药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/07/29 – 2025/08/04
- New acceptances this week
- 400
- Drugs with new generic filings (by drug name, de-duplicated)
- 74
- Accepted this week, now under review
- 83
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
400filings, 97 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 193 |
| Generic | 97 |
| New drug | 63 |
| Import | 25 |
| Import re-registration | 16 |
| Unspecified | 4 |
| 药械组合产品 | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 248 |
| TCM | 87 |
| 治疗用生物制品 | 59 |
| Unspecified | 3 |
| 预防用生物制品 | 2 |
| Biologic | 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
74 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 | 4 | 2 | 72 |
| 2 | 头孢托仑匹酯颗粒 | 3 | 2 | 18 |
| 3 | 达格列净片 | 3 | 2 | 82 |
| 4 | 布瑞哌唑片 | 3 | 1 | 31 |
| 5 | ω-3脂肪酸乙酯90软胶囊 | 2 | 2 | 11 |
| 6 | 佩玛贝特片 | 2 | 2 | 25 |
| 7 | 双氯芬酸钠盐酸利多卡因注射液 | 2 | 2 | 8 |
| 8 | 头孢克肟干混悬剂 | 2 | 2 | 3 |
| 9 | 盐酸曲唑酮缓释片 | 2 | 2 | 20 |
| 10 | 硝普钠氯化钠注射液 | 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
251 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 四川科伦药业股份有限公司 | 14 | 5 | 1 |
| 2 | 山西华康药业股份有限公司 | 10 | 9 | 0 |
| 3 | 齐鲁制药有限公司 | 8 | 4 | 1 |
| 4 | 百济神州（苏州）生物科技有限公司 | 8 | 3 | 0 |
| 5 | Amgen Inc. | 6 | 3 | 0 |
| 6 | Novo Nordisk A/S | 6 | 2 | 0 |
| 7 | 河南新乡华星药厂 | 6 | 2 | 0 |
| 8 | AstraZeneca UK Limited | 6 | 1 | 0 |
| 9 | 长春海外制药集团有限公司 | 5 | 5 | 0 |
| 10 | 广东恒瑞医药有限公司 | 5 | 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
107 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/08/04Generic · Class 3 | 聚普瑞锌颗粒CYHS2502808 | 福建海西新药创制股份有限公司; 广东安诺药业股份有限公司 |
| 2025/08/04Generic · Class 3 | 倍他米松磷酸钠注射液CYHS2502807 | 安徽均大高科医药科技有限公司; 津药和平（天津）制药有限公司 |
| 2025/08/04Generic · Class 3 | 中性腹膜透析液（乳酸盐-G2.5%）CYHS2502806 | 石家庄四药有限公司 |
| 2025/08/04Generic · Class 3 | 中性低钙腹膜透析液（乳酸盐-G2.5%）CYHS2502805 | 石家庄四药有限公司 |
| 2025/08/04Generic · Class 3 | 硫酸镁注射液CYHS2502804 | 酒泉大得利制药股份有限公司 |
| 2025/08/04Generic · Class 3 | 法莫替丁注射液CYHS2502800 | 绪必迪药业（沧州）有限公司; 河北凯威制药有限责任公司 |
| 2025/08/04New drug · Class 1.2 | 杜仲木脂素胶囊CXZL2500061 | 江西普正制药股份有限公司; 上海现代药物制剂工程研究中心有限公司 |
| 2025/08/04New drug · Class 1.2 | 杜仲木脂素提取物CXZL2500060 | 江西普正制药股份有限公司; 上海现代药物制剂工程研究中心有限公司 |
| 2025/08/04New drug · Class 1 | FNX020片CXHL2500805 | 成都凡诺西生物医药科技有限公司 |
| 2025/08/04New drug · Class 1 | FNX020片CXHL2500804 | 成都凡诺西生物医药科技有限公司 |
| 2025/08/02Import · Class 2.1 | Onasemnogene abeparvovec鞘内注射液JXSS2500106 | Novartis Pharma Schweiz AG; Novartis Gene Therapies Inc.; Beijing Novartis Pharma Co. Ltd. |
| 2025/08/02Import · Class 1 | ABBV-400注射用粉末JXSL2500137 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2025/08/02Generic · Class 3 | 复方醋酸钠葡萄糖注射液CYHS2502797 | 四川奇裕医药科技有限公司; 四川美大康佳乐药业有限公司 |
| 2025/08/02Generic · Class 3 | 复方醋酸钠葡萄糖注射液CYHS2502796 | 四川奇裕医药科技有限公司; 四川美大康佳乐药业有限公司 |
| 2025/08/02Generic · Class 3 | 吡格列酮二甲双胍片CYHS2502785 | 广东方盛健盟药业有限公司; 湖南方盛制药股份有限公司 |
| 2025/08/02Generic · Class 3 | 维生素B？？注射液CYHS2502772 | 海南钧华医疗科技有限公司; 酒泉大得利制药股份有限公司 |
| 2025/08/02Generic · Class 3 | 瑞卢戈利片CYHL2500136 | 广东方盛健盟药业有限公司 |
| 2025/08/02New drug · Class 1.1 | 益气升脉颗粒CXZL2500059 | 瑞阳制药股份有限公司 |
| 2025/08/02New drug · Class 1 | VPD/FC01002 注射液CXSL2500652 | 微能生命科技集团有限公司 |
| 2025/08/02New drug · Class 1 | VUM02注射液CXSL2500651 | 武汉光谷中源药业有限公司 |
| 2025/08/02New drug · Class 1 | HTB-C042鼻喷雾剂CXSL2500650 | 上海惠盾因泰生物科技有限公司; 上海惠盾生物技术有限公司 |
| 2025/08/02New drug · Class 1 | 注射用JSKN003CXSL2500649 | 上海津曼特生物科技有限公司 |
| 2025/08/02New drug · Class 1 | 注射用JSKN022CXSL2500648 | 江苏康宁杰瑞生物制药有限公司 |
| 2025/08/02New drug · Class 1 | SNC115注射液CXSL2500647 | 上海先博生物科技有限公司 |
| 2025/08/02New drug · Class 1 | HS-20117-2 注射液CXSL2500646 | 上海翰森生物医药科技有限公司; 常州恒邦药业有限公司 |
| 2025/08/02New drug · Class 1 | TQB2868注射液CXSL2500645 | 正大天晴药业集团南京顺欣制药有限公司 |
| 2025/08/02New drug · Class 2.2 | 注射用瑞康曲妥珠单抗CXSL2500644 | 苏州盛迪亚生物医药有限公司 |
| 2025/08/02New drug · Class 1 | 玛氘诺沙韦片CXHS2500089 | 嘉兴安帝康生物科技有限公司; 上海合全医药有限公司 |
| 2025/08/02New drug · Class 1 | APH03621片CXHL2500803 | 广州一品红制药有限公司 |
| 2025/08/02New drug · Class 1 | APH03621片CXHL2500802 | 广州一品红制药有限公司 |
77 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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