药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/03/29 – 2022/04/04
- New acceptances this week
- 180
- Drugs with new generic filings (by drug name, de-duplicated)
- 29
- 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
180filings, 36 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 94 |
| Generic | 36 |
| New drug | 31 |
| Import | 15 |
| Unspecified | 2 |
| Import re-registration | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 137 |
| TCM | 23 |
| 治疗用生物制品 | 19 |
| 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
29 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 磷酸奥司他韦胶囊 | 3 | 1 | 42 |
| 2 | 头孢丙烯干混悬剂 | 2 | 1 | 2 |
| 3 | 氨甲环酸注射液 | 2 | 1 | 11 |
| 4 | 硫代硫酸钠注射液 | 2 | 1 | 5 |
| 5 | 艾司奥美拉唑镁肠溶胶囊 | 2 | 1 | 4 |
| 6 | 达格列净片 | 2 | 1 | 82 |
| 7 | 丙戊酸钠口服溶液 | 1 | 1 | 1 |
| 8 | 卡前列素氨丁三醇注射液 | 1 | 1 | 2 |
| 9 | 卡络磺钠注射液 | 1 | 1 | 1 |
| 10 | 吸入用硫酸沙丁胺醇溶液 | 1 | 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
115 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 湖南铭德医药科技有限公司 | 5 | 5 | 0 |
| 2 | Pfizer Inc. | 5 | 3 | 0 |
| 3 | 上海皇象铁力蓝天制药有限公司 | 4 | 4 | 0 |
| 4 | 安徽九洲方圆制药有限公司 | 4 | 4 | 0 |
| 5 | Genzyme Europe B.V. | 4 | 2 | 0 |
| 6 | 正大天晴药业集团股份有限公司 | 4 | 2 | 0 |
| 7 | 盛世泰科生物医药技术（苏州）有限公司 | 4 | 2 | 0 |
| 8 | A. Menarini GmbH | 4 | 1 | 0 |
| 9 | 江苏恒瑞医药股份有限公司 | 4 | 1 | 0 |
| 10 | 科兴生物制药股份有限公司 | 4 | 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
56 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/04/02Import · Class 2.4 | 阿贝西利片JXHL2200081 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2022/04/02Generic · Class 3 | 艾司奥美拉唑镁肠溶胶囊CYHS2200526 | 青岛百洋制药有限公司 |
| 2022/04/02Generic · Class 3 | 艾司奥美拉唑镁肠溶胶囊CYHS2200525 | 青岛百洋制药有限公司 |
| 2022/04/02Generic · Class 3 | 头孢丙烯干混悬剂CYHS2200523 | 金鸿药业股份有限公司 |
| 2022/04/02Generic · Class 3 | 头孢丙烯干混悬剂CYHS2200521 | 金鸿药业股份有限公司 |
| 2022/04/02Generic · Class 3 | 阿立哌唑口服溶液CYHS2200519 | 山东朗诺制药有限公司 |
| 2022/04/02Generic · Class 3 | 注射用盐酸达巴万星CYHL2200027 | 扬子江药业集团有限公司 |
| 2022/04/02New drug · Class 1 | JS007注射液CXSL2200159 | 上海君实生物医药科技股份有限公司 |
| 2022/04/02New drug · Class 1 | 注射用RC98CXSL2200158 | 荣昌生物制药（烟台）股份有限公司 |
| 2022/04/02New drug · Class 1 | TQC2938注射液CXSL2200157 | 正大天晴药业集团南京顺欣制药有限公司 |
| 2022/04/02New drug · Class 1 | JDB175片CXHL2200216 | 上海嘉葆药银医药科技有限公司 |
| 2022/04/02New drug · Class 1 | JDB175片CXHL2200215 | 上海嘉葆药银医药科技有限公司 |
| 2022/04/02New drug · Class 1 | K-13片CXHL2200214 | 上海懿峰生物科技有限公司 |
| 2022/04/02New drug · Class 1 | K-13片CXHL2200213 | 上海懿峰生物科技有限公司 |
| 2022/04/02New drug · Class 1 | K-13片CXHL2200212 | 上海懿峰生物科技有限公司 |
| 2022/04/02New drug · Class 1 | CGT-1881片CXHL2200211 | 盛世泰科生物医药技术（苏州）有限公司 |
| 2022/04/02New drug · Class 1 | CGT-1881片CXHL2200210 | 盛世泰科生物医药技术（苏州）有限公司 |
| 2022/04/02New drug · Class 1 | CGT-9475片CXHL2200209 | 盛世泰科生物医药技术（苏州）有限公司 |
| 2022/04/02New drug · Class 1 | CGT-9475片CXHL2200208 | 盛世泰科生物医药技术（苏州）有限公司 |
| 2022/04/01Import · Class 2.6 | 20价肺炎球菌多糖结合疫苗JXSL2200043 | Wyeth Pharmaceuticals LLC a subsidiary of Pfizer Inc.; Pfizer Investment CO Ltd. |
| 2022/04/01Import · Class 1 | 注射用PF-06730512JXSL2200042 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2022/04/01Import · Class 1 | BI685509片JXHL2200074 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2022/04/01Import · Class 1 | BI685509片JXHL2200073 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2022/04/01Import · Class 1 | BI685509片JXHL2200072 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2022/04/01Generic · Class 3 | 马来酸依那普利口服溶液CYHS2200518 | 成都苑东生物制药股份有限公司; 华益药业科技（安徽）有限公司 |
| 2022/04/01Generic · Class 3 | 奥赛利定富马酸盐注射液CYHS2200516 | 江苏恩华药业股份有限公司 |
| 2022/03/31Import · Class 2.2 | HL242吸入气雾剂JXHL2200079 | HAISCO HOLDINGS PTE. LTD.; Haisco Pharmaceutical Group Co. Ltd. |
| 2022/03/31Import · Class 2.2 | HL242吸入气雾剂JXHL2200078 | HAISCO HOLDINGS PTE. LTD.; Haisco Pharmaceutical Group Co. Ltd. |
| 2022/03/31Import · Class 2.2 | HL242吸入气雾剂JXHL2200077 | HAISCO HOLDINGS PTE. LTD.; Haisco Pharmaceutical Group Co. Ltd. |
| 2022/03/31Generic · Class 3 | 卡络磺钠注射液CYHS2200513 | 湖北欣泽霏药业有限公司; 武汉华龙生物制药有限公司 |
26 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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