药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/02/27 – 2024/03/04
- New acceptances this week
- 344
- Drugs with new generic filings (by drug name, de-duplicated)
- 44
- 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
344filings, 57 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 199 |
| Generic | 57 |
| New drug | 43 |
| Import | 24 |
| Unspecified | 13 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 203 |
| TCM | 87 |
| 治疗用生物制品 | 50 |
| 预防用生物制品 | 3 |
| 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
44 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 二羟丙茶碱注射液 | 4 | 4 | 7 |
| 2 | 甲硫酸新斯的明注射液 | 3 | 1 | 4 |
| 3 | 亚叶酸钙注射液 | 2 | 2 | 4 |
| 4 | 富马酸伏诺拉生片 | 2 | 1 | 58 |
| 5 | 富马酸比索洛尔片 | 2 | 1 | 6 |
| 6 | 恩扎卢胺片 | 2 | 1 | 2 |
| 7 | 枸橼酸西地那非片 | 2 | 1 | 12 |
| 8 | 盐酸维洛沙秦缓释胶囊 | 2 | 1 | 0 |
| 9 | 长链脂肪乳注射液(OO) | 2 | 1 | 0 |
| 10 | 马来酸氟伏沙明片 | 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
188 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 石家庄御泽堂制药有限公司 | 51 | 39 | 0 |
| 2 | 山东新华制药股份有限公司 | 6 | 5 | 2 |
| 3 | EUROAPI Germany GmbH | 5 | 5 | 0 |
| 4 | Dr. Falk Pharma GmbH | 5 | 2 | 0 |
| 5 | 正大天晴药业集团股份有限公司 | 5 | 2 | 0 |
| 6 | 吉林省力盛制药有限公司 | 4 | 4 | 0 |
| 7 | 四川科伦药业股份有限公司 | 4 | 2 | 4 |
| 8 | 国药集团贵州生物制药有限公司 | 4 | 2 | 0 |
| 9 | H. Lundbeck A/S | 4 | 1 | 0 |
| 10 | Sanofi-Aventis Recherche & Developpement | 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
92 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/03/04Import · Class 1 | PF-07220060JXHL2400059 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2024/03/04Import · Class 1 | PF-07220060JXHL2400058 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2024/03/04Import · Class 1 | PF-07220060JXHL2400057 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2024/03/04Import · Class 1 | Lu AF28996 胶囊JXHL2400056 | H. Lundbeck A/S |
| 2024/03/04Import · Class 1 | Lu AF28996 胶囊JXHL2400055 | H. Lundbeck A/S |
| 2024/03/04Import · Class 1 | Lu AF28996 胶囊JXHL2400054 | H. Lundbeck A/S |
| 2024/03/04Import · Class 1 | Lu AF28996 胶囊JXHL2400053 | H. Lundbeck A/S |
| 2024/03/04Import · Class 1 | ARV-471(PF-07850327)片JXHL2400052 | Pfizer Inc; Pfizer Investment CO. Ltd. |
| 2024/03/04Generic · Class 3 | 甲硫酸新斯的明注射液CYHS2400752 | 南京海辰药业股份有限公司 |
| 2024/03/04Generic · Class 3 | 甲硫酸新斯的明注射液CYHS2400751 | 南京海辰药业股份有限公司 |
| 2024/03/04Generic · Class 3 | 甲硫酸新斯的明注射液CYHS2400750 | 南京海辰药业股份有限公司 |
| 2024/03/04Generic · Class 3 | 醋酸地非法林注射液CYHL2400051 | 齐鲁制药(海南)有限公司 |
| 2024/03/04New drug · Class 1 | 己二酸他雷替尼胶囊CXHS2400020 | 葆元生物医药科技(杭州)有限公司; 凯莱英生命科学技术(天津)有限公司 |
| 2024/03/02Import · Class 3.1 | 注射用利纳西普JXSS2400016 | Kiniksa Pharmaceuticals (UK) Ltd.; Jubilant HollisterStier LLC; HANGZHOU ZHONGMEI HUADONG PHARMACEUTICALS CO. LTD |
| 2024/03/02Import · Class 1 | RO7435846片JXHL2400051 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2024/03/02Import · Class 1 | RO7435846片JXHL2400050 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2024/03/02Import · Class 1 | RO7435846片JXHL2400049 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2024/03/02Generic · Class 3 | 注射用德拉沙星CYHS2400746 | 江苏奥赛康药业有限公司 |
| 2024/03/02Generic · Class 3 | 复方电解质注射液(V)CYHS2400745 | 河北天成药业股份有限公司 |
| 2024/03/02Generic · Class 3 | 盐酸维洛沙秦缓释胶囊CYHL2400050 | 江苏恩华药业股份有限公司; 苏州恩华生物医药科技有限公司 |
| 2024/03/02Generic · Class 3 | 盐酸维洛沙秦缓释胶囊CYHL2400049 | 江苏恩华药业股份有限公司; 苏州恩华生物医药科技有限公司 |
| 2024/03/02New drug · Class 1 | SSGJ-707注射液CXSL2400171 | 沈阳三生制药有限责任公司; 三生国健药业(上海)股份有限公司 |
| 2024/03/02New drug · Class 1 | 盐酸去甲乌药碱注射液CXHS2400019 | 珠海润都制药股份有限公司 |
| 2024/03/01Import · Class 2.4 | 米罗那非片JXHL2400048 | AriBio Co. Ltd.; Panacro (Hefei) Pharmaceutical Technology Co. Ltd. |
| 2024/03/01Import · Class 2.4 | 米罗那非片JXHL2400047 | AriBio Co. Ltd.; Panacro (Hefei) Pharmaceutical Technology Co. Ltd. |
| 2024/03/01Generic · Class 3 | 二羟丙茶碱注射液CYHS2400741 | 扬州中宝药业股份有限公司 |
| 2024/03/01Generic · Class 3 | 地氯雷他定口服溶液CYHS2400738 | 江苏开元药业有限公司; 南京海纳制药有限公司 |
| 2024/03/01Generic · Class 3 | 磷酸奥司他韦干混悬剂CYHS2400734 | 哈药集团技术中心 |
| 2024/03/01Generic · Class 3 | 维生素B6注射液CYHS2400733 | 海南元盈医药科技有限公司; 酒泉大得利制药股份有限公司 |
| 2024/03/01Generic · Class 3 | 托吡酯口服溶液CYHS2400730 | 重庆华森制药股份有限公司; 华益药业科技(安徽)有限公司 |
62 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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