药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2026/09/08 – 2026/09/14
- New acceptances this week
- 341
- Drugs with new generic filings (by drug name, de-duplicated)
- 34
- Accepted this week, now under review
- 297
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
341filings, 45 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 212 |
| New drug | 68 |
| Generic | 45 |
| Import | 10 |
| Import re-registration | 4 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 141 |
| TCM | 124 |
| 治疗用生物制品 | 70 |
| 预防用生物制品 | 3 |
| Biologic | 2 |
| 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
34 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 碳酸氢钠注射液 | 3 | 2 | 11 |
| 2 | 富马酸奥赛利定注射液 | 3 | 1 | 3 |
| 3 | 聚多卡醇注射液 | 3 | 1 | 22 |
| 4 | 富马酸伏诺拉生片 | 2 | 1 | 58 |
| 5 | 尼洛替尼胶囊 | 2 | 1 | 6 |
| 6 | 盐酸氨溴索口服溶液 | 2 | 1 | 45 |
| 7 | 盐酸齐拉西酮胶囊 | 2 | 1 | 7 |
| 8 | 磷酸奥司他韦胶囊 | 2 | 1 | 42 |
| 9 | 乳果糖口服溶液 | 1 | 1 | 40 |
| 10 | 二十碳五烯酸乙酯软胶囊 | 1 | 1 | 25 |
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
209 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 太极集团重庆桐君阁药厂有限公司 | 13 | 13 | 0 |
| 2 | 陕西华西制药股份有限公司 | 9 | 9 | 0 |
| 3 | 博晖生物制药（云南）有限公司 | 6 | 5 | 0 |
| 4 | 深圳翰宇药业股份有限公司 | 6 | 1 | 0 |
| 5 | 江西华太药业有限公司 | 5 | 5 | 0 |
| 6 | 陕西欧珂药业有限公司 | 5 | 5 | 0 |
| 7 | 吉林玉仁制药股份有限公司 | 4 | 4 | 0 |
| 8 | 四川德峰药业有限公司 | 4 | 4 | 0 |
| 9 | 黑龙江鼎恒升药业有限公司 | 4 | 4 | 0 |
| 10 | Novartis Pharma AG | 4 | 2 | 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
92 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/09/14New drug · Class 1 | SHR-2004注射液CXSS2600151 | 北京盛迪医药有限公司; 苏州盛迪亚生物医药有限公司 |
| 2026/09/14New drug · Class 1 | 注射用IMD2113CXSL2600999 | 上海英脉德医疗科技有限公司 |
| 2026/09/11Import · Class 1 | LY4405094注射液JXSL2600242 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD |
| 2026/09/11Import · Class 2.2 | 乌帕替尼口服溶液JXHL2600401 | AbbVie Inc.; AbbVie Pharmaceutical Trading(Shanghai) Co. Ltd. |
| 2026/09/11Import · Class 2.4 | 乌帕替尼缓释片JXHL2600400 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2026/09/11Generic · Class 3 | 注射用甲磺酸萘莫司他CYHS2602272 | 武汉华龙生物制药有限公司 |
| 2026/09/11Generic · Class 3 | 硫酸奈替米星注射液CYHS2602268 | 成都倍特药业股份有限公司 |
| 2026/09/11New drug · Class 3.1 | 温胆汤颗粒CXZS2600049 | 海南斯达制药有限公司; 安徽宏信药业发展有限公司 |
| 2026/09/11New drug · Class 1.1 | 夏黄颗粒CXZL2600090 | 一又生物（上海）有限公司; 梦阳药业（上海）有限公司 |
| 2026/09/11New drug · Class 1 | 注射用TQB2102CXSS2600150 | 正大天晴药业集团南京顺欣制药有限公司; 正大天晴药业集团南京顺欣制药有限公司（注射用TQB2102有效载荷及连接子TQ21777：连云港润众制药有限公司） |
| 2026/09/11New drug · Class 1 | TQH2722注射液CXSS2600149 | 上海正大天晴医药科技开发有限公司; 正大天晴药业集团南京顺欣制药有限公司 |
| 2026/09/11New drug · Class 3.3 | 地舒单抗注射液CXSS2600148 | 复星汉霖（深圳）生物技术有限公司; 上海复宏汉霖生物医药有限公司 |
| 2026/09/11New drug · Class 1 | 人脐带间充质干细胞注射液CXSL2600995 | 安明康源制药（吉林）有限公司; 安康源生物科技（吉林）有限公司 |
| 2026/09/11New drug · Class 1 | 注射用SHR-1219CXSL2600994 | 苏州盛迪亚生物医药有限公司 |
| 2026/09/11New drug · Class 1 | SYS6065CXSL2600993 | 石药集团巨石生物制药有限公司 |
| 2026/09/11New drug · Class 1 | JY2002注射液CXSL2600992 | 江苏济烨生物制药有限公司; 上海济煜医药科技股份有限公司 |
| 2026/09/11New drug · Class 1 | 人脐带间充质干细胞注射液CXSL2600991 | 江苏赛亿生物技术有限公司 |
| 2026/09/11New drug · Class 1 | IBI354CXSL2600990 | 信达生物医药科技（杭州）有限公司 |
| 2026/09/11New drug · Class 1 | BL0175注射液CXHL2601109 | 上海弼领生物技术有限公司 |
| 2026/09/11New drug · Class 1 | HTD1801胶囊CXHL2601108 | 上海福药生物技术有限公司; 中国医学科学院医药生物技术研究所 |
| 2026/09/10Import · Class 2.1;2.2 | 索特西普注射液JXSL2600241 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2026/09/10Import · Class 1 | NCX 470滴眼液JXHS2600105 | OCUMENSION（HONG KONG）LIMITED; Alliance Medical Products Inc. （dba. Siegfried Irvine）; Ocumension Therapeutics(Suzhou)Co. Ltd. |
| 2026/09/10Generic · Class 3 | 比拉斯汀口服溶液CYHS2602267 | 安徽四环科宝制药有限公司 |
| 2026/09/10Generic · Class 3 | 盐酸奥洛他定口崩片CYHS2602266 | 宏越科技（湖州）有限公司; 浙江皓格药业有限公司 |
| 2026/09/10Generic · Class 3 | 盐酸伐地那非口崩片CYHS2602261 | 北京茗泽中和药物研究有限公司; 华益药业科技（安徽）有限公司 |
| 2026/09/10New drug · Class 3.1 | 温胆汤颗粒CXZS2600048 | 华润三九医药股份有限公司 |
| 2026/09/10New drug · Class 1.3 | 三价流感重组蛋白疫苗CXSL2600989 | 珠海市丽珠单抗生物技术有限公司 |
| 2026/09/10New drug · Class 1.3 | 三价流感重组蛋白疫苗CXSL2600988 | 珠海市丽珠单抗生物技术有限公司 |
| 2026/09/10New drug · Class 1 | HLX109注射液CXSL2600987 | 上海复宏汉霖生物医药有限公司; 上海复宏瑞霖生物技术有限公司 |
| 2026/09/10New drug · Class 1 | KHN923注射液CXSL2600986 | 成都康弘生物科技有限公司 |
62 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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