药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/01/02 – 2024/01/08

Period
2024/01/02 to 2024/01/08, 7 days inclusive
Data as of
2026/11/06 06:00
Cached records
94,364 acceptance records, 11,708 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
326
Drugs with new generic filings (by drug name, de-duplicated)
73
Accepted this week, now under review
3

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

326filings, 98 of them generic

By application type

Application typeFilings
Supplement152
Generic98
New drug48
Import16
Unspecified6
Import re-registration6

By drug type

Drug typeFilings
Chemical drug248
治疗用生物制品39
TCM36
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

73 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

197 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
2024/01/08Generic · Class 3 硫酸特布他林口服溶液CYHS2400090 合肥国药诺和药业有限公司; 华益药业科技(安徽)有限公司
2024/01/08Generic · Class 3 硫酸特布他林口服溶液CYHS2400089 合肥国药诺和药业有限公司; 华益药业科技(安徽)有限公司
2024/01/08Generic · Class 3 西格列汀二甲双胍缓释片CYHS2400088 广东东阳光药业股份有限公司; 宜昌东阳光长江药业股份有限公司
2024/01/08Generic · Class 3 西格列汀二甲双胍缓释片CYHS2400087 广东东阳光药业股份有限公司; 宜昌东阳光长江药业股份有限公司
2024/01/08Generic · Class 3 卡络磺钠片CYHS2400086 成都倍特药业股份有限公司
2024/01/08New drug · Class 1 SYS6023CXSL2400013 石药集团巨石生物制药有限公司
2024/01/08New drug · Class 1 注射用NC18CXSL2400012 诺灵生物医药科技(杭州)有限公司
2024/01/08New drug · Class 1 SYH2039片CXHL2400030 石药集团中奇制药技术(石家庄)有限公司
2024/01/08New drug · Class 1 SYH2039片CXHL2400029 石药集团中奇制药技术(石家庄)有限公司
2024/01/06Import · Class 1 Itepekimab注射液JXSL2400008 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2024/01/06Import · Class 1 ABBV-383输注用溶液JXSL2400007 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/01/06Import · Class 1 TAK-279胶囊JXHL2400004 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd
2024/01/06Import · Class 1 TAK-279胶囊JXHL2400003 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd
2024/01/06Generic · Class 3 乙酰半胱氨酸注射液CYHS2400081 杭州云柏医药科技有限公司; 浙江赛默制药有限公司
2024/01/06Generic · Class 3 呋塞米口服溶液CYHS2400080 江苏康缘药业股份有限公司
2024/01/06Generic · Class 3 己酮可可碱注射液CYHS2400077 广东迈恒医药研发有限公司; 中孚药业股份有限公司
2024/01/06Generic · Class 3 氨甲环酸氯化钠注射液CYHS2400076 石家庄四药有限公司
2024/01/06Generic · Class 3 马来酸噻吗洛尔滴眼液CYHS2400075 石家庄四药有限公司
2024/01/06Generic · Class 3 氨氯地平贝那普利胶囊CYHS2400074 北京万辉双鹤药业有限责任公司; 华润双鹤药业股份有限公司
2024/01/06Generic · Class 3 盐酸苯海拉明注射液CYHS2400071 海南秋实医药科技有限公司; 河南润弘制药股份有限公司
2024/01/06Generic · Class 3 盐酸多巴酚丁胺注射液CYHS2400068 山西德元堂药业有限公司
2024/01/06Generic · Class 3 复方枸橼酸铋钾胶囊CYHL2400007 湖北荆江源制药股份有限公司
2024/01/06New drug · Class 3.3 QL2109注射液CXSL2400011 齐鲁制药有限公司
2024/01/06New drug · Class 1 注射用VDJ010CXSL2400010 北京伟德杰生物科技有限公司
2024/01/06New drug · Class 2.4;2.2 LY102片CXHL2400028 青岛海洋生物医药研究院; 青岛海济生物医药有限公司; 中国海洋大学
2024/01/06New drug · Class 2.4;2.2 LY102片CXHL2400027 青岛海洋生物医药研究院; 青岛海济生物医药有限公司; 中国海洋大学
2024/01/06New drug · Class 1 LPM526000133富马酸盐胶囊CXHL2400026 绿叶嘉奥制药石家庄有限公司
2024/01/06New drug · Class 1 LPM526000133富马酸盐胶囊CXHL2400025 绿叶嘉奥制药石家庄有限公司
2024/01/06New drug · Class 1 LPM526000133富马酸盐胶囊CXHL2400024 绿叶嘉奥制药石家庄有限公司
2024/01/06New drug · Class 1 LPM526000133富马酸盐胶囊CXHL2400023 绿叶嘉奥制药石家庄有限公司

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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