药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/01/31 – 2023/02/06
- New acceptances this week
- 420
- Drugs with new generic filings (by drug name, de-duplicated)
- 81
- 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
420filings, 118 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 182 |
| Generic | 118 |
| New drug | 76 |
| Import | 21 |
| Import re-registration | 15 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 331 |
| 治疗用生物制品 | 45 |
| TCM | 43 |
| 预防用生物制品 | 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
81 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 氨溴特罗口服溶液 | 5 | 3 | 23 |
| 2 | 乳果糖口服溶液 | 4 | 2 | 36 |
| 3 | 盐酸去氧肾上腺素注射液 | 4 | 2 | 5 |
| 4 | 米诺地尔外用溶液 | 4 | 2 | 0 |
| 5 | 左亚叶酸钙注射液 | 4 | 1 | 0 |
| 6 | 间苯三酚注射液 | 3 | 3 | 2 |
| 7 | 乙酰半胱氨酸颗粒 | 3 | 2 | 4 |
| 8 | 帕拉米韦注射液 | 3 | 2 | 7 |
| 9 | 注射用阿莫西林钠 | 3 | 1 | 0 |
| 10 | 吲哚布芬片 | 2 | 2 | 7 |
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
240 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 平光制药股份有限公司 | 13 | 12 | 0 |
| 2 | 安徽省先锋制药有限公司 | 9 | 3 | 0 |
| 3 | 上海博莱科信谊药业有限责任公司 | 8 | 1 | 0 |
| 4 | 月明堂（山西）中药有限公司 | 7 | 7 | 0 |
| 5 | 杭州高光制药有限公司 | 7 | 2 | 0 |
| 6 | 天津百特医疗用品有限公司 | 6 | 6 | 6 |
| 7 | 齐鲁制药有限公司 | 6 | 3 | 1 |
| 8 | Bracco Imaging Italia s.r.l. | 6 | 1 | 0 |
| 9 | 四川汇宇制药股份有限公司 | 5 | 4 | 5 |
| 10 | 四川科伦药业股份有限公司 | 5 | 4 | 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
143 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/02/06Generic · Class 3 | 吲哚布芬片CYHS2300362 | 成都硕德药业有限公司 |
| 2023/02/06Generic · Class 3 | 呋塞米注射液CYHS2300361 | 仁合益康集团有限公司; 河北仁合益康药业有限公司 |
| 2023/02/06Generic · Class 3 | 呋塞米注射液CYHS2300360 | 仁合益康集团有限公司; 河北仁合益康药业有限公司 |
| 2023/02/04Import · Class 3.1 | 尘螨变应原舌下片JXSS2300015 | ALK-Abelló A/S; Catalent UK Swindon Zydis Limited |
| 2023/02/04Import · Class 3.1 | 注射用tisotumab vedotinJXSL2300032 | Seagen Inc.; Zai Lab (Shanghai) CO. Ltd. |
| 2023/02/04Import · Class 1 | Milvexian片JXHL2300019 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/02/04Generic · Class 3 | 美沙拉秦缓释胶囊CYHS2300356 | 江苏安必生制药有限公司 |
| 2023/02/04Generic · Class 3 | 奥美拉唑碳酸氢钠干混悬剂（Ⅰ）CYHS2300355 | 山东益康药业股份有限公司 |
| 2023/02/04Generic · Class 3 | 奥沙利铂注射液CYHS2300352 | 上海创诺制药有限公司 |
| 2023/02/04Generic · Class 3 | 盐酸倍他司汀片CYHS2300349 | 森淼（山东）药业有限公司; 济南永宁制药股份有限公司 |
| 2023/02/04Generic · Class 3 | 法莫替丁注射液CYHS2300342 | 广州绿十字制药股份有限公司; 山西普德药业有限公司 |
| 2023/02/04Generic · Class 3 | 盐酸异丙肾上腺素注射液CYHS2300340 | 石家庄四药有限公司 |
| 2023/02/04Generic · Class 3 | 盐酸二甲双胍缓释片CYHS2300337 | 浙江众延医药科技有限公司; 石家庄市华新药业有限责任公司 |
| 2023/02/04Generic · Class 3 | 左亚叶酸钙注射液CYHS2300334 | 浙江普利药业有限公司 |
| 2023/02/04Generic · Class 3 | 左亚叶酸钙注射液CYHS2300333 | 浙江普利药业有限公司 |
| 2023/02/04Generic · Class 3 | 左亚叶酸钙注射液CYHS2300332 | 浙江普利药业有限公司 |
| 2023/02/04Generic · Class 3 | 左亚叶酸钙注射液CYHS2300331 | 浙江普利药业有限公司 |
| 2023/02/04New drug · Class 1 | HG004眼用注射液CXSL2300088 | 辉大（上海）生物科技有限公司 |
| 2023/02/04New drug · Class 1 | HG004眼用注射液CXSL2300087 | 辉大（上海）生物科技有限公司 |
| 2023/02/04New drug · Class 1 | 注射用XYD-9668-198抗体偶联剂CXSL2300086 | 昆山新蕴达生物科技有限公司 |
| 2023/02/04New drug · Class 1 | 9MW2821CXSL2300085 | 迈威（上海）生物科技股份有限公司 |
| 2023/02/04New drug · Class 1 | SIM1811-03注射液CXSL2300084 | 江苏先声生物制药有限公司 |
| 2023/02/04New drug · Class 1 | TQB2450注射液CXSL2300083 | 正大天晴药业集团南京顺欣制药有限公司 |
| 2023/02/04New drug · Class 1 | 注射用9MW2921CXSL2300082 | 迈威（上海）生物科技股份有限公司 |
| 2023/02/04New drug · Class 1 | 注射用SHR-A1811CXSL2300081 | 苏州盛迪亚生物医药有限公司 |
| 2023/02/04New drug · Class 2.2 | VGT-I01CXSL2300080 | 上海天泽云泰生物医药有限公司 |
| 2023/02/04New drug · Class 1 | BD111注射液CXSL2300079 | 上海本导基因技术有限公司 |
| 2023/02/04New drug · Class 1 | TLL-018缓释片CXHL2300172 | 杭州高光制药有限公司 |
| 2023/02/04New drug · Class 1 | TLL-018缓释片CXHL2300171 | 杭州高光制药有限公司 |
| 2023/02/04New drug · Class 1 | TLL-018缓释片CXHL2300170 | 杭州高光制药有限公司 |
113 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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