药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/02/06 – 2024/02/12

Period
2024/02/06 to 2024/02/12, 7 days inclusive
Data as of
2026/11/06 06:00
Cached records
94,364 acceptance records, 11,708 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
382
Drugs with new generic filings (by drug name, de-duplicated)
86
Accepted this week, now under review
0

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

382filings, 111 of them generic

By application type

Application typeFilings
Supplement152
Generic111
New drug78
Import21
Unspecified11
Import re-registration9

By drug type

Drug typeFilings
Chemical drug286
治疗用生物制品52
TCM35
预防用生物制品5
Biologic4

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

86 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

230 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

137 this week

AcceptedDrugApplicants
2024/02/10Generic · Class 3 盐酸甲氧氯普胺注射液CYHS2400606 武汉天安医药科技有限公司; 湖北津药药业股份有限公司
2024/02/09Import · Class 1 SGN-B6AJXSL2400043 Seagen Inc.; IQVIA RDS (Shanghai) Co. Ltd
2024/02/09Generic · Class 3 依巴斯汀口服溶液CYHS2400603 北京沃邦医药科技有限公司; 江苏欧歌制药有限公司
2024/02/09New drug · Class 1 TQB3107片CXHL2400193 正大天晴药业集团南京顺欣制药有限公司
2024/02/09New drug · Class 1 TQB3107片CXHL2400192 正大天晴药业集团南京顺欣制药有限公司
2024/02/09New drug · Class 1 TQG3926片CXHL2400191 正大天晴药业集团股份有限公司
2024/02/09New drug · Class 1 TQG3926片CXHL2400190 正大天晴药业集团股份有限公司
2024/02/08Import · Class 3.1 注射用德曲妥珠单抗JXSS2400013 Daiichi Sankyo Europe GmbH; Baxter Oncology GmbH; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD.
2024/02/08Import · Class 3.1 塔奎妥单抗注射液JXSS2400012 Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd.
2024/02/08Import · Class 3.1 塔奎妥单抗注射液JXSS2400011 Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd.
2024/02/08Import · Class 1 镥[177Lu]Lu-NeoB注射液JXHL2400032 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/02/08Import · Class 1 用于制备放射性药物[68Ga]Ga-NeoB注射液的药盒JXHL2400031 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/02/08Generic · Class 3 氯化钙注射液CYHS2400602 华夏生生药业(北京)有限公司
2024/02/08Generic · Class 3 盐酸苯海拉明注射液CYHS2400599 南京泽恒医药技术开发有限公司; 亚邦医药股份有限公司
2024/02/08Generic · Class 3 盐酸苯海拉明注射液CYHS2400598 南京泽恒医药技术开发有限公司; 亚邦医药股份有限公司
2024/02/08Generic · Class 3 盐酸非索非那定口服混悬液CYHS2400592 哈尔滨葵花药业有限公司; 葵花药业集团重庆小葵花儿童制药有限公司
2024/02/08Generic · Class 3 吡拉西坦注射液CYHS2400580 四川新斯顿制药股份有限公司
2024/02/08Generic · Class 3 盐酸美金刚口崩片CYHS2400578 北京星昊医药股份有限公司; 北京星昊盈盛药业有限公司
2024/02/08Generic · Class 3 盐酸美金刚口崩片CYHS2400577 北京星昊医药股份有限公司; 北京星昊盈盛药业有限公司
2024/02/08Generic · Class 3 吸入用盐酸丙卡特罗溶液CYHS2400570 北京柏雅联合药物研究所有限公司; 山东华鲁制药有限公司
2024/02/08Generic · Class 3 碳酸氢钠注射液CYHS2400568 广州合和医药有限公司; 广东星昊药业有限公司
2024/02/08Generic · Class 3 乙酰半胱氨酸注射液CYHS2400567 中润药业有限公司; 成都市海通药业有限公司
2024/02/08Generic · Class 3 酒石酸匹莫范色林胶囊CYHL2400037 华中药业股份有限公司
2024/02/08New drug · Class 1 夫那奇珠单抗注射液CXSS2400019 苏州盛迪亚生物医药有限公司
2024/02/08New drug · Class 1 夫那奇珠单抗注射液CXSS2400018 苏州盛迪亚生物医药有限公司
2024/02/08New drug · Class 1 夫那奇珠单抗注射液CXSS2400017 苏州盛迪亚生物医药有限公司
2024/02/08New drug · Class 1 M108单抗注射液CXSL2400118 明济生物制药(北京)有限公司
2024/02/08New drug · Class 1 RJK002注射液CXSL2400117 上海瑞吉康生物医药有限公司
2024/02/08New drug · Class 1 MSCohi-O镜片CXSL2400116 广东普罗凯融生物医药科技有限公司
2024/02/08New drug · Class 1 MSCohi-O镜片CXSL2400115 广东普罗凯融生物医药科技有限公司

107 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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