药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2023/07/11 – 2023/07/17

Period
2023/07/11 to 2023/07/17, 7 days inclusive
Data as of
2026/11/07 06:00
Cached records
94,440 acceptance records, 11,686 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
428
Drugs with new generic filings (by drug name, de-duplicated)
55
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

428filings, 77 of them generic

By application type

Application typeFilings
Supplement228
Generic77
New drug58
Import32
Import re-registration25
Unspecified8

By drug type

Drug typeFilings
Chemical drug327
治疗用生物制品49
TCM43
预防用生物制品8
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

55 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

228 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
2023/07/17Import · Class 1 AZD9833片JXHL2300166 AstraZeneca AB; AstraZeneca Investment (China) Co. Limited
2023/07/17Import · Class 1 AZD5305JXHL2300165 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2023/07/17Import · Class 1 AZD5305JXHL2300164 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2023/07/17Import · Class 1 AZD5305JXHL2300163 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2023/07/17Import · Class 1 AZD5305JXHL2300162 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2023/07/17Generic · Class 3 吸入用盐酸丙卡特罗溶液CYHS2301922 云南先施药业有限公司; 浙江赛默制药有限公司
2023/07/17Generic · Class 3 吸入用盐酸丙卡特罗溶液CYHS2301921 云南先施药业有限公司; 浙江赛默制药有限公司
2023/07/17New drug · Class 1 盐酸佐利替尼片CXHL2300789 江苏晨泰医药科技有限公司
2023/07/17New drug · Class 1 盐酸佐利替尼片CXHL2300788 江苏晨泰医药科技有限公司
2023/07/17New drug · Class 1 PG-011凝胶(Ⅱ)CXHL2300787 北京普祺医药科技股份有限公司
2023/07/17New drug · Class 1 PG-011凝胶(Ⅱ)CXHL2300786 北京普祺医药科技股份有限公司
2023/07/15New drug · Class 2.1 泰它西普注射液CXSL2300485 荣昌生物制药(烟台)股份有限公司
2023/07/15New drug · Class 1 MC-1-50细胞制剂CXSL2300484 重庆精准生物技术有限公司
2023/07/15New drug · Class 1 重组抗PD-1全人源单克隆抗体注射液CXSL2300482 石药集团中奇制药技术(石家庄)有限公司
2023/07/15New drug · Class 1 LQ3片CXHL2300785 四川易阿索医药科技有限公司
2023/07/15New drug · Class 1 LQ3片CXHL2300784 四川易阿索医药科技有限公司
2023/07/15New drug · Class 1 LQ3片CXHL2300783 四川易阿索医药科技有限公司
2023/07/14Import · Class 2.2 法瑞西单抗注射液JXSS2300058 Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche AG
2023/07/14Import · Class 1 IMG-020注射液JXSL2300129 INMAGENE PTE. LTD.; Inmagene Biopharmaceuticals (Hangzhou) Co. Ltd.
2023/07/14Import · Class 1 RO7435846片JXHL2300161 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2023/07/14Import · Class 1 RO7435846片JXHL2300160 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2023/07/14Import · Class 1 RO7435846片JXHL2300159 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2023/07/14Generic · Class 3 盐酸多巴酚丁胺注射液CYHS2301904 仁合益康集团有限公司; 河北仁合益康药业有限公司
2023/07/14Generic · Class 3 盐酸右美托咪定注射液CYHS2301902 江西赣南海欣药业股份有限公司
2023/07/14Generic · Class 3 盐酸右美托咪定注射液CYHS2301901 江西赣南海欣药业股份有限公司
2023/07/14Generic · Class 3 地奈德乳膏CYHS2301899 江苏知原药业股份有限公司
2023/07/14Generic · Class 3 腺苷钴胺胶囊CYHS2301894 圣嘉(滨海)生物医药科技有限公司; 中孚药业股份有限公司
2023/07/14New drug · Class 1 注射用ASKG315CXSL2300481 江苏奥赛康生物医药有限公司
2023/07/14New drug · Class 1.2 自复制RNA带状疱疹疫苗(JCXH-105注射液)CXSL2300480 嘉晨西海(杭州)生物技术有限公司
2023/07/14New drug · Class 1 重组人源抗狂犬病病毒单克隆抗体注射液CXSL2300479 兰州生物制品研究所有限责任公司

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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