药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/03/21 – 2023/03/27
- New acceptances this week
- 279
- Drugs with new generic filings (by drug name, de-duplicated)
- 49
- 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
279filings, 66 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 133 |
| Generic | 66 |
| New drug | 32 |
| Import | 24 |
| Unspecified | 18 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 204 |
| TCM | 35 |
| 治疗用生物制品 | 33 |
| Biologic | 5 |
| 预防用生物制品 | 2 |
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
49 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 聚乙烯醇滴眼液 | 4 | 3 | 22 |
| 2 | 注射用氨苄西林钠舒巴坦钠 | 3 | 1 | 13 |
| 3 | 帕米膦酸二钠注射液 | 2 | 2 | 2 |
| 4 | 重酒石酸去甲肾上腺素注射液 | 2 | 2 | 9 |
| 5 | 奥卡西平口服混悬液 | 2 | 1 | 2 |
| 6 | 对乙酰氨基酚注射液 | 2 | 1 | 1 |
| 7 | 左卡尼汀注射液 | 2 | 1 | 5 |
| 8 | 托拉塞米片 | 2 | 1 | 0 |
| 9 | 氯雷他定糖浆 | 2 | 1 | 7 |
| 10 | 玻璃酸钠滴眼液 | 2 | 1 | 29 |
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
174 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 上海青平药业有限公司 | 9 | 8 | 0 |
| 2 | 株洲千金药业股份有限公司 | 6 | 5 | 0 |
| 3 | 石家庄四药有限公司 | 6 | 3 | 2 |
| 4 | Eli Lilly and Company | 6 | 1 | 0 |
| 5 | Janssen Research & Development LLC | 4 | 2 | 0 |
| 6 | Novartis Europharm Limited | 4 | 2 | 0 |
| 7 | 和记黄埔医药(上海)有限公司 | 4 | 2 | 0 |
| 8 | 上海长征富民金山制药有限公司 | 3 | 3 | 3 |
| 9 | 广西圣民制药有限公司 | 3 | 3 | 0 |
| 10 | 正大天晴药业集团南京顺欣制药有限公司 | 3 | 3 | 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
81 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/03/27Generic · Class 3 | 胞磷胆碱钠注射液CYHS2300904 | 北京四环科宝药业有限公司; 北京四环科宝制药股份有限公司 |
| 2023/03/27Generic · Class 3 | 胞磷胆碱钠注射液CYHS2300903 | 北京四环科宝药业有限公司; 北京四环科宝制药股份有限公司 |
| 2023/03/27New drug · Class 1 | APG-2575片CXHL2300333 | 苏州亚盛药业有限公司 |
| 2023/03/27New drug · Class 1 | APG-2575片CXHL2300332 | 苏州亚盛药业有限公司 |
| 2023/03/27New drug · Class 2.4 | 奥雷巴替尼片CXHL2300331 | 广州顺健生物医药科技有限公司 |
| 2023/03/25Import · Class 2.2 | 贝利尤单抗注射液(皮下注射)JXSL2300061 | GlaxoSmithKline (Ireland) Limited; GlaxoSmithKline (China) Investment Company Limited |
| 2023/03/25Generic · Class 3 | 盐酸去氧肾上腺素注射液CYHS2300901 | 石家庄四药有限公司 |
| 2023/03/25Generic · Class 3 | 聚乙烯醇滴眼液CYHS2300898 | 浙江恒研医药科技有限公司; 浙江赛默制药有限公司 |
| 2023/03/25Generic · Class 3 | 聚乙烯醇滴眼液CYHS2300897 | 四川海梦智森生物制药有限公司; 浙江赛默制药有限公司 |
| 2023/03/25New drug · Class 1 | 赛立奇单抗注射液CXSS2300015 | 重庆智翔金泰生物制药股份有限公司 |
| 2023/03/25New drug · Class 1 | SHR-3167注射液CXSL2300216 | 江苏恒瑞医药股份有限公司 |
| 2023/03/25New drug · Class 1 | HJ178胶囊CXHL2300330 | 成都华健未来科技有限公司 |
| 2023/03/25New drug · Class 1 | HJ178胶囊CXHL2300329 | 成都华健未来科技有限公司 |
| 2023/03/24Import · Class 1 | 注射用SAR443579JXSL2300060 | Sanofi-Aventis Recherche & Développement; SANOFI (CHINA) INVESTMENT CO. LTD |
| 2023/03/24Import · Class 3.1 | Bimekizumab注射液JXSL2300059 | UCB Pharma S.A.; UCB Trading (Shanghai) Co. Ltd |
| 2023/03/24Import · Class 1 | Amlitelimab注射液JXSL2300058 | Sanofi-Aventis Recherche & Développement; Sanofi(China) Investment Co. LTD |
| 2023/03/24Import · Class 1 | Zibotentan胶囊JXHL2300060 | Astrazeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/03/24Import · Class 1 | Zibotentan胶囊JXHL2300059 | Astrazeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/03/24Import · Class 1 | Zibotentan胶囊JXHL2300058 | Astrazeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/03/24Import · Class 2.3 | 注射用氨曲南阿维巴坦JXHL2300057 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2023/03/24Generic · Class 3 | 注射用左亚叶酸钙CYHS2300895 | 四川百利药业有限责任公司 |
| 2023/03/24Generic · Class 3 | 帕米膦酸二钠注射液CYHS2300894 | 成都欣捷高新技术开发股份有限公司; 成都市海通药业有限公司 |
| 2023/03/24Generic · Class 3 | 帕米膦酸二钠注射液CYHS2300892 | 仁合益康集团有限公司; 河北仁合益康药业有限公司 |
| 2023/03/24Generic · Class 3 | 重酒石酸间羟胺注射液CYHS2300889 | 河南蓝图制药有限公司; 江苏悦兴药业有限公司 |
| 2023/03/24Generic · Class 3 | 阿立哌唑口崩片CYHS2300888 | 澳美制药(海南)有限公司 |
| 2023/03/24Generic · Class 3 | 阿立哌唑口崩片CYHS2300887 | 澳美制药(海南)有限公司 |
| 2023/03/24Generic · Class 3 | 聚乙烯醇滴眼液CYHS2300885 | 远大医药(中国)有限公司; 湖北远大天天明制药有限公司 |
| 2023/03/24Generic · Class 3 | 聚乙烯醇滴眼液CYHS2300884 | 远大医药(中国)有限公司; 湖北远大天天明制药有限公司 |
| 2023/03/24Generic · Class 3 | 西咪替丁注射液CYHS2300880 | 温岭市创新生物医药科技股份有限公司; 万邦德制药集团有限公司 |
| 2023/03/24Generic · Class 3 | 水溶性黄体酮注射液CYHS2300879 | 长春金赛药业有限责任公司; 吉林省金派格药业有限责任公司 |
51 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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