药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/02/04 – 2025/02/10
- New acceptances this week
- 356
- Drugs with new generic filings (by drug name, de-duplicated)
- 93
- Accepted this week, now under review
- 16
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
356filings, 135 of them generic
By application type
| Application type | Filings |
|---|---|
| Generic | 135 |
| Supplement | 110 |
| New drug | 80 |
| Import | 15 |
| Import re-registration | 11 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 266 |
| 治疗用生物制品 | 54 |
| TCM | 30 |
| 预防用生物制品 | 4 |
| Biologic | 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
93 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 富马酸伏诺拉生片 | 11 | 7 | 58 |
| 2 | 布瑞哌唑片 | 6 | 2 | 31 |
| 3 | 他克莫司胶囊 | 4 | 2 | 2 |
| 4 | 盐酸纳美芬注射液 | 3 | 2 | 1 |
| 5 | 聚多卡醇注射液 | 3 | 1 | 21 |
| 6 | 枸橼酸托法替布缓释片 | 2 | 2 | 2 |
| 7 | 沙库巴曲缬沙坦钠片 | 2 | 2 | 72 |
| 8 | 注射用醋酸西曲瑞克 | 2 | 2 | 4 |
| 9 | 瑞舒伐他汀依折麦布片(I) | 2 | 2 | 9 |
| 10 | 盐酸舍曲林口服浓缩液 | 2 | 2 | 3 |
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
222 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 江苏豪森药业集团有限公司 | 11 | 3 | 0 |
| 2 | 成都百利多特生物药业有限责任公司 | 9 | 3 | 0 |
| 3 | 黑龙江深行生物医药科技有限公司 | 5 | 5 | 0 |
| 4 | 江苏润恒制药有限公司 | 5 | 4 | 5 |
| 5 | 四川科伦药业股份有限公司 | 5 | 3 | 2 |
| 6 | 北京华神制药有限公司 | 4 | 4 | 0 |
| 7 | 南京维立志博生物科技股份有限公司 | 4 | 2 | 0 |
| 8 | 江苏康缘药业股份有限公司 | 4 | 2 | 4 |
| 9 | 济南高华制药有限公司 | 4 | 2 | 4 |
| 10 | 深圳珐玛易药品科技有限公司 | 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
128 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/02/10New drug · Class 1.1 | 复方芎蕲软胶囊CXZL2500008 | 四川省中医药科学院(四川省中药研究所); 中国科学院兰州化学物理研究所 |
| 2025/02/10New drug · Class 1 | 自体淋巴细胞注射液CXSL2500131 | 康爱瑞浩生物医药(浙江)股份有限公司 |
| 2025/02/10New drug · Class 2.3 | DYTH201片CXHL2500184 | 山西德元堂药业有限公司 |
| 2025/02/10New drug · Class 2.3 | DYTH201片CXHL2500183 | 山西德元堂药业有限公司 |
| 2025/02/09Import · Class 1 | Bleximenib片JXHL2500023 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2025/02/09Import · Class 1 | Bleximenib片JXHL2500022 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2025/02/09Import · Class 1 | Bleximenib片JXHL2500021 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2025/02/09Import · Class 2.4 | 放射性药物镓[68Ga]oxodotreotide注射液配制用药盒JXHL2500020 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/02/09Import · Class 2.4 | 镥[177Lu]oxodotreotide注射液JXHL2500019 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/02/09Generic · Class 3 | 盐酸舍曲林口服浓缩液CYHS2500685 | 江苏润恒制药有限公司 |
| 2025/02/09Generic · Class 3 | 盐酸舍曲林口服浓缩液CYHS2500677 | 万特制药(海南)有限公司 |
| 2025/02/09Generic · Class 3 | 盐酸纳美芬注射液CYHS2500675 | 新乡市常乐制药有限责任公司 |
| 2025/02/09Generic · Class 3 | 盐酸纳美芬注射液CYHS2500673 | 新乡市常乐制药有限责任公司 |
| 2025/02/09Generic · Class 3 | 山梨醇甘露醇冲洗剂CYHS2500672 | 青岛奥瑞森医疗科技有限公司; 青岛瑞奈医疗科技有限公司 |
| 2025/02/09Generic · Class 3 | 美沙拉秦肠溶缓释胶囊CYHS2500660 | 成都倍特药业股份有限公司 |
| 2025/02/09Generic · Class 3 | 贝派度酸依折麦布片CYHL2500034 | 江西施美药业股份有限公司 |
| 2025/02/09Generic · Class 3 | 甘露醇山梨醇注射液CYHL2500033 | 四川美大康佳乐药业有限公司 |
| 2025/02/09New drug · Class 3.1 | 芍药甘草颗粒CXZS2500004 | 山东润中药业有限公司 |
| 2025/02/09New drug · Class 1.1 | 七福饮颗粒CXZL2500007 | 河南福地生物科技有限公司 |
| 2025/02/09New drug · Class 1.2 | 重组带状疱疹疫苗(CHO细胞)CXSS2500027 | 绿竹生物制药(珠海市)有限公司 |
| 2025/02/09New drug · Class 3.3 | 德谷胰岛素注射液CXSS2500026 | 宜昌东阳光长江药业股份有限公司 |
| 2025/02/09New drug · Class 3.3 | 德谷胰岛素注射液CXSS2500025 | 宜昌东阳光长江药业股份有限公司 |
| 2025/02/09New drug · Class 1.2 | YKYY025注射液CXSL2500130 | 杭州天龙药业有限公司 |
| 2025/02/09New drug · Class 1 | 人牙囊间充质干细胞注射液CXSL2500129 | 成都世联康健生物科技有限公司 |
| 2025/02/09New drug · Class 1 | 注射用KJ103CXSL2500128 | 上海宝济药业股份有限公司 |
| 2025/02/09New drug · Class 3.3 | 地舒单抗注射液CXSL2500127 | 华兰基因工程(河南)有限公司; 华兰基因工程有限公司 |
| 2025/02/09New drug · Class 1 | NCR201注射液CXSL2500126 | 中盛溯源(广州)生物科技有限公司; 安徽中盛溯源生物科技有限公司 |
| 2025/02/09New drug · Class 1 | HWS116注射液CXSL2500125 | 武汉人福创新药物研发中心有限公司 |
| 2025/02/09New drug · Class 1 | DNTH103注射液CXSL2500124 | 元羿生物科技(上海)有限公司 |
| 2025/02/09New drug · Class 1 | IBI3020CXSL2500123 | 信达生物医药科技(杭州)有限公司 |
98 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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