药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2026/08/11 – 2026/08/17
- New acceptances this week
- 504
- Drugs with new generic filings (by drug name, de-duplicated)
- 57
- Accepted this week, now under review
- 305
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
504filings, 77 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 309 |
| Generic | 77 |
| New drug | 67 |
| Import | 40 |
| Unspecified | 6 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 251 |
| TCM | 165 |
| 治疗用生物制品 | 80 |
| 预防用生物制品 | 5 |
| Biologic | 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
57 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 注射用磷酸左奥硝唑酯二钠 | 3 | 2 | 20 |
| 2 | 苯磺酸左氨氯地平片 | 3 | 2 | 47 |
| 3 | 布瑞哌唑口崩片 | 3 | 1 | 10 |
| 4 | 布瑞哌唑片 | 3 | 1 | 31 |
| 5 | 普瑞巴林缓释片 | 3 | 1 | 12 |
| 6 | 硫酸氨基葡萄糖胶囊 | 2 | 2 | 50 |
| 7 | 醋酸地非法林注射液 | 2 | 2 | 8 |
| 8 | 伊班膦酸钠注射液 | 2 | 1 | 4 |
| 9 | 左氧氟沙星滴眼液 | 2 | 1 | 16 |
| 10 | 注射用醋酸卡泊芬净 | 2 | 1 | 8 |
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
278 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 上海民为生物技术有限公司 | 14 | 1 | 0 |
| 2 | F. Hoffmann-La Roche Ltd | 13 | 3 | 0 |
| 3 | 吉林高邈药业股份有限公司 | 9 | 9 | 0 |
| 4 | 江苏恒瑞医药股份有限公司 | 9 | 3 | 0 |
| 5 | AstraZeneca AB | 8 | 5 | 0 |
| 6 | 宜昌人福药业有限责任公司 | 8 | 4 | 4 |
| 7 | 广东泰恩康制药厂有限公司 | 8 | 3 | 0 |
| 8 | Novo Nordisk A/S | 8 | 2 | 0 |
| 9 | 信达生物科技有限公司 | 8 | 1 | 0 |
| 10 | 吉林省辉南长龙生化药业股份有限公司 | 7 | 7 | 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 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
134 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/08/17Import · Class 1 | VAY736注射液JXSL2600208 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/08/17Import · Class 1 | ALPN-303注射液JXSL2600207 | Vertex Pharmaceuticals Incorporated; —— |
| 2026/08/17Import · Class 1 | CDR132L注射液JXHL2600346 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/08/17Generic · Class 3 | 盐酸溴己新口服溶液CYHS2602035 | 四川群乐康药业有限公司; 江西和盈药业有限公司 |
| 2026/08/17Generic · Class 3 | 螺内酯片CYHS2602033 | 津威士（天津）科技有限公司; 天津力生制药股份有限公司 |
| 2026/08/17Generic · Class 3 | 螺内酯片CYHS2602032 | 津威士（天津）科技有限公司; 天津力生制药股份有限公司 |
| 2026/08/17Generic · Class 3 | 盐酸西替利嗪注射液CYHS2602030 | 山东百诺医药股份有限公司; 哈尔滨誉衡制药有限公司 |
| 2026/08/17Generic · Class 3 | 比拉斯汀口腔崩解片CYHS2602029 | 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 |
| 2026/08/17Generic · Class 3 | 二硫化硒洗剂CYHS2602027 | 宏越科技（湖州）有限公司; 裕松源药业有限公司 |
| 2026/08/17Generic · Class 3 | 吲哚布芬片CYHS2602023 | 深圳市朗博生物医药股份有限公司; 博志研新泰州药物技术有限公司 |
| 2026/08/17New drug · Class 1.1 | 天葛定眩颗粒CXZL2600077 | 四川光大制药有限公司 |
| 2026/08/17New drug · Class 2.2 | 安尼妥单抗注射液CXSS2600126 | 上海津曼特生物科技有限公司; 江苏康宁杰瑞生物制药有限公司 |
| 2026/08/17New drug · Class 3.3 | 司美格鲁肽注射液CXSS2600125 | 质肽药业（泰州）有限公司 |
| 2026/08/17New drug · Class 3.3 | 司美格鲁肽注射液CXSS2600124 | 质肽药业（泰州）有限公司 |
| 2026/08/17New drug · Class 1 | SHR-1139注射液CXSL2600876 | 广东恒瑞医药有限公司 |
| 2026/08/17New drug · Class 2.4 | 注射用重组A型肉毒毒素（Sf9细胞，150 kD天然氨基酸序列）CXSL2600875 | 苏州若弋生物科技有限公司 |
| 2026/08/17New drug · Class 1 | SZ1003注射液CXSL2600874 | 广东普罗凯融生物医药科技有限公司 |
| 2026/08/17New drug · Class 2.2 | 艾米迈托赛注射液CXSL2600873 | 铂生卓越生物科技（北京）有限公司 |
| 2026/08/17New drug · Class 1 | 注射用Efimosfermin alfaCXSL2600872 | 葛兰素史克（中国）投资有限公司 |
| 2026/08/17New drug · Class 1 | 人脐带间充质干细胞注射液CXSL2600871 | 长春拓华医药有限公司 |
| 2026/08/17New drug · Class 1 | 注射用GenSci136CXSL2600870 | 长春金赛药业有限责任公司 |
| 2026/08/17New drug · Class 2.2 | 注射用多西他赛（白蛋白结合型）CXHS2600118 | 石药集团中诺药业（石家庄）有限公司 |
| 2026/08/17New drug · Class 1 | SIM0518胶囊CXHL2601010 | 上海先声再明科技有限公司 |
| 2026/08/17New drug · Class 1 | SIM0518胶囊CXHL2601009 | 上海先声再明科技有限公司 |
| 2026/08/17New drug · Class 1 | 68Ga-NRT6020注射液CXHL2601008 | 成都纽瑞特医疗科技股份有限公司 |
| 2026/08/14Import · Class 1 | RO7795068注射液JXHL2600345 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/14Import · Class 1 | RO7795068注射液JXHL2600344 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/14Import · Class 1 | RO7795068注射液JXHL2600343 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/14Import · Class 1 | RO7795068注射液JXHL2600342 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/14Import · Class 1 | RO7795068注射液JXHL2600341 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
104 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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