药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/03/16 – 2021/03/22
- New acceptances this week
- 164
- Drugs with new generic filings (by drug name, de-duplicated)
- 11
- 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
164filings, 20 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 89 |
| Import | 24 |
| Generic | 20 |
| New drug | 16 |
| Import re-registration | 9 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 128 |
| 治疗用生物制品 | 24 |
| TCM | 6 |
| 预防用生物制品 | 3 |
| Biologic | 2 |
| 体外诊断试剂 | 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
11 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 阿加曲班注射液 | 3 | 3 | 2 |
| 2 | 丙戊酸钠注射用浓溶液 | 3 | 1 | 0 |
| 3 | 布瑞哌唑片 | 3 | 1 | 31 |
| 4 | 沙格列汀片 | 2 | 1 | 0 |
| 5 | 注射用培美曲塞二钠 | 2 | 1 | 2 |
| 6 | 非布司他片 | 2 | 1 | 15 |
| 7 | 氯化钾缓释片(I) | 1 | 1 | 0 |
| 8 | 氯甲西泮注射液 | 1 | 1 | 0 |
| 9 | 盐酸二甲双胍缓释片 | 1 | 1 | 11 |
| 10 | 盐酸奥普力农注射液 | 1 | 1 | 1 |
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
89 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 北京四环生物制药有限公司 | 10 | 1 | 0 |
| 2 | 正大天晴药业集团南京顺欣制药有限公司 | 9 | 5 | 0 |
| 3 | Astrazeneca UK Limited | 6 | 1 | 0 |
| 4 | LABORATORIOS FARMACEUTICOS ROVI S.A. | 5 | 1 | 0 |
| 5 | AstraZeneca UK Limited | 4 | 1 | 0 |
| 6 | Loxo Oncology Inc. | 4 | 1 | 0 |
| 7 | Mirum Pharmaceuticals Inc. | 4 | 1 | 0 |
| 8 | Pfizer Healthcare Ireland | 4 | 1 | 0 |
| 9 | Novartis Pharma Schweiz AG | 3 | 2 | 0 |
| 10 | Eli Lilly and Company | 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
36 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/03/22New drug · Class 1 | IBI302CXSL2101006 | 信达生物制药(苏州)有限公司 |
| 2021/03/20Import · Class 1 | Maralixibat口服溶液JXHL2100100 | Mirum Pharmaceuticals Inc. |
| 2021/03/20Import · Class 1 | Maralixibat口服溶液JXHL2100099 | Mirum Pharmaceuticals Inc. |
| 2021/03/20Import · Class 1 | Maralixibat口服溶液JXHL2100098 | Mirum Pharmaceuticals Inc. |
| 2021/03/20Import · Class 1 | Maralixibat口服溶液JXHL2100097 | Mirum Pharmaceuticals Inc. |
| 2021/03/20Import · Class 1 | Atrasentan片JXHL2100096 | Chinook Therapeutics U.S. Inc. |
| 2021/03/20Import · Class 1 | LOXO-305JXHL2100093 | Loxo Oncology Inc. |
| 2021/03/20Import · Class 1 | LOXO-305JXHL2100092 | Loxo Oncology Inc. |
| 2021/03/20Import · Class 1 | LOXO-305JXHL2100091 | Loxo Oncology Inc. |
| 2021/03/20Import · Class 1 | LOXO-305JXHL2100090 | Loxo Oncology Inc. |
| 2021/03/20Import · Class 2.4 | 甲磺酸仑伐替尼胶囊JXHL2100089 | Eisai Europe Ltd. |
| 2021/03/20Import · Class 2.4 | 甲磺酸仑伐替尼胶囊JXHL2100088 | Eisai Europe Ltd. |
| 2021/03/20New drug · Class 1 | 阿基仑赛注射液CXSL2100098 | 复星凯特生物科技有限公司 |
| 2021/03/19New drug · Class 2.4 | 富马酸丙酚替诺福韦片CXHS2100010 | 华北制药华坤河北生物技术有限公司; 华北制药股份有限公司 |
| 2021/03/19New drug · Class 1 | ASC42片CXHL2101008 | 歌礼生物科技(杭州)有限公司 |
| 2021/03/19New drug · Class 1 | ASC42片CXHL2101007 | 歌礼生物科技(杭州)有限公司 |
| 2021/03/18Generic · Class 3 | 丙戊酸钠注射用浓溶液CYHS2101023 | 四川汇宇制药股份有限公司 |
| 2021/03/18Generic · Class 3 | 丙戊酸钠注射用浓溶液CYHS2101022 | 四川汇宇制药股份有限公司 |
| 2021/03/18Generic · Class 3 | 丙戊酸钠注射用浓溶液CYHS2101021 | 四川汇宇制药股份有限公司 |
| 2021/03/18New drug · Class 2.2 | 替雷利珠单抗注射液CXSL2101005 | 百济神州(上海)生物科技有限公司 |
| 2021/03/18New drug · Class 1 | HTD1801胶囊CXHL2100190 | 深圳君圣泰生物技术有限公司 |
| 2021/03/17Generic · Class 3 | 氯甲西泮注射液CYHL2100017 | 江苏华泰晨光药业有限公司 |
| 2021/03/17New drug · Class 1 | 阴道用四联乳杆菌活菌胶囊CXSL2101004 | 四川厌氧生物科技有限责任公司 |
| 2021/03/17New drug · Class 1 | 阴道用四联乳杆菌活菌胶囊CXSL2101003 | 四川厌氧生物科技有限责任公司 |
| 2021/03/17New drug · Class 1 | ASC42片CXHL2101004 | 甘莱制药有限公司 |
| 2021/03/17New drug · Class 1 | ASC42片CXHL2101003 | 甘莱制药有限公司 |
| 2021/03/16Generic · Class 3 | 氯化钾缓释片(I)CYHS2100285 | 宜昌人福药业有限责任公司 |
| 2021/03/16Generic · Class 3 | 布瑞哌唑片CYHS2100283 | 重庆药友制药有限责任公司 |
| 2021/03/16Generic · Class 3 | 布瑞哌唑片CYHS2100282 | 重庆药友制药有限责任公司 |
| 2021/03/16Generic · Class 3 | 布瑞哌唑片CYHS2100281 | 重庆药友制药有限责任公司 |
6 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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