药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/12/19 – 2023/12/25
- New acceptances this week
- 349
- Drugs with new generic filings (by drug name, de-duplicated)
- 75
- Accepted this week, now under review
- 3
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
349filings, 105 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 142 |
| Generic | 105 |
| New drug | 61 |
| Import | 22 |
| Unspecified | 11 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 243 |
| TCM | 63 |
| 治疗用生物制品 | 36 |
| Biologic | 3 |
| 预防用生物制品 | 3 |
| 体外诊断试剂 | 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
75 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 乳果糖口服溶液 | 4 | 3 | 40 |
| 2 | 卡铂注射液 | 4 | 2 | 11 |
| 3 | 富马酸伏诺拉生片 | 4 | 2 | 58 |
| 4 | 沙库巴曲缬沙坦钠片 | 3 | 2 | 70 |
| 5 | 盐酸西替利嗪口服溶液 | 3 | 2 | 6 |
| 6 | 氨溴特罗口服溶液 | 2 | 2 | 23 |
| 7 | 注射用头孢他啶阿维巴坦钠 | 2 | 2 | 12 |
| 8 | 酒石酸溴莫尼定滴眼液 | 2 | 2 | 4 |
| 9 | 黄体酮阴道缓释凝胶 | 2 | 2 | 2 |
| 10 | 叶酸注射液 | 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
215 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | AstraZeneca AB | 8 | 4 | 0 |
| 2 | 沈阳红药集团股份有限公司 | 7 | 6 | 0 |
| 3 | 贵州百灵企业集团制药股份有限公司 | 6 | 3 | 0 |
| 4 | 杭州中美华东制药有限公司 | 6 | 2 | 0 |
| 5 | 重庆迪康中药制药有限公司 | 5 | 5 | 0 |
| 6 | 正大天晴药业集团股份有限公司 | 5 | 2 | 0 |
| 7 | 海南煦沃药业有限公司 | 4 | 4 | 0 |
| 8 | 北京布霖生物科技有限公司 | 4 | 2 | 4 |
| 9 | 山东盛迪医药有限公司 | 4 | 2 | 0 |
| 10 | 成都倍特药业股份有限公司 | 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
113 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/12/25Import · Class 1 | AZD9829JXSL2300234 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd |
| 2023/12/25Import · Class 1 | EtavopivatJXHL2300326 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2023/12/25Generic · Class 3 | 腺苷钴胺胶囊CYHS2303595 | 石药集团欧意药业有限公司 |
| 2023/12/25Generic · Class 3 | 盐酸溴己新口服溶液CYHS2303594 | 浙江赛默制药有限公司 |
| 2023/12/25Generic · Class 3 | 叶酸注射液CYHS2303593 | 北京布霖生物科技有限公司; 华夏生生药业(北京)有限公司 |
| 2023/12/25Generic · Class 3 | 叶酸注射液CYHS2303592 | 北京布霖生物科技有限公司; 华夏生生药业(北京)有限公司 |
| 2023/12/25New drug · Class 2.2 | SH081012口服用浓溶液CXHL2301441 | 山东百诺医药股份有限公司 |
| 2023/12/23Import · Class 1 | Aficamten片JXHL2300325 | Cytokinetics Incorporated; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd |
| 2023/12/23Import · Class 2.4 | 布地格福吸入气雾剂JXHL2300324 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2023/12/23Generic · Class 3 | 氨溴特罗口服溶液CYHS2303591 | 广东江正药业有限公司; 天大药业(珠海)有限公司 |
| 2023/12/23Generic · Class 3 | 氯化钾注射液CYHS2303590 | 江西博泰药业有限公司; 江西东抚制药有限公司 |
| 2023/12/23Generic · Class 3 | 氯化钾注射液CYHS2303589 | 江西博泰药业有限公司; 江西东抚制药有限公司 |
| 2023/12/23Generic · Class 3 | 复方聚乙二醇电解质散(II)CYHS2303588 | 黑龙江博宇制药有限公司; 四川科伦药业股份有限公司 |
| 2023/12/23Generic · Class 3 | 复方聚乙二醇电解质散(II)CYHS2303587 | 黑龙江博宇制药有限公司; 四川科伦药业股份有限公司 |
| 2023/12/23New drug · Class 1.4 | 24价肺炎球菌多糖结合疫苗CXSL2300887 | 北京科兴中维生物技术有限公司; 北京科兴生物制品有限公司 |
| 2023/12/23New drug · Class 1.4 | 24价肺炎球菌多糖结合疫苗CXSL2300886 | 北京科兴中维生物技术有限公司; 北京科兴生物制品有限公司 |
| 2023/12/23New drug · Class 1 | FL115注射液CXSL2300885 | 苏州复融生物技术有限公司 |
| 2023/12/23New drug · Class 1 | LP-005 注射液CXSL2300884 | 天辰生物医药(苏州)有限公司 |
| 2023/12/23New drug · Class 1 | LP-003 注射液CXSL2300883 | 天辰生物医药(苏州)有限公司 |
| 2023/12/23New drug · Class 1 | LP-005 注射液CXSL2300882 | 天辰生物医药(苏州)有限公司 |
| 2023/12/22Import · Class 2.2 | 注射用TafasitamabJXSL2300233 | Incyte Biosciences Distribution B.V.; Beijing InnoCare Pharma Tech Co. Ltd. |
| 2023/12/22Import · Class 1 | DS-1062aJXSL2300232 | Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited |
| 2023/12/22Import · Class 1 | Zilurgisertib片JXHL2300323 | Incyte Corporation; Incyte Biosciences Shanghai Co. Ltd. |
| 2023/12/22Import · Class 2.4 | 甲磺酸奥希替尼片JXHL2300322 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/12/22Import · Class 2.4 | 甲磺酸奥希替尼片JXHL2300321 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/12/22Import · Class 2.4 | 甲磺酸奥希替尼片JXHL2300320 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2023/12/22Import · Class 2.4 | 甲磺酸奥希替尼片JXHL2300319 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2023/12/22Generic · Class 3 | 氨溴特罗口服溶液CYHS2303577 | 山东益康药业股份有限公司 |
| 2023/12/22Generic · Class 3 | 盐酸多巴酚丁胺注射液CYHS2303576 | 成都百裕制药股份有限公司 |
| 2023/12/22Generic · Class 3 | 酮咯酸氨丁三醇注射液CYHS2303575 | 重庆莱美药业股份有限公司 |
83 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.
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.