药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2025/07/01 – 2025/07/07

Period
2025/07/01 to 2025/07/07, 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
299
Drugs with new generic filings (by drug name, de-duplicated)
49
Accepted this week, now under review
57

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

299filings, 69 of them generic

By application type

Application typeFilings
Supplement152
Generic69
New drug56
Import15
Import re-registration5
Unspecified2

By drug type

Drug typeFilings
Chemical drug191
TCM55
治疗用生物制品51
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

49 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

188 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

96 this week

AcceptedDrugApplicants
2025/07/07New drug · Class 3.3 QL2106注射液CXSL2500545 齐鲁制药有限公司
2025/07/05Import · Class 1 乙磺酸LY4066434片JXHL2500161 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/07/05Import · Class 1 乙磺酸LY4066434片JXHL2500160 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/07/05Import · Class 1 乙磺酸LY4066434片JXHL2500159 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/07/05Generic · Class 3 阿昔洛韦片CYHS2502385 浙江车头制药股份有限公司; 浙江京新药业股份有限公司
2025/07/05Generic · Class 3 阿昔洛韦片CYHS2502384 浙江车头制药股份有限公司; 浙江京新药业股份有限公司
2025/07/05Generic · Class 3 阿昔洛韦片CYHS2502383 浙江车头制药股份有限公司; 浙江京新药业股份有限公司
2025/07/05Generic · Class 3 普瑞巴林口服溶液CYHS2502378 石家庄市华新药业有限责任公司
2025/07/05New drug · Class 1.1 参榆消银软膏CXZL2500044 北京斯利安药业有限公司
2025/07/05New drug · Class 3.3 司美格鲁肽注射液CXSL2500551 太极集团重庆涪陵制药厂有限公司
2025/07/05New drug · Class 3.3 司美格鲁肽注射液CXSL2500550 太极集团重庆涪陵制药厂有限公司
2025/07/05New drug · Class 1 HEC-151注射液CXSL2500549 东莞市东阳光生物药研发有限公司; 广东东阳光药业股份有限公司
2025/07/05New drug · Class 1 人脐带CD146间充质干细胞注射液CXSL2500548 北京三有利康细胞科技有限公司
2025/07/05New drug · Class 1 宫血间充质干细胞注射液CXSL2500547 浙江生创精准医疗科技有限公司
2025/07/05New drug · Class 1 QH104A细胞注射液CXSL2500546 北京清辉联诺生物科技有限责任公司
2025/07/05New drug · Class 1 IPG0521注射液CXSL2500544 南京艾美斐生物医药科技有限公司
2025/07/05New drug · Class 1 GZR101-80注射液CXSL2500543 甘李药业山东有限公司
2025/07/05New drug · Class 1 注射用MCLA-129CXSL2500542 贝达药业股份有限公司
2025/07/05New drug · Class 1 人源化抗CD19 CAR-T细胞注射液CXSL2500541 沈阳竞生生物科技有限公司
2025/07/05New drug · Class 1 ZHB110舌下片CXSL2500540 江苏众红生物工程创药研究院有限公司
2025/07/05New drug · Class 1 ZHB110舌下片CXSL2500539 江苏众红生物工程创药研究院有限公司
2025/07/05New drug · Class 2.2 布瑞哌唑口溶膜CXHS2500072 深圳市宇健生物医药有限公司; 深圳市新阳唯康科技有限公司
2025/07/05New drug · Class 2.2 布瑞哌唑口溶膜CXHS2500071 深圳市宇健生物医药有限公司; 深圳市新阳唯康科技有限公司
2025/07/05New drug · Class 1 硫酸酯化聚古罗糖醛酸钠颗粒CXHL2500650 中国科学院上海药物研究所; 绿谷(上海)医药科技有限公司
2025/07/05New drug · Class 1 SYH2066片CXHL2500649 石药集团欧意药业有限公司
2025/07/05New drug · Class 1 SYH2066片CXHL2500648 石药集团欧意药业有限公司
2025/07/05New drug · Class 2.4 盐酸恩沙替尼胶囊CXHL2500647 贝达药业股份有限公司
2025/07/05New drug · Class 2.4 盐酸恩沙替尼胶囊CXHL2500646 贝达药业股份有限公司
2025/07/04Import · Class 2.3 迈之灵片JXZL2500002 Aescuven Pharma Deutschland GmbH & Co.KG; Shenzhen Xingyin Pharmaceutical Co. Ltd.
2025/07/04Import · Class 2.3 迈之灵片JXZL2500001 Aescuven Pharma Deutschland GmbH & Co. KG; Shenzhen Xingyin Pharmaceutical Co. Ltd.

66 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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