药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2025/11/18 – 2025/11/24

Period
2025/11/18 to 2025/11/24, 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
321
Drugs with new generic filings (by drug name, de-duplicated)
62
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

321filings, 82 of them generic

By application type

Application typeFilings
Supplement141
Generic82
New drug61
Unspecified14
Import re-registration12
Import11

By drug type

Drug typeFilings
Chemical drug173
TCM85
治疗用生物制品48
Biologic10
预防用生物制品5

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

62 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

213 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

103 this week

AcceptedDrugApplicants
2025/11/24Import · Class 1 注射用IPN10200JXSL2500225 Ipsen Innovation; Ipsen (Shanghai) Innovation Pharmaceutical Co. Ltd
2025/11/24Generic · Class 3 中性腹膜透析液(碳酸氢盐-G2.5%)CYHS2504045 石家庄四药有限公司
2025/11/24Generic · Class 3 叶酸片CYHS2504044 北京福元医药股份有限公司
2025/11/24Generic · Class 3 叶酸片CYHS2504043 北京福元医药股份有限公司
2025/11/24New drug · Class 1 EP-0210单抗注射液CXSL2501001 成都优洛生物科技有限公司
2025/11/24New drug · Class 1 R01注射液CXSL2501000 杭州纽安津生物科技有限公司
2025/11/22Import · Class 1 Itepekimab注射液JXSL2500224 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2025/11/22Import · Class 1 Omecamtiv Mecarbil缓释片JXHL2500362 Cytokinetics Incorporated; PPD Pharmaceutical Development (Beijing) Co. Ltd
2025/11/22Import · Class 1 Omecamtiv Mecarbil缓释片JXHL2500361 Cytokinetics Incorporated; PPD Pharmaceutical Development (Beijing) Co. Ltd
2025/11/22Import · Class 1 Omecamtiv Mecarbil缓释片JXHL2500360 Cytokinetics, Incorporated; PPD Pharmaceutical Development (Beijing) Co. Ltd
2025/11/22Generic · Class 3 右酮洛芬氨丁三醇注射液CYHS2504037 山东达冠医药科技有限公司; 山东辉成药业有限公司
2025/11/22Generic · Class 3 地氯雷他定口服溶液CYHS2504035 广东南国药业有限公司
2025/11/22New drug · Class 3.4 注射用重组人凝血因子ⅧCXSS2500125 远大蜀阳生命科学(成都)有限公司; 南京蓬勃生物科技有限公司
2025/11/22New drug · Class 1 注射用LM-24C5CXSL2500999 礼新医药科技(上海)有限公司
2025/11/22New drug · Class 3.2 流感病毒裂解疫苗(高剂量)CXSL2500998 成大生物(本溪)有限公司; 辽宁成大生物股份有限公司
2025/11/22New drug · Class 2.4 硫酸艾玛昔替尼片CXHS2500141 江苏恒瑞医药股份有限公司
2025/11/22New drug · Class 1 HYP-6589片CXHL2501289 四川汇宇海玥医药科技有限公司
2025/11/22New drug · Class 1 HYP-6589片CXHL2501288 四川汇宇海玥医药科技有限公司
2025/11/21Generic · Class 3 注射用氨磷汀CYHS2504020 大连美罗中药厂有限公司; 美罗药业股份有限公司
2025/11/21New drug · Class 2.3 湿润烧伤膏CXZL2500117 汕头市美宝制药有限公司
2025/11/21New drug · Class 1 注射用BL-B01D1CXSS2500124 成都百利多特生物药业有限责任公司
2025/11/21New drug · Class 1 注射用SKB518CXSL2500997 四川科伦博泰生物医药股份有限公司
2025/11/21New drug · Class 1 注射用HLX43CXSL2500996 上海复宏汉霖生物技术股份有限公司; 上海复宏汉霖生物医药有限公司
2025/11/21New drug · Class 1 重组抗EGFR人源化单克隆抗体注射液CXSL2500995 上海复宏瑞霖生物技术有限公司; 上海复宏汉霖生物医药有限公司
2025/11/21New drug · Class 1 注射用JSKN003CXSL2500994 江苏康宁杰瑞生物制药有限公司
2025/11/21New drug · Class 1 QLP2117注射液CXSL2500993 齐鲁制药有限公司
2025/11/21New drug · Class 2.2 QL2107注射液CXSL2500992 齐鲁制药有限公司
2025/11/21New drug · Class 3.3 水痘减毒活疫苗CXSL2500991 云南沃森生物技术股份有限公司; 云南疫苗实验室有限公司; 北京沃森创新生物技术有限公司; 玉溪沃森生物技术有限公司
2025/11/21New drug · Class 2.2 氢溴酸伏硫西汀口崩片CXHS2500138 深圳市泛谷药业股份有限公司; 华益泰康药业股份有限公司
2025/11/21New drug · Class 2.2 氢溴酸伏硫西汀口崩片CXHS2500137 深圳市泛谷药业股份有限公司; 华益泰康药业股份有限公司

73 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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