药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2025/10/28 – 2025/11/03

Period
2025/10/28 to 2025/11/03, 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
341
Drugs with new generic filings (by drug name, de-duplicated)
52
Accepted this week, now under review
79

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

341filings, 64 of them generic

By application type

Application typeFilings
Supplement185
Generic64
New drug59
Import re-registration12
Unspecified11
Import10

By drug type

Drug typeFilings
Chemical drug233
TCM72
治疗用生物制品31
Biologic3
预防用生物制品2

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

52 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

222 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

86 this week

AcceptedDrugApplicants
2025/11/03Import · Class 1 Solbinsiran注射液JXHL2500336 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/11/01Generic · Class 3 氯化钾颗粒CYHS2503852 福建瑞泰来医药科技有限公司; 安徽佳和药业有限公司
2025/11/01Generic · Class 3 硫糖铝口服混悬液CYHS2503851 安徽杰玺医药有限公司; 安徽永生堂药业有限责任公司
2025/11/01Generic · Class 3 碳酸镧颗粒CYHS2503849 卡文迪许(泰州)药业有限公司; 江苏悦兴药业有限公司
2025/11/01New drug · Class 1.2 FS2303分散片CXZL2500107 大连富生天然药物开发有限公司
2025/11/01New drug · Class 1 阴道用卷曲乳杆菌活菌胶囊CXSS2500117 苏州欧赛微科生物医药科技有限公司
2025/11/01New drug · Class 2.2 兰索拉唑碳酸氢钠干混悬剂CXHS2500135 南京海纳制药有限公司
2025/11/01New drug · Class 2.2 CB446CXHL2501201 杭州成邦医药科技有限公司
2025/11/01New drug · Class 2.2 ASECG肠溶干混悬剂CXHL2501200 北京天衡药物研究院有限公司
2025/10/31Import · Class 2.4 宗艾替尼片JXHS2500124 Boehringer Ingelheim International GmbH; Hovione Farmaciencia S.A.; Boehringer Ingelheim (China) Investment Co. Ltd
2025/10/31Generic · Class 3 西格列汀二甲双胍缓释片CYHS2503846 河南中杰药业有限公司
2025/10/31Generic · Class 3 西格列汀二甲双胍缓释片CYHS2503845 河南中杰药业有限公司
2025/10/31Generic · Class 3 盐酸克林霉素棕榈酸酯颗粒CYHS2503842 山东睿亿医药有限公司; 华益药业科技(安徽)有限公司
2025/10/31Generic · Class 3 复方聚乙二醇(3350)电解质维C散CYHS2503841 合肥盛秦医药科技有限公司; 安徽金太阳生化药业有限公司
2025/10/31Generic · Class 3 氢溴酸加兰他敏口服溶液CYHS2503839 上海葆隆生物科技有限公司; 上海美优制药有限公司
2025/10/31Generic · Class 3 腺苷钴胺胶囊CYHS2503835 湖北邦泽医药有限公司; 中孚药业股份有限公司
2025/10/31Generic · Class 3 瑞加诺生注射液CYHL2500195 河北赛谱熠辉医药科技有限公司
2025/10/31New drug · Class 1.3 重组带状疱疹疫苗(CHO细胞)CXSL2500935 华兰生物疫苗股份有限公司
2025/10/31New drug · Class 1 NWRD18CXHL2501199 诺未生物技术(无锡)有限公司; 诺未科技(北京)有限公司; 诺未生物技术(天津)有限公司
2025/10/31New drug · Class 2.2;2.4 SY-606滴眼液CXHL2501198 北京银谷医药科技有限公司
2025/10/31New drug · Class 2.2;2.4 SY-606滴眼液CXHL2501197 北京银谷医药科技有限公司
2025/10/31New drug · Class 2.2;2.4 SY-606滴眼液CXHL2501196 北京银谷医药科技有限公司
2025/10/31New drug · Class 2.2;2.4 SY-606滴眼液CXHL2501195 北京银谷医药科技有限公司
2025/10/30Import · Class 3.1 Nemolizumab注射液JXSL2500208 Galderma SA; Q-Med International Trading (Shanghai) Co. Ltd
2025/10/30Import · Class 1 GSK6042981片JXHL2500334 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Company Limited
2025/10/30New drug · Class 1.2 栀子西红花酸提取物(C2235)CXZL2500106 浙江尖峰药业有限公司
2025/10/30New drug · Class 1 柯美奇拜单抗注射液CXSS2500116 上海麦济医药有限公司; 鼎康(武汉)生物医药有限公司
2025/10/30New drug · Class 1 注射用QLS5316CXSL2500934 齐鲁制药有限公司
2025/10/30New drug · Class 2.2 布瑞哌唑口溶膜CXHS2500133 甘肃普安制药股份有限公司
2025/10/30New drug · Class 2.2 布瑞哌唑口溶膜CXHS2500132 甘肃普安制药股份有限公司

56 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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