药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/11/12 – 2024/11/18

Period
2024/11/12 to 2024/11/18, 7 days inclusive
Data as of
2026/11/05 06:00
Cached records
94,245 acceptance records, 11,689 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
373
Drugs with new generic filings (by drug name, de-duplicated)
79
Accepted this week, now under review
9

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

373filings, 114 of them generic

By application type

Application typeFilings
Supplement169
Generic114
New drug60
Import13
Unspecified9
Import re-registration7
药械组合1

By drug type

Drug typeFilings
Chemical drug271
TCM59
治疗用生物制品29
预防用生物制品9
Biologic4
体外诊断试剂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

79 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

244 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

117 this week

AcceptedDrugApplicants
2024/11/18Generic · Class 3 西格列汀二甲双胍缓释片CYHS2403955 杭州和泽坤元药业有限公司; 浙江四维医药科技有限公司
2024/11/18Generic · Class 3 碳酸氢钠注射液CYHS2403952 湖北多瑞药业有限公司
2024/11/18Generic · Class 3 依帕司他片CYHS2403950 广东九明制药有限公司
2024/11/18Generic · Class 3 硝苯地平缓释片(Ⅱ)CYHS2403949 四川依科制药有限公司
2024/11/18New drug · Class 2.2 恩朗苏拜单抗注射液CXSL2400782 石药集团巨石生物制药有限公司
2024/11/18New drug · Class 2.4 注射用KJ101CXSL2400781 上海宝济药业股份有限公司
2024/11/16Import · Class 1 JNJ-77242113-AAC片JXHL2400267 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/11/16Generic · Class 3 右美沙芬安非他酮缓释片CYHL2400228 四川科伦药业股份有限公司
2024/11/16New drug · Class 1 注射用SKB445CXSL2400780 四川科伦博泰生物医药股份有限公司
2024/11/16New drug · Class 1 自体天然肿瘤浸润淋巴细胞注射液CXSL2400779 上海君赛生物科技有限公司
2024/11/16New drug · Class 1 力胜克拉片CXHS2400114 苏州亚盛药业有限公司; 江苏宣泰药业有限公司
2024/11/16New drug · Class 1 力胜克拉片CXHS2400113 苏州亚盛药业有限公司; 江苏宣泰药业有限公司
2024/11/16New drug · Class 1 力胜克拉片CXHS2400112 苏州亚盛药业有限公司; 江苏宣泰药业有限公司
2024/11/16New drug · Class 1 BL0175注射液CXHL2401248 上海弼领生物技术有限公司
2024/11/16New drug · Class 2.2;2.4 KEM2111凝胶贴膏CXHL2401247 深圳珐玛易药品科技有限公司
2024/11/16New drug · Class 2.2;2.4 KEM2111凝胶贴膏CXHL2401246 深圳珐玛易药品科技有限公司
2024/11/16New drug · Class 2.2;2.4 KEM2111凝胶贴膏CXHL2401245 深圳珐玛易药品科技有限公司
2024/11/15Generic · Class 3 洛索洛芬钠口服溶液CYHS2403938 合肥启旸生物医药科技有限公司; 合肥华威药业有限公司
2024/11/15Generic · Class 3 盐酸甲氧氯普胺注射液CYHS2403936 重庆天致药业股份有限公司; 河南天致药业有限公司
2024/11/15Generic · Class 3 注射用哌拉西林钠CYHS2403935 江苏睿实生物科技有限公司; 四川制药制剂有限公司
2024/11/15Generic · Class 3 注射用哌拉西林钠CYHS2403934 江苏睿实生物科技有限公司; 四川制药制剂有限公司
2024/11/15Generic · Class 3 恩格列净二甲双胍缓释片CYHS2403928 江苏谦仁生物科技有限公司
2024/11/15Generic · Class 3 琥珀酸亚铁片CYHS2403926 江苏万高药业股份有限公司
2024/11/15Generic · Class 3 钠钾镁钙注射用浓溶液CYHS2403923 海西新药创制(福州)有限公司; 福安药业集团宁波天衡制药有限公司
2024/11/15Generic · Class 3 普瑞巴林口服溶液CYHS2403917 盖天力医药控股集团制药股份有限公司; 江苏欧歌制药有限公司
2024/11/15Generic · Class 3 普瑞巴林口服溶液CYHS2403916 盖天力医药控股集团制药股份有限公司; 江苏欧歌制药有限公司
2024/11/15Generic · Class 3 普瑞巴林口服溶液CYHS2403915 盖天力医药控股集团制药股份有限公司; 江苏欧歌制药有限公司
2024/11/15Generic · Class 3 格隆溴铵新斯的明注射液CYHL2400227 南京正科医药股份有限公司
2024/11/15New drug · Class 3.3 13价肺炎球菌多糖结合疫苗CXSS2400123 艾美坚持生物制药有限公司
2024/11/15New drug · Class 1.2 SYS6017(带状疱疹mRNA疫苗)CXSL2400778 石药集团巨石生物制药有限公司

87 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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