药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/08/06 – 2024/08/12

Period
2024/08/06 to 2024/08/12, 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
390
Drugs with new generic filings (by drug name, de-duplicated)
81
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

390filings, 123 of them generic

By application type

Application typeFilings
Supplement165
Generic123
New drug54
Import19
Unspecified18
Import re-registration11

By drug type

Drug typeFilings
Chemical drug291
TCM46
治疗用生物制品37
Biologic10
预防用生物制品6

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

81 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

229 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

135 this week

AcceptedDrugApplicants
2024/08/12Generic · Class 3 米诺地尔外用溶液CYHS2402603 江苏济茗医药有限公司; 江苏万高药业股份有限公司
2024/08/12Generic · Class 3 米诺地尔外用溶液CYHS2402602 江苏济茗医药有限公司; 江苏万高药业股份有限公司
2024/08/12Generic · Class 3 盐酸拉贝洛尔注射液CYHS2402599 江苏神龙药业有限公司; 西安安健药业有限公司
2024/08/12Generic · Class 3 盐酸拉贝洛尔注射液CYHS2402598 江苏神龙药业有限公司; 西安安健药业有限公司
2024/08/12Generic · Class 3 盐酸拉贝洛尔注射液CYHS2402597 江苏神龙药业有限公司; 西安安健药业有限公司
2024/08/12New drug · Class 2.2 特瑞普利单抗注射液CXSS2400085 上海君实生物医药科技股份有限公司; 苏州众合生物医药科技有限公司; 上海君实生物工程有限公司
2024/08/12New drug · Class 2.2 特瑞普利单抗注射液CXSS2400084 上海君实生物医药科技股份有限公司; 苏州众合生物医药科技有限公司; 上海君实生物工程有限公司
2024/08/12New drug · Class 1 TG-1000胶囊CXHS2400073 健康元药业集团股份有限公司; 凯莱英生命科学技术(天津)有限公司
2024/08/10Import · Class 1 ALPN-303注射液JXSL2400147 Alpine Immune Sciences Inc.; ——
2024/08/10Generic · Class 3 尼美舒利片CYHS2402594 上海理想制药有限公司
2024/08/10Generic · Class 3 米诺地尔搽剂CYHS2402593 山东鲁抗医药集团赛特有限责任公司
2024/08/10Generic · Class 3 米诺地尔搽剂CYHS2402592 山东鲁抗医药集团赛特有限责任公司
2024/08/10Generic · Class 3 吡格列酮二甲双胍片(15mg/850mg)CYHS2402591 安徽杰玺医药有限公司; 华益药业科技(安徽)有限公司
2024/08/10Generic · Class 3 己酮可可碱缓释片CYHS2402588 广州市联瑞制药有限公司
2024/08/10Generic · Class 3 二羟丙茶碱注射液CYHS2402586 江西亿友药业有限公司; 裕松源药业有限公司
2024/08/10Generic · Class 3 氯化钙注射液CYHS2402585 湖南埃威格林医药科技有限公司; 浙江赛默制药有限公司
2024/08/10New drug · Class 3.3 地舒单抗注射液CXSL2400532 华兰基因工程(河南)有限公司; 华兰基因工程有限公司
2024/08/10New drug · Class 1 HC022注射液CXSL2400531 上海宏成药业有限公司
2024/08/10New drug · Class 3.3 精蛋白人胰岛素混合注射液 (30R)CXSL2400530 恒敬合创生物医药(浙江)有限公司
2024/08/10New drug · Class 2.2 SHR-8068注射液CXSL2400529 苏州盛迪亚生物医药有限公司
2024/08/10New drug · Class 2.2 BIOS2210CXHL2400815 杭州百诚医药科技股份有限公司
2024/08/10New drug · Class 2.2 BIOS2210CXHL2400814 杭州百诚医药科技股份有限公司
2024/08/10New drug · Class 2.2 司美格鲁肽注射液CXHL2400813 山西嘉源生物医药有限公司
2024/08/10New drug · Class 2.2 司美格鲁肽注射液CXHL2400812 山西嘉源生物医药有限公司
2024/08/10New drug · Class 2.2 BM2216缓释片CXHL2400811 南京佰麦生物技术有限公司
2024/08/10New drug · Class 2.2 BM2216缓释片CXHL2400810 南京佰麦生物技术有限公司
2024/08/10New drug · Class 2.2 BM2216缓释片CXHL2400809 南京佰麦生物技术有限公司
2024/08/09Import · Class 2.4 艾伏尼布片JXHL2400198 Institut de Recherches Internationales Servier; Servier (Beijing) Pharmaceutical Research & Development Co. LTD
2024/08/09Generic · Class 3 盐酸去氧肾上腺素注射液CYHS2402578 上海炫鑫医药科技有限公司; 山东方明药业集团股份有限公司
2024/08/09Generic · Class 3 枸橼酸西地那非口溶膜CYHS2402577 四川科伦药业股份有限公司

105 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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