药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/12/26 – 2024/01/01
- New acceptances this week
- 343
- Drugs with new generic filings (by drug name, de-duplicated)
- 77
- Accepted this week, now under review
- 1
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
343filings, 100 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 146 |
| Generic | 100 |
| New drug | 74 |
| Import | 10 |
| Import re-registration | 10 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 266 |
| TCM | 36 |
| 治疗用生物制品 | 36 |
| 预防用生物制品 | 5 |
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
77 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 美阿沙坦钾片 | 4 | 2 | 33 |
| 2 | 注射用青霉素钠 | 4 | 1 | 2 |
| 3 | 西格列汀二甲双胍缓释片 | 3 | 2 | 14 |
| 4 | 利丙双卡因乳膏 | 2 | 2 | 25 |
| 5 | 替米沙坦氨氯地平片 | 2 | 2 | 10 |
| 6 | 氧 | 2 | 2 | 15 |
| 7 | 注射用尼可地尔 | 2 | 2 | 1 |
| 8 | 盐酸奈福泮注射液 | 2 | 2 | 3 |
| 9 | 碳酸氢钠注射液 | 2 | 2 | 11 |
| 10 | 卡泊三醇倍他米松软膏 | 2 | 1 | 1 |
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
208 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 博瑞新创生物医药科技（无锡）有限公司 | 14 | 1 | 0 |
| 2 | 华夏生生药业（北京）有限公司 | 8 | 7 | 7 |
| 3 | Boehringer Ingelheim International GmbH | 7 | 2 | 0 |
| 4 | 北京四环科宝药业有限公司 | 5 | 3 | 0 |
| 5 | 江苏恒瑞医药股份有限公司 | 5 | 2 | 0 |
| 6 | 成都倍特生物制药有限公司 | 5 | 1 | 0 |
| 7 | 吉林三九金复康药业有限公司 | 4 | 4 | 0 |
| 8 | 哈药集团三精千鹤制药有限公司 | 4 | 4 | 0 |
| 9 | 国药集团同济堂（贵州）制药有限公司 | 4 | 2 | 0 |
| 10 | 山东罗欣药业集团股份有限公司 | 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 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
134 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/12/30Import · Class 3.1 | 瑞利珠单抗注射液JXSS2300095 | Alexion Europe SAS; Alexion Pharma International Operations Limited Alexion Athlone Manufacturing Facility (AAMF); AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/12/30Import · Class 3.1 | 瑞利珠单抗注射液JXSS2300094 | Alexion Europe SAS; Alexion Pharma International Operations Limited Alexion Athlone Manufacturing Facility (AAMF); AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/12/30Generic · Class 3 | 盐酸左西替利嗪口服溶液CYHS2303686 | 国药集团汕头金石制药有限公司 |
| 2023/12/30Generic · Class 3 | 盐酸多巴胺注射液CYHS2303684 | 成都百裕制药股份有限公司 |
| 2023/12/30Generic · Class 3 | 盐酸多巴胺注射液CYHS2303683 | 成都百裕制药股份有限公司 |
| 2023/12/30Generic · Class 3 | 盐酸普萘洛尔注射液CYHS2303682 | 福州基石医药科技有限公司 |
| 2023/12/30Generic · Class 3 | 维生素B6注射液CYHS2303681 | 广州绿十字制药股份有限公司; 山东豪瑞恩制药有限公司 |
| 2023/12/30New drug · Class 3.3 | 四价流感病毒裂解疫苗CXSS2300101 | 浙江天元生物药业有限公司 |
| 2023/12/30New drug · Class 1 | CG-BM1异体人骨髓间充质干细胞注射液CXSL2300909 | 广州赛隽生物科技有限公司 |
| 2023/12/30New drug · Class 1 | 3HP-2827片CXHL2301485 | 思康睿奇（苏州）药业有限公司 |
| 2023/12/30New drug · Class 1 | 3HP-2827片CXHL2301484 | 思康睿奇（苏州）药业有限公司 |
| 2023/12/30New drug · Class 1 | INV-1120胶囊CXHL2301483 | 佛山市原力生物科技有限公司 |
| 2023/12/30New drug · Class 1 | INV-1120胶囊CXHL2301482 | 佛山市原力生物科技有限公司 |
| 2023/12/30New drug · Class 1 | KPG-818胶囊CXHL2301481 | 康朴生物医药技术（合肥）有限公司 |
| 2023/12/30New drug · Class 1 | KPG-818胶囊CXHL2301480 | 康朴生物医药技术（合肥）有限公司 |
| 2023/12/30New drug · Class 1 | GT919胶囊CXHL2301479 | 标新生物医药科技（上海）有限公司 |
| 2023/12/30New drug · Class 1 | GT919胶囊CXHL2301478 | 标新生物医药科技（上海）有限公司 |
| 2023/12/30New drug · Class 1 | GT919胶囊CXHL2301477 | 标新生物医药科技（上海）有限公司 |
| 2023/12/30New drug · Class 1 | ABP-745片CXHL2301476 | 江苏新元素医药科技有限公司 |
| 2023/12/30New drug · Class 1 | ABP-745片CXHL2301475 | 江苏新元素医药科技有限公司 |
| 2023/12/30New drug · Class 1 | ABP-745片CXHL2301474 | 江苏新元素医药科技有限公司 |
| 2023/12/30New drug · Class 1 | HX101胶囊CXHL2301473 | 华夏生生药业（北京）有限公司 |
| 2023/12/30New drug · Class 1 | CYH001肠溶胶囊CXHL2301472 | 北京承颐医药科技有限公司 |
| 2023/12/30New drug · Class 1 | CYH001肠溶胶囊CXHL2301471 | 北京承颐医药科技有限公司 |
| 2023/12/30New drug · Class 1 | XP-102SC胶囊CXHL2301470 | 徐诺药业（南京）有限公司 |
| 2023/12/29Generic · Class 3 | 复方匹可硫酸钠口服溶液CYHS2303677 | 北京民康百草医药科技有限公司; 天大药业（珠海）有限公司 |
| 2023/12/29Generic · Class 3 | 重酒石酸间羟胺注射液CYHS2303676 | 武汉久安药业有限公司; 朗天药业（湖北）有限公司 |
| 2023/12/29Generic · Class 3 | 碳酸氢钠注射液CYHS2303675 | 北京民康百草医药科技有限公司; 山西诺成制药有限公司 |
| 2023/12/29Generic · Class 3 | 注射用尼可地尔CYHS2303672 | 河北龙海药业有限公司; 河北一品制药股份有限公司 |
| 2023/12/29Generic · Class 3 | 阿奇霉素滴眼液CYHL2300168 | 南京恒道医药科技股份有限公司 |
104 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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