药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2026/06/02 – 2026/06/08
- New acceptances this week
- 473
- Drugs with new generic filings (by drug name, de-duplicated)
- 69
- Accepted this week, now under review
- 140
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
473filings, 99 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 243 |
| Generic | 99 |
| New drug | 83 |
| Import | 37 |
| Import re-registration | 6 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 234 |
| TCM | 157 |
| 治疗用生物制品 | 77 |
| 预防用生物制品 | 3 |
| Biologic | 2 |
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
69 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 多替诺雷片 | 5 | 3 | 49 |
| 2 | 富马酸伏诺拉生片 | 4 | 2 | 58 |
| 3 | 艾普拉唑肠溶片 | 3 | 3 | 26 |
| 4 | 普瑞巴林口崩片 | 3 | 1 | 3 |
| 5 | 盐酸二甲双胍缓释片 | 3 | 1 | 8 |
| 6 | 罗替高汀贴片 | 3 | 1 | 7 |
| 7 | 注射用甲磺酸萘莫司他 | 2 | 2 | 38 |
| 8 | 注射用盐酸兰地洛尔 | 2 | 2 | 19 |
| 9 | 注射用西维来司他钠 | 2 | 2 | 4 |
| 10 | 洛索洛芬钠口服溶液 | 2 | 2 | 6 |
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
280 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 津药达仁堂集团股份有限公司达仁堂制药厂 | 19 | 14 | 0 |
| 2 | Eli Lilly and Company | 13 | 2 | 0 |
| 3 | Novo Nordisk A/S | 12 | 1 | 0 |
| 4 | Eli Lilly Nederland B.V. | 8 | 1 | 0 |
| 5 | 海思科医药集团股份有限公司 | 6 | 2 | 0 |
| 6 | Celgene Corporation a Bristol-Myers Squibb Company | 6 | 1 | 0 |
| 7 | 成都华森奥睿药业有限公司 | 6 | 1 | 0 |
| 8 | 江苏豪森药业集团有限公司 | 6 | 1 | 0 |
| 9 | 山东步长制药股份有限公司 | 5 | 5 | 0 |
| 10 | 齐鲁制药有限公司 | 5 | 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 no longer on the under-review list whose last snapshot sighting falls in this week, meaning approved or terminated, to be verified. Companies are counted by first applicant.
Class 3 and new-drug acceptances
153 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/06/08Import · Class 2.2 | 注射用罗特西普JXSS2600051 | Celgene Corporation a Bristol-Myers Squibb Company; Patheon Italia S.p.A.; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2026/06/08Import · Class 2.2 | 注射用罗特西普JXSS2600050 | Celgene Corporation a Bristol-Myers Squibb Company; Patheon Italia S.p.A.; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2026/06/08Import · Class 1 | GIA632注射液JXSL2600140 | Novartis Pharma AG |
| 2026/06/08Generic · Class 3 | 盐酸多塞平片CYHS2601336 | 沈阳华泰药物研究有限公司 |
| 2026/06/08Generic · Class 3 | 西甲硅油咀嚼片CYHS2601335 | 江西施美药业股份有限公司 |
| 2026/06/08Generic · Class 3 | 普瑞巴林口崩片CYHS2601334 | 山东创新药物研发有限公司; 江西施美药业股份有限公司 |
| 2026/06/08Generic · Class 3 | 普瑞巴林口崩片CYHS2601333 | 山东创新药物研发有限公司; 江西施美药业股份有限公司 |
| 2026/06/08Generic · Class 3 | 普瑞巴林口崩片CYHS2601332 | 山东创新药物研发有限公司; 江西施美药业股份有限公司 |
| 2026/06/08Generic · Class 3 | 美洛昔康注射液（III）CYHS2601331 | 健康元药业集团股份有限公司; 健康元海滨药业有限公司 |
| 2026/06/08Generic · Class 3 | 普瑞巴林缓释片CYHS2601329 | 北京泰德制药股份有限公司 |
| 2026/06/08Generic · Class 3 | 普瑞巴林缓释片CYHS2601328 | 北京泰德制药股份有限公司 |
| 2026/06/08Generic · Class 3 | 注射用甲磺酸萘莫司他CYHS2601327 | 湖南埃威格林医药科技有限公司; 湖南赛隆药业（长沙）有限公司 |
| 2026/06/08Generic · Class 3 | 洛索洛芬钠口服溶液CYHS2601325 | 江西众泽源医药科技有限公司; 安徽永生堂药业有限责任公司 |
| 2026/06/08Generic · Class 3 | 马来酸噻吗洛尔滴眼液CYHS2601324 | 广东南国药业有限公司 |
| 2026/06/08New drug · Class 1.1 | 芪地通便颗粒CXZL2600054 | 山东汉方制药股份有限公司 |
| 2026/06/08New drug · Class 1 | Pumitamig注射液CXSL2600617 | 百欧恩泰（上海）医药有限公司; 百时美施贵宝（中国）投资有限公司 |
| 2026/06/08New drug · Class 1 | 注射用RT023CXSL2600616 | 上海偌妥生物科技有限公司 |
| 2026/06/08New drug · Class 2.2 | 西妥昔单抗β注射液CXSL2600615 | 泰州迈博太科药业有限公司 |
| 2026/06/08New drug · Class 1 | ZMPB-NK006注射液CXSL2600614 | 北京美欧赛奥金生物科技有限公司 |
| 2026/06/08New drug · Class 1 | IBR822细胞注射液CXSL2600613 | 英百瑞（杭州）生物医药股份有限公司 |
| 2026/06/08New drug · Class 1 | IBR822细胞注射液CXSL2600612 | 英百瑞（杭州）生物医药股份有限公司 |
| 2026/06/08New drug · Class 1 | RG002注射液CXSL2600611 | 仁景（苏州）生物科技有限公司 |
| 2026/06/08New drug · Class 1 | CA-301注射液CXHL2600682 | 原研港脑科学技术（上海）有限公司; 原研药港生命科学技术（北京）集团有限公司 |
| 2026/06/08New drug · Class 2.4 | 莫米司特片CXHL2600681 | 赣州和美药业股份有限公司 |
| 2026/06/08New drug · Class 1 | HSK47388片（I）CXHL2600680 | 海思科医药集团股份有限公司 |
| 2026/06/08New drug · Class 1 | HSK47388片（I）CXHL2600679 | 海思科医药集团股份有限公司 |
| 2026/06/08New drug · Class 1 | YL-13027片CXHL2600678 | 上海璎黎药业有限公司 |
| 2026/06/08New drug · Class 1 | YL-13027片CXHL2600677 | 上海璎黎药业有限公司 |
| 2026/06/05Import · Class 1 | NNC0487-0111注射液JXSL2600139 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/06/05Import · Class 1 | NNC0487-0111注射液JXSL2600138 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
123 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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