药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/06/18 – 2024/06/24
- New acceptances this week
- 267
- Drugs with new generic filings (by drug name, de-duplicated)
- 53
- 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
267filings, 75 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 130 |
| Generic | 75 |
| New drug | 31 |
| Import | 12 |
| Import re-registration | 11 |
| Unspecified | 6 |
| 药械组合产品 | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 166 |
| TCM | 51 |
| 治疗用生物制品 | 40 |
| 预防用生物制品 | 6 |
| 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
53 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 盐酸卡利拉嗪胶囊 | 4 | 2 | 3 |
| 2 | 左卡尼汀口服溶液 | 3 | 3 | 9 |
| 3 | 伊班膦酸钠注射液 | 3 | 1 | 4 |
| 4 | 布立西坦片 | 3 | 1 | 16 |
| 5 | 注射用青霉素钠 | 3 | 1 | 2 |
| 6 | 聚多卡醇注射液 | 3 | 1 | 21 |
| 7 | 去氧胆酸注射液 | 2 | 2 | 0 |
| 8 | 比索洛尔氨氯地平片 | 2 | 2 | 8 |
| 9 | 硫酸氨基葡萄糖胶囊 | 2 | 2 | 50 |
| 10 | 西格列汀二甲双胍缓释片 | 2 | 2 | 14 |
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
180 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 秦皇岛爱晖药业有限公司 | 7 | 5 | 0 |
| 2 | Novartis Pharma Schweiz AG | 5 | 3 | 0 |
| 3 | 成都市海通药业有限公司 | 5 | 3 | 4 |
| 4 | 河北天成药业股份有限公司 | 4 | 4 | 0 |
| 5 | 江苏联环药业股份有限公司 | 4 | 2 | 0 |
| 6 | 辰欣药业股份有限公司 | 4 | 2 | 3 |
| 7 | 上海信谊万象药业股份有限公司 | 3 | 3 | 0 |
| 8 | 山东宜岛康制药有限公司 | 3 | 3 | 0 |
| 9 | 李时珍医药集团有限公司 | 3 | 3 | 0 |
| 10 | 赛灵药业科技集团股份有限公司 | 3 | 3 | 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
74 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/06/24Import · Class 2.4 | 盐酸阿来替尼胶囊JXHL2400145 | F.Hoffmann-La Roche Ltd |
| 2024/06/22Generic · Class 3 | 阿达帕林过氧苯甲酰凝胶CYHS2401869 | 苏州高迈药业有限公司; 药源生物科技(启东)有限公司 |
| 2024/06/22Generic · Class 3 | 间苯三酚口崩片CYHS2401867 | 河北汇德旭盛医药科技有限公司; 河北创健药业有限公司 |
| 2024/06/22Generic · Class 3 | 恩格列净二甲双胍缓释片CYHS2401866 | 浙江昂利康制药股份有限公司 |
| 2024/06/22Generic · Class 3 | 盐酸卡利拉嗪胶囊CYHL2400125 | 成都奥邦药业有限公司 |
| 2024/06/22Generic · Class 3 | 盐酸卡利拉嗪胶囊CYHL2400124 | 成都奥邦药业有限公司 |
| 2024/06/22New drug · Class 1 | 注射用SSGJ-709CXSL2400408 | 沈阳三生制药有限责任公司 |
| 2024/06/22New drug · Class 1 | TQC3721吸入粉雾剂CXHL2400625 | 正大天晴药业集团股份有限公司 |
| 2024/06/22New drug · Class 1 | TQC3721吸入粉雾剂CXHL2400624 | 正大天晴药业集团股份有限公司 |
| 2024/06/22New drug · Class 1 | CVL237片CXHL2400623 | 甫康(上海)健康科技有限责任公司; 浙江甫康制药有限公司 |
| 2024/06/22New drug · Class 2.3 | BCM476胶囊CXHL2400622 | 上海云晟研新生物科技有限公司 |
| 2024/06/22New drug · Class 2.2 | 注射用醋酸曲普瑞林缓释微球CXHL2400621 | 南京恒生制药有限公司 |
| 2024/06/21Import · Class 3.1 | 注射用坦昔妥单抗JXSS2400050 | Incyte Biosciences Distribution B.V.; Baxter Oncology GmbH; Beijing InnoCare Pharma Tech Co. Ltd. |
| 2024/06/21Import · Class 3.1 | 司库奇尤单抗注射液JXSS2400049 | Novartis Pharma Schweiz AG; Novartis Pharma Stein AG; Novartis Pharmaceutical Manufacturing GmbH |
| 2024/06/21Import · Class 3.1 | 司库奇尤单抗注射液JXSS2400048 | Novartis Pharma Schweiz AG; Novartis Pharma Stein AG |
| 2024/06/21Import · Class 2.2 | 贝利尤单抗注射液(皮下注射)JXSL2400116 | GlaxoSmithKline (Ireland) Limited; GlaxoSmithKline (China) Investment Company Limited |
| 2024/06/21Import · Class 2.4 | 甲磺酸奥希替尼片JXHS2400042 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2024/06/21Import · Class 2.4 | 甲磺酸奥希替尼片JXHS2400041 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2024/06/21Generic · Class 3 | 吡格列酮二甲双胍片CYHS2401853 | 浙江江北药业有限公司 |
| 2024/06/21Generic · Class 3 | 注射用青霉素钠CYHS2401852 | 辽宁省连科药业有限公司; 江苏海宏制药有限公司 |
| 2024/06/21Generic · Class 3 | 注射用青霉素钠CYHS2401851 | 辽宁省连科药业有限公司; 江苏海宏制药有限公司 |
| 2024/06/21Generic · Class 3 | 注射用青霉素钠CYHS2401850 | 辽宁省连科药业有限公司; 江苏海宏制药有限公司 |
| 2024/06/21Generic · Class 3 | 注射用磷霉素钠CYHS2401849 | 广州艾奇西新药研究有限公司; 国药集团国瑞药业有限公司 |
| 2024/06/21Generic · Class 3 | 注射用磷霉素钠CYHS2401848 | 广州艾奇西新药研究有限公司; 国药集团国瑞药业有限公司 |
| 2024/06/21Generic · Class 3 | 盐酸米诺环素泡沫剂CYHL2400123 | 山西振东安欣生物制药有限公司 |
| 2024/06/21Generic · Class 3 | 盐酸米诺环素泡沫剂CYHL2400122 | 山西振东安欣生物制药有限公司 |
| 2024/06/21Generic · Class 3 | 去氧胆酸注射液CYHL2400121 | 北京藏卫信康医药研发有限公司 |
| 2024/06/21Generic · Class 3 | 立他司特滴眼液CYHL2400120 | 浙江莎普爱思药业股份有限公司 |
| 2024/06/21Generic · Class 3 | 氟[18F]妥司特注射液CYHL2400119 | 北京先通国际医药科技股份有限公司 |
| 2024/06/21New drug · Class 1 | 注射用HS-20089CXSL2400407 | 上海翰森生物医药科技有限公司; 常州恒邦药业有限公司 |
44 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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