药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/01/30 – 2024/02/05

Period
2024/01/30 to 2024/02/05, 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
412
Drugs with new generic filings (by drug name, de-duplicated)
93
Accepted this week, now under review
8

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

412filings, 127 of them generic

By application type

Application typeFilings
Supplement185
Generic127
New drug58
Import23
Unspecified10
Import re-registration9

By drug type

Drug typeFilings
Chemical drug278
治疗用生物制品68
TCM52
预防用生物制品9
Biologic5

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

264 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

131 this week

AcceptedDrugApplicants
2024/02/05Import · Class 1 Livmoniplimab 注射液JXSL2400035 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/02/05Import · Class 2.2 注射用德曲妥珠单抗JXSL2400034 Daiichi Sankyo Inc.; IQVIA RDS (Shanghai) Co. Ltd.
2024/02/05Generic · Class 3 己酮可可碱注射液CYHS2400498 辰欣药业股份有限公司
2024/02/05Generic · Class 3 复合磷酸氢钾注射液CYHS2400497 广州艾格生物科技有限公司; 广东星昊药业有限公司
2024/02/05Generic · Class 3 复合磷酸氢钾注射液CYHS2400496 广州艾格生物科技有限公司; 广东星昊药业有限公司
2024/02/05Generic · Class 3 别嘌醇片CYHS2400495 石家庄四药有限公司
2024/02/05Generic · Class 3 地氯雷他定口服溶液CYHS2400494 圣嘉(滨海)生物医药科技有限公司; 江苏欧歌制药有限公司
2024/02/05Generic · Class 3 乙酰半胱氨酸注射液CYHS2400493 合肥国药诺和药业有限公司; 国药集团国瑞药业有限公司
2024/02/05Generic · Class 3 酮咯酸氨丁三醇注射液CYHS2400490 江苏明圣康源药业有限公司; 江苏九旭药业有限公司
2024/02/05Generic · Class 3 己酮可可碱缓释片CYHS2400489 石药集团中诺药业(石家庄)有限公司; 石药集团欧意药业有限公司
2024/02/05Generic · Class 3 布洛芬注射液CYHS2400488 陕西天宇制药有限公司
2024/02/05Generic · Class 3 氨溴特罗口服溶液CYHS2400486 湖北凯纳药业有限公司; 湖北美思创药业有限公司
2024/02/05Generic · Class 3 布洛芬注射液CYHS2400485 陕西天宇制药有限公司
2024/02/05Generic · Class 3 小儿复方氨基酸注射液(19AA-Ⅰ)CYHS2400484 四川科伦药业股份有限公司
2024/02/05Generic · Class 3 小儿复方氨基酸注射液(19AA-Ⅰ)CYHS2400483 四川科伦药业股份有限公司
2024/02/05Generic · Class 3 加替沙星滴眼液CYHS2400482 合肥利民制药有限公司
2024/02/05Generic · Class 3 氨氯地平贝那普利胶囊CYHS2400478 东阳祥昇医药科技有限公司; 乐普制药科技有限公司
2024/02/05Generic · Class 3 二羟丙茶碱注射液CYHS2400476 成都欣捷高新技术开发股份有限公司; 成都市海通药业有限公司
2024/02/05Generic · Class 3 二羟丙茶碱注射液CYHS2400475 海南爱科制药有限公司
2024/02/05Generic · Class 3 吸入用雷芬那辛溶液CYHL2400035 云南龙海天然植物药业有限公司
2024/02/05New drug · Class 2.2 注射用重组人组织型纤溶酶原激酶衍生物CXSS2400016 华润昂德生物药业有限公司
2024/02/05New drug · Class 1.4 26价肺炎球菌结合疫苗CXSL2400099 北京智飞绿竹生物制药有限公司
2024/02/05New drug · Class 1 KAL-002CXSL2400098 四川厌氧生物科技有限责任公司
2024/02/05New drug · Class 1 KAL-002CXSL2400097 四川厌氧生物科技有限责任公司
2024/02/05New drug · Class 1 KAL-002CXSL2400096 四川厌氧生物科技有限责任公司
2024/02/05New drug · Class 1 KAL-002CXSL2400095 四川厌氧生物科技有限责任公司
2024/02/05New drug · Class 1 LY01620CXSL2400094 南京吉迈生物技术有限公司
2024/02/05New drug · Class 1 HLX53CXSL2400093 上海复宏汉霖生物技术股份有限公司; 上海复宏汉霖生物制药有限公司
2024/02/05New drug · Class 1 SK-08片CXHL2400142 广州康臣药业有限公司
2024/02/05New drug · Class 1 SK-08片CXHL2400141 广州康臣药业有限公司

101 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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