药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/06/04 – 2024/06/10
- New acceptances this week
- 296
- Drugs with new generic filings (by drug name, de-duplicated)
- 71
- Accepted this week, now under review
- 4
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
296filings, 92 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 130 |
| Generic | 92 |
| New drug | 44 |
| Import | 16 |
| Import re-registration | 9 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 205 |
| TCM | 44 |
| 治疗用生物制品 | 38 |
| 预防用生物制品 | 8 |
| Biologic | 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
71 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 注射用硫酸艾沙康唑 | 3 | 3 | 15 |
| 2 | 吸入用盐酸丙卡特罗溶液 | 3 | 2 | 2 |
| 3 | 尼可地尔片 | 2 | 2 | 4 |
| 4 | 巴瑞替尼片 | 2 | 2 | 32 |
| 5 | 氯化钾口服溶液 | 2 | 2 | 12 |
| 6 | 盐酸尼卡地平注射液 | 2 | 2 | 12 |
| 7 | 富马酸伏诺拉生片 | 2 | 1 | 58 |
| 8 | 恩格列净片 | 2 | 1 | 20 |
| 9 | 氢溴酸伏硫西汀片 | 2 | 1 | 8 |
| 10 | 沙库巴曲缬沙坦钠片 | 2 | 1 | 72 |
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
188 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 贵州瑞和制药有限公司 | 11 | 11 | 1 |
| 2 | AbbVie Inc. | 8 | 4 | 0 |
| 3 | 吉林恒星科技制药有限公司 | 7 | 6 | 0 |
| 4 | 秦皇岛爱晖药业有限公司 | 7 | 6 | 0 |
| 5 | 上海懿峰生物科技有限公司 | 6 | 1 | 0 |
| 6 | 青海鲁抗大地药业有限公司 | 4 | 4 | 0 |
| 7 | 遂成药业股份有限公司 | 4 | 3 | 4 |
| 8 | Merck Sharp & Dohme LLC | 4 | 2 | 0 |
| 9 | SANOFI WINTHROP INDUSTRIE | 4 | 2 | 0 |
| 10 | 江苏修正制药有限公司 | 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
95 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/06/08Import · Class 2.2 | Upadacitinib口服溶液JXHL2400131 | AbbVie Inc.; AbbVie Pharmaceutical Trading(Shanghai) Co. Ltd. |
| 2024/06/08Import · Class 2.2 | Upadacitinib口服溶液JXHL2400130 | AbbVie Inc.; AbbVie Pharmaceutical Trading(Shanghai) Co. Ltd. |
| 2024/06/08Generic · Class 3 | 地奈德乳膏CYHS2401736 | 杭州民生药业股份有限公司 |
| 2024/06/08Generic · Class 3 | 草酸艾司西酞普兰口服溶液CYHS2401733 | 江苏长泰药业股份有限公司 |
| 2024/06/08Generic · Class 3 | 舒必利注射液CYHS2401731 | 海南卓科制药有限公司 |
| 2024/06/08Generic · Class 3 | 舒必利注射液CYHS2401730 | 海南卓科制药有限公司 |
| 2024/06/08Generic · Class 3 | 甲硫酸新斯的明注射液CYHS2401728 | 河北一品制药股份有限公司 |
| 2024/06/08Generic · Class 3 | 重酒石酸卡巴拉汀口服溶液CYHS2401727 | 广州一品红制药有限公司 |
| 2024/06/08Generic · Class 3 | ω-3 鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液CYHS2401726 | 福建盛迪医药有限公司; 江苏恒瑞医药股份有限公司 |
| 2024/06/08Generic · Class 3 | 甘露醇山梨醇注射液CYHL2400104 | 石家庄四药有限公司 |
| 2024/06/08New drug · Class 3.1 | 升陷颗粒CXZS2400020 | 吉林敖东洮南药业股份有限公司 |
| 2024/06/08New drug · Class 1 | HZ-L105片CXHL2400582 | 杭州和正医药有限公司; 广东弘烨医药科技有限公司 |
| 2024/06/08New drug · Class 1 | HZ-L105片CXHL2400581 | 杭州和正医药有限公司; 广东弘烨医药科技有限公司 |
| 2024/06/08New drug · Class 1 | HZ-L105片CXHL2400580 | 杭州和正医药有限公司; 广东弘烨医药科技有限公司 |
| 2024/06/07Import · Class 1 | RO7200220 注射液JXSL2400112 | F. Hoffmann-La Roche Ltd. |
| 2024/06/07Import · Class 1 | RO7200220 注射液JXSL2400111 | F. Hoffmann-La Roche Ltd. |
| 2024/06/07Import · Class 2.4 | Upadacitinib片JXHL2400129 | AbbVie Inc. |
| 2024/06/07Import · Class 2.4 | Upadacitinib片JXHL2400128 | AbbVie Inc. |
| 2024/06/07Import · Class 2.4 | Upadacitinib片JXHL2400127 | AbbVie Inc. |
| 2024/06/07Generic · Class 3 | 吸入用盐酸丙卡特罗溶液CYHS2401723 | 浙江福瑞喜药业有限公司 |
| 2024/06/07Generic · Class 3 | 吸入用盐酸丙卡特罗溶液CYHS2401722 | 浙江福瑞喜药业有限公司 |
| 2024/06/07Generic · Class 3 | 吸入用盐酸丙卡特罗溶液CYHS2401717 | 石家庄四药有限公司 |
| 2024/06/07Generic · Class 3 | 苯磺酸氨氯地平口崩片CYHS2401715 | 广东万泰科创药业有限公司; 深圳信立泰药业股份有限公司 |
| 2024/06/07Generic · Class 3 | 氨磺必利口服溶液CYHS2401713 | 宏越科技(湖州)有限公司; 浙江莎普爱思药业股份有限公司 |
| 2024/06/07Generic · Class 3 | 盐酸丙卡特罗口服溶液CYHS2401710 | 黑龙江澳利达奈德制药有限公司 |
| 2024/06/07Generic · Class 3 | 盐酸丙卡特罗口服溶液CYHS2401709 | 黑龙江澳利达奈德制药有限公司 |
| 2024/06/07Generic · Class 3 | 盐酸甲氧氯普胺注射液CYHS2401705 | 嘉实(湖南)医药科技有限公司; 康普药业股份有限公司 |
| 2024/06/07New drug · Class 1 | 注射用泽尼达妥单抗CXSS2400056 | 百济神州(苏州)生物科技有限公司; 无锡药明生物技术股份有限公司 |
| 2024/06/07New drug · Class 2.2;2.4 | 注射用重组A型肉毒毒素CXSL2400373 | 君合盟生物制药(通化)有限公司 |
| 2024/06/07New drug · Class 1 | PreS1胶束注射液(冻干)CXSL2400372 | 普瑞斯万(武汉)生物科技有限公司 |
65 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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