药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/05/14 – 2024/05/20

Period
2024/05/14 to 2024/05/20, 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
301
Drugs with new generic filings (by drug name, de-duplicated)
56
Accepted this week, now under review
3

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

301filings, 75 of them generic

By application type

Application typeFilings
Supplement121
Generic75
New drug68
Import re-registration15
Import14
Unspecified5
药械组合产品3

By drug type

Drug typeFilings
Chemical drug202
治疗用生物制品54
TCM34
预防用生物制品8
药械3

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

56 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

190 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

108 this week

AcceptedDrugApplicants
2024/05/18Import · Class 2.4 甲磺酸贝舒地尔片JXHL2400115 Kadmon Pharmaceuticals LLC; Sanofi (China) Investment Co. Ltd.
2024/05/18Import · Class 2.4 Fezolinetant片JXHL2400114 Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd.
2024/05/18Generic · Class 3 乙酰半胱氨酸注射液CYHS2401507 湖南华纳大药厂股份有限公司
2024/05/18Generic · Class 3 乌苯美司胶囊CYHS2401505 西安万隆制药股份有限公司
2024/05/18Generic · Class 3 洛索洛芬钠口服溶液CYHS2401502 合肥诚志生物制药有限公司
2024/05/18Generic · Class 3 利格列汀二甲双胍缓释片CYHS2401498 湖北广辰药业有限公司
2024/05/18Generic · Class 3 利格列汀二甲双胍缓释片CYHS2401497 湖北广辰药业有限公司
2024/05/18Generic · Class 3 丁酸氯维地平注射用乳剂CYHS2401496 齐鲁制药(海南)有限公司
2024/05/18Generic · Class 3 葡萄糖酸钙氯化钠注射液CYHS2401493 石家庄四药有限公司
2024/05/18Generic · Class 3 复方聚乙二醇(3350)电解质散CYHS2401489 湖北莱康医疗技术有限公司; 广东华南药业集团有限公司
2024/05/18Generic · Class 3 右酮洛芬氨丁三醇注射液CYHL2400098 北京百奥药业有限责任公司
2024/05/18New drug · Class 1.2 JKN2303CXZL2400029 江西中医药大学; 广西馨海药业科技有限公司
2024/05/18New drug · Class 1.2 JKN2303吸入溶液CXZL2400028 广西馨海药业科技有限公司; 健康元药业集团股份有限公司
2024/05/18New drug · Class 1.2 JKN2303吸入溶液CXZL2400027 广西馨海药业科技有限公司; 健康元药业集团股份有限公司
2024/05/18New drug · Class 1.2 JKN2303吸入溶液CXZL2400026 广西馨海药业科技有限公司; 健康元药业集团股份有限公司
2024/05/18New drug · Class 1.2 JKN2303吸入溶液CXZL2400025 广西馨海药业科技有限公司; 健康元药业集团股份有限公司
2024/05/18New drug · Class 3.3 四价流感病毒裂解疫苗CXSL2400331 深圳康泰生物制品股份有限公司
2024/05/18New drug · Class 1 PM1032注射液CXSL2400330 普米斯生物技术(珠海)有限公司
2024/05/18New drug · Class 2.2 SL001CXHL2400511 四川省三星堆制药有限公司
2024/05/17Import · Class 1 注射用M9140JXSL2400096 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd.
2024/05/17Import · Class 2.2 Dostarlimab注射液JXSL2400095 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. LTD
2024/05/17Import · Class 2.2 Dostarlimab注射液JXSL2400094 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd.
2024/05/17Import · Class 1 Amlitelimab注射液JXSL2400093 Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD
2024/05/17Generic · Class 3 氨磺必利注射液CYHS2401488 南京正科医药股份有限公司
2024/05/17Generic · Class 3 氨磺必利注射液CYHS2401487 南京正科医药股份有限公司
2024/05/17Generic · Class 3 布美他尼注射液CYHS2401480 四川奥邦古得药业有限公司; 成都利尔药业有限公司
2024/05/17Generic · Class 3 盐酸纳美芬注射液CYHS2401479 海南爱科制药有限公司
2024/05/17Generic · Class 3 重酒石酸间羟胺注射液CYHS2401477 广州惠沣德生物技术有限公司; 博瑞制药(苏州)有限公司
2024/05/17Generic · Class 3 二甲双胍格列本脲片CYHS2401476 通化万通药业股份有限公司
2024/05/17Generic · Class 3 二甲双胍格列本脲片CYHS2401475 通化万通药业股份有限公司

78 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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