药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/05/21 – 2024/05/27

Period
2024/05/21 to 2024/05/27, 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
310
Drugs with new generic filings (by drug name, de-duplicated)
57
Accepted this week, now under review
0

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

310filings, 73 of them generic

By application type

Application typeFilings
Supplement159
Generic73
New drug41
Import re-registration20
Import12
Unspecified5

By drug type

Drug typeFilings
Chemical drug194
TCM66
治疗用生物制品45
预防用生物制品3
体外诊断试剂1
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

57 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

184 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
2024/05/27Import · Class 2.4 盐酸非苏拉生片JXHL2400117 Daewoong Pharmaceutical Co. Ltd.; Yangtze River Pharmaceutical Group Shanghai Haini Pharmceutical Co. Ltd.
2024/05/27Generic · Class 3 吡格列酮二甲双胍片CYHS2401579 成都倍特药业股份有限公司
2024/05/27Generic · Class 3 布立西坦口服溶液CYHS2401578 海南全星制药有限公司
2024/05/25Generic · Class 3 盐酸甲氧氯普胺注射液CYHS2401573 北京民康百草医药科技有限公司; 山西诺成制药有限公司
2024/05/25Generic · Class 3 乙酰半胱氨酸注射液CYHS2401572 湖北津药药业股份有限公司
2024/05/25New drug · Class 1 LY01620CXSL2400349 南京吉迈生物技术有限公司
2024/05/25New drug · Class 1 注射用ZGGS18CXSL2400348 苏州泽璟生物制药股份有限公司
2024/05/25New drug · Class 1 注射用ZG005CXSL2400347 苏州泽璟生物制药股份有限公司
2024/05/25New drug · Class 1 RC148注射液CXSL2400346 荣昌生物制药(烟台)股份有限公司
2024/05/25New drug · Class 1 注射用RC118CXSL2400345 荣昌生物制药(烟台)股份有限公司
2024/05/25New drug · Class 2.4 青蒿琥酯片CXHL2400527 桂林南药股份有限公司; 上海交通大学
2024/05/24Import · Class 1 Astegolimab注射液JXSL2400103 F. Hoffmann-La Roche Ltd; Roche(China) Holding Ltd.
2024/05/24Import · Class 2.2 Epcoritamab注射用浓溶液JXSL2400102 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/05/24Import · Class 2.2 Epcoritamab注射用浓溶液JXSL2400101 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/05/24Import · Class 2.2 Epcoritamab注射液JXSL2400100 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/05/24Import · Class 2.2 Epcoritamab注射液JXSL2400099 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/05/24Generic · Class 3 盐酸布比卡因注射液CYHS2401571 北京民康百草医药科技有限公司; 山西诺成制药有限公司
2024/05/24Generic · Class 3 盐酸布比卡因注射液CYHS2401570 北京民康百草医药科技有限公司; 山西诺成制药有限公司
2024/05/24Generic · Class 3 尼麦角林片CYHS2401569 海南通用三洋药业有限公司
2024/05/24Generic · Class 3 尼麦角林片CYHS2401567 海南通用三洋药业有限公司
2024/05/24Generic · Class 3 盐酸倍他司汀片CYHS2401560 上海理想制药有限公司
2024/05/24Generic · Class 3 吸入用盐酸丙卡特罗溶液CYHS2401557 成都天之翼尚品医药科技有限公司; 知和(山东)大药厂有限公司
2024/05/24Generic · Class 3 复方氨基酸(15AA-II)/葡萄糖(10%)电解质注射液CYHS2401556 山东齐都药业有限公司
2024/05/24Generic · Class 3 盐酸布比卡因注射液CYHS2401555 广州艾格生物科技有限公司; 成都天台山制药股份有限公司
2024/05/24Generic · Class 3 复方氨基酸(15AA-II)/葡萄糖(10%)电解质注射液CYHS2401554 山东齐都药业有限公司
2024/05/24Generic · Class 3 盐酸布比卡因注射液CYHS2401553 广州艾格生物科技有限公司; 成都天台山制药股份有限公司
2024/05/24Generic · Class 3 米诺地尔泡沫剂(女用)CYHL2400101 山西振东安欣生物制药有限公司
2024/05/24Generic · Class 3 米诺地尔泡沫剂(男用)CYHL2400100 山西振东安欣生物制药有限公司
2024/05/24New drug · Class 1 注射用HS-20124CXSL2400344 常州恒邦药业有限公司; 上海翰森生物医药科技有限公司
2024/05/24New drug · Class 1 GenSci098注射液CXSL2400343 长春金赛药业有限责任公司

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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