药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/08/12 – 2025/08/18
- New acceptances this week
- 364
- Drugs with new generic filings (by drug name, de-duplicated)
- 74
- Accepted this week, now under review
- 97
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
364filings, 110 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 155 |
| Generic | 110 |
| New drug | 53 |
| Import | 21 |
| Unspecified | 19 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 247 |
| 治疗用生物制品 | 58 |
| TCM | 47 |
| Biologic | 7 |
| 预防用生物制品 | 5 |
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 | 巴瑞替尼片 | 3 | 2 | 32 |
| 3 | 盐酸曲唑酮缓释片 | 3 | 2 | 20 |
| 4 | 中性低钙腹膜透析液（碳酸氢盐-G2.5%） | 3 | 1 | 8 |
| 5 | 中性腹膜透析液（碳酸氢盐-G1.5%） | 3 | 1 | 7 |
| 6 | 中性腹膜透析液（碳酸氢盐-G2.5%） | 3 | 1 | 7 |
| 7 | 乳果糖口服溶液 | 3 | 1 | 40 |
| 8 | 呫诺美林曲司氯铵胶囊 | 3 | 1 | 0 |
| 9 | 注射用氨苄西林钠舒巴坦钠 | 3 | 1 | 13 |
| 10 | 磷酸芦可替尼片 | 3 | 1 | 27 |
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
213 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 成都青山利康药业股份有限公司 | 15 | 5 | 9 |
| 2 | 齐鲁制药有限公司 | 10 | 6 | 3 |
| 3 | AstraZeneca AB | 9 | 4 | 0 |
| 4 | 河南羚锐制药股份有限公司 | 6 | 6 | 0 |
| 5 | 江苏恒瑞医药股份有限公司 | 6 | 2 | 0 |
| 6 | Terumo Corporation Kofu Factory | 5 | 1 | 0 |
| 7 | 山东二叶制药有限公司 | 5 | 1 | 0 |
| 8 | 江苏中新医药有限公司 | 5 | 1 | 0 |
| 9 | 山东新华制药股份有限公司 | 4 | 4 | 1 |
| 10 | Sanofi-Aventis Recherche & Développement | 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
115 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/08/16Import · Class 2.4 | Rilzabrutinib片JXHL2500217 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2025/08/16Generic · Class 3 | 盐酸卡替洛尔滴眼液CYHS2503016 | 成都地奥九泓制药厂; 浙江莎普爱思药业股份有限公司 |
| 2025/08/16Generic · Class 3 | 洛索洛芬钠颗粒CYHS2503013 | 辽宁海一制药有限公司 |
| 2025/08/16Generic · Class 3 | 联苯苄唑溶液CYHS2503009 | 中山万汉制药有限公司 |
| 2025/08/16Generic · Class 3 | 盐酸多巴酚丁胺注射液CYHS2503006 | 石家庄四药有限公司 |
| 2025/08/16Generic · Class 3 | 联苯苄唑溶液CYHS2503005 | 杭州上禾健康科技有限公司; 杭州万邦天诚药业有限公司 |
| 2025/08/16Generic · Class 3 | 盐酸西替利嗪口服溶液CYHS2503004 | 海南万玮制药有限公司 |
| 2025/08/16Generic · Class 3 | 布比卡因脂质体注射液CYHS2503003 | 浙江博崤生物制药有限公司 |
| 2025/08/16Generic · Class 3 | 布比卡因脂质体注射液CYHS2503002 | 浙江博崤生物制药有限公司 |
| 2025/08/16Generic · Class 3 | 氨磺必利口服溶液CYHS2503000 | 河北义海医药科技有限公司; 知和(山东)大药厂有限公司 |
| 2025/08/16New drug · Class 3.3 | 司美格鲁肽注射液CXSS2500084 | 惠升生物制药股份有限公司 |
| 2025/08/16New drug · Class 3.3 | 司美格鲁肽注射液CXSS2500083 | 惠升生物制药股份有限公司 |
| 2025/08/16New drug · Class 1 | 注射用乙型脑炎溶瘤病毒CXSL2500709 | 四川安可康生物医药有限公司 |
| 2025/08/16New drug · Class 1 | 注射用乙型脑炎溶瘤病毒CXSL2500708 | 四川安可康生物医药有限公司 |
| 2025/08/16New drug · Class 1 | 注射用乙型脑炎溶瘤病毒CXSL2500707 | 四川安可康生物医药有限公司 |
| 2025/08/16New drug · Class 1 | 注射用乙型脑炎溶瘤病毒CXSL2500706 | 四川安可康生物医药有限公司 |
| 2025/08/16New drug · Class 2.6 | 吸附无细胞百白破（组分）联合疫苗（成人及青少年用）CXSL2500705 | 北京智飞绿竹生物制药有限公司 |
| 2025/08/16New drug · Class 1 | SHR-1139注射液CXSL2500704 | 广东恒瑞医药有限公司 |
| 2025/08/16New drug · Class 2.2;2.4 | XZ022CXHL2500860 | 山东新时代药业有限公司 |
| 2025/08/16New drug · Class 1 | MAX-001胶囊CXHL2500859 | 安炎达医药技术（广州）有限公司 |
| 2025/08/16New drug · Class 1 | MAX-001胶囊CXHL2500858 | 安炎达医药技术（广州）有限公司 |
| 2025/08/16New drug · Class 2.3 | HWH217片CXHL2500857 | 湖北生物医药产业技术研究院有限公司 |
| 2025/08/16New drug · Class 2.3 | HWH217片CXHL2500856 | 湖北生物医药产业技术研究院有限公司 |
| 2025/08/15Generic · Class 3 | 枸橼酸西地那非口溶膜CYHS2502996 | 杭州和泽坤元药业有限公司; 江苏和晨药业有限公司 |
| 2025/08/15Generic · Class 3 | JP-1366片CYHS2502991 | 丽珠医药集团股份有限公司; 丽珠集团丽珠制药厂 |
| 2025/08/15Generic · Class 3 | 聚乙二醇4000散CYHS2502988 | 西安安健药业有限公司 |
| 2025/08/15Generic · Class 3 | 普瑞巴林口服溶液CYHS2502986 | 江苏贝佳制药有限公司 |
| 2025/08/15Generic · Class 3 | 普瑞巴林口服溶液CYHS2502983 | 江苏贝佳制药有限公司 |
| 2025/08/15Generic · Class 3 | 瑞卢戈利片CYHL2500147 | 山东朗诺制药有限公司 |
| 2025/08/15New drug · Class 1 | GenSci098注射液CXSL2500703 | 长春金赛药业有限责任公司 |
85 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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