药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/02/22 – 2022/02/28
- New acceptances this week
- 168
- Drugs with new generic filings (by drug name, de-duplicated)
- 13
- 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
168filings, 19 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 91 |
| New drug | 23 |
| Generic | 19 |
| Import re-registration | 18 |
| Import | 10 |
| Unspecified | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 114 |
| TCM | 36 |
| 治疗用生物制品 | 18 |
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
13 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 吸入用盐酸氨溴索溶液 | 2 | 2 | 10 |
| 2 | 氯雷他定糖浆 | 2 | 1 | 7 |
| 3 | 注射用头孢呋辛钠/氯化钠注射液 | 2 | 1 | 5 |
| 4 | 注射用阿莫西林钠克拉维酸钾（10:1） | 2 | 1 | 0 |
| 5 | 硝酸甘油注射液 | 2 | 1 | 7 |
| 6 | 草酸艾司西酞普兰片 | 2 | 1 | 6 |
| 7 | 丙酸氟替卡松雾化吸入用混悬液 | 1 | 1 | 7 |
| 8 | 头孢地尼颗粒 | 1 | 1 | 3 |
| 9 | 氟维司群注射液 | 1 | 1 | 0 |
| 10 | 氧（液态） | 1 | 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
84 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bayer Vital GmbH | 16 | 2 | 0 |
| 2 | Novo Nordisk A/S | 8 | 2 | 0 |
| 3 | 广东心宝药业科技有限公司 | 7 | 7 | 0 |
| 4 | 黑龙江珍宝岛药业股份有限公司 | 7 | 7 | 0 |
| 5 | 南京赛瑞谱顿制药有限公司 | 6 | 4 | 0 |
| 6 | 安徽贤桂医药科技有限公司 | 5 | 5 | 0 |
| 7 | Boehringer Ingelheim International GmbH | 4 | 1 | 0 |
| 8 | GE Healthcare AS | 4 | 1 | 0 |
| 9 | 广东金城金素制药有限公司 | 4 | 1 | 0 |
| 10 | 惠升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
35 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/02/28New drug · Class 1 | 重组人源化单克隆抗体MIL98注射液CXSL2200106 | 北京天广实生物技术股份有限公司 |
| 2022/02/28New drug · Class 1 | 加格列净片CXHS2200015 | 惠升生物制药股份有限公司; 北京四环制药有限公司 |
| 2022/02/28New drug · Class 1 | 加格列净片CXHS2200014 | 惠升生物制药股份有限公司; 北京四环制药有限公司 |
| 2022/02/28New drug · Class 1 | 加格列净片CXHS2200013 | 惠升生物制药股份有限公司; 北京四环制药有限公司 |
| 2022/02/28New drug · Class 1 | 加格列净片CXHS2200012 | 惠升生物制药股份有限公司; 北京四环制药有限公司 |
| 2022/02/28New drug · Class 2.2 | 异氟烷注射液CXHS2200011 | 宜昌人福药业有限责任公司 |
| 2022/02/25Import · Class 1 | MK-1084片JXHL2200043 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2022/02/25Import · Class 1 | MK-1084片JXHL2200042 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2022/02/25Import · Class 1 | BAY 2927088片JXHL2200041 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2022/02/25Import · Class 1 | BAY 2927088片JXHL2200040 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2022/02/25Generic · Class 3 | 吸入用盐酸氨溴索溶液CYHS2200380 | 四川美大康华康药业有限公司 |
| 2022/02/25Generic · Class 3 | 硝酸甘油注射液CYHS2200378 | 青海晨菲制药有限公司 |
| 2022/02/25Generic · Class 3 | 硝酸甘油注射液CYHS2200377 | 青海晨菲制药有限公司 |
| 2022/02/25Generic · Class 3 | 注射用阿莫西林钠克拉维酸钾（10:1）CYHS2200376 | 深圳华润九新药业有限公司; 中孚药业股份有限公司 |
| 2022/02/25Generic · Class 3 | 注射用阿莫西林钠克拉维酸钾（10:1）CYHS2200375 | 深圳华润九新药业有限公司; 中孚药业股份有限公司 |
| 2022/02/25Generic · Class 3 | 吸入用盐酸氨溴索溶液CYHS2200374 | 重庆世森医药科技有限公司; 湖南华纳大药厂股份有限公司 |
| 2022/02/25Generic · Class 3 | 磷酸奥司他韦干混悬剂CYHS2200373 | 广东九瑞科技开发有限公司; 天津汉瑞药业有限公司 |
| 2022/02/25Generic · Class 3 | 注射用盐酸罗沙替丁醋酸酯CYHS2200371 | 北京品尚品医药科技有限公司; 山西普德药业有限公司 |
| 2022/02/25New drug · Class 1 | 艾贝格司亭α注射液CXSS2200018 | 亿一生物制药（北京）有限公司 |
| 2022/02/25New drug · Class 1 | 斯鲁利单抗注射液CXSL2200105 | 上海复宏汉霖生物技术股份有限公司 |
| 2022/02/25New drug · Class 1 | HLX26单抗注射液CXSL2200104 | 上海复宏汉霖生物技术股份有限公司 |
| 2022/02/25New drug · Class 1 | GC301腺相关病毒注射液CXSL2200103 | 北京锦篮基因科技有限公司 |
| 2022/02/25New drug · Class 1 | 谷美替尼片CXHS2200010 | 上海海和药物研究开发股份有限公司; 江苏宣泰药业有限公司 |
| 2022/02/25New drug · Class 1 | 维卡格雷胶囊CXHL2200123 | 江苏威凯尔医药科技有限公司 |
| 2022/02/25New drug · Class 1 | FCN-159片CXHL2200122 | 上海复星医药产业发展有限公司 |
| 2022/02/25New drug · Class 1 | FCN-159片CXHL2200121 | 上海复星医药产业发展有限公司 |
| 2022/02/25New drug · Class 1 | FCN-159片CXHL2200120 | 上海复星医药产业发展有限公司 |
| 2022/02/23New drug · Class 1 | GC301腺相关病毒注射液CXSL2200102 | 北京锦篮基因科技有限公司 |
| 2022/02/23New drug · Class 2.2 | 注射用泰它西普CXSL2200101 | 荣昌生物制药（烟台）股份有限公司 |
| 2022/02/23New drug · Class 2.2;2.4 | 纳米炭铁混悬注射液CXHL2200119 | 四川瀛瑞医药科技有限公司 |
5 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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