药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/06/27 – 2023/07/03
- New acceptances this week
- 386
- Drugs with new generic filings (by drug name, de-duplicated)
- 65
- Accepted this week, now under review
- 0
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
386filings, 90 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 195 |
| Generic | 90 |
| New drug | 57 |
| Import | 25 |
| Import re-registration | 16 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 262 |
| TCM | 80 |
| 治疗用生物制品 | 41 |
| 预防用生物制品 | 3 |
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
65 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 吡仑帕奈片 | 4 | 2 | 2 |
| 2 | 米诺地尔搽剂 | 4 | 2 | 49 |
| 3 | 乳果糖口服溶液 | 3 | 2 | 36 |
| 4 | 阿立哌唑片 | 3 | 2 | 2 |
| 5 | 复方聚乙二醇(3350)电解质散 | 2 | 2 | 5 |
| 6 | 氯化钾注射液 | 2 | 2 | 10 |
| 7 | 盐酸多巴胺注射液 | 2 | 2 | 3 |
| 8 | 盐酸甲氧氯普胺注射液 | 2 | 2 | 6 |
| 9 | 丁酸氯维地平注射用脂肪乳 | 2 | 1 | 0 |
| 10 | 他达拉非片 | 2 | 1 | 23 |
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
207 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 石岐制药(广东)有限公司 | 22 | 20 | 0 |
| 2 | 修正药业集团天汉药业有限公司 | 14 | 13 | 0 |
| 3 | 润缘制药有限公司 | 13 | 13 | 0 |
| 4 | Boehringer Ingelheim International GmbH | 9 | 2 | 0 |
| 5 | 海南爱科制药有限公司 | 7 | 2 | 0 |
| 6 | 吉林省密之康药业有限责任公司 | 6 | 6 | 0 |
| 7 | 海南中旺医疗科技开发有限公司 | 6 | 1 | 0 |
| 8 | 河南省百泉制药有限公司 | 5 | 5 | 0 |
| 9 | 湖南方盛制药股份有限公司 | 5 | 5 | 0 |
| 10 | 东阳祥昇医药科技有限公司 | 5 | 3 | 2 |
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
104 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/07/03Generic · Class 3 | 盐酸甲氧氯普胺注射液CYHS2301782 | 东阳祥昇医药科技有限公司; 浙江北生药业汉生制药有限公司 |
| 2023/07/03Generic · Class 3 | 门冬氨酸钾注射液CYHS2301779 | 海南倍特药业有限公司 |
| 2023/07/03New drug · Class 3.1 | 芍药甘草汤颗粒CXZS2300013 | 合肥华润神鹿药业有限公司 |
| 2023/07/03New drug · Class 3.3 | 贝伐珠单抗注射液CXSS2300048 | 华兰基因工程有限公司 |
| 2023/07/02New drug · Class 2.2 | LPC-011口溶膜CXHL2300729 | 海南中旺医疗科技开发有限公司 |
| 2023/07/02New drug · Class 2.2 | LPC-011口溶膜CXHL2300728 | 海南中旺医疗科技开发有限公司 |
| 2023/07/02New drug · Class 2.2 | LPC-011口溶膜CXHL2300727 | 海南中旺医疗科技开发有限公司 |
| 2023/07/02New drug · Class 2.2 | LPC-011口溶膜CXHL2300726 | 海南中旺医疗科技开发有限公司 |
| 2023/07/02New drug · Class 2.2 | LPC-011口溶膜CXHL2300725 | 海南中旺医疗科技开发有限公司 |
| 2023/07/02New drug · Class 2.2 | LPC-011口溶膜CXHL2300724 | 海南中旺医疗科技开发有限公司 |
| 2023/07/01Import · Class 1 | ALPN-303注射液JXSL2300124 | Alpine Immune Sciences Inc.; —— |
| 2023/07/01Generic · Class 3 | 氯化钾注射液CYHS2301778 | 辽宁民康制药有限公司; 湖南科伦制药有限公司 |
| 2023/07/01Generic · Class 3 | 丁酸氯维地平注射用脂肪乳CYHS2301777 | 四川科伦药业股份有限公司 |
| 2023/07/01Generic · Class 3 | 丁酸氯维地平注射用脂肪乳CYHS2301776 | 四川科伦药业股份有限公司 |
| 2023/07/01Generic · Class 3 | 米诺地尔搽剂CYHS2301775 | 福元药业有限公司 |
| 2023/07/01Generic · Class 3 | 米诺地尔搽剂CYHS2301774 | 福元药业有限公司 |
| 2023/07/01Generic · Class 3 | 米诺地尔搽剂CYHS2301771 | 北京诺博特生物科技有限公司; 江苏知原药业股份有限公司 |
| 2023/07/01Generic · Class 3 | 米诺地尔搽剂CYHS2301770 | 北京诺博特生物科技有限公司; 江苏知原药业股份有限公司 |
| 2023/07/01Generic · Class 3 | 左乙拉西坦缓释片CYHS2301768 | 东北制药集团沈阳第一制药有限公司 |
| 2023/07/01New drug · Class 1 | QX005N注射液CXSL2300449 | 江苏荃信生物医药股份有限公司 |
| 2023/06/30Import · Class 1 | BI 907828片JXHL2300153 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/06/30Import · Class 1 | BI 907828片JXHL2300152 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/06/30Import · Class 1 | BI 907828片JXHL2300151 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/06/30Generic · Class 3 | 依帕司他片CYHS2301765 | 江苏东科康德药业有限公司; 宁波美诺华天康药业有限公司 |
| 2023/06/30Generic · Class 3 | 复方聚乙二醇(3350)电解质散CYHS2301763 | 海南斯达制药有限公司; 海南赛立克药业有限公司 |
| 2023/06/30Generic · Class 3 | 普瑞巴林口崩片CYHS2301762 | 江西施美药业股份有限公司 |
| 2023/06/30Generic · Class 3 | 普瑞巴林口崩片CYHS2301761 | 江西施美药业股份有限公司 |
| 2023/06/30Generic · Class 3 | 己酮可可碱注射液CYHS2301750 | 河南朗冠药品制剂研究院有限公司; 酒泉大得利制药股份有限公司 |
| 2023/06/30New drug · Class 1.2 | 射干止咳胶囊CXZL2300046 | 辽宁省中医药研究院(辽宁中医药大学附属第二医院) |
| 2023/06/30New drug · Class 1.2 | 射干提取物CXZL2300045 | 辽宁省中医药研究院(辽宁中医药大学附属第二医院) |
74 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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