药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2023/06/27 – 2023/07/03

Period
2023/06/27 to 2023/07/03, 7 days inclusive
Data as of
2026/11/07 06:00
Cached records
94,440 acceptance records, 11,686 under review now
Source
Public data from the CDE acceptance list and under-review list
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 typeFilings
Supplement195
Generic90
New drug57
Import25
Import re-registration16
Unspecified3

By drug type

Drug typeFilings
Chemical drug262
TCM80
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

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

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

AcceptedDrugApplicants
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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