制药股份有限公司 |
| 2021/12/03New drug · Class 1 | JS009注射液CXSL2101462 | 上海君实生物医药科技股份有限公司 |
| 2021/12/03New drug · Class 1 | MSB0254注射液CXSL2101449 | 迈博斯生物医药（苏州）有限公司 |
| 2021/12/03New drug · Class 1 | MSB2311注射液CXSL2101448 | 迈博斯生物医药（苏州）有限公司 |
| 2021/12/03New drug · Class 1 | ASKC202片CXHL2101712 | 江苏奥赛康药业有限公司 |
| 2021/12/03New drug · Class 1 | ASKC202片CXHL2101711 | 江苏奥赛康药业有限公司 |
| 2021/12/03New drug · Class 1 | HY010101胶囊CXHL2101709 | 北京原基华毅生物科技有限公司 |
| 2021/12/03New drug · Class 1 | HY010101胶囊CXHL2101708 | 北京原基华毅生物科技有限公司 |
| 2021/12/03New drug · Class 1 | HY010101胶囊CXHL2101707 | 北京原基华毅生物科技有限公司 |
| 2021/12/03New drug · Class 1 | TLL-018片CXHL2101706 | 杭州高光制药有限公司 |
| 2021/12/02Import · Class 2.2 | 注射用维博妥珠单抗（拟定）JXSS2101035 | Roche Pharma （Schweiz）AG; F. Hoffmann-La Roche AG |
| 2021/12/02Import · Class 2.2 | 注射用维博妥珠单抗（拟定）JXSS2101034 | Roche Pharma （Schweiz）AG; BSP Pharmaceuticals S.p.A. |
| 2021/12/02Import · Class 3.3 | 特立帕肽注射液JXSL2101143 | Alvogen Inc.; Beijing Kangchen Biological Technology Co. Ltd. |
| 2021/12/02Import · Class 1 | QGE031注射液JXSL2101141 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2021/12/02Generic · Class 3 | 羧甲司坦口服溶液CYHS2102126 | 成都倍特得诺药业有限公司 |
| 2021/12/02Generic · Class 3 | 氟比洛芬酯注射液CYHL2101046 | 山东威高药业股份有限公司 |
25 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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