药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/11/19 – 2024/11/25

Period
2024/11/19 to 2024/11/25, 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
330
Drugs with new generic filings (by drug name, de-duplicated)
79
Accepted this week, now under review
6

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

330filings, 101 of them generic

By application type

Application typeFilings
Supplement135
Generic101
New drug61
Import15
Unspecified10
Import re-registration8

By drug type

Drug typeFilings
Chemical drug244
治疗用生物制品42
TCM38
预防用生物制品6

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

79 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

208 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

111 this week

AcceptedDrugApplicants
2024/11/25Generic · Class 3 左氧氟沙星注射液CYHS2404048 江苏长江药业有限公司; 江苏大红鹰恒顺药业有限公司
2024/11/25Generic · Class 3 硫辛酸片CYHS2404041 北京双鹭药业股份有限公司
2024/11/25New drug · Class 3.1 桃红四物颗粒CXZS2400035 河北万邦复临药业有限公司
2024/11/25New drug · Class 1.4 吸附无细胞百(三组分)白破b型流感嗜血杆菌(结合)-ACYW135群脑膜炎球菌(结合)联合疫苗CXSL2400797 康希诺生物股份公司
2024/11/25New drug · Class 2.2 ZL2301CXHL2401280 广东众丽医药科技有限公司
2024/11/25New drug · Class 1 XH-S004片CXHL2401279 浙江星浩澎博医药有限公司
2024/11/25New drug · Class 1 XH-S004片CXHL2401278 浙江星浩澎博医药有限公司
2024/11/25New drug · Class 2.1 GW901肠溶软胶囊CXHL2401277 成都国为生物医药有限公司
2024/11/23Import · Class 2.2 罗莫索珠单抗注射液JXSL2400227 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2024/11/23Import · Class 1 输注用无菌冻干粉Telisotuzumab vedotinJXSL2400226 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/11/23Generic · Class 3 倍他米松磷酸钠注射液CYHS2404040 安徽美来药业股份有限公司; 河南科伦药业有限公司
2024/11/23Generic · Class 3 碳酸司维拉姆干混悬剂CYHS2404034 山东新华制药股份有限公司
2024/11/23Generic · Class 3 碳酸司维拉姆干混悬剂CYHS2404033 山东新华制药股份有限公司
2024/11/23Generic · Class 3 醋酸特利加压素注射液CYHS2404027 成都圣诺生物制药有限公司
2024/11/23Generic · Class 3 氨甲环酸氯化钠注射液CYHS2404023 湖北津药药业股份有限公司
2024/11/23Generic · Class 3 盐酸丁螺环酮片CYHS2404018 山东京卫制药有限公司
2024/11/23Generic · Class 3 盐酸丁螺环酮片CYHS2404017 山东京卫制药有限公司
2024/11/23Generic · Class 3 吸入用盐酸氨溴索溶液CYHL2400234 北京韩美药品有限公司
2024/11/23Generic · Class 3 双氯芬酸钠贴剂CYHL2400233 四川科伦药业股份有限公司
2024/11/23Generic · Class 3 双氯芬酸钠贴剂CYHL2400232 四川科伦药业股份有限公司
2024/11/23New drug · Class 2.2 ZY-A001CXZL2400079 亚宝药业集团股份有限公司
2024/11/23New drug · Class 1 伊诺格鲁肽注射液CXSS2400129 杭州先为达生物科技股份有限公司; 美药星(南京)制药有限公司
2024/11/23New drug · Class 3.3 利妥昔单抗注射液CXSS2400128 华兰安康生物股份有限公司
2024/11/23New drug · Class 3.3 利妥昔单抗注射液CXSS2400127 华兰安康生物股份有限公司
2024/11/23New drug · Class 1 BA1106注射液CXSL2400796 山东博安生物技术股份有限公司
2024/11/23New drug · Class 2.2 LY01015注射液CXSL2400795 山东博安生物技术股份有限公司
2024/11/23New drug · Class 2.2 LY01015注射液CXSL2400794 山东博安生物技术股份有限公司
2024/11/23New drug · Class 1 AWT020注射用无菌粉末CXSL2400793 上海君实生物医药科技股份有限公司
2024/11/23New drug · Class 1 注射用BL-M07D1CXSL2400792 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
2024/11/23New drug · Class 1 QB0208-1胶囊CXHL2401276 北京清博汇能医药科技有限公司

81 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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