药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2025/02/04 – 2025/02/10

Period
2025/02/04 to 2025/02/10, 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
356
Drugs with new generic filings (by drug name, de-duplicated)
93
Accepted this week, now under review
16

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

356filings, 135 of them generic

By application type

Application typeFilings
Generic135
Supplement110
New drug80
Import15
Import re-registration11
Unspecified5

By drug type

Drug typeFilings
Chemical drug266
治疗用生物制品54
TCM30
预防用生物制品4
Biologic2

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

93 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

222 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

128 this week

AcceptedDrugApplicants
2025/02/10New drug · Class 1.1 复方芎蕲软胶囊CXZL2500008 四川省中医药科学院(四川省中药研究所); 中国科学院兰州化学物理研究所
2025/02/10New drug · Class 1 自体淋巴细胞注射液CXSL2500131 康爱瑞浩生物医药(浙江)股份有限公司
2025/02/10New drug · Class 2.3 DYTH201片CXHL2500184 山西德元堂药业有限公司
2025/02/10New drug · Class 2.3 DYTH201片CXHL2500183 山西德元堂药业有限公司
2025/02/09Import · Class 1 Bleximenib片JXHL2500023 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2025/02/09Import · Class 1 Bleximenib片JXHL2500022 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2025/02/09Import · Class 1 Bleximenib片JXHL2500021 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2025/02/09Import · Class 2.4 放射性药物镓[68Ga]oxodotreotide注射液配制用药盒JXHL2500020 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/02/09Import · Class 2.4 镥[177Lu]oxodotreotide注射液JXHL2500019 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/02/09Generic · Class 3 盐酸舍曲林口服浓缩液CYHS2500685 江苏润恒制药有限公司
2025/02/09Generic · Class 3 盐酸舍曲林口服浓缩液CYHS2500677 万特制药(海南)有限公司
2025/02/09Generic · Class 3 盐酸纳美芬注射液CYHS2500675 新乡市常乐制药有限责任公司
2025/02/09Generic · Class 3 盐酸纳美芬注射液CYHS2500673 新乡市常乐制药有限责任公司
2025/02/09Generic · Class 3 山梨醇甘露醇冲洗剂CYHS2500672 青岛奥瑞森医疗科技有限公司; 青岛瑞奈医疗科技有限公司
2025/02/09Generic · Class 3 美沙拉秦肠溶缓释胶囊CYHS2500660 成都倍特药业股份有限公司
2025/02/09Generic · Class 3 贝派度酸依折麦布片CYHL2500034 江西施美药业股份有限公司
2025/02/09Generic · Class 3 甘露醇山梨醇注射液CYHL2500033 四川美大康佳乐药业有限公司
2025/02/09New drug · Class 3.1 芍药甘草颗粒CXZS2500004 山东润中药业有限公司
2025/02/09New drug · Class 1.1 七福饮颗粒CXZL2500007 河南福地生物科技有限公司
2025/02/09New drug · Class 1.2 重组带状疱疹疫苗(CHO细胞)CXSS2500027 绿竹生物制药(珠海市)有限公司
2025/02/09New drug · Class 3.3 德谷胰岛素注射液CXSS2500026 宜昌东阳光长江药业股份有限公司
2025/02/09New drug · Class 3.3 德谷胰岛素注射液CXSS2500025 宜昌东阳光长江药业股份有限公司
2025/02/09New drug · Class 1.2 YKYY025注射液CXSL2500130 杭州天龙药业有限公司
2025/02/09New drug · Class 1 人牙囊间充质干细胞注射液CXSL2500129 成都世联康健生物科技有限公司
2025/02/09New drug · Class 1 注射用KJ103CXSL2500128 上海宝济药业股份有限公司
2025/02/09New drug · Class 3.3 地舒单抗注射液CXSL2500127 华兰基因工程(河南)有限公司; 华兰基因工程有限公司
2025/02/09New drug · Class 1 NCR201注射液CXSL2500126 中盛溯源(广州)生物科技有限公司; 安徽中盛溯源生物科技有限公司
2025/02/09New drug · Class 1 HWS116注射液CXSL2500125 武汉人福创新药物研发中心有限公司
2025/02/09New drug · Class 1 DNTH103注射液CXSL2500124 元羿生物科技(上海)有限公司
2025/02/09New drug · Class 1 IBI3020CXSL2500123 信达生物医药科技(杭州)有限公司

98 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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