药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/09/21 – 2021/09/27
- New acceptances this week
- 186
- 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
186filings, 25 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 109 |
| New drug | 31 |
| Generic | 25 |
| Import | 8 |
| Unspecified | 7 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 129 |
| 治疗用生物制品 | 29 |
| TCM | 23 |
| Biologic | 4 |
| 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 | 克林霉素磷酸酯注射液 | 3 | 1 | 4 |
| 2 | 艾司奥美拉唑镁肠溶干混悬剂 | 3 | 1 | 4 |
| 3 | 盐酸多巴胺注射液 | 2 | 2 | 3 |
| 4 | 布洛芬混悬液 | 2 | 1 | 14 |
| 5 | 非洛地平缓释片 | 2 | 1 | 1 |
| 6 | 复方α-酮酸片 | 1 | 1 | 0 |
| 7 | 左氧氟沙星氯化钠注射液 | 1 | 1 | 14 |
| 8 | 左氧氟沙星片 | 1 | 1 | 8 |
| 9 | 泊沙康唑口服混悬液 | 1 | 1 | 3 |
| 10 | 注射用盐酸罗沙替丁醋酸酯 | 1 | 1 | 5 |
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
95 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 浙江医药股份有限公司新昌制药厂 | 17 | 8 | 0 |
| 2 | 杭州九源基因工程有限公司 | 10 | 1 | 0 |
| 3 | 赛灵药业科技集团股份有限公司 | 9 | 8 | 0 |
| 4 | Kyowa Kirin Co. Ltd | 6 | 1 | 0 |
| 5 | 南京艾美斐生物医药科技有限公司 | 6 | 1 | 0 |
| 6 | 湖北叶真堂药业有限公司 | 5 | 5 | 0 |
| 7 | 江苏恒瑞医药股份有限公司 | 5 | 2 | 0 |
| 8 | Bristol-Myers Squibb Pharma EEIG | 5 | 1 | 0 |
| 9 | Upjohn US 2 LLC | 4 | 1 | 0 |
| 10 | AstraZeneca AB | 3 | 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 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
47 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/09/26Import · Class 1 | VAY736注射液JXSL2101110 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2021/09/26Import · Class 2.4 | Vericiguat片JXHL2101186 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2021/09/26Import · Class 2.4 | Vericiguat片JXHL2101185 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2021/09/26Import · Class 2.4 | Vericiguat片JXHL2101184 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2021/09/26Import · Class 1 | LOU064片JXHL2101183 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2021/09/26Generic · Class 3 | 克林霉素磷酸酯注射液CYHS2101784 | 吉林四环制药有限公司 |
| 2021/09/26Generic · Class 3 | 克林霉素磷酸酯注射液CYHS2101783 | 吉林四环制药有限公司 |
| 2021/09/26Generic · Class 3 | 克林霉素磷酸酯注射液CYHS2101782 | 吉林四环制药有限公司 |
| 2021/09/26Generic · Class 3 | 复方α-酮酸片CYHS2101780 | 浙江昂利康制药股份有限公司 |
| 2021/09/26Generic · Class 3 | 艾司奥美拉唑镁肠溶干混悬剂CYHS2101779 | 上海安必生制药技术有限公司; 青岛百洋制药有限公司 |
| 2021/09/26Generic · Class 3 | 艾司奥美拉唑镁肠溶干混悬剂CYHS2101778 | 上海安必生制药技术有限公司; 青岛百洋制药有限公司 |
| 2021/09/26Generic · Class 3 | 艾司奥美拉唑镁肠溶干混悬剂CYHS2101777 | 上海安必生制药技术有限公司; 青岛百洋制药有限公司 |
| 2021/09/26Generic · Class 3 | 注射用盐酸罗沙替丁醋酸酯CYHS2101771 | 江苏奥赛康药业有限公司 |
| 2021/09/26Generic · Class 3 | 盐酸多巴胺注射液CYHS2101770 | 弘和制药有限公司; 吉林四环制药有限公司 |
| 2021/09/26New drug · Class 2.3 | 荆防合剂CXZL2101027 | 鲁南厚普制药有限公司 |
| 2021/09/26New drug · Class 1 | 凯得宁单抗注射液CXSS2101032 | 康方药业有限公司; 中山康方生物医药有限公司 |
| 2021/09/26New drug · Class 1 | 斯鲁利单抗注射液CXSL2101343 | 上海复宏汉霖生物技术股份有限公司 |
| 2021/09/26New drug · Class 1 | 重组人源化抗PD-1单克隆抗体注射液CXSL2101342 | 泰州翰中生物医药有限公司 |
| 2021/09/26New drug · Class 1 | 注射用MRG002CXSL2101341 | 上海美雅珂生物技术有限责任公司 |
| 2021/09/26New drug · Class 1 | CG-BM1异体人骨髓间充质干细胞注射液CXSL2101334 | 广州赛隽生物科技有限公司 |
| 2021/09/26New drug · Class 1 | LVGN6051单克隆抗体注射液CXSL2101332 | 礼进生物医药科技（上海）有限公司 |
| 2021/09/26New drug · Class 1 | KL290052胶囊CXHL2101510 | 四川科伦博泰生物医药股份有限公司 |
| 2021/09/26New drug · Class 1 | KL290052胶囊CXHL2101509 | 四川科伦博泰生物医药股份有限公司 |
| 2021/09/26New drug · Class 1 | IPG1094片CXHL2101508 | 南京艾美斐生物医药科技有限公司 |
| 2021/09/26New drug · Class 1 | IPG1094片CXHL2101507 | 南京艾美斐生物医药科技有限公司 |
| 2021/09/26New drug · Class 1 | IPG1094片CXHL2101506 | 南京艾美斐生物医药科技有限公司 |
| 2021/09/26New drug · Class 2.4 | 硫酸阿托品滴眼液CXHL2101505 | 杭州赫尔斯科技有限公司 |
| 2021/09/26New drug · Class 1 | IPG1094片CXHL2101504 | 南京艾美斐生物医药科技有限公司 |
| 2021/09/26New drug · Class 1 | IPG1094片CXHL2101503 | 南京艾美斐生物医药科技有限公司 |
| 2021/09/26New drug · Class 1 | IPG1094片CXHL2101502 | 南京艾美斐生物医药科技有限公司 |
17 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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