药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/10/28 – 2025/11/03
- New acceptances this week
- 341
- Drugs with new generic filings (by drug name, de-duplicated)
- 52
- Accepted this week, now under review
- 79
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
341filings, 64 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 185 |
| Generic | 64 |
| New drug | 59 |
| Import re-registration | 12 |
| Unspecified | 11 |
| Import | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 233 |
| TCM | 72 |
| 治疗用生物制品 | 31 |
| Biologic | 3 |
| 预防用生物制品 | 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
52 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 非奈利酮片 | 4 | 2 | 71 |
| 2 | 佩玛贝特片 | 2 | 2 | 25 |
| 3 | 克立硼罗软膏 | 2 | 2 | 28 |
| 4 | 利多卡因丁卡因乳膏 | 2 | 2 | 2 |
| 5 | 夫西地酸乳膏 | 2 | 2 | 16 |
| 6 | 富马酸伏诺拉生片 | 2 | 1 | 58 |
| 7 | 普瑞巴林胶囊 | 2 | 1 | 12 |
| 8 | 注射用托伐普坦磷酸钠 | 2 | 1 | 15 |
| 9 | 瑞舒伐他汀钙片 | 2 | 1 | 18 |
| 10 | 西格列汀二甲双胍缓释片 | 2 | 1 | 14 |
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 | 新疆华世丹药业股份有限公司 | 7 | 1 | 0 |
| 2 | 津药达仁堂集团股份有限公司隆顺榕制药厂 | 5 | 5 | 0 |
| 3 | Bayer Vital GmbH | 5 | 2 | 0 |
| 4 | 山东盛迪医药有限公司 | 5 | 2 | 0 |
| 5 | 北京质肽生物医药科技有限公司 | 5 | 1 | 0 |
| 6 | 石药集团恩必普药业有限公司 | 5 | 1 | 0 |
| 7 | Ferring GmbH | 4 | 4 | 0 |
| 8 | 江苏恒瑞医药股份有限公司 | 4 | 4 | 0 |
| 9 | Eli Lilly and Company | 4 | 3 | 0 |
| 10 | Novartis Pharma Schweiz AG | 4 | 3 | 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
86 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/11/03Import · Class 1 | Solbinsiran注射液JXHL2500336 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/11/01Generic · Class 3 | 氯化钾颗粒CYHS2503852 | 福建瑞泰来医药科技有限公司; 安徽佳和药业有限公司 |
| 2025/11/01Generic · Class 3 | 硫糖铝口服混悬液CYHS2503851 | 安徽杰玺医药有限公司; 安徽永生堂药业有限责任公司 |
| 2025/11/01Generic · Class 3 | 碳酸镧颗粒CYHS2503849 | 卡文迪许(泰州)药业有限公司; 江苏悦兴药业有限公司 |
| 2025/11/01New drug · Class 1.2 | FS2303分散片CXZL2500107 | 大连富生天然药物开发有限公司 |
| 2025/11/01New drug · Class 1 | 阴道用卷曲乳杆菌活菌胶囊CXSS2500117 | 苏州欧赛微科生物医药科技有限公司 |
| 2025/11/01New drug · Class 2.2 | 兰索拉唑碳酸氢钠干混悬剂CXHS2500135 | 南京海纳制药有限公司 |
| 2025/11/01New drug · Class 2.2 | CB446CXHL2501201 | 杭州成邦医药科技有限公司 |
| 2025/11/01New drug · Class 2.2 | ASECG肠溶干混悬剂CXHL2501200 | 北京天衡药物研究院有限公司 |
| 2025/10/31Import · Class 2.4 | 宗艾替尼片JXHS2500124 | Boehringer Ingelheim International GmbH; Hovione Farmaciencia S.A.; Boehringer Ingelheim (China) Investment Co. Ltd |
| 2025/10/31Generic · Class 3 | 西格列汀二甲双胍缓释片CYHS2503846 | 河南中杰药业有限公司 |
| 2025/10/31Generic · Class 3 | 西格列汀二甲双胍缓释片CYHS2503845 | 河南中杰药业有限公司 |
| 2025/10/31Generic · Class 3 | 盐酸克林霉素棕榈酸酯颗粒CYHS2503842 | 山东睿亿医药有限公司; 华益药业科技(安徽)有限公司 |
| 2025/10/31Generic · Class 3 | 复方聚乙二醇(3350)电解质维C散CYHS2503841 | 合肥盛秦医药科技有限公司; 安徽金太阳生化药业有限公司 |
| 2025/10/31Generic · Class 3 | 氢溴酸加兰他敏口服溶液CYHS2503839 | 上海葆隆生物科技有限公司; 上海美优制药有限公司 |
| 2025/10/31Generic · Class 3 | 腺苷钴胺胶囊CYHS2503835 | 湖北邦泽医药有限公司; 中孚药业股份有限公司 |
| 2025/10/31Generic · Class 3 | 瑞加诺生注射液CYHL2500195 | 河北赛谱熠辉医药科技有限公司 |
| 2025/10/31New drug · Class 1.3 | 重组带状疱疹疫苗(CHO细胞)CXSL2500935 | 华兰生物疫苗股份有限公司 |
| 2025/10/31New drug · Class 1 | NWRD18CXHL2501199 | 诺未生物技术(无锡)有限公司; 诺未科技(北京)有限公司; 诺未生物技术(天津)有限公司 |
| 2025/10/31New drug · Class 2.2;2.4 | SY-606滴眼液CXHL2501198 | 北京银谷医药科技有限公司 |
| 2025/10/31New drug · Class 2.2;2.4 | SY-606滴眼液CXHL2501197 | 北京银谷医药科技有限公司 |
| 2025/10/31New drug · Class 2.2;2.4 | SY-606滴眼液CXHL2501196 | 北京银谷医药科技有限公司 |
| 2025/10/31New drug · Class 2.2;2.4 | SY-606滴眼液CXHL2501195 | 北京银谷医药科技有限公司 |
| 2025/10/30Import · Class 3.1 | Nemolizumab注射液JXSL2500208 | Galderma SA; Q-Med International Trading (Shanghai) Co. Ltd |
| 2025/10/30Import · Class 1 | GSK6042981片JXHL2500334 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Company Limited |
| 2025/10/30New drug · Class 1.2 | 栀子西红花酸提取物(C2235)CXZL2500106 | 浙江尖峰药业有限公司 |
| 2025/10/30New drug · Class 1 | 柯美奇拜单抗注射液CXSS2500116 | 上海麦济医药有限公司; 鼎康(武汉)生物医药有限公司 |
| 2025/10/30New drug · Class 1 | 注射用QLS5316CXSL2500934 | 齐鲁制药有限公司 |
| 2025/10/30New drug · Class 2.2 | 布瑞哌唑口溶膜CXHS2500133 | 甘肃普安制药股份有限公司 |
| 2025/10/30New drug · Class 2.2 | 布瑞哌唑口溶膜CXHS2500132 | 甘肃普安制药股份有限公司 |
56 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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