药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2026/09/01 – 2026/09/07
- New acceptances this week
- 423
- Drugs with new generic filings (by drug name, de-duplicated)
- 53
- Accepted this week, now under review
- 353
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
423filings, 68 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 230 |
| New drug | 79 |
| Generic | 68 |
| Import | 32 |
| Import re-registration | 10 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 205 |
| TCM | 139 |
| 治疗用生物制品 | 75 |
| 预防用生物制品 | 4 |
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
53 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 阿达帕林过氧苯甲酰凝胶 | 3 | 2 | 30 |
| 2 | 罗替高汀贴片 | 3 | 1 | 7 |
| 3 | 右酮洛芬氨丁三醇注射液 | 2 | 2 | 5 |
| 4 | 乳果糖口服溶液 | 2 | 1 | 40 |
| 5 | 多替诺雷片 | 2 | 1 | 49 |
| 6 | 恩格列净片 | 2 | 1 | 19 |
| 7 | 替格瑞洛片 | 2 | 1 | 12 |
| 8 | 玻璃酸钠滴眼液 | 2 | 1 | 29 |
| 9 | 瑞舒伐他汀钙片 | 2 | 1 | 18 |
| 10 | 盐酸曲唑酮缓释片 | 2 | 1 | 20 |
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
257 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | AbbVie Inc. | 8 | 1 | 0 |
| 2 | 甘李药业山东有限公司 | 8 | 1 | 0 |
| 3 | AstraZeneca AB | 7 | 3 | 0 |
| 4 | Novartis Pharma AG | 6 | 4 | 0 |
| 5 | 北京康蒂尼药业股份有限公司 | 5 | 5 | 0 |
| 6 | 青海琦鹰汉藏生物制药股份有限公司 | 5 | 5 | 0 |
| 7 | 哈尔滨珍宝制药有限公司 | 5 | 4 | 0 |
| 8 | Pfizer Inc. | 5 | 3 | 0 |
| 9 | 百济神州（苏州）生物科技有限公司 | 5 | 1 | 0 |
| 10 | 长春金赛药业有限责任公司 | 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
131 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/09/07Import · Class 1 | DKB903注射用浓溶液JXSL2600240 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/09/07Generic · Class 3 | 复方葡萄糖/电解质颅脑手术冲洗液CYHS2602231 | 芜湖道润药业有限责任公司 |
| 2026/09/07Generic · Class 3 | 恩替卡韦口服溶液CYHS2602228 | 安徽康融药业有限公司 |
| 2026/09/07Generic · Class 3 | 盐酸精氨酸注射液CYHS2602227 | 江苏长江药业有限公司 |
| 2026/09/07Generic · Class 3 | 酒石酸匹莫范色林胶囊CYHS2602224 | 天津天士力圣特制药有限公司 |
| 2026/09/07Generic · Class 3 | 盐酸非索非那定片CYHS2602222 | 合肥合源药业有限公司 |
| 2026/09/07Generic · Class 3 | 右酮洛芬氨丁三醇注射液CYHS2602215 | 山东新华制药股份有限公司 |
| 2026/09/07Generic · Class 3 | 酒石酸匹莫范色林片CYHS2602212 | 天津天士力圣特制药有限公司 |
| 2026/09/07Generic · Class 3 | 黄体酮注射液（Ⅱ）CYHS2602210 | 武汉九珑医药有限责任公司; 浙江赛默制药有限公司 |
| 2026/09/07New drug · Class 3.3 | 司美格鲁肽注射液CXSS2600147 | 重庆宸安生物制药有限公司 |
| 2026/09/07New drug · Class 3.3 | 司美格鲁肽注射液CXSS2600146 | 重庆宸安生物制药有限公司 |
| 2026/09/07New drug · Class 1 | JH035注射液CXSL2600966 | 百泰生物药业有限公司; 安博泰克药业有限公司 |
| 2026/09/07New drug · Class 2.2 | 吸附无细胞百（五组分）白破联合疫苗CXSL2600965 | 康希诺生物股份公司 |
| 2026/09/07New drug · Class 2.2 | 恩朗苏拜单抗注射液CXSL2600964 | 石药集团巨石生物制药有限公司 |
| 2026/09/07New drug · Class 1 | SYS6085注射液CXSL2600963 | 北京抗创联生物制药技术研究有限公司 |
| 2026/09/07New drug · Class 1 | 奥莱泊肽注射液CXHS2600126 | 江苏豪森药业集团有限公司; 江苏豪森药业集团有限公司(预填充注射笔的组装和最终成品包装: 江苏恒瑞医药股份有限公司) |
| 2026/09/07New drug · Class 2.2 | 司美格鲁肽微针贴片CXHL2601084 | 珠海科瑞微医药科技有限公司 |
| 2026/09/07New drug · Class 2.2 | 司美格鲁肽微针贴片CXHL2601083 | 珠海科瑞微医药科技有限公司 |
| 2026/09/07New drug · Class 2.2 | 司美格鲁肽微针贴片CXHL2601082 | 珠海科瑞微医药科技有限公司 |
| 2026/09/07New drug · Class 1 | HRS-4518舌下片CXHL2601081 | 北京盛迪医药有限公司 |
| 2026/09/07New drug · Class 1 | HRS-4518舌下片CXHL2601080 | 北京盛迪医药有限公司 |
| 2026/09/04Import · Class 1 | JNJ-79635322JXSL2600239 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2026/09/04Import · Class 1 | JNJ-79635322JXSL2600238 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2026/09/04Import · Class 1 | FUB523注射液JXSL2600237 | Novartis Pharma AG |
| 2026/09/04Import · Class 1 | Giredestrant胶囊JXHL2600397 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/09/04Import · Class 2.4 | Zavegepant鼻喷雾剂JXHL2600396 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/09/04Import · Class 1 | MK-1084片JXHL2600395 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2026/09/04Import · Class 1 | MK-1084片JXHL2600394 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2026/09/04Generic · Class 3 | 西甲硅油咀嚼片CYHS2602208 | 吉林省博采众科生物医药有限公司; 吉林省博大伟业制药有限公司 |
| 2026/09/04Generic · Class 3 | 磷酸奥司他韦干混悬剂CYHS2602206 | 河北华晨药业集团有限公司 |
101 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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