药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2025/11/25 – 2025/12/01

Period
2025/11/25 to 2025/12/01, 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
338
Drugs with new generic filings (by drug name, de-duplicated)
56
Accepted this week, now under review
88

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

338filings, 70 of them generic

By application type

Application typeFilings
Supplement166
Generic70
New drug61
Import24
Unspecified14
Import re-registration3

By drug type

Drug typeFilings
Chemical drug196
TCM86
治疗用生物制品50
Biologic5
预防用生物制品1

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

56 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

199 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

107 this week

AcceptedDrugApplicants
2025/12/01Generic · Class 3 复方电解质醋酸钠注射液CYHS2504127 山东齐都药业有限公司
2025/12/01Generic · Class 3 盐酸西替利嗪滴眼液CYHL2500210 南京海纳制药有限公司
2025/11/29Import · Class 2.2 利妥昔单抗注射液JXSS2500147 Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH
2025/11/29Import · Class 2.2 利妥昔单抗注射液JXSS2500146 Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH
2025/11/29Import · Class 1 JNJ-88545223片JXHL2500367 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2025/11/29Import · Class 1 JNJ-88545223片JXHL2500366 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2025/11/29Generic · Class 3 乙酰半胱氨酸片CYHS2504115 浙江皓格药业有限公司; 成都通德药业有限公司
2025/11/29Generic · Class 3 盐酸左西替利嗪口服溶液CYHS2504113 重庆和平制药有限公司
2025/11/29Generic · Class 3 盐酸左西替利嗪口服溶液CYHS2504112 重庆和平制药有限公司
2025/11/29Generic · Class 3 盐酸溴己新片CYHS2504110 四川依科制药有限公司
2025/11/29Generic · Class 3 复方聚乙二醇电解质散(II)CYHS2504109 重庆仁泽医药科技有限公司; 成都通德药业有限公司
2025/11/29Generic · Class 3 ω-3甘油三酯(2%)中/长链脂肪乳/氨基酸(16)/葡萄糖(16%)注射液CYHS2504108 浙江国镜药业有限公司; 四川科伦药业股份有限公司
2025/11/29New drug · Class 2.1;2.2 泰它西普注射液CXSL2501028 荣昌生物制药(烟台)股份有限公司
2025/11/29New drug · Class 1 注射用SSS57CXSL2501027 沈阳三生制药有限责任公司
2025/11/29New drug · Class 1 AK139注射液CXSL2501026 中山康方生物医药有限公司
2025/11/29New drug · Class 1 AK139注射液CXSL2501025 中山康方生物医药有限公司
2025/11/29New drug · Class 1 AK139注射液CXSL2501024 中山康方生物医药有限公司
2025/11/29New drug · Class 1 AK139注射液CXSL2501023 中山康方生物医药有限公司
2025/11/29New drug · Class 1 AK139注射液CXSL2501022 中山康方生物医药有限公司
2025/11/29New drug · Class 1 人自体多克隆调节性T细胞注射液CXSL2501020 上海赛尔欣生物医疗科技有限公司
2025/11/29New drug · Class 1 注射用SSS57CXSL2501019 沈阳三生制药有限责任公司
2025/11/29New drug · Class 1 CMS-D017胶囊CXHL2501314 深圳市康哲生物科技有限公司
2025/11/29New drug · Class 1 CMS-D017胶囊CXHL2501313 深圳市康哲生物科技有限公司
2025/11/29New drug · Class 1 CMS-D017胶囊CXHL2501312 深圳市康哲生物科技有限公司
2025/11/29New drug · Class 1 CMS-D017胶囊CXHL2501311 深圳市康哲生物科技有限公司
2025/11/29New drug · Class 1 RG002C0106注射液CXHL2501310 北京炫景瑞医药科技有限公司; 苏州炫景生物科技有限公司
2025/11/29New drug · Class 1 注射用SJ001CXHL2501309 上海施江生物科技有限公司
2025/11/29New drug · Class 1 BEBT-701注射液CXHL2501308 广州必贝特医药股份有限公司
2025/11/29New drug · Class 2.2 DP22001口服乳CXHL2501307 中国科学院上海药物研究所
2025/11/29New drug · Class 1 UBT251注射液CXHL2501306 联邦生物科技(珠海横琴)有限公司

77 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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