药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/12/02 – 2025/12/08
- New acceptances this week
- 462
- Drugs with new generic filings (by drug name, de-duplicated)
- 76
- Accepted this week, now under review
- 126
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
462filings, 102 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 222 |
| Generic | 102 |
| New drug | 84 |
| Import | 25 |
| Import re-registration | 15 |
| Unspecified | 14 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 263 |
| TCM | 120 |
| 治疗用生物制品 | 63 |
| Biologic | 10 |
| 体外诊断试剂 | 4 |
| 预防用生物制品 | 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
76 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 重酒石酸去甲肾上腺素注射液 | 5 | 3 | 9 |
| 2 | 利奥西呱片 | 3 | 1 | 4 |
| 3 | 恩格列净二甲双胍缓释片 | 3 | 1 | 12 |
| 4 | 莫匹罗星软膏 | 2 | 2 | 31 |
| 5 | 他达拉非片 | 2 | 1 | 23 |
| 6 | 多种微量元素注射液（IV） | 2 | 1 | 4 |
| 7 | 奥洛他定莫米松鼻喷雾剂 | 2 | 1 | 1 |
| 8 | 左羟丙哌嗪糖浆 | 2 | 1 | 0 |
| 9 | 恩曲替尼胶囊 | 2 | 1 | 5 |
| 10 | 拉呋替丁片 | 2 | 1 | 2 |
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
267 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 抚松县中药有限责任公司 | 30 | 30 | 0 |
| 2 | Eli Lilly and Company | 12 | 1 | 0 |
| 3 | 百济神州（苏州）生物科技有限公司 | 6 | 2 | 0 |
| 4 | 爱民药业集团股份有限公司 | 5 | 5 | 0 |
| 5 | 北京赛而生物药业有限公司 | 5 | 4 | 5 |
| 6 | 苏州盛迪亚生物医药有限公司 | 5 | 4 | 0 |
| 7 | Terumo Corporation Kofu Factory | 5 | 1 | 0 |
| 8 | 杭州诺澳生物医药科技有限公司 | 5 | 1 | 0 |
| 9 | 石药集团百克（山东）生物制药股份有限公司 | 5 | 1 | 0 |
| 10 | 上海科华生物工程股份有限公司 | 4 | 4 | 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 whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.
Class 3 and new-drug acceptances
143 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/12/08Generic · Class 3 | 左羟丙哌嗪糖浆CYHS2504213 | 湖北唯森制药有限公司 |
| 2025/12/08Generic · Class 3 | 左羟丙哌嗪糖浆CYHS2504212 | 湖北唯森制药有限公司 |
| 2025/12/08Generic · Class 3 | 重酒石酸去甲肾上腺素注射液CYHS2504211 | 山东达冠医药科技有限公司; 山西普恒制药有限公司 |
| 2025/12/08New drug · Class 3.1 | 温经汤颗粒CXZS2500050 | 山东润中药业有限公司 |
| 2025/12/08New drug · Class 2.2 | 信迪利单抗注射液CXSL2501060 | 信达生物制药（苏州）有限公司 |
| 2025/12/08New drug · Class 1 | 靶向BCMA的嵌合抗原受体T细胞注射液CXSL2501059 | 深圳普瑞金生物药业股份有限公司 |
| 2025/12/08New drug · Class 3.3 | 重组抗CD38全人单克隆抗体注射液-皮下注射CXSL2501058 | 上海复宏瑞霖生物技术有限公司; 上海复宏汉霖生物医药有限公司; 上海复宏汉霖生物技术股份有限公司 |
| 2025/12/08New drug · Class 2.2 | 贝伐珠单抗注射液CXSL2501057 | 信达生物制药（苏州）有限公司 |
| 2025/12/08New drug · Class 1 | 重组人源化抗HER2双特异性抗体注射液CXSL2501056 | 上海津曼特生物科技有限公司 |
| 2025/12/08New drug · Class 1 | SYS6023CXSL2501055 | 石药集团巨石生物制药有限公司 |
| 2025/12/08New drug · Class 1 | MRG006ACXSL2501054 | 乐普生物科技股份有限公司 |
| 2025/12/08New drug · Class 1 | DXC006CXSL2501053 | 杭州多禧生物科技有限公司 |
| 2025/12/08New drug · Class 2.2 | 阿得贝利单抗注射液CXSL2501052 | 上海盛迪医药有限公司 |
| 2025/12/08New drug · Class 1 | HZ-A-018胶囊CXHL2501345 | 杭州和正医药有限公司 |
| 2025/12/08New drug · Class 1 | HZ-A-018胶囊CXHL2501344 | 杭州和正医药有限公司 |
| 2025/12/08New drug · Class 2.4 | 注射用西罗莫司（白蛋白结合型）CXHL2501343 | 石药集团中奇制药技术（石家庄）有限公司 |
| 2025/12/06Generic · Class 3 | 格隆溴铵新斯的明注射液CYHS2504210 | 南京正科医药股份有限公司 |
| 2025/12/06Generic · Class 3 | 多种微量元素注射液（IV）CYHS2504209 | 南京恩泰医药科技有限公司; 辰欣药业股份有限公司 |
| 2025/12/06Generic · Class 3 | 多种微量元素注射液（IV）CYHS2504207 | 南京恩泰医药科技有限公司; 辰欣药业股份有限公司 |
| 2025/12/06Generic · Class 3 | 重酒石酸去甲肾上腺素注射液CYHS2504204 | 四川益生智同医药生物科技发展有限公司; 成都市海通药业有限公司 |
| 2025/12/06Generic · Class 3 | 重酒石酸去甲肾上腺素注射液CYHS2504203 | 四川益生智同医药生物科技发展有限公司; 成都市海通药业有限公司 |
| 2025/12/06Generic · Class 3 | 依巴斯汀口崩片CYHS2504202 | 山东朗诺制药有限公司 |
| 2025/12/06Generic · Class 3 | 二硫化硒洗剂CYHS2504199 | 深圳大佛药业股份有限公司; 裕松源药业有限公司 |
| 2025/12/06Generic · Class 3 | 恩格列净二甲双胍缓释片CYHS2504197 | 湖北午时药业股份有限公司 |
| 2025/12/06Generic · Class 3 | 恩格列净二甲双胍缓释片CYHS2504196 | 湖北午时药业股份有限公司 |
| 2025/12/06Generic · Class 3 | 恩格列净二甲双胍缓释片CYHS2504195 | 湖北午时药业股份有限公司 |
| 2025/12/06New drug · Class 3.1 | 清金化痰颗粒CXZS2500049 | 山东凤凰制药股份有限公司 |
| 2025/12/06New drug · Class 1.1 | 九味儿感颗粒CXZL2500125 | 重庆市中药研究院(重庆市中药博物馆）; 四川省中医药科学院（四川省中药研究所） |
| 2025/12/06New drug · Class 2 | 乙型肝炎病毒表面抗原诊断试剂盒（化学发光法）CXSS2500135 | 上海科华生物工程股份有限公司 |
| 2025/12/06New drug · Class 3.3 | 冻干人用狂犬病疫苗（2BS细胞）CXSS2500134 | 成都生物制品研究所有限责任公司 |
113 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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