药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2025/09/16 – 2025/09/22

Period
2025/09/16 to 2025/09/22, 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
352
Drugs with new generic filings (by drug name, de-duplicated)
69
Accepted this week, now under review
111

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

352filings, 92 of them generic

By application type

Application typeFilings
Supplement176
Generic92
New drug47
Import28
Import re-registration7
Unspecified2

By drug type

Drug typeFilings
Chemical drug182
TCM81
治疗用生物制品80
预防用生物制品7
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

69 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

218 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

99 this week

AcceptedDrugApplicants
2025/09/22Import · Class 2.4 甲磺酸奥希替尼片JXHS2500108 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/09/22Import · Class 2.4 甲磺酸奥希替尼片JXHS2500107 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/09/22Import · Class 1 LY3537021注射液JXHL2500295 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd
2025/09/22New drug · Class 3.3 QL2110注射液CXSL2500812 齐鲁制药有限公司
2025/09/22New drug · Class 3.3 QL2110注射液CXSL2500811 齐鲁制药有限公司
2025/09/22New drug · Class 1 富马酸仑博替尼胶囊CXHS2500120 四川科伦博泰生物医药股份有限公司; 湖南科伦制药有限公司
2025/09/22New drug · Class 1 富马酸仑博替尼胶囊CXHS2500119 四川科伦博泰生物医药股份有限公司; 湖南科伦制药有限公司
2025/09/22New drug · Class 1 注射用GMDTCCXHL2501019 广州健尔圣医药科技有限公司
2025/09/20Generic · Class 3 米诺地尔搽剂CYHS2503477 海南钧华医疗科技有限公司; 北京京丰制药(河北)有限公司
2025/09/20Generic · Class 3 注射用泼尼松龙琥珀酸钠CYHL2500173 南京恩泰医药科技有限公司
2025/09/20Generic · Class 3 注射用泼尼松龙琥珀酸钠CYHL2500172 南京恩泰医药科技有限公司
2025/09/20Generic · Class 3 注射用泼尼松龙琥珀酸钠CYHL2500171 南京恩泰医药科技有限公司
2025/09/20New drug · Class 1.1 柴芍解郁颗粒CXZL2500084 黑龙江省济仁药业有限公司
2025/09/20New drug · Class 1 靶向CD19基因修饰的异体嵌合抗原受体T细胞注射液CXSL2500810 上海邦耀生物科技有限公司
2025/09/20New drug · Class 3.3 重组人促卵泡激素注射液CXSL2500809 成都景泽生物制药有限公司
2025/09/20New drug · Class 3.3 重组人促卵泡激素注射液CXSL2500808 成都景泽生物制药有限公司
2025/09/20New drug · Class 2.2 WGP03CXSL2500807 深圳市卫光生物制品股份有限公司; 深圳瑞健生命科学研究院有限公司
2025/09/19Import · Class 1 注射用AZD0292JXSL2500182 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd
2025/09/19Generic · Class 3 地氯雷他定口服溶液CYHS2503469 广州聚力医药开发有限公司; 广东众生药业股份有限公司
2025/09/19Generic · Class 3 注射用盐酸多西环素CYHS2503467 湖北美林药业有限公司
2025/09/19Generic · Class 3 利多卡因丁卡因乳膏CYHS2503466 江苏盈科生物制药有限公司
2025/09/19Generic · Class 3 维生素K1注射液CYHS2503464 江苏九旭药业有限公司
2025/09/19New drug · Class 1.1 参苏止咳颗粒CXZL2500083 玉森(江西)新药研发有限公司
2025/09/19New drug · Class 3.3 阿柏西普眼内注射溶液CXSS2500098 迈威(上海)生物科技股份有限公司; 江苏泰康生物医药有限公司
2025/09/19New drug · Class 1 泰卡西单抗注射液CXSS2500097 深圳信立泰药业股份有限公司; 信立泰(苏州)药业有限公司
2025/09/19New drug · Class 1 泰卡西单抗注射液CXSS2500096 深圳信立泰药业股份有限公司; 信立泰(苏州)药业有限公司
2025/09/19New drug · Class 1 注射用SSGJ-709CXSL2500806 沈阳三生制药有限责任公司
2025/09/19New drug · Class 1.2 冻干带状疱疹病毒mRNA疫苗CXSL2500805 北京沃森创新生物技术有限公司; 云南疫苗实验室有限公司; 复旦大学; 上海蓝鹊生物医药有限公司; 玉溪沃森生物技术有限公司
2025/09/19New drug · Class 1.2 冻干带状疱疹病毒mRNA疫苗CXSL2500804 北京沃森创新生物技术有限公司; 云南疫苗实验室有限公司; 复旦大学; 上海蓝鹊生物医药有限公司; 玉溪沃森生物技术有限公司
2025/09/19New drug · Class 2.2 注射用苏维西塔单抗CXSL2500803 江苏先声生物制药有限公司

69 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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