药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/11/19 – 2024/11/25
- New acceptances this week
- 330
- Drugs with new generic filings (by drug name, de-duplicated)
- 79
- Accepted this week, now under review
- 6
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
330filings, 101 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 135 |
| Generic | 101 |
| New drug | 61 |
| Import | 15 |
| Unspecified | 10 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 244 |
| 治疗用生物制品 | 42 |
| TCM | 38 |
| 预防用生物制品 | 6 |
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
79 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 | 4 | 2 | 58 |
| 2 | 米库氯铵注射液 | 4 | 2 | 3 |
| 3 | 阿达帕林凝胶 | 3 | 3 | 31 |
| 4 | 丙戊酸钠缓释片(Ⅰ) | 2 | 2 | 4 |
| 5 | 硫酸氨基葡萄糖胶囊 | 2 | 2 | 50 |
| 6 | 西甲硅油乳剂 | 2 | 2 | 3 |
| 7 | 双氯芬酸钠贴剂 | 2 | 1 | 0 |
| 8 | 拉莫三嗪片 | 2 | 1 | 0 |
| 9 | 注射用阿立哌唑 | 2 | 1 | 4 |
| 10 | 盐酸丁螺环酮片 | 2 | 1 | 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
208 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 山东威智百科药业有限公司 | 13 | 6 | 0 |
| 2 | 黑龙江省福乐康药业有限公司 | 6 | 5 | 0 |
| 3 | 上海润石医药科技有限公司 | 6 | 1 | 0 |
| 4 | Boehringer Ingelheim International GmbH | 5 | 1 | 0 |
| 5 | Novo Nordisk A/S | 5 | 1 | 0 |
| 6 | 万邦德制药集团有限公司 | 4 | 4 | 0 |
| 7 | 重庆希尔安药业有限公司 | 4 | 4 | 0 |
| 8 | 山西同达药业有限公司 | 4 | 3 | 2 |
| 9 | 齐鲁制药有限公司 | 4 | 3 | 2 |
| 10 | Amgen Inc. | 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
111 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/11/25Generic · Class 3 | 左氧氟沙星注射液CYHS2404048 | 江苏长江药业有限公司; 江苏大红鹰恒顺药业有限公司 |
| 2024/11/25Generic · Class 3 | 硫辛酸片CYHS2404041 | 北京双鹭药业股份有限公司 |
| 2024/11/25New drug · Class 3.1 | 桃红四物颗粒CXZS2400035 | 河北万邦复临药业有限公司 |
| 2024/11/25New drug · Class 1.4 | 吸附无细胞百(三组分)白破b型流感嗜血杆菌(结合)-ACYW135群脑膜炎球菌(结合)联合疫苗CXSL2400797 | 康希诺生物股份公司 |
| 2024/11/25New drug · Class 2.2 | ZL2301CXHL2401280 | 广东众丽医药科技有限公司 |
| 2024/11/25New drug · Class 1 | XH-S004片CXHL2401279 | 浙江星浩澎博医药有限公司 |
| 2024/11/25New drug · Class 1 | XH-S004片CXHL2401278 | 浙江星浩澎博医药有限公司 |
| 2024/11/25New drug · Class 2.1 | GW901肠溶软胶囊CXHL2401277 | 成都国为生物医药有限公司 |
| 2024/11/23Import · Class 2.2 | 罗莫索珠单抗注射液JXSL2400227 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2024/11/23Import · Class 1 | 输注用无菌冻干粉Telisotuzumab vedotinJXSL2400226 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2024/11/23Generic · Class 3 | 倍他米松磷酸钠注射液CYHS2404040 | 安徽美来药业股份有限公司; 河南科伦药业有限公司 |
| 2024/11/23Generic · Class 3 | 碳酸司维拉姆干混悬剂CYHS2404034 | 山东新华制药股份有限公司 |
| 2024/11/23Generic · Class 3 | 碳酸司维拉姆干混悬剂CYHS2404033 | 山东新华制药股份有限公司 |
| 2024/11/23Generic · Class 3 | 醋酸特利加压素注射液CYHS2404027 | 成都圣诺生物制药有限公司 |
| 2024/11/23Generic · Class 3 | 氨甲环酸氯化钠注射液CYHS2404023 | 湖北津药药业股份有限公司 |
| 2024/11/23Generic · Class 3 | 盐酸丁螺环酮片CYHS2404018 | 山东京卫制药有限公司 |
| 2024/11/23Generic · Class 3 | 盐酸丁螺环酮片CYHS2404017 | 山东京卫制药有限公司 |
| 2024/11/23Generic · Class 3 | 吸入用盐酸氨溴索溶液CYHL2400234 | 北京韩美药品有限公司 |
| 2024/11/23Generic · Class 3 | 双氯芬酸钠贴剂CYHL2400233 | 四川科伦药业股份有限公司 |
| 2024/11/23Generic · Class 3 | 双氯芬酸钠贴剂CYHL2400232 | 四川科伦药业股份有限公司 |
| 2024/11/23New drug · Class 2.2 | ZY-A001CXZL2400079 | 亚宝药业集团股份有限公司 |
| 2024/11/23New drug · Class 1 | 伊诺格鲁肽注射液CXSS2400129 | 杭州先为达生物科技股份有限公司; 美药星(南京)制药有限公司 |
| 2024/11/23New drug · Class 3.3 | 利妥昔单抗注射液CXSS2400128 | 华兰安康生物股份有限公司 |
| 2024/11/23New drug · Class 3.3 | 利妥昔单抗注射液CXSS2400127 | 华兰安康生物股份有限公司 |
| 2024/11/23New drug · Class 1 | BA1106注射液CXSL2400796 | 山东博安生物技术股份有限公司 |
| 2024/11/23New drug · Class 2.2 | LY01015注射液CXSL2400795 | 山东博安生物技术股份有限公司 |
| 2024/11/23New drug · Class 2.2 | LY01015注射液CXSL2400794 | 山东博安生物技术股份有限公司 |
| 2024/11/23New drug · Class 1 | AWT020注射用无菌粉末CXSL2400793 | 上海君实生物医药科技股份有限公司 |
| 2024/11/23New drug · Class 1 | 注射用BL-M07D1CXSL2400792 | 成都百利多特生物药业有限责任公司; 四川百利药业有限责任公司 |
| 2024/11/23New drug · Class 1 | QB0208-1胶囊CXHL2401276 | 北京清博汇能医药科技有限公司 |
81 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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