药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/07/22 – 2025/07/28
- New acceptances this week
- 366
- Drugs with new generic filings (by drug name, de-duplicated)
- 76
- Accepted this week, now under review
- 92
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
366filings, 103 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 155 |
| Generic | 103 |
| New drug | 73 |
| Import | 27 |
| Unspecified | 4 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 243 |
| TCM | 71 |
| 治疗用生物制品 | 48 |
| Biologic | 2 |
| 预防用生物制品 | 2 |
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
76 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 盐酸达泊西汀片 | 6 | 3 | 20 |
| 2 | 非奈利酮片 | 4 | 2 | 71 |
| 3 | 氨甲环酸注射液 | 3 | 1 | 11 |
| 4 | 磷酸芦可替尼片 | 3 | 1 | 27 |
| 5 | 吗啉硝唑氯化钠注射液 | 2 | 2 | 10 |
| 6 | 硫酸氨基葡萄糖胶囊 | 2 | 2 | 50 |
| 7 | 丙泊酚中/长链脂肪乳注射液 | 2 | 1 | 3 |
| 8 | 利丙双卡因乳膏 | 2 | 1 | 25 |
| 9 | 呋喹替尼胶囊 | 2 | 1 | 4 |
| 10 | 复方电解质醋酸钠葡萄糖注射液 | 2 | 1 | 22 |
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
237 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 云南金碧制药有限公司 | 6 | 6 | 0 |
| 2 | AbbVie Inc. | 6 | 1 | 0 |
| 3 | Eli Lilly and Company | 6 | 1 | 0 |
| 4 | 山东二叶制药有限公司 | 5 | 2 | 2 |
| 5 | 河南真实生物科技有限公司 | 5 | 2 | 0 |
| 6 | 广东香山堂制药有限公司 | 4 | 3 | 0 |
| 7 | 江西南昌济生制药有限责任公司 | 4 | 3 | 0 |
| 8 | 上海壹典医药科技开发有限公司 | 4 | 1 | 0 |
| 9 | 杭州先为达生物科技股份有限公司 | 4 | 1 | 0 |
| 10 | 海湃泰克(北京)生物医药科技有限公司 | 4 | 1 | 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
124 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/07/28Generic · Class 3 | 吲哚布芬片CYHS2502710 | 成都纵联医疗健康科技有限公司; 成都天台山制药股份有限公司 |
| 2025/07/28Generic · Class 3 | 中性低钙腹膜透析液(碳酸氢盐-G2.5%)CYHS2502705 | 青岛瑞奈医疗科技有限公司 |
| 2025/07/28Generic · Class 3 | 中性低钙腹膜透析液(碳酸氢盐-G1.5%)CYHS2502704 | 青岛瑞奈医疗科技有限公司 |
| 2025/07/28Generic · Class 3 | 氯化钾注射液CYHS2502703 | 河北天成药业股份有限公司 |
| 2025/07/28Generic · Class 3 | 丙氯拉嗪栓CYHL2500132 | 海鸿恒隆(海南)生物科技有限公司 |
| 2025/07/28New drug · Class 1.2 | HQY总黄酮胶囊CXZL2500057 | 南京三同医药科技有限公司; 南京中医药大学; 江苏省中医药研究院; 南京市中医院 |
| 2025/07/28New drug · Class 1.2 | HQY总黄酮提取物CXZL2500056 | 南京三同医药科技有限公司; 南京中医药大学; 江苏省中医药研究院; 南京市中医院 |
| 2025/07/28New drug · Class 1.1 | 糖宁通络片CXZL2500055 | 百灵毓秀(珠海)医药有限公司 |
| 2025/07/28New drug · Class 1 | IBI354CXSL2500632 | 信达生物医药科技(杭州)有限公司 |
| 2025/07/28New drug · Class 1 | 镥[177Lu]-BL-ARC001注射液CXSL2500631 | 成都百利多特生物药业有限责任公司; 四川百利药业有限责任公司 |
| 2025/07/28New drug · Class 2.2 | LY01015注射液CXSL2500630 | 山东博安生物技术股份有限公司 |
| 2025/07/28New drug · Class 2.2 | LY01015注射液CXSL2500629 | 山东博安生物技术股份有限公司 |
| 2025/07/28New drug · Class 1 | 注射用BA1301CXSL2500628 | 山东博安生物技术股份有限公司 |
| 2025/07/28New drug · Class 1 | 人脐带间充质干细胞注射液CXSL2500627 | 北京第一生物科技开发有限公司 |
| 2025/07/28New drug · Class 1 | MG-K10人源化单抗注射液CXSL2500626 | 湖南麦济生物技术股份有限公司 |
| 2025/07/28New drug · Class 1 | MG-K10人源化单抗注射液CXSL2500625 | 湖南麦济生物技术股份有限公司 |
| 2025/07/28New drug · Class 2.2 | 拉莫三嗪干混悬剂CXHS2500087 | 上海奥科远制药有限公司 |
| 2025/07/28New drug · Class 2.2 | 拉莫三嗪干混悬剂CXHS2500086 | 上海奥科远制药有限公司 |
| 2025/07/28New drug · Class 1 | BGB-53038胶囊CXHL2500768 | 百济神州(苏州)生物科技有限公司 |
| 2025/07/28New drug · Class 1 | BGB-53038胶囊CXHL2500767 | 百济神州(苏州)生物科技有限公司 |
| 2025/07/28New drug · Class 2.4 | 注射用多西他赛(白蛋白结合型)CXHL2500766 | 石药集团中奇制药技术(石家庄)有限公司 |
| 2025/07/28New drug · Class 1 | BGB-53038胶囊CXHL2500765 | 百济神州(苏州)生物科技有限公司 |
| 2025/07/28New drug · Class 1 | AL28979片CXHL2500764 | 南京爱德程医药科技有限公司 |
| 2025/07/28New drug · Class 1 | TQB3217片CXHL2500763 | 正大天晴药业集团南京顺欣制药有限公司 |
| 2025/07/28New drug · Class 1 | TQB3217片CXHL2500762 | 正大天晴药业集团南京顺欣制药有限公司 |
| 2025/07/28New drug · Class 2.3 | HKGM-453CXHL2500761 | 黑龙江亿达鸿药业有限公司 |
| 2025/07/25Import · Class 1 | MK-7240注射液JXSL2500132 | Merck Sharp & Dahme LLC; 不适用 |
| 2025/07/25Import · Class 2.2 | Risankizumab注射液JXSL2500131 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2025/07/25Import · Class 2.2 | Risankizumab注射液JXSL2500130 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2025/07/25Import · Class 2.2 | Risankizumab注射液JXSL2500129 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
94 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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