药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/07/23 – 2024/07/29

Period
2024/07/23 to 2024/07/29, 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)
64
Accepted this week, now under review
4

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, 93 of them generic

By application type

Application typeFilings
Supplement161
Generic93
New drug56
Unspecified22
Import10
Import re-registration6

By drug type

Drug typeFilings
Chemical drug241
TCM55
治疗用生物制品38
Biologic10
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

216 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

95 this week

AcceptedDrugApplicants
2024/07/29New drug · Class 1.4 流感病毒亚单位疫苗(佐剂)CXSL2400493 江苏中慧元通生物科技股份有限公司; 易慧生物技术(上海)有限公司
2024/07/29New drug · Class 1 NK510细胞注射液CXSL2400492 上海贝斯昂科生物科技有限公司; 珠海贝斯昂科科技有限责任公司
2024/07/27Import · Class 2.2 阿替利珠单抗注射液(皮下注射)JXSS2400064 Roche Registration GmbH; Roche Diagnostics GmbH; Roche (China) Holding Ltd.
2024/07/27Import · Class 3.1 阿替利珠单抗注射液(皮下注射)JXSS2400063 Roche Registration GmbH; Roche Diagnostics GmbH; Roche (China) Holding Ltd.
2024/07/27Generic · Class 3 盐酸曲唑酮片CYHS2402382 浙江诺得药业有限公司
2024/07/27Generic · Class 3 复方电解质醋酸钠葡萄糖注射液CYHS2402380 江苏正大丰海制药有限公司
2024/07/27Generic · Class 3 复方电解质醋酸钠葡萄糖注射液CYHS2402378 江苏正大丰海制药有限公司
2024/07/27Generic · Class 3 依帕司他片CYHS2402372 宁夏康亚药业股份有限公司
2024/07/27New drug · Class 1.2 ZY13提取物CXZL2400043 浙江康恩贝制药股份有限公司
2024/07/27New drug · Class 1.2 ZY13片CXZL2400042 浙江康恩贝制药股份有限公司
2024/07/27New drug · Class 1.1 通塞颗粒CXZL2400041 河南中医药大学
2024/07/27New drug · Class 2.2 依沃西单抗注射液CXSS2400080 康方赛诺医药有限公司; 康方药业有限公司
2024/07/27New drug · Class 1 注射用SHR-9839CXSL2400491 上海恒瑞医药有限公司
2024/07/27New drug · Class 1 注射用SHR-1826CXSL2400490 苏州盛迪亚生物医药有限公司
2024/07/27New drug · Class 2.2 SHR-8068注射液CXSL2400489 苏州盛迪亚生物医药有限公司
2024/07/27New drug · Class 2.2 贝伐珠单抗注射液CXSL2400488 苏州盛迪亚生物医药有限公司
2024/07/27New drug · Class 2.2 阿得贝利单抗注射液CXSL2400487 上海盛迪医药有限公司
2024/07/27New drug · Class 1 SHR-6934注射液CXSL2400486 北京盛迪医药有限公司; 北京拓界生物医药科技有限公司; 上海迈晋生物医药科技有限公司
2024/07/27New drug · Class 1.3 四价流感病毒裂解疫苗(ZFA02佐剂)CXSL2400485 安徽智飞龙科马生物制药有限公司
2024/07/27New drug · Class 1 注射用重组人源化抗BCMA/CD3双特异性抗体CXSL2400484 山东新时代药业有限公司
2024/07/27New drug · Class 1 注射用AK138D1CXSL2400483 中山康方生物医药有限公司
2024/07/27New drug · Class 1 POV-601-1A1溶瘤病毒注射液CXSL2400482 苏州般若生物科技有限公司
2024/07/27New drug · Class 2.2 棕榈酸帕利哌酮注射液(II)CXHS2400066 山东绿叶制药有限公司
2024/07/27New drug · Class 2.2 棕榈酸帕利哌酮注射液(II)CXHS2400065 山东绿叶制药有限公司
2024/07/27New drug · Class 2.2 棕榈酸帕利哌酮注射液(II)CXHS2400064 山东绿叶制药有限公司
2024/07/27New drug · Class 2.2 棕榈酸帕利哌酮注射液(II)CXHS2400063 山东绿叶制药有限公司
2024/07/27New drug · Class 2.2 棕榈酸帕利哌酮注射液(II)CXHS2400062 山东绿叶制药有限公司
2024/07/27New drug · Class 2.2 棕榈酸帕利哌酮注射液(II)CXHS2400061 山东绿叶制药有限公司
2024/07/27New drug · Class 1 GTA182片CXHL2400763 上海湃隆生物科技有限公司
2024/07/27New drug · Class 1 GTA182片CXHL2400762 上海湃隆生物科技有限公司

65 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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