药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2026/08/04 – 2026/08/10
- New acceptances this week
- 482
- Drugs with new generic filings (by drug name, de-duplicated)
- 55
- Accepted this week, now under review
- 307
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
482filings, 76 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 279 |
| New drug | 88 |
| Generic | 76 |
| Import | 29 |
| Import re-registration | 6 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 210 |
| TCM | 193 |
| 治疗用生物制品 | 76 |
| 预防用生物制品 | 3 |
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
55 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 | 替尔泊肽注射液 | 4 | 1 | 26 |
| 3 | 洛索洛芬钠贴剂 | 3 | 2 | 30 |
| 4 | 吸入用盐酸氨溴索溶液 | 3 | 1 | 10 |
| 5 | 鱼油（3%）橄榄油中/长链脂肪乳/氨基酸（16）/葡萄糖（13%）注射液 | 3 | 1 | 6 |
| 6 | 乌帕替尼缓释片 | 2 | 2 | 43 |
| 7 | 依达拉奉右莰醇注射用浓溶液 | 2 | 2 | 32 |
| 8 | 注射用西维来司他钠 | 2 | 2 | 4 |
| 9 | 注射用环磷酰胺 | 2 | 1 | 3 |
| 10 | 注射用甲磺酸萘莫司他 | 2 | 1 | 38 |
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
276 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 北京宝树堂科技药业有限公司 | 17 | 16 | 0 |
| 2 | 辽宁上药好护士药业（集团）有限公司 | 7 | 5 | 0 |
| 3 | Eli Lilly and Company | 7 | 1 | 0 |
| 4 | 天方药业有限公司 | 6 | 6 | 0 |
| 5 | Bayer Inc. | 6 | 1 | 0 |
| 6 | Gilead Sciences Inc. | 6 | 1 | 0 |
| 7 | 丽珠集团利民制药厂 | 6 | 1 | 0 |
| 8 | GlaxoSmithKline Trading Services Limited | 5 | 2 | 0 |
| 9 | 恒翼生物医药（江苏）有限公司 | 5 | 1 | 0 |
| 10 | 连云港润众制药有限公司 | 5 | 1 | 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
138 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/08/10Import · Class 1.4 | PG4JXSL2600189 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2026/08/10Import · Class 1 | VenglustatJXHL2600333 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd |
| 2026/08/10Import · Class 1 | VenglustatJXHL2600332 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd |
| 2026/08/10Generic · Class 3 | 硫酸特布他林口服溶液CYHS2601951 | 上海美优制药有限公司 |
| 2026/08/10Generic · Class 3 | 注射用盐酸兰地洛尔CYHS2601949 | 海南灵康制药有限公司 |
| 2026/08/10Generic · Class 3 | 普罗布考片CYHS2601948 | 浙江江北药业有限公司 |
| 2026/08/10Generic · Class 3 | 注射用西维来司他钠CYHS2601944 | 山东新时代药业有限公司 |
| 2026/08/10New drug · Class 1.2 | CE-201片CXZL2600074 | 原研港（上海）中药科技有限公司; 原研药港生命科学技术（北京）集团有限公司 |
| 2026/08/10New drug · Class 1.2 | CE-201片CXZL2600073 | 原研港（上海）中药科技有限公司; 原研药港生命科学技术（北京）集团有限公司 |
| 2026/08/10New drug · Class 1.2 | CE-101CXZL2600072 | 原研港（上海）中药科技有限公司; 原研药港生命科学技术（北京）集团有限公司 |
| 2026/08/10New drug · Class 2.1 | 注射用正清风痛宁CXZL2600071 | 湖南正清制药集团股份有限公司 |
| 2026/08/10New drug · Class 1 | CM551注射液CXSL2600851 | 康诺亚生物医药科技有限公司 |
| 2026/08/10New drug · Class 3.3 | AK2401注射液CXSL2600850 | 安徽安科生物工程（集团）股份有限公司 |
| 2026/08/10New drug · Class 1 | ICP-B381CXSL2600849 | 北京诺诚健华医药科技有限公司 |
| 2026/08/10New drug · Class 1 | BJ045注射液（皮下注射）CXSL2600848 | 上海宝济药业股份有限公司 |
| 2026/08/10New drug · Class 1 | 90Y-NRT6020注射液CXHL2600980 | 成都纽瑞特医疗科技股份有限公司 |
| 2026/08/10New drug · Class 1 | HRS-5346 片CXHL2600979 | 山东盛迪医药有限公司 |
| 2026/08/10New drug · Class 1 | HRS-2189片CXHL2600978 | 山东盛迪医药有限公司 |
| 2026/08/10New drug · Class 1 | HRS-2189片CXHL2600977 | 山东盛迪医药有限公司 |
| 2026/08/07Import · Class 3.1 | 尼塞韦单抗注射液JXSS2600072 | Sanofi Winthrop Industrie; Patheon Manufacturing Services LLC; Sanofi (China) Investment Co. Ltd. |
| 2026/08/07Import · Class 3.1 | 尼塞韦单抗注射液JXSS2600071 | Sanofi Winthrop Industrie; Patheon Manufacturing Services LLC; Sanofi (China) Investment Co. Ltd. |
| 2026/08/07Import · Class 1 | Edecesertib 片JXHL2600331 | Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd. |
| 2026/08/07Import · Class 1 | Edecesertib 片JXHL2600330 | Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd. |
| 2026/08/07Import · Class 1 | Edecesertib 片JXHL2600329 | Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd. |
| 2026/08/07Generic · Class 3 | 琥珀酸亚铁片CYHS2601935 | 安徽正药医药科技有限公司; 华益药业科技（安徽）有限公司 |
| 2026/08/07Generic · Class 3 | 对乙酰氨基酚注射液CYHS2601934 | 山东百诺医药股份有限公司; 哈尔滨三联药业股份有限公司 |
| 2026/08/07Generic · Class 3 | 加替沙星滴眼液CYHS2601932 | 润尔眼科药物（广州）有限公司 |
| 2026/08/07Generic · Class 3 | 盐酸罗匹尼罗片CYHS2601930 | 大桐制药（中国）有限责任公司 |
| 2026/08/07New drug · Class 3.1 | 当归六黄汤颗粒CXZS2600045 | 神威药业集团有限公司 |
| 2026/08/07New drug · Class 3.1 | 厚朴温中汤颗粒CXZS2600044 | 神威药业集团有限公司 |
108 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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