药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2023/07/18 – 2023/07/24

Period
2023/07/18 to 2023/07/24, 7 days inclusive
Data as of
2026/11/07 06:00
Cached records
94,440 acceptance records, 11,686 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
265
Drugs with new generic filings (by drug name, de-duplicated)
42
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

265filings, 54 of them generic

By application type

Application typeFilings
Supplement123
Generic54
New drug51
Import22
Unspecified11
Import re-registration4

By drug type

Drug typeFilings
Chemical drug166
治疗用生物制品48
TCM47
预防用生物制品3
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

42 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

170 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

89 this week

AcceptedDrugApplicants
2023/07/24New drug · Class 1 注射用LBL-024CXSL2300508 南京维立志博生物科技有限公司
2023/07/22Import · Class 1 Bemarituzumab注射液JXSL2300138 Amgen Inc.; Zai Lab (Shanghai) CO. Ltd.
2023/07/22Import · Class 1 Cetrelimab注射液JXSL2300137 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/07/22Import · Class 1 Cetrelimab注射液JXSL2300136 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/07/22Import · Class 2.2 Anifrolumab注射液JXSL2300135 AstraZeneca AB; AstraZeneca Investment (China)Co. Ltd
2023/07/22Import · Class 1 ForimtamigJXSL2300134 F. Hoffmann-La Roche Ltd; Roche R&D Center (China) Ltd.
2023/07/22Import · Class 1 ForimtamigJXSL2300133 F. Hoffmann-La Roche Ltd; Roche R&D Center (China) Ltd.
2023/07/22Import · Class 1 VAY736注射液JXSL2300132 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2023/07/22Import · Class 1 BMS-986278-01片JXHL2300175 Bristol-Myers Squibb Company; Bristol-Myers Squibb(China)Investment Co. Ltd
2023/07/22Import · Class 1 BMS-986278-01片JXHL2300174 Bristol-Myers Squibb Company; Bristol-Myers Squibb(China)Investment Co. Ltd
2023/07/22Import · Class 1 BMS-986278-01片JXHL2300173 Bristol-Myers Squibb Company; Bristol-Myers Squibb(China)Investment Co. Ltd
2023/07/22Generic · Class 3 磷酸奥司他韦颗粒CYHS2301973 成都第一制药有限公司
2023/07/22Generic · Class 3 乙酰半胱氨酸注射液CYHS2301972 海口天行健药物研究有限公司; 海南爱科制药有限公司
2023/07/22Generic · Class 3 倍他米松磷酸钠注射液CYHS2301970 汇禹远和(海南)药业有限公司; 津药和平(天津)制药有限公司
2023/07/22New drug · Class 3.4 重组人II型肿瘤坏死因子受体-抗体融合蛋白注射液CXSS2300056 杭州博之锐生物制药有限公司
2023/07/22New drug · Class 3.4 重组人II型肿瘤坏死因子受体-抗体融合蛋白注射液CXSS2300055 杭州博之锐生物制药有限公司
2023/07/22New drug · Class 1 NWRD08裸质粒DNA注射液CXSL2300507 诺未生物技术(无锡)有限公司; 诺未科技(北京)有限公司
2023/07/22New drug · Class 1 JYB1931注射液CXSL2300506 江苏济烨生物制药有限公司
2023/07/22New drug · Class 1 TQ05105片CXHL2300809 正大天晴药业集团股份有限公司
2023/07/22New drug · Class 1 TQB3909片CXHL2300808 正大天晴药业集团南京顺欣制药有限公司
2023/07/21Import · Class 1 BMS-986278-01片JXHL2300172 Bristol-Myers Squibb Company; Bristol-Myers Squibb(China)Investment Co. Ltd
2023/07/21Generic · Class 3 洛索洛芬钠口服溶液CYHS2301966 云南先施药业有限公司; 湖南九典制药股份有限公司
2023/07/21Generic · Class 3 米诺地尔泡沫剂CYHS2301965 辰光(天津)制药有限公司
2023/07/21Generic · Class 3 米诺地尔泡沫剂CYHS2301964 辰光(天津)制药有限公司
2023/07/21Generic · Class 3 注射用苯唑西林钠CYHS2301954 山东蓝晶生物技术有限公司; 山东睿鹰制药集团有限公司
2023/07/21New drug · Class 1 IMD101注射液CXSL2300505 上海英脉德医疗科技有限公司
2023/07/21New drug · Class 1 IMD101注射液CXSL2300504 上海英脉德医疗科技有限公司
2023/07/21New drug · Class 1 人白介素-12注射液CXSL2300503 康立泰生物医药(青岛)有限公司
2023/07/21New drug · Class 1 注射用重组人骨形态发生蛋白6CXSL2300502 安济盛生物医药技术(广州)有限公司
2023/07/21New drug · Class 1 ELPIS人脐带间充质干细胞注射液CXSL2300501 华夏源(上海)生物科技有限公司; 江西华夏源生物科技有限公司

59 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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