药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/04/08 – 2025/04/14
- New acceptances this week
- 371
- Drugs with new generic filings (by drug name, de-duplicated)
- 86
- Accepted this week, now under review
- 45
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
371filings, 121 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 169 |
| Generic | 121 |
| New drug | 55 |
| Import | 17 |
| Unspecified | 5 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 260 |
| TCM | 69 |
| 治疗用生物制品 | 36 |
| 预防用生物制品 | 5 |
| 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
86 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 | 5 | 3 | 58 |
| 2 | 沙库巴曲缬沙坦钠片 | 5 | 2 | 72 |
| 3 | 盐酸多巴胺注射液 | 4 | 2 | 3 |
| 4 | 盐酸达泊西汀片 | 3 | 2 | 20 |
| 5 | 非奈利酮片 | 3 | 2 | 71 |
| 6 | 注射用氨苄西林钠 | 3 | 1 | 8 |
| 7 | 注射用苯唑西林钠 | 3 | 1 | 15 |
| 8 | 复方聚乙二醇（3350）电解质散 | 2 | 2 | 5 |
| 9 | 比索洛尔氨氯地平片 | 2 | 2 | 8 |
| 10 | 瑞舒伐他汀依折麦布片（Ⅰ） | 2 | 2 | 5 |
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
244 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 广州市联瑞制药有限公司 | 10 | 10 | 0 |
| 2 | Boehringer Ingelheim International GmbH | 8 | 4 | 0 |
| 3 | 山东鲁抗医药集团赛特有限责任公司 | 6 | 4 | 6 |
| 4 | 沈阳东新药业有限公司 | 6 | 4 | 0 |
| 5 | AstraZeneca AB | 6 | 3 | 0 |
| 6 | 江右制药（常德）有限公司 | 5 | 5 | 0 |
| 7 | 四川科伦药业股份有限公司 | 5 | 1 | 0 |
| 8 | 广州白云山医药集团股份有限公司白云山制药总厂 | 5 | 1 | 0 |
| 9 | 神威药业集团有限公司 | 4 | 3 | 0 |
| 10 | Takeda Pharmaceuticals U.S.A. 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
116 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/04/14Generic · Class 3 | 注射用氨苄西林钠CYHS2501427 | 山东安信制药有限公司 |
| 2025/04/14Generic · Class 3 | 注射用氨苄西林钠CYHS2501426 | 山东安信制药有限公司 |
| 2025/04/14Generic · Class 3 | 注射用氨苄西林钠CYHS2501425 | 山东安信制药有限公司 |
| 2025/04/14Generic · Class 3 | 盐酸甲氧氯普胺注射液CYHS2501424 | 湖南先施制药有限公司 |
| 2025/04/14Generic · Class 3 | 格隆溴铵新斯的明注射液CYHL2500080 | 成都诺和晟鸿生物制药有限公司 |
| 2025/04/14New drug · Class 2.1 | GD-19乳状注射液CXHL2500385 | 天津谷堆生物医药科技有限公司 |
| 2025/04/12Generic · Class 3 | 多种维生素注射液（13）CYHS2501413 | 辽宁海思科制药有限公司 |
| 2025/04/12Generic · Class 3 | 硫代硫酸钠注射液CYHS2501410 | 湖北成健药业有限公司; 武汉滨湖双鹤药业有限责任公司 |
| 2025/04/12Generic · Class 3 | 注射用乳糖酸红霉素CYHS2501408 | 海南倍特药业有限公司 |
| 2025/04/12New drug · Class 3.3 | 吸附破伤风疫苗CXSL2500296 | 远大赛威信生命科学（南京）有限公司; 远大赛威信生命科学（杭州）有限公司 |
| 2025/04/12New drug · Class 1 | 注射用RGL-232CXSL2500295 | 上海瑞宏迪医药有限公司; 广州瑞领医药有限公司 |
| 2025/04/12New drug · Class 2.2 | LN2222CXHL2500384 | 山东新时代药业有限公司 |
| 2025/04/12New drug · Class 2.2 | LN2222CXHL2500383 | 山东新时代药业有限公司 |
| 2025/04/11Import · Class 1.4 | 21价肺炎球菌多糖结合疫苗JXSL2500058 | Sanofi Pasteur Inc.; Shenzhen Sanofi Pasteur Biological Products Co. Ltd. |
| 2025/04/11Generic · Class 3 | 维生素K1注射液CYHS2501407 | 海南全盈药业有限公司; 扬州中宝药业股份有限公司 |
| 2025/04/11Generic · Class 3 | 盐酸美金刚口服溶液CYHS2501406 | 重庆赛诺生物药业股份有限公司; 重庆和平制药有限公司 |
| 2025/04/11Generic · Class 3 | 二硫化硒洗剂CYHS2501404 | 江苏迪赛诺制药有限公司 |
| 2025/04/11Generic · Class 3 | 乙酰半胱氨酸片CYHS2501401 | 广州仁恒医药科技股份有限公司; 广州绿十字制药股份有限公司 |
| 2025/04/11Generic · Class 3 | 复方聚乙二醇（3350）电解质散CYHS2501398 | 合肥源丰顺医药科技有限公司; 蚌埠丰原涂山制药有限公司 |
| 2025/04/11Generic · Class 3 | 聚乙二醇4000散CYHS2501395 | 成都恒瑞制药有限公司 |
| 2025/04/11Generic · Class 3 | 吡拉西坦注射液CYHS2501394 | 亚邦医药股份有限公司 |
| 2025/04/11New drug · Class 1 | 注射用HY0001aCXSL2500294 | 四川汇宇海玥医药科技有限公司 |
| 2025/04/11New drug · Class 1 | CRG-B191注射液CXSL2500293 | 上海科锐克医药科技有限公司 |
| 2025/04/11New drug · Class 1 | XKH001注射液CXSL2500292 | 浙江鑫康合生物医药科技有限公司; 北京鑫康合生物医药科技有限公司 |
| 2025/04/11New drug · Class 1 | XKH001注射液CXSL2500291 | 浙江鑫康合生物医药科技有限公司; 北京鑫康合生物医药科技有限公司 |
| 2025/04/11New drug · Class 1 | PM1300注射用冻干制剂CXSL2500290 | 珠海普米斯生物科技有限公司; 百欧恩泰（上海）医药有限公司 |
| 2025/04/11New drug · Class 3.3 | 人生长激素注射液CXSL2500289 | 亿帆医药（上海）有限公司 |
| 2025/04/11New drug · Class 1 | QX029N注射液CXSL2500288 | 江苏荃信生物医药股份有限公司 |
| 2025/04/11New drug · Class 2.3 | PXT3003CXHS2500027 | 江苏天士力帝益药业有限公司 |
| 2025/04/11New drug · Class 2.4 | 盐酸羟钴胺注射液CXHL2500382 | 石药集团中奇制药技术（石家庄）有限公司 |
86 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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