药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2025/08/05 – 2025/08/11

Period
2025/08/05 to 2025/08/11, 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
377
Drugs with new generic filings (by drug name, de-duplicated)
75
Accepted this week, now under review
107

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

377filings, 107 of them generic

By application type

Application typeFilings
Supplement159
Generic107
New drug77
Import16
Import re-registration15
Unspecified3

By drug type

Drug typeFilings
Chemical drug234
TCM78
治疗用生物制品63
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

75 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

210 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

126 this week

AcceptedDrugApplicants
2025/08/11Import · Class 1 Icotrokinra片JXHL2500213 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2025/08/11Import · Class 2.4;2.2 马立巴韦干混悬剂JXHL2500212 Takeda Pharmaceuticals U.S.A. Inc; Takeda(China) International Company Ltd.
2025/08/11Import · Class 2.4;2.2 马立巴韦干混悬剂JXHL2500211 Takeda Pharmaceuticals U.S.A. Inc.; Takeda(China) International Company Ltd.
2025/08/11New drug · Class 2.4 海曲泊帕乙醇胺片CXHS2500094 江苏恒瑞医药股份有限公司
2025/08/11New drug · Class 2.4 海曲泊帕乙醇胺片CXHS2500093 江苏恒瑞医药股份有限公司
2025/08/11New drug · Class 2.4 海曲泊帕乙醇胺片CXHS2500092 江苏恒瑞医药股份有限公司
2025/08/09Generic · Class 3 格隆溴铵注射液CYHS2502894 河南普瑞药业有限公司
2025/08/09Generic · Class 3 格隆溴铵注射液CYHS2502893 河南普瑞药业有限公司
2025/08/09Generic · Class 3 艾拉戈克钠片CYHS2502892 南京正大天晴制药有限公司
2025/08/09Generic · Class 3 艾拉戈克钠片CYHS2502891 南京正大天晴制药有限公司
2025/08/09Generic · Class 3 盐酸纳洛酮注射液CYHS2502890 云南药科院生物医药股份有限公司; 楚雄和创药业有限责任公司
2025/08/09Generic · Class 3 注射用多黏菌素E甲磺酸钠CYHL2500139 南京正科医药股份有限公司
2025/08/09Generic · Class 3 普瑞巴林缓释片CYHL2500138 宜昌人福药业有限责任公司
2025/08/09Generic · Class 3 普瑞巴林缓释片CYHL2500137 宜昌人福药业有限责任公司
2025/08/09New drug · Class 3.3 西妥昔单抗注射液CXSS2500081 广东安普泽生物医药股份有限公司; 澳斯康生物(南通)股份有限公司
2025/08/09New drug · Class 2.2 特瑞普利单抗注射液CXSS2500080 上海君实生物医药科技股份有限公司; 上海君实生物工程有限公司; 苏州众合生物医药科技有限公司
2025/08/09New drug · Class 2.2 特瑞普利单抗注射液CXSS2500079 上海君实生物医药科技股份有限公司; 上海君实生物工程有限公司; 苏州众合生物医药科技有限公司
2025/08/09New drug · Class 1 注射用SHR-1826CXSL2500689 苏州盛迪亚生物医药有限公司
2025/08/09New drug · Class 1 注射用SHR-A2009CXSL2500688 苏州盛迪亚生物医药有限公司
2025/08/09New drug · Class 1 注射用FH-006CXSL2500687 上海甫弘生物医药有限公司; 江苏恒瑞医药股份有限公司
2025/08/09New drug · Class 1 SHR-4610注射液CXSL2500686 上海盛迪医药有限公司
2025/08/09New drug · Class 1 注射用SHR-9839 (sc)CXSL2500685 苏州盛迪亚生物医药有限公司; 上海恒瑞医药有限公司
2025/08/09New drug · Class 2.2 注射用瑞康曲妥珠单抗CXSL2500684 苏州盛迪亚生物医药有限公司
2025/08/09New drug · Class 1 注射用SHR-A2102CXSL2500683 苏州盛迪亚生物医药有限公司; 上海恒瑞医药有限公司
2025/08/09New drug · Class 1 注射用SHR-A2102CXSL2500682 苏州盛迪亚生物医药有限公司; 上海恒瑞医药有限公司
2025/08/09New drug · Class 2.2 阿得贝利单抗注射液CXSL2500681 上海盛迪医药有限公司
2025/08/09New drug · Class 1 注射用BL-M24D1CXSL2500680 成都百利多特生物药业有限责任公司; 四川百利药业有限责任公司
2025/08/09New drug · Class 1 QX029N注射液CXSL2500679 江苏荃信生物医药股份有限公司; 杭州中美华东制药有限公司
2025/08/09New drug · Class 1 HRS-7058片CXHL2500832 山东盛迪医药有限公司
2025/08/09New drug · Class 1 HRS-7058片CXHL2500831 山东盛迪医药有限公司

96 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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