药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/03/07 – 2023/03/13
- New acceptances this week
- 334
- Drugs with new generic filings (by drug name, de-duplicated)
- 58
- Accepted this week, now under review
- 9
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
334filings, 79 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 175 |
| Generic | 79 |
| New drug | 46 |
| Import | 14 |
| Import re-registration | 12 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 250 |
| TCM | 43 |
| 治疗用生物制品 | 36 |
| Biologic | 3 |
| 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
58 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 法莫替丁注射液 | 3 | 3 | 8 |
| 2 | 氨溴特罗口服溶液 | 3 | 2 | 23 |
| 3 | 米诺地尔外用溶液 | 3 | 2 | 0 |
| 4 | 哌柏西利胶囊 | 3 | 1 | 0 |
| 5 | 氧 | 2 | 2 | 15 |
| 6 | 利培酮口崩片 | 2 | 1 | 0 |
| 7 | 吸入用布地奈德混悬液 | 2 | 1 | 7 |
| 8 | 奥贝胆酸片 | 2 | 1 | 0 |
| 9 | 富马酸二甲酯肠溶胶囊 | 2 | 1 | 0 |
| 10 | 恩格列净利格列汀片 | 2 | 1 | 0 |
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
195 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 天津和治药业集团有限公司 | 8 | 8 | 0 |
| 2 | 上海青平药业有限公司 | 8 | 5 | 0 |
| 3 | Actelion Pharmaceuticals Ltd | 8 | 1 | 0 |
| 4 | 黑龙江亿达鸿药业有限公司 | 7 | 6 | 0 |
| 5 | 鸿祥(黑龙江)制药有限公司 | 6 | 6 | 0 |
| 6 | 石家庄四药有限公司 | 6 | 4 | 1 |
| 7 | 山东润泽制药有限公司 | 6 | 1 | 0 |
| 8 | Eurofins Analytical Science Laboratories Inc. | 5 | 5 | 0 |
| 9 | 亳州亚英医药科技有限公司 | 5 | 5 | 0 |
| 10 | 四川依科制药有限公司 | 5 | 5 | 1 |
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
94 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/03/13Import · Class 1 | LY3454738注射液JXSL2300050 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/03/13Generic · Class 3 | 头孢丙烯干混悬剂CYHS2300773 | 国药集团致君(深圳)制药有限公司 |
| 2023/03/13Generic · Class 3 | 奥贝胆酸片CYHL2300036 | 杭州民生药业股份有限公司 |
| 2023/03/13Generic · Class 3 | 奥贝胆酸片CYHL2300035 | 杭州民生药业股份有限公司 |
| 2023/03/13New drug · Class 2.2 | 替格瑞洛缓释片CXHL2300303 | 越洋医药开发(广州)有限公司 |
| 2023/03/11Import · Class 3.1 | 度伐利尤单抗注射液JXSS2300025 | AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca Investment (China) Co. Ltd. |
| 2023/03/11Import · Class 3.1 | 度伐利尤单抗注射液JXSS2300024 | AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca Investment (China) Co. Ltd. |
| 2023/03/11Import · Class 1 | elranatamabJXSL2300049 | Pfizer Inc; Pfizer Investment CO. Ltd. |
| 2023/03/11Import · Class 1 | Zavegepant鼻喷雾剂JXHL2300044 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2023/03/11Generic · Class 3 | 恩格列净利格列汀片CYHS2300770 | 齐鲁制药(海南)有限公司 |
| 2023/03/11Generic · Class 3 | 恩格列净利格列汀片CYHS2300769 | 齐鲁制药(海南)有限公司 |
| 2023/03/11Generic · Class 3 | 法莫替丁注射液CYHS2300763 | 南京恒道医药科技股份有限公司; 江苏九旭药业有限公司 |
| 2023/03/11New drug · Class 1 | HH-012注射液CXSL2300182 | 华辉安健(北京)生物科技有限公司 |
| 2023/03/11New drug · Class 2.4 | 氟维司群注射液CXHL2300302 | 正大天晴药业集团股份有限公司 |
| 2023/03/11New drug · Class 2.4 | 氟维司群注射液CXHL2300301 | 正大天晴药业集团股份有限公司 |
| 2023/03/11New drug · Class 1 | 替拉扎明注射液CXHL2300300 | 杭州瑞臻医药有限公司 |
| 2023/03/11New drug · Class 1 | VC004凝胶CXHL2300299 | 江苏威凯尔医药科技有限公司 |
| 2023/03/11New drug · Class 1 | VC004凝胶CXHL2300298 | 江苏威凯尔医药科技有限公司 |
| 2023/03/11New drug · Class 1 | VC004凝胶CXHL2300297 | 江苏威凯尔医药科技有限公司 |
| 2023/03/11New drug · Class 1 | VC004凝胶CXHL2300296 | 江苏威凯尔医药科技有限公司 |
| 2023/03/11New drug · Class 1 | NRT6008注射液CXHL2300295 | 成都纽瑞特医疗科技股份有限公司 |
| 2023/03/10Import · Class 3.1 | 注射用维恩妥尤单抗JXSS2300023 | Astellas Pharma Europe B.V.; Baxter Oncology GmbH; Astellas (China) Investment Co. Ltd. |
| 2023/03/10Import · Class 3.1 | 注射用维恩妥尤单抗JXSS2300022 | Astellas Pharma Europe B.V.; Baxter Oncology GmbH; Astellas (China) Investment Co Ltd. |
| 2023/03/10Generic · Class 3 | 法莫替丁注射液CYHS2300762 | 合肥亿帆生物制药有限公司 |
| 2023/03/10Generic · Class 3 | 盐酸多巴酚丁胺注射液CYHS2300761 | 沈阳双鼎制药有限公司 |
| 2023/03/10Generic · Class 3 | 盐酸多巴酚丁胺注射液CYHS2300760 | 沈阳双鼎制药有限公司 |
| 2023/03/10Generic · Class 3 | 艾司奥美拉唑镁肠溶胶囊CYHS2300759 | 通化万通药业股份有限公司 |
| 2023/03/10Generic · Class 3 | 艾司奥美拉唑镁肠溶胶囊CYHS2300758 | 通化万通药业股份有限公司 |
| 2023/03/10Generic · Class 3 | 奥沙利铂注射液CYHS2300754 | 吉斯美(武汉)制药有限公司 |
| 2023/03/10Generic · Class 3 | 重酒石酸卡巴拉汀口服溶液CYHS2300753 | 山东朗诺制药有限公司 |
64 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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