药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2025/07/22 – 2025/07/28

Period
2025/07/22 to 2025/07/28, 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
366
Drugs with new generic filings (by drug name, de-duplicated)
76
Accepted this week, now under review
92

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

366filings, 103 of them generic

By application type

Application typeFilings
Supplement155
Generic103
New drug73
Import27
Unspecified4
Import re-registration4

By drug type

Drug typeFilings
Chemical drug243
TCM71
治疗用生物制品48
Biologic2
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

76 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

237 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

124 this week

AcceptedDrugApplicants
2025/07/28Generic · Class 3 吲哚布芬片CYHS2502710 成都纵联医疗健康科技有限公司; 成都天台山制药股份有限公司
2025/07/28Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G2.5%)CYHS2502705 青岛瑞奈医疗科技有限公司
2025/07/28Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G1.5%)CYHS2502704 青岛瑞奈医疗科技有限公司
2025/07/28Generic · Class 3 氯化钾注射液CYHS2502703 河北天成药业股份有限公司
2025/07/28Generic · Class 3 丙氯拉嗪栓CYHL2500132 海鸿恒隆(海南)生物科技有限公司
2025/07/28New drug · Class 1.2 HQY总黄酮胶囊CXZL2500057 南京三同医药科技有限公司; 南京中医药大学; 江苏省中医药研究院; 南京市中医院
2025/07/28New drug · Class 1.2 HQY总黄酮提取物CXZL2500056 南京三同医药科技有限公司; 南京中医药大学; 江苏省中医药研究院; 南京市中医院
2025/07/28New drug · Class 1.1 糖宁通络片CXZL2500055 百灵毓秀(珠海)医药有限公司
2025/07/28New drug · Class 1 IBI354CXSL2500632 信达生物医药科技(杭州)有限公司
2025/07/28New drug · Class 1 镥[177Lu]-BL-ARC001注射液CXSL2500631 成都百利多特生物药业有限责任公司; 四川百利药业有限责任公司
2025/07/28New drug · Class 2.2 LY01015注射液CXSL2500630 山东博安生物技术股份有限公司
2025/07/28New drug · Class 2.2 LY01015注射液CXSL2500629 山东博安生物技术股份有限公司
2025/07/28New drug · Class 1 注射用BA1301CXSL2500628 山东博安生物技术股份有限公司
2025/07/28New drug · Class 1 人脐带间充质干细胞注射液CXSL2500627 北京第一生物科技开发有限公司
2025/07/28New drug · Class 1 MG-K10人源化单抗注射液CXSL2500626 湖南麦济生物技术股份有限公司
2025/07/28New drug · Class 1 MG-K10人源化单抗注射液CXSL2500625 湖南麦济生物技术股份有限公司
2025/07/28New drug · Class 2.2 拉莫三嗪干混悬剂CXHS2500087 上海奥科远制药有限公司
2025/07/28New drug · Class 2.2 拉莫三嗪干混悬剂CXHS2500086 上海奥科远制药有限公司
2025/07/28New drug · Class 1 BGB-53038胶囊CXHL2500768 百济神州(苏州)生物科技有限公司
2025/07/28New drug · Class 1 BGB-53038胶囊CXHL2500767 百济神州(苏州)生物科技有限公司
2025/07/28New drug · Class 2.4 注射用多西他赛(白蛋白结合型)CXHL2500766 石药集团中奇制药技术(石家庄)有限公司
2025/07/28New drug · Class 1 BGB-53038胶囊CXHL2500765 百济神州(苏州)生物科技有限公司
2025/07/28New drug · Class 1 AL28979片CXHL2500764 南京爱德程医药科技有限公司
2025/07/28New drug · Class 1 TQB3217片CXHL2500763 正大天晴药业集团南京顺欣制药有限公司
2025/07/28New drug · Class 1 TQB3217片CXHL2500762 正大天晴药业集团南京顺欣制药有限公司
2025/07/28New drug · Class 2.3 HKGM-453CXHL2500761 黑龙江亿达鸿药业有限公司
2025/07/25Import · Class 1 MK-7240注射液JXSL2500132 Merck Sharp & Dahme LLC; 不适用
2025/07/25Import · Class 2.2 Risankizumab注射液JXSL2500131 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2025/07/25Import · Class 2.2 Risankizumab注射液JXSL2500130 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2025/07/25Import · Class 2.2 Risankizumab注射液JXSL2500129 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.

94 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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