药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/08/27 – 2024/09/02

Period
2024/08/27 to 2024/09/02, 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
348
Drugs with new generic filings (by drug name, de-duplicated)
81
Accepted this week, now under review
1

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

348filings, 107 of them generic

By application type

Application typeFilings
Supplement156
Generic107
New drug63
Import11
Unspecified9
Import re-registration2

By drug type

Drug typeFilings
Chemical drug237
TCM67
治疗用生物制品36
预防用生物制品7
Biologic1

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

81 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

228 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

109 this week

AcceptedDrugApplicants
2024/09/02New drug · Class 3.1 二冬颗粒CXZS2400029 神威药业集团有限公司
2024/09/02New drug · Class 1 ALMB-0168注射液CXSL2400582 上海恩乐迈生物科技有限公司
2024/09/02New drug · Class 1 人生长激素-Fc融合蛋白注射液CXSL2400581 长春生物制品研究所有限责任公司
2024/09/02New drug · Class 2.2 尼莫地平注射用浓溶液CXHL2400895 北京德立福瑞医药科技有限公司
2024/09/02New drug · Class 1 RAY1225注射液CXHL2400894 广东众生睿创生物科技有限公司
2024/09/01Generic · Class 3 中性腹膜透析液(碳酸氢盐-G1.5%)CYHS2402869 上海长征富民金山制药有限公司
2024/09/01Generic · Class 3 中性腹膜透析液(碳酸氢盐-G2.5%)CYHS2402868 上海长征富民金山制药有限公司
2024/09/01Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G2.5%)CYHS2402867 上海长征富民金山制药有限公司
2024/09/01Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G1.5%)CYHS2402866 上海长征富民金山制药有限公司
2024/08/31Import · Class 2.4 注射用六氟化硫微泡JXHS2400060 Bracco International B.V.; Bracco Suisse SA; Bracco Imaging Medical Technologies (Shanghai) Co. Ltd
2024/08/31Generic · Class 3 氯化钙注射液CYHS2402865 石家庄杏泽医药科技有限公司; 山东华鲁制药有限公司
2024/08/31Generic · Class 3 维生素B6注射液CYHS2402860 江苏润恒制药有限公司
2024/08/31Generic · Class 3 富马酸依美斯汀缓释胶囊CYHS2402858 湖南普道医药技术有限公司; 湖南九典制药股份有限公司
2024/08/31Generic · Class 3 吸入用雷芬那辛溶液CYHL2400182 长风药业股份有限公司
2024/08/31New drug · Class 1.1 玉蚕颗粒CXZL2400049 武汉人福创新药物研发中心有限公司; 上海复活石医药科技有限公司
2024/08/31New drug · Class 1.1 膝痛颗粒CXZL2400048 仲颐(广州)科技创新研究有限公司; 中国中医科学院中药研究所
2024/08/31New drug · Class 3.3 冻干人用狂犬病疫苗(人二倍体细胞)CXSS2400092 成大生物(本溪)有限公司
2024/08/31New drug · Class 2.2 氨酚羟考酮缓释片CXHS2400088 成都苑东生物制药股份有限公司
2024/08/31New drug · Class 1 CPI-818片CXHL2400893 嘉兴和剂药业有限公司
2024/08/31New drug · Class 1 CPI-818片CXHL2400892 嘉兴和剂药业有限公司
2024/08/30Generic · Class 3 阿瑞匹坦注射液CYHS2402842 江苏康禾生物制药有限公司
2024/08/30Generic · Class 3 盐酸拉贝洛尔注射液CYHS2402839 海南慧通生物医药科技有限公司; 山东北大高科华泰制药有限公司
2024/08/30Generic · Class 3 盐酸拉贝洛尔注射液CYHS2402838 海南慧通生物医药科技有限公司; 山东北大高科华泰制药有限公司
2024/08/30Generic · Class 3 硝普钠注射液CYHS2402836 华夏生生药业(北京)有限公司
2024/08/30Generic · Class 3 维生素B6注射液CYHS2402833 国仁健康制药(北京)有限公司; 西安汉丰药业有限责任公司
2024/08/30Generic · Class 3 己酮可可碱缓释片CYHS2402832 本溪匠成医药科技有限公司; 吉林四环制药有限公司
2024/08/30Generic · Class 3 盐酸曲唑酮片CYHS2402827 浙江江北药业有限公司
2024/08/30Generic · Class 3 脂溶性维生素注射液(Ⅰ)CYHS2402823 石家庄四药有限公司
2024/08/30Generic · Class 3 吡格列酮二甲双胍片CYHS2402822 杭州呋欧医药科技有限公司; 浙江赛默制药有限公司
2024/08/30Generic · Class 3 注射用甲磺酸萘莫司他CYHL2400181 杭州沐源生物医药科技有限公司

79 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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