药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/08/31 – 2021/09/06
- New acceptances this week
- 266
- Drugs with new generic filings (by drug name, de-duplicated)
- 18
- Accepted this week, now under review
- 0
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
266filings, 26 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 172 |
| New drug | 42 |
| Generic | 26 |
| Import | 12 |
| Unspecified | 11 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 134 |
| TCM | 96 |
| 治疗用生物制品 | 35 |
| 预防用生物制品 | 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
18 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 盐酸托莫西汀口服溶液 | 2 | 2 | 0 |
| 2 | 磷酸奥司他韦胶囊 | 2 | 2 | 42 |
| 3 | 乙磺酸尼达尼布软胶囊 | 2 | 1 | 6 |
| 4 | 他达拉非片 | 2 | 1 | 23 |
| 5 | 普瑞巴林胶囊 | 2 | 1 | 12 |
| 6 | 注射用拉氧头孢钠 | 2 | 1 | 1 |
| 7 | 盐酸普拉克索缓释片 | 2 | 1 | 0 |
| 8 | 非布司他片 | 2 | 1 | 15 |
| 9 | 吸入用盐酸溴己新溶液 | 1 | 1 | 1 |
| 10 | 头孢地尼颗粒 | 1 | 1 | 3 |
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
117 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 湖北叶真堂药业有限公司 | 39 | 39 | 0 |
| 2 | 秦皇岛大恩药业有限公司 | 29 | 29 | 0 |
| 3 | 甘肃佛阁藏药有限公司 | 16 | 16 | 0 |
| 4 | Dr. Falk Pharma GmbH | 8 | 3 | 0 |
| 5 | 上海皇象铁力蓝天制药有限公司 | 6 | 6 | 0 |
| 6 | AstraZeneca Pharmaceuticals LP | 5 | 1 | 0 |
| 7 | Novartis Europharm Limited | 4 | 2 | 0 |
| 8 | 江苏海宏制药有限公司 | 4 | 1 | 0 |
| 9 | 重庆复创医药研究有限公司 | 4 | 1 | 0 |
| 10 | 国药集团致君（深圳）制药有限公司 | 3 | 2 | 1 |
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
51 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/09/06Generic · Class 3 | 头孢地尼颗粒CYHS2101687 | 国药集团致君（深圳）制药有限公司 |
| 2021/09/06New drug · Class 1.3 | 马甲子叶CXZL2101026 | 四川省中医药科学院（四川省中药研究所） |
| 2021/09/06New drug · Class 1.3 | 马甲子胶囊CXZL2101025 | 四川省中医药科学院（四川省中药研究所） |
| 2021/09/06New drug · Class 3.3 | 地舒单抗注射液CXSS2101027 | 齐鲁制药有限公司 |
| 2021/09/06New drug · Class 1 | 舒格利单抗注射液CXSS2101026 | 基石药业（苏州）有限公司; 无锡药明生物技术股份有限公司 |
| 2021/09/06New drug · Class 1 | 重组抗CD20人源化单克隆抗体注射液CXSL2101308 | 上海医药集团股份有限公司 |
| 2021/09/06New drug · Class 1 | ASC42片CXHL2101456 | 甘莱制药有限公司 |
| 2021/09/06New drug · Class 1 | ASC42片CXHL2101455 | 甘莱制药有限公司 |
| 2021/09/06New drug · Class 1 | TR64片CXHL2101450 | 安徽中科拓苒药物科学研究有限公司 |
| 2021/09/03New drug · Class 3.3 | 重组抗PD-1全人源单克隆抗体注射液CXSL2101307 | 东莞市东阳光生物药研发有限公司 |
| 2021/09/03New drug · Class 2.2 | 特瑞普利单抗注射液CXSL2101304 | 上海君实生物医药科技股份有限公司 |
| 2021/09/03New drug · Class 2.2 | 特瑞普利单抗注射液CXSL2101303 | 上海君实生物医药科技股份有限公司 |
| 2021/09/03New drug · Class 2.2 | 特瑞普利单抗注射液CXSL2101302 | 上海君实生物医药科技股份有限公司 |
| 2021/09/03New drug · Class 1 | TQB2916注射液CXSL2101299 | 正大天晴药业集团南京顺欣制药有限公司 |
| 2021/09/03New drug · Class 2.2 | 小儿头孢呋辛酯干混悬剂（微球型）CXHL2101454 | 上海金城素智药业有限公司 |
| 2021/09/02Import · Class 2.2 | Anifrolumab注射液JXSL2101106 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2021/09/02New drug · Class 3.3 | 利拉鲁肽注射液CXSS2101025 | 杭州中美华东制药有限公司; 杭州九源基因工程有限公司 |
| 2021/09/02New drug · Class 3.3 | 利拉鲁肽注射液CXSS2101024 | 杭州中美华东制药有限公司; 杭州九源基因工程有限公司 |
| 2021/09/02New drug · Class 1 | TC-E202注射液CXSL2101306 | 广东天科雅生物医药科技有限公司 |
| 2021/09/02New drug · Class 1 | K1注射液CXSL2101305 | 江苏康禾生物制药有限公司 |
| 2021/09/02New drug · Class 3.2 | 人凝血因子Ⅷ/血管性血友病因子复合物CXSL2101301 | 山东泰邦生物制品有限公司 |
| 2021/09/02New drug · Class 3.2 | 人凝血因子Ⅷ/血管性血友病因子复合物CXSL2101300 | 山东泰邦生物制品有限公司 |
| 2021/09/02New drug · Class 1 | 人脐带间充质干细胞注射液CXSL2101296 | 上海莱馥医疗科技有限公司 |
| 2021/09/02New drug · Class 1 | H018片CXHL2101453 | 江苏柯菲平医药股份有限公司 |
| 2021/09/02New drug · Class 1 | HMPL-653胶囊CXHL2101452 | 和记黄埔医药（上海）有限公司 |
| 2021/09/02New drug · Class 1 | HMPL-653胶囊CXHL2101451 | 和记黄埔医药（上海）有限公司 |
| 2021/09/02New drug · Class 1 | AB-106胶囊CXHL2101449 | 葆元生物医药科技（杭州）有限公司 |
| 2021/09/01Generic · Class 3 | 福多司坦口服溶液CYHS2101672 | 苏州华健瑞达医药技术有限公司; 浙江康恩贝制药股份有限公司 |
| 2021/09/01Generic · Class 3 | 注射用拉氧头孢钠CYHS2101669 | 重庆吉斯瑞制药有限责任公司 |
| 2021/09/01Generic · Class 3 | 注射用拉氧头孢钠CYHS2101668 | 重庆吉斯瑞制药有限责任公司 |
21 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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