药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/02/25 – 2025/03/03
- New acceptances this week
- 347
- Drugs with new generic filings (by drug name, de-duplicated)
- 68
- Accepted this week, now under review
- 11
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
347filings, 83 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 196 |
| Generic | 83 |
| New drug | 38 |
| Import | 16 |
| Unspecified | 8 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 219 |
| TCM | 83 |
| 治疗用生物制品 | 34 |
| 预防用生物制品 | 6 |
| Biologic | 4 |
| 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
68 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 达格列净片 | 4 | 2 | 82 |
| 2 | 奥沙利铂注射液 | 3 | 1 | 2 |
| 3 | 盐酸溴己新注射液 | 2 | 2 | 8 |
| 4 | 乳果糖口服溶液 | 2 | 1 | 40 |
| 5 | 伊布替尼片 | 2 | 1 | 0 |
| 6 | 吸入用盐酸丙卡特罗溶液 | 2 | 1 | 2 |
| 7 | 注射用头孢呋辛钠 | 2 | 1 | 8 |
| 8 | 注射用赖氨匹林 | 2 | 1 | 8 |
| 9 | 盐酸丙卡特罗吸入溶液 | 2 | 1 | 3 |
| 10 | 盐酸左沙丁胺醇雾化吸入溶液 | 2 | 1 | 2 |
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
203 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 黑龙江林海雪原药业有限公司 | 24 | 22 | 0 |
| 2 | 哈尔滨珍宝制药有限公司 | 16 | 9 | 0 |
| 3 | 百济神州（苏州）生物科技有限公司 | 10 | 3 | 0 |
| 4 | 贵州三仁堂药业有限公司 | 8 | 8 | 0 |
| 5 | 黑龙江省布家唐药业有限公司 | 6 | 6 | 0 |
| 6 | 上海北杰集团关东药业有限公司 | 5 | 5 | 0 |
| 7 | Boehringer Ingelheim International GmbH | 5 | 4 | 0 |
| 8 | 黑龙江汉鸿药业有限公司 | 4 | 4 | 0 |
| 9 | 重庆希尔安药业有限公司 | 4 | 2 | 0 |
| 10 | Baxter Holding B.V. | 3 | 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
91 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/03/03Generic · Class 3 | 醋酸地非法林注射液CYHS2500902 | 齐鲁制药（海南）有限公司 |
| 2025/03/03Generic · Class 3 | 头孢地尼干混悬剂CYHS2500901 | 广东万泰元科创药业有限公司; 四川赛卓药业股份有限公司 |
| 2025/03/03Generic · Class 3 | 碳酸司维拉姆干混悬剂CYHS2500900 | 中美华世通生物医药科技（武汉）股份有限公司; 湖北华世通生物医药科技有限公司 |
| 2025/03/03Generic · Class 3 | 碳酸司维拉姆干混悬剂CYHS2500899 | 中美华世通生物医药科技（武汉）股份有限公司; 湖北华世通生物医药科技有限公司 |
| 2025/03/03Generic · Class 3 | 熊去氧胆酸颗粒CYHS2500897 | 辽宁海一制药有限公司 |
| 2025/03/03Generic · Class 3 | 阿瑞匹坦注射液CYHS2500896 | 石药集团中诺药业（石家庄）有限公司 |
| 2025/03/03Generic · Class 3 | 葡萄糖酸钙氯化钠注射液CYHS2500895 | 湖北津药药业股份有限公司 |
| 2025/03/03Generic · Class 3 | 瑞卢戈利片CYHL2500055 | 山西振东制药股份有限公司 |
| 2025/03/03New drug · Class 2.3 | SMF-217CXHL2500233 | 江西施美药业股份有限公司 |
| 2025/03/01Import · Class 2.2 | CHF5993-IIJXHL2500032 | Chiesi Farmaceutici S.p.A.; Chiesi Pharmaceutical Consulting (Shanghai) Co. Ltd. |
| 2025/03/01Generic · Class 3 | 伊布替尼片CYHS2500891 | 重庆华邦制药有限公司 |
| 2025/03/01Generic · Class 3 | 伊布替尼片CYHS2500890 | 重庆华邦制药有限公司 |
| 2025/03/01Generic · Class 3 | 盐酸丙卡特罗吸入溶液CYHS2500889 | 江苏万高药业股份有限公司 |
| 2025/03/01Generic · Class 3 | 盐酸丙卡特罗吸入溶液CYHS2500888 | 江苏万高药业股份有限公司 |
| 2025/03/01Generic · Class 3 | 聚乙二醇4000散（儿童型）CYHS2500885 | 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 |
| 2025/03/01New drug · Class 1 | IMB071703注射液CXSL2500189 | 北京免疫方舟医药科技有限公司 |
| 2025/03/01New drug · Class 1 | LBM801CXSL2500188 | 上海利康瑞生物工程有限公司; 上海博赛美生物科技有限公司 |
| 2025/03/01New drug · Class 1 | 注射用Neu-001CXHL2500232 | 神瞻医药（深圳）有限公司 |
| 2025/03/01New drug · Class 2.4 | TAP-1503 乳膏CXHL2500231 | 上海泽德曼医药科技有限公司 |
| 2025/02/28Generic · Class 3 | 琥珀酸亚铁片CYHS2500883 | 湖南千金湘江药业股份有限公司 |
| 2025/02/28Generic · Class 3 | 联苯苄唑溶液CYHS2500881 | 唐山红星药业有限责任公司 |
| 2025/02/28Generic · Class 3 | 苯磺酸氨氯地平口服溶液CYHS2500880 | 山东朗诺制药有限公司 |
| 2025/02/28Generic · Class 3 | 奥沙利铂注射液CYHS2500879 | 湖北一半天制药有限公司 |
| 2025/02/28Generic · Class 3 | 奥沙利铂注射液CYHS2500878 | 湖北一半天制药有限公司 |
| 2025/02/28Generic · Class 3 | 奥沙利铂注射液CYHS2500877 | 湖北一半天制药有限公司 |
| 2025/02/28Generic · Class 3 | 布立西坦口服溶液CYHS2500876 | 江苏正大丰海制药有限公司; 华益药业科技（安徽）有限公司 |
| 2025/02/28Generic · Class 3 | 复方聚乙二醇（3350）电解质散CYHS2500872 | 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 |
| 2025/02/28Generic · Class 3 | 甲硝唑阴道凝胶CYHL2500053 | 华控创新（北京）药物研究院有限公司 |
| 2025/02/28New drug · Class 3.1 | 半夏泻心汤颗粒CXZS2500010 | 山西广誉远国药有限公司 |
| 2025/02/28New drug · Class 1 | 人脐带间充质干细胞注射液CXSL2500187 | 北京拓华伟业生物科技有限公司 |
61 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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