药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/05/21 – 2024/05/27
- New acceptances this week
- 310
- Drugs with new generic filings (by drug name, de-duplicated)
- 57
- 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
310filings, 73 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 159 |
| Generic | 73 |
| New drug | 41 |
| Import re-registration | 20 |
| Import | 12 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 194 |
| TCM | 66 |
| 治疗用生物制品 | 45 |
| 预防用生物制品 | 3 |
| 体外诊断试剂 | 1 |
| Biologic | 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
57 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 盐酸布比卡因注射液 | 4 | 2 | 4 |
| 2 | 氨溴特罗口服溶液 | 2 | 2 | 23 |
| 3 | 硫酸氨基葡萄糖胶囊 | 2 | 2 | 50 |
| 4 | 复方氨基酸(15AA-II)/葡萄糖(10%)电解质注射液 | 2 | 1 | 0 |
| 5 | 尼麦角林片 | 2 | 1 | 1 |
| 6 | 左乙拉西坦缓释片 | 2 | 1 | 0 |
| 7 | 巴瑞替尼片 | 2 | 1 | 32 |
| 8 | 帕拉米韦氯化钠注射液 | 2 | 1 | 17 |
| 9 | 平衡盐冲洗液 | 2 | 1 | 0 |
| 10 | 法莫替丁注射液 | 2 | 1 | 8 |
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
184 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 秦皇岛山海关药业股份有限公司 | 6 | 6 | 0 |
| 2 | 上海复星医药产业发展有限公司 | 6 | 2 | 0 |
| 3 | Bracco Imaging S.P.A. | 6 | 1 | 0 |
| 4 | AbbVie Inc. | 5 | 3 | 0 |
| 5 | 浙江仙琚制药股份有限公司 | 5 | 2 | 0 |
| 6 | 上海万仕诚药业有限公司 | 4 | 4 | 0 |
| 7 | 安徽中晨制药有限公司 | 4 | 4 | 0 |
| 8 | 陕西康惠制药股份有限公司 | 4 | 4 | 0 |
| 9 | 吉林恒星科技制药有限公司 | 4 | 3 | 0 |
| 10 | 广东恒瑞医药有限公司 | 4 | 2 | 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
89 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/05/27Import · Class 2.4 | 盐酸非苏拉生片JXHL2400117 | Daewoong Pharmaceutical Co. Ltd.; Yangtze River Pharmaceutical Group Shanghai Haini Pharmceutical Co. Ltd. |
| 2024/05/27Generic · Class 3 | 吡格列酮二甲双胍片CYHS2401579 | 成都倍特药业股份有限公司 |
| 2024/05/27Generic · Class 3 | 布立西坦口服溶液CYHS2401578 | 海南全星制药有限公司 |
| 2024/05/25Generic · Class 3 | 盐酸甲氧氯普胺注射液CYHS2401573 | 北京民康百草医药科技有限公司; 山西诺成制药有限公司 |
| 2024/05/25Generic · Class 3 | 乙酰半胱氨酸注射液CYHS2401572 | 湖北津药药业股份有限公司 |
| 2024/05/25New drug · Class 1 | LY01620CXSL2400349 | 南京吉迈生物技术有限公司 |
| 2024/05/25New drug · Class 1 | 注射用ZGGS18CXSL2400348 | 苏州泽璟生物制药股份有限公司 |
| 2024/05/25New drug · Class 1 | 注射用ZG005CXSL2400347 | 苏州泽璟生物制药股份有限公司 |
| 2024/05/25New drug · Class 1 | RC148注射液CXSL2400346 | 荣昌生物制药(烟台)股份有限公司 |
| 2024/05/25New drug · Class 1 | 注射用RC118CXSL2400345 | 荣昌生物制药(烟台)股份有限公司 |
| 2024/05/25New drug · Class 2.4 | 青蒿琥酯片CXHL2400527 | 桂林南药股份有限公司; 上海交通大学 |
| 2024/05/24Import · Class 1 | Astegolimab注射液JXSL2400103 | F. Hoffmann-La Roche Ltd; Roche(China) Holding Ltd. |
| 2024/05/24Import · Class 2.2 | Epcoritamab注射用浓溶液JXSL2400102 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2024/05/24Import · Class 2.2 | Epcoritamab注射用浓溶液JXSL2400101 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2024/05/24Import · Class 2.2 | Epcoritamab注射液JXSL2400100 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2024/05/24Import · Class 2.2 | Epcoritamab注射液JXSL2400099 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2024/05/24Generic · Class 3 | 盐酸布比卡因注射液CYHS2401571 | 北京民康百草医药科技有限公司; 山西诺成制药有限公司 |
| 2024/05/24Generic · Class 3 | 盐酸布比卡因注射液CYHS2401570 | 北京民康百草医药科技有限公司; 山西诺成制药有限公司 |
| 2024/05/24Generic · Class 3 | 尼麦角林片CYHS2401569 | 海南通用三洋药业有限公司 |
| 2024/05/24Generic · Class 3 | 尼麦角林片CYHS2401567 | 海南通用三洋药业有限公司 |
| 2024/05/24Generic · Class 3 | 盐酸倍他司汀片CYHS2401560 | 上海理想制药有限公司 |
| 2024/05/24Generic · Class 3 | 吸入用盐酸丙卡特罗溶液CYHS2401557 | 成都天之翼尚品医药科技有限公司; 知和(山东)大药厂有限公司 |
| 2024/05/24Generic · Class 3 | 复方氨基酸(15AA-II)/葡萄糖(10%)电解质注射液CYHS2401556 | 山东齐都药业有限公司 |
| 2024/05/24Generic · Class 3 | 盐酸布比卡因注射液CYHS2401555 | 广州艾格生物科技有限公司; 成都天台山制药股份有限公司 |
| 2024/05/24Generic · Class 3 | 复方氨基酸(15AA-II)/葡萄糖(10%)电解质注射液CYHS2401554 | 山东齐都药业有限公司 |
| 2024/05/24Generic · Class 3 | 盐酸布比卡因注射液CYHS2401553 | 广州艾格生物科技有限公司; 成都天台山制药股份有限公司 |
| 2024/05/24Generic · Class 3 | 米诺地尔泡沫剂(女用)CYHL2400101 | 山西振东安欣生物制药有限公司 |
| 2024/05/24Generic · Class 3 | 米诺地尔泡沫剂(男用)CYHL2400100 | 山西振东安欣生物制药有限公司 |
| 2024/05/24New drug · Class 1 | 注射用HS-20124CXSL2400344 | 常州恒邦药业有限公司; 上海翰森生物医药科技有限公司 |
| 2024/05/24New drug · Class 1 | GenSci098注射液CXSL2400343 | 长春金赛药业有限责任公司 |
59 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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