药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/02/06 – 2024/02/12
- New acceptances this week
- 382
- Drugs with new generic filings (by drug name, de-duplicated)
- 86
- 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
382filings, 111 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 152 |
| Generic | 111 |
| New drug | 78 |
| Import | 21 |
| Unspecified | 11 |
| Import re-registration | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 286 |
| 治疗用生物制品 | 52 |
| TCM | 35 |
| 预防用生物制品 | 5 |
| Biologic | 4 |
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
86 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 沙库巴曲缬沙坦钠片 | 5 | 2 | 70 |
| 2 | 磷酸奥司他韦胶囊 | 3 | 1 | 42 |
| 3 | 夫西地酸乳膏 | 2 | 2 | 16 |
| 4 | 洛索洛芬钠凝胶贴膏 | 2 | 2 | 8 |
| 5 | 甲钴胺片 | 2 | 2 | 16 |
| 6 | 硫酸镁注射液 | 2 | 2 | 7 |
| 7 | 他克莫司胶囊 | 2 | 1 | 2 |
| 8 | 他克莫司软膏 | 2 | 1 | 8 |
| 9 | 他达拉非片 | 2 | 1 | 23 |
| 10 | 双氯芬酸钠缓释片 | 2 | 1 | 10 |
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
230 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 回音必集团江西东亚制药有限公司 | 11 | 9 | 0 |
| 2 | 百济神州(苏州)生物科技有限公司 | 9 | 2 | 0 |
| 3 | 河北扁鹊制药有限公司 | 7 | 7 | 0 |
| 4 | 山东新时代药业有限公司 | 6 | 5 | 5 |
| 5 | 浙江赛默制药有限公司 | 6 | 4 | 6 |
| 6 | 广州嘉越医药科技有限公司 | 6 | 1 | 0 |
| 7 | 杭州高光制药有限公司 | 6 | 1 | 0 |
| 8 | 正大天晴药业集团股份有限公司 | 5 | 3 | 0 |
| 9 | AbbVie Inc. | 5 | 1 | 0 |
| 10 | 苏州特瑞药业股份有限公司 | 5 | 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
137 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/02/10Generic · Class 3 | 盐酸甲氧氯普胺注射液CYHS2400606 | 武汉天安医药科技有限公司; 湖北津药药业股份有限公司 |
| 2024/02/09Import · Class 1 | SGN-B6AJXSL2400043 | Seagen Inc.; IQVIA RDS (Shanghai) Co. Ltd |
| 2024/02/09Generic · Class 3 | 依巴斯汀口服溶液CYHS2400603 | 北京沃邦医药科技有限公司; 江苏欧歌制药有限公司 |
| 2024/02/09New drug · Class 1 | TQB3107片CXHL2400193 | 正大天晴药业集团南京顺欣制药有限公司 |
| 2024/02/09New drug · Class 1 | TQB3107片CXHL2400192 | 正大天晴药业集团南京顺欣制药有限公司 |
| 2024/02/09New drug · Class 1 | TQG3926片CXHL2400191 | 正大天晴药业集团股份有限公司 |
| 2024/02/09New drug · Class 1 | TQG3926片CXHL2400190 | 正大天晴药业集团股份有限公司 |
| 2024/02/08Import · Class 3.1 | 注射用德曲妥珠单抗JXSS2400013 | Daiichi Sankyo Europe GmbH; Baxter Oncology GmbH; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD. |
| 2024/02/08Import · Class 3.1 | 塔奎妥单抗注射液JXSS2400012 | Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd. |
| 2024/02/08Import · Class 3.1 | 塔奎妥单抗注射液JXSS2400011 | Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd. |
| 2024/02/08Import · Class 1 | 镥[177Lu]Lu-NeoB注射液JXHL2400032 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2024/02/08Import · Class 1 | 用于制备放射性药物[68Ga]Ga-NeoB注射液的药盒JXHL2400031 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2024/02/08Generic · Class 3 | 氯化钙注射液CYHS2400602 | 华夏生生药业(北京)有限公司 |
| 2024/02/08Generic · Class 3 | 盐酸苯海拉明注射液CYHS2400599 | 南京泽恒医药技术开发有限公司; 亚邦医药股份有限公司 |
| 2024/02/08Generic · Class 3 | 盐酸苯海拉明注射液CYHS2400598 | 南京泽恒医药技术开发有限公司; 亚邦医药股份有限公司 |
| 2024/02/08Generic · Class 3 | 盐酸非索非那定口服混悬液CYHS2400592 | 哈尔滨葵花药业有限公司; 葵花药业集团重庆小葵花儿童制药有限公司 |
| 2024/02/08Generic · Class 3 | 吡拉西坦注射液CYHS2400580 | 四川新斯顿制药股份有限公司 |
| 2024/02/08Generic · Class 3 | 盐酸美金刚口崩片CYHS2400578 | 北京星昊医药股份有限公司; 北京星昊盈盛药业有限公司 |
| 2024/02/08Generic · Class 3 | 盐酸美金刚口崩片CYHS2400577 | 北京星昊医药股份有限公司; 北京星昊盈盛药业有限公司 |
| 2024/02/08Generic · Class 3 | 吸入用盐酸丙卡特罗溶液CYHS2400570 | 北京柏雅联合药物研究所有限公司; 山东华鲁制药有限公司 |
| 2024/02/08Generic · Class 3 | 碳酸氢钠注射液CYHS2400568 | 广州合和医药有限公司; 广东星昊药业有限公司 |
| 2024/02/08Generic · Class 3 | 乙酰半胱氨酸注射液CYHS2400567 | 中润药业有限公司; 成都市海通药业有限公司 |
| 2024/02/08Generic · Class 3 | 酒石酸匹莫范色林胶囊CYHL2400037 | 华中药业股份有限公司 |
| 2024/02/08New drug · Class 1 | 夫那奇珠单抗注射液CXSS2400019 | 苏州盛迪亚生物医药有限公司 |
| 2024/02/08New drug · Class 1 | 夫那奇珠单抗注射液CXSS2400018 | 苏州盛迪亚生物医药有限公司 |
| 2024/02/08New drug · Class 1 | 夫那奇珠单抗注射液CXSS2400017 | 苏州盛迪亚生物医药有限公司 |
| 2024/02/08New drug · Class 1 | M108单抗注射液CXSL2400118 | 明济生物制药(北京)有限公司 |
| 2024/02/08New drug · Class 1 | RJK002注射液CXSL2400117 | 上海瑞吉康生物医药有限公司 |
| 2024/02/08New drug · Class 1 | MSCohi-O镜片CXSL2400116 | 广东普罗凯融生物医药科技有限公司 |
| 2024/02/08New drug · Class 1 | MSCohi-O镜片CXSL2400115 | 广东普罗凯融生物医药科技有限公司 |
107 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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