药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/08/20 – 2024/08/26

Period
2024/08/20 to 2024/08/26, 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
323
Drugs with new generic filings (by drug name, de-duplicated)
64
Accepted this week, now under review
2

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

323filings, 95 of them generic

By application type

Application typeFilings
Supplement148
Generic95
New drug38
Unspecified21
Import re-registration11
Import10

By drug type

Drug typeFilings
Chemical drug199
TCM73
治疗用生物制品35
Biologic12
预防用生物制品4

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

64 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

206 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

84 this week

AcceptedDrugApplicants
2024/08/26Import · Class 2.2 司美格鲁肽注射液JXSS2400069 Novo Nordisk Pharma AG; Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2024/08/26Import · Class 2.2 司美格鲁肽注射液JXSS2400068 Novo Nordisk Pharma AG; Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2024/08/26Import · Class 2.1 Amivantamab注射液(皮下注射)JXSL2400156 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/08/26Import · Class 2.1 Amivantamab注射液(皮下注射)JXSL2400155 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/08/26Import · Class 2.4 Lazertinib片JXHL2400207 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/08/26New drug · Class 2.2 九价人乳头瘤病毒疫苗(大肠埃希菌)CXSS2400089 厦门万泰沧海生物技术有限公司
2024/08/26New drug · Class 2.2 九价人乳头瘤病毒疫苗(大肠埃希菌)CXSS2400088 厦门万泰沧海生物技术有限公司
2024/08/26New drug · Class 1 CA1001注射液CXSL2400563 西西欧艾(杭州)生物医药有限责任公司
2024/08/24Import · Class 1 Nivolumab/Relatlimab固定剂量复方注射液JXSL2400154 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2024/08/24Generic · Class 3 注射用苯唑西林钠CYHS2402775 江苏瑜兴医药科技有限公司; 海南通用康力制药有限公司
2024/08/24New drug · Class 1 KYS202003A注射液CXSL2400562 江苏康缘药业股份有限公司
2024/08/24New drug · Class 1 人脐带间充质干细胞注射液CXSL2400561 北京贝来药业有限公司
2024/08/24New drug · Class 2.4 苯环喹溴铵鼻喷雾剂CXHS2400083 银谷制药有限责任公司
2024/08/24New drug · Class 2.4 苯环喹溴铵鼻喷雾剂CXHS2400082 银谷制药有限责任公司
2024/08/24New drug · Class 1 HYP-6589片CXHL2400863 四川汇宇海玥医药科技有限公司
2024/08/24New drug · Class 1 HYP-6589片CXHL2400862 四川汇宇海玥医药科技有限公司
2024/08/24New drug · Class 2.2 醋酸地非法林片CXHL2400861 成都国为生物医药有限公司
2024/08/24New drug · Class 2.2 醋酸地非法林片CXHL2400860 成都国为生物医药有限公司
2024/08/24New drug · Class 2.2 醋酸地非法林片CXHL2400859 成都国为生物医药有限公司
2024/08/23Import · Class 2.1 Amivantamab注射液(皮下注射)JXSL2400153 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/08/23Import · Class 2.1 Amivantamab注射液(皮下注射)JXSL2400152 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/08/23Import · Class 2.1 Amivantamab注射液(皮下注射)JXSL2400151 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/08/23Import · Class 2.1 Amivantamab注射液(皮下注射)JXSL2400150 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/08/23Generic · Class 3 盐酸纳洛酮注射液CYHS2402759 山西振东泰盛制药有限公司
2024/08/23Generic · Class 3 盐酸曲唑酮片CYHS2402756 四川科伦药业股份有限公司
2024/08/23Generic · Class 3 盐酸曲唑酮片CYHS2402755 四川科伦药业股份有限公司
2024/08/23Generic · Class 3 复方聚乙二醇(3350)电解质口服溶液CYHS2402754 哈尔滨葵花药业有限公司; 葵花药业集团(唐山)生物制药有限公司
2024/08/23Generic · Class 3 水合氯醛灌肠剂CYHS2402753 杭州和泽坤元药业有限公司; 浙江康恩贝制药股份有限公司
2024/08/23Generic · Class 3 盐酸利多卡因眼用凝胶CYHL2400175 沈阳兴齐眼药股份有限公司
2024/08/23Generic · Class 3 盐酸依匹斯汀滴眼液CYHL2400174 百善科技(湖州)有限公司

54 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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