药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/12/10 – 2024/12/16

Period
2024/12/10 to 2024/12/16, 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
429
Drugs with new generic filings (by drug name, de-duplicated)
83
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

429filings, 113 of them generic

By application type

Application typeFilings
Supplement188
Generic113
New drug93
Import22
Unspecified10
Import re-registration3

By drug type

Drug typeFilings
Chemical drug289
TCM70
治疗用生物制品54
预防用生物制品9
Biologic6
体外诊断试剂1

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

83 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

277 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

146 this week

AcceptedDrugApplicants
2024/12/16Import · Class 2.1;2.2 Amivantamab注射液(皮下注射)JXSL2400239 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/12/16Import · Class 2.1;2.2 Amivantamab注射液(皮下注射)JXSL2400238 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/12/16Generic · Class 3 注射用甲磺酸萘莫司他CYHL2400260 山东化药医药科技有限公司
2024/12/14Import · Class 1 Amycretin注射液JXSL2400237 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2024/12/14Import · Class 2.4 替尔泊肽注射液JXHS2400111 Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/12/14Import · Class 2.4 替尔泊肽注射液JXHS2400110 Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/12/14Import · Class 2.4 替尔泊肽注射液JXHS2400109 Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/12/14Import · Class 2.4 替尔泊肽注射液JXHS2400108 Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/12/14Generic · Class 3 小儿复方氨基酸注射液(19AA-Ⅰ)CYHS2404359 武汉久安药物研究院有限公司; 四川科伦药业股份有限公司
2024/12/14Generic · Class 3 头孢泊肟酯干混悬剂CYHS2404352 石家庄四药有限公司
2024/12/14Generic · Class 3 己酮可可碱缓释片CYHS2404350 杭州康恩贝制药有限公司
2024/12/14Generic · Class 3 复方聚乙二醇电解质散(II)CYHS2404347 湖南普道医药技术有限公司; 湖南九典制药股份有限公司
2024/12/14Generic · Class 3 阿齐沙坦氨氯地平片CYHL2400259 北京百奥药业有限责任公司
2024/12/14New drug · Class 2.2 吸附无细胞百(三组分)白破联合疫苗CXSS2400139 康希诺生物股份公司
2024/12/14New drug · Class 3.3 阿达木单抗注射液CXSS2400138 浙江华海生物科技有限公司
2024/12/14New drug · Class 1 注射用DXC008CXSL2400868 杭州多禧生物科技有限公司
2024/12/14New drug · Class 2.2 阿得贝利单抗注射液CXSL2400867 上海盛迪医药有限公司
2024/12/14New drug · Class 1 注射用SHR-A2102CXSL2400866 苏州盛迪亚生物医药有限公司; 上海恒瑞医药有限公司
2024/12/14New drug · Class 1 注射用SHR-4602CXSL2400865 苏州盛迪亚生物医药有限公司; 上海盛迪医药有限公司
2024/12/14New drug · Class 1 注射用KKD001CXSL2400864 上饶市康可得生物科技有限公司
2024/12/14New drug · Class 1 注射用KKD001CXSL2400863 上饶市康可得生物科技有限公司
2024/12/14New drug · Class 1 IMM01CXSL2400862 宜明昂科生物医药技术(上海)股份有限公司
2024/12/14New drug · Class 1 IMM2510CXSL2400861 宜明昂科生物医药技术(上海)股份有限公司
2024/12/14New drug · Class 1.2 冻干二价呼吸道合胞病毒mRNA疫苗CXSL2400860 武汉瑞佶生物科技有限公司; 深圳瑞吉生物科技有限公司
2024/12/14New drug · Class 1 人骨髓间充质干细胞注射液CXSL2400859 九芝堂美科(北京)细胞技术有限公司
2024/12/14New drug · Class 1 JMT108注射液CXSL2400858 上海津曼特生物科技有限公司
2024/12/14New drug · Class 1 JYP0015片CXHL2401384 广州嘉越医药科技有限公司
2024/12/14New drug · Class 1 JYP0015片CXHL2401383 广州嘉越医药科技有限公司
2024/12/14New drug · Class 1 JYP0015片CXHL2401382 广州嘉越医药科技有限公司
2024/12/14New drug · Class 1 JYP0015片CXHL2401381 广州嘉越医药科技有限公司

116 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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