药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/10/17 – 2023/10/23
- New acceptances this week
- 312
- Drugs with new generic filings (by drug name, de-duplicated)
- 55
- Accepted this week, now under review
- 2
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
312filings, 70 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 168 |
| Generic | 70 |
| New drug | 48 |
| Import | 17 |
| Unspecified | 5 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 216 |
| TCM | 62 |
| 治疗用生物制品 | 30 |
| 预防用生物制品 | 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
55 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 枸橼酸伊沙佐米胶囊 | 3 | 1 | 7 |
| 2 | 吸入用盐酸氨溴索溶液 | 2 | 1 | 10 |
| 3 | 坎地沙坦酯氢氯噻嗪片 | 2 | 1 | 0 |
| 4 | 复方电解质醋酸钠葡萄糖注射液 | 2 | 1 | 22 |
| 5 | 奥氮平片 | 2 | 1 | 4 |
| 6 | 枸橼酸坦度螺酮片 | 2 | 1 | 2 |
| 7 | 氢溴酸替格列汀片 | 2 | 1 | 10 |
| 8 | 琥珀酸普芦卡必利片 | 2 | 1 | 1 |
| 9 | 盐酸乌拉地尔注射液 | 2 | 1 | 5 |
| 10 | 磷酸奥司他韦干混悬剂 | 2 | 1 | 2 |
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
192 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 江苏修正制药有限公司 | 16 | 15 | 0 |
| 2 | 海南普利制药股份有限公司 | 9 | 1 | 0 |
| 3 | 商丘市鑫马生物科技有限公司 | 4 | 4 | 0 |
| 4 | Pfizer Europe MA EEIG | 4 | 3 | 0 |
| 5 | 吉利德（上海）医药科技有限公司 | 4 | 2 | 0 |
| 6 | 西南药业股份有限公司 | 4 | 2 | 0 |
| 7 | JANSSEN-CILAG NV | 4 | 1 | 0 |
| 8 | TRUEMED LTD. | 4 | 1 | 0 |
| 9 | 上海上药新亚药业有限公司 | 4 | 1 | 0 |
| 10 | 长春金赛药业有限责任公司 | 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
95 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/10/23Import · Class 2.4 | 亮丙瑞林注射乳剂JXHL2300265 | Foresee Pharmaceuticals Co. Ltd; Changchun GeneScience Pharmaceuticals Co. Ltd. |
| 2023/10/23Generic · Class 3 | 维A酸乳膏CYHS2302848 | 上海瑞替诺医药科技有限公司; 山东良福制药有限公司 |
| 2023/10/23Generic · Class 3 | 维A酸乳膏CYHS2302847 | 上海瑞替诺医药科技有限公司; 山东良福制药有限公司 |
| 2023/10/23Generic · Class 3 | 喷他佐辛注射液CYHS2302846 | 天津药物研究院药业有限责任公司 |
| 2023/10/21Import · Class 2.2 | Benralizumab注射液JXSL2300188 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/10/21Import · Class 1 | BI 1015550 片JXHL2300264 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/10/21Import · Class 1 | BI 1015550 片JXHL2300263 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/10/21Generic · Class 3 | 铝碳酸镁混悬液CYHS2302845 | 重庆中创科医药有限公司; 亚宝药业贵阳制药有限公司 |
| 2023/10/21Generic · Class 3 | 己酮可可碱注射液CYHS2302843 | 浙江北生药业汉生制药有限公司 |
| 2023/10/21Generic · Class 3 | 注射用硫酸多黏菌素BCYHS2302839 | 四川汇宇海玥医药科技有限公司; 四川汇宇制药股份有限公司 |
| 2023/10/21Generic · Class 3 | 对乙酰氨基酚颗粒CYHS2302836 | 石家庄四药有限公司 |
| 2023/10/21Generic · Class 3 | 氨氯地平贝那普利胶囊CYHS2302835 | 广东粤和泽药物研究有限公司; 江苏和晨药业有限公司 |
| 2023/10/21Generic · Class 3 | 磷酸奥司他韦干混悬剂CYHS2302833 | 葵花药业集团（衡水）得菲尔有限公司 |
| 2023/10/21Generic · Class 3 | 磷酸奥司他韦干混悬剂CYHS2302832 | 葵花药业集团（衡水）得菲尔有限公司 |
| 2023/10/21Generic · Class 3 | 聚乙二醇4000散(儿童型)CYHS2302831 | 湖北莱康医疗技术有限公司; 广东华南药业集团有限公司 |
| 2023/10/21Generic · Class 3 | 羧甲司坦口服溶液CYHS2302828 | 广州市联瑞制药有限公司; 广州一品红制药有限公司 |
| 2023/10/21Generic · Class 3 | 地塞米松磷酸钠注射液CYHS2302827 | 四川美大康华康药业有限公司 |
| 2023/10/21Generic · Class 3 | 普瑞巴林口服溶液CYHS2302826 | 浙江浙北药业有限公司 |
| 2023/10/21New drug · Class 1.1 | 六金清瘟颗粒CXZL2300066 | 山东宏济堂制药集团股份有限公司 |
| 2023/10/21New drug · Class 2.3 | 口服六价重配轮状病毒减毒活疫苗（Vero细胞）CXSL2300722 | 科兴（大连）疫苗技术有限公司; 北京科兴中维生物技术有限公司 |
| 2023/10/21New drug · Class 1 | BPAb002注射液CXSL2300721 | 博品泽荣（深圳）生物医药科技有限公司 |
| 2023/10/21New drug · Class 1 | 重组抗PEAR1单克隆抗体雾化吸入溶液CXSL2300720 | 上海循曜生物科技有限公司 |
| 2023/10/21New drug · Class 1 | 68Ga-NYM005注射液制备用药盒CXHL2301147 | 无锡诺宇医药科技有限公司 |
| 2023/10/21New drug · Class 1 | RLA-23174片CXHL2301146 | 上海璎黎药业有限公司 |
| 2023/10/21New drug · Class 1 | RLA-23174片CXHL2301145 | 上海璎黎药业有限公司 |
| 2023/10/21New drug · Class 2.2 | CXG86吸入粉雾剂CXHL2301144 | 杭州希溪制药有限公司 |
| 2023/10/21New drug · Class 1 | QR056251胶囊CXHL2301143 | 武汉朗来科技发展有限公司 |
| 2023/10/21New drug · Class 1 | QR056251胶囊CXHL2301142 | 武汉朗来科技发展有限公司 |
| 2023/10/21New drug · Class 1 | ISM5411片CXHL2301141 | 英矽智能科技（上海）有限公司 |
| 2023/10/21New drug · Class 1 | ISM5411片CXHL2301140 | 英矽智能科技（上海）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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