药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/10/05 – 2021/10/11
- New acceptances this week
- 116
- Drugs with new generic filings (by drug name, de-duplicated)
- 16
- 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
116filings, 20 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 65 |
| Generic | 20 |
| New drug | 16 |
| Unspecified | 8 |
| Import | 6 |
| Import re-registration | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 76 |
| 治疗用生物制品 | 22 |
| TCM | 14 |
| Biologic | 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
16 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 注射用帕瑞昔布钠 | 3 | 2 | 2 |
| 2 | 奥硝唑注射液 | 2 | 1 | 0 |
| 3 | 环磷酰胺胶囊 | 2 | 1 | 2 |
| 4 | 利多卡因凝胶贴膏 | 1 | 1 | 7 |
| 5 | 吸入用硫酸沙丁胺醇溶液 | 1 | 1 | 2 |
| 6 | 地夸磷索钠滴眼液 | 1 | 1 | 5 |
| 7 | 奥美沙坦酯片 | 1 | 1 | 1 |
| 8 | 枸橼酸西地那非片 | 1 | 1 | 12 |
| 9 | 氧 | 1 | 1 | 15 |
| 10 | 氨氯地平阿托伐他汀钙片 | 1 | 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
80 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 海南卓科制药有限公司 | 4 | 1 | 0 |
| 2 | 杭州民生药业股份有限公司 | 3 | 3 | 0 |
| 3 | 江西地康药业有限公司 | 3 | 3 | 0 |
| 4 | Janssen-Cilag International NV | 3 | 2 | 0 |
| 5 | 承德新爱民制药有限公司 | 3 | 2 | 0 |
| 6 | 南京征祥医药有限公司 | 3 | 1 | 0 |
| 7 | 山东轩竹医药科技有限公司 | 3 | 1 | 0 |
| 8 | 浙江国镜药业有限公司 | 3 | 1 | 0 |
| 9 | 浙江都邦药业股份有限公司 | 3 | 1 | 0 |
| 10 | 深圳立健药业有限公司 | 3 | 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 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
28 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/10/11Generic · Class 3 | 盐酸替罗非班氯化钠注射液CYHS2101830 | 华夏生生药业（北京）有限公司 |
| 2021/10/11Generic · Class 3 | 奥硝唑注射液CYHS2101828 | 石家庄四药有限公司 |
| 2021/10/11Generic · Class 3 | 奥硝唑注射液CYHS2101827 | 石家庄四药有限公司 |
| 2021/10/11Generic · Class 3 | 利多卡因凝胶贴膏CYHS2101824 | 海南回元堂药业有限公司 |
| 2021/10/11New drug · Class 1 | QLF31911注射液CXSL2101354 | 齐鲁制药有限公司 |
| 2021/10/11New drug · Class 1 | 人源TH-SC01细胞注射液CXSL2101353 | 江苏拓弘康恒医药有限公司 |
| 2021/10/11New drug · Class 1 | ZX-101A胶囊CXHL2101543 | 南京征祥医药有限公司 |
| 2021/10/11New drug · Class 1 | ZX-101A胶囊CXHL2101542 | 南京征祥医药有限公司 |
| 2021/10/11New drug · Class 1 | ZX-101A胶囊CXHL2101541 | 南京征祥医药有限公司 |
| 2021/10/11New drug · Class 1 | AN4005片CXHL2101540 | 杭州阿诺生物医药科技有限公司 |
| 2021/10/11New drug · Class 1 | AN4005片CXHL2101539 | 杭州阿诺生物医药科技有限公司 |
| 2021/10/11New drug · Class 2.2 | 复方对乙酰氨基酚缓释片CXHL2101530 | 越洋医药开发（广州）有限公司 |
| 2021/10/09Import · Class 1 | Troriluzole 胶囊JXHL2101196 | Bioshin Limited; BioShin (Shanghai) Co. Ltd. |
| 2021/10/09Import · Class 1 | Troriluzole 胶囊JXHL2101195 | Bioshin Limited; BioShin (Shanghai) Co. Ltd. |
| 2021/10/09Import · Class 1 | 注射用 WCK5222JXHL2101191 | Wockhardt Bio AG; Labcorp Pharmaceutical Research and Development (Beijing) Co. Ltd. |
| 2021/10/09Generic · Class 3 | 盐酸奥普力农注射液CYHS2101826 | 芜湖杨燕制药有限公司 |
| 2021/10/09New drug · Class 1.1 | 九味疏风平喘颗粒CXZL2101028 | 江苏康缘药业股份有限公司 |
| 2021/10/09New drug · Class 1 | LBL-019注射液CXSL2101348 | 南京维立志博生物科技有限公司 |
| 2021/10/09New drug · Class 1 | TST005注射液CXSL2101346 | 迈博斯生物医药（苏州）有限公司 |
| 2021/10/09New drug · Class 1 | SHR-1314注射液CXSL2101345 | 苏州盛迪亚生物医药有限公司 |
| 2021/10/08Import · Class 2.2 | 阿替利珠单抗注射液JXSL2101116 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2021/10/08Import · Class 1 | BI-1206JXSL2101115 | BioInvent International AB; CASI Pharmaceuticals (China) Co. Ltd. |
| 2021/10/08Generic · Class 3 | 环磷酰胺胶囊CYHS2101811 | 江苏恒瑞医药股份有限公司 |
| 2021/10/08Generic · Class 3 | 环磷酰胺胶囊CYHS2101810 | 江苏恒瑞医药股份有限公司 |
| 2021/10/08New drug · Class 1 | LY01019注射液CXSL2101351 | 山东博安生物技术股份有限公司 |
| 2021/10/08New drug · Class 1 | SIM1811-03注射液CXSL2101350 | 江苏先声生物制药有限公司 |
| 2021/10/08New drug · Class 1 | 重组人源化单克隆抗体MIL62注射液CXSL2101347 | 北京天广实生物技术股份有限公司 |
| 2021/10/08New drug · Class 2.2 | 醋酸阿比特龙软胶囊CXHL2101528 | 浙江和泽医药科技股份有限公司 |
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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.