药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/12/23 – 2025/12/29
- New acceptances this week
- 520
- Drugs with new generic filings (by drug name, de-duplicated)
- 78
- Accepted this week, now under review
- 127
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
520filings, 117 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 230 |
| New drug | 123 |
| Generic | 117 |
| Import | 21 |
| Unspecified | 15 |
| Import re-registration | 14 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 312 |
| TCM | 103 |
| 治疗用生物制品 | 92 |
| 预防用生物制品 | 9 |
| Biologic | 3 |
| 体外诊断试剂 | 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
78 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 西诺氨酯片 | 6 | 2 | 21 |
| 2 | 达格列净片 | 5 | 3 | 82 |
| 3 | 布瑞哌唑片 | 5 | 2 | 31 |
| 4 | 乌帕替尼缓释片 | 4 | 4 | 43 |
| 5 | 乙酰半胱氨酸口服溶液 | 4 | 2 | 11 |
| 6 | 硫酸氨基葡萄糖胶囊 | 3 | 3 | 50 |
| 7 | 氢溴酸伏硫西汀片 | 3 | 2 | 8 |
| 8 | 磷酸奥司他韦胶囊 | 3 | 1 | 42 |
| 9 | 克立硼罗软膏 | 2 | 2 | 28 |
| 10 | 玛巴洛沙韦片 | 2 | 2 | 12 |
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
301 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Amgen Inc. | 15 | 3 | 0 |
| 2 | 哈药集团世一堂制药厂 | 13 | 13 | 0 |
| 3 | 吉林省德商药业股份有限公司 | 8 | 7 | 0 |
| 4 | AstraZeneca AB | 8 | 5 | 0 |
| 5 | medac Gesellschaft für klinische Spezialpr？parate mbH | 8 | 1 | 0 |
| 6 | Merck Sharp & Dohme LLC | 7 | 4 | 0 |
| 7 | 湖南天济草堂制药股份有限公司 | 6 | 6 | 0 |
| 8 | 重庆长新制药有限公司 | 5 | 5 | 0 |
| 9 | 湖南九典制药股份有限公司 | 5 | 4 | 1 |
| 10 | 山东百诺医药股份有限公司 | 5 | 3 | 2 |
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
177 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/12/29Import · Class 1 | 注射用MK-1022JXSL2500250 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2025/12/29Import · Class 2.4 | 匹妥布替尼片JXHS2500142 | Eli Lilly Nederland B.V.; Lilly del Caribe lnc.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/12/29Import · Class 2.4 | 匹妥布替尼片JXHS2500141 | Eli Lilly Nederland B.V.; Lilly del Caribe lnc.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/12/29Import · Class 1 | AMG 436JXHL2500397 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd. |
| 2025/12/29Import · Class 1 | AMG 436JXHL2500396 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd. |
| 2025/12/29Generic · Class 3 | 瑞卢戈利片CYHS2504454 | 江西山香药业有限公司 |
| 2025/12/29Generic · Class 3 | 琥珀酸亚铁片CYHS2504452 | 江苏润恒制药有限公司 |
| 2025/12/29Generic · Class 3 | 达普司他片CYHL2500233 | 安徽宏业药业有限公司 |
| 2025/12/29New drug · Class 3.3 | 重组带状疱疹疫苗（CHO细胞）CXSS2500145 | 江苏瑞科生物技术股份有限公司 |
| 2025/12/29New drug · Class 1 | LQ036雾化液CXSL2501157 | 上海洛启生物医药技术有限公司 |
| 2025/12/29New drug · Class 1 | 重组L-IFN腺病毒注射液CXSL2501156 | 上海元宋生物技术有限公司 |
| 2025/12/29New drug · Class 1 | SV003注射液CXSL2501155 | 上海循曜生物科技有限公司; 绍兴循曜磐拓生物医药科技有限公司 |
| 2025/12/29New drug · Class 3.2 | 20价肺炎球菌多糖结合疫苗CXSL2501154 | 山东亦度生物技术有限公司北京分公司; 重庆亦度生物技术（集团）有限公司; 山东亦度生物技术有限公司 |
| 2025/12/29New drug · Class 1 | 注射用AK150CXSL2501152 | 中山康方生物医药有限公司 |
| 2025/12/29New drug · Class 1 | BKB020靶向活化型T细胞注射液CXSL2501151 | 本康生物制药（深圳）有限公司 |
| 2025/12/29New drug · Class 1 | QY211凝胶CXHL2501492 | 启元生物（杭州）有限公司 |
| 2025/12/29New drug · Class 1 | QY211凝胶CXHL2501491 | 启元生物（杭州）有限公司 |
| 2025/12/29New drug · Class 1 | IAMA-001凝胶CXHL2501490 | 南京吉盛澳玛生物医药有限公司 |
| 2025/12/29New drug · Class 1 | HSK55879片CXHL2501489 | 上海海思盛诺医药科技有限公司 |
| 2025/12/29New drug · Class 1 | IAMA-001凝胶CXHL2501488 | 南京吉盛澳玛生物医药有限公司 |
| 2025/12/29New drug · Class 1 | HSK55879片CXHL2501487 | 上海海思盛诺医药科技有限公司 |
| 2025/12/29New drug · Class 1 | HSK55879片CXHL2501486 | 上海海思盛诺医药科技有限公司 |
| 2025/12/29New drug · Class 1 | GD-20片CXHL2501485 | 天津谷堆生物医药科技有限公司 |
| 2025/12/29New drug · Class 1 | GD-20片CXHL2501484 | 天津谷堆生物医药科技有限公司 |
| 2025/12/29New drug · Class 1 | 注射用TRD221CXHL2501483 | 中国医学科学院药物研究所; 北京泰德制药股份有限公司 |
| 2025/12/27Import · Class 1 | Iberdomide胶囊JXHS2500139 | Bristol-Myers Squibb Pharma EEIG; Celgene International Sarl; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/12/27Import · Class 1 | Iberdomide胶囊JXHS2500138 | Bristol-Myers Squibb Pharma EEIG; Celgene International Sarl; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/12/27Generic · Class 3 | 草酸艾司西酞普兰口服溶液CYHS2504440 | 山东百诺医药股份有限公司; 吉林省西点药业科技发展股份有限公司 |
| 2025/12/27Generic · Class 3 | 托吡司特片CYHL2500232 | 鲁南贝特制药有限公司 |
| 2025/12/27Generic · Class 3 | 托吡司特片CYHL2500231 | 鲁南贝特制药有限公司 |
147 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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