药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/06/04 – 2024/06/10

Period
2024/06/04 to 2024/06/10, 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
296
Drugs with new generic filings (by drug name, de-duplicated)
71
Accepted this week, now under review
4

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

296filings, 92 of them generic

By application type

Application typeFilings
Supplement130
Generic92
New drug44
Import16
Import re-registration9
Unspecified5

By drug type

Drug typeFilings
Chemical drug205
TCM44
治疗用生物制品38
预防用生物制品8
Biologic1

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

71 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

188 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

95 this week

AcceptedDrugApplicants
2024/06/08Import · Class 2.2 Upadacitinib口服溶液JXHL2400131 AbbVie Inc.; AbbVie Pharmaceutical Trading(Shanghai) Co. Ltd.
2024/06/08Import · Class 2.2 Upadacitinib口服溶液JXHL2400130 AbbVie Inc.; AbbVie Pharmaceutical Trading(Shanghai) Co. Ltd.
2024/06/08Generic · Class 3 地奈德乳膏CYHS2401736 杭州民生药业股份有限公司
2024/06/08Generic · Class 3 草酸艾司西酞普兰口服溶液CYHS2401733 江苏长泰药业股份有限公司
2024/06/08Generic · Class 3 舒必利注射液CYHS2401731 海南卓科制药有限公司
2024/06/08Generic · Class 3 舒必利注射液CYHS2401730 海南卓科制药有限公司
2024/06/08Generic · Class 3 甲硫酸新斯的明注射液CYHS2401728 河北一品制药股份有限公司
2024/06/08Generic · Class 3 重酒石酸卡巴拉汀口服溶液CYHS2401727 广州一品红制药有限公司
2024/06/08Generic · Class 3 ω-3 鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液CYHS2401726 福建盛迪医药有限公司; 江苏恒瑞医药股份有限公司
2024/06/08Generic · Class 3 甘露醇山梨醇注射液CYHL2400104 石家庄四药有限公司
2024/06/08New drug · Class 3.1 升陷颗粒CXZS2400020 吉林敖东洮南药业股份有限公司
2024/06/08New drug · Class 1 HZ-L105片CXHL2400582 杭州和正医药有限公司; 广东弘烨医药科技有限公司
2024/06/08New drug · Class 1 HZ-L105片CXHL2400581 杭州和正医药有限公司; 广东弘烨医药科技有限公司
2024/06/08New drug · Class 1 HZ-L105片CXHL2400580 杭州和正医药有限公司; 广东弘烨医药科技有限公司
2024/06/07Import · Class 1 RO7200220 注射液JXSL2400112 F. Hoffmann-La Roche Ltd.
2024/06/07Import · Class 1 RO7200220 注射液JXSL2400111 F. Hoffmann-La Roche Ltd.
2024/06/07Import · Class 2.4 Upadacitinib片JXHL2400129 AbbVie Inc.
2024/06/07Import · Class 2.4 Upadacitinib片JXHL2400128 AbbVie Inc.
2024/06/07Import · Class 2.4 Upadacitinib片JXHL2400127 AbbVie Inc.
2024/06/07Generic · Class 3 吸入用盐酸丙卡特罗溶液CYHS2401723 浙江福瑞喜药业有限公司
2024/06/07Generic · Class 3 吸入用盐酸丙卡特罗溶液CYHS2401722 浙江福瑞喜药业有限公司
2024/06/07Generic · Class 3 吸入用盐酸丙卡特罗溶液CYHS2401717 石家庄四药有限公司
2024/06/07Generic · Class 3 苯磺酸氨氯地平口崩片CYHS2401715 广东万泰科创药业有限公司; 深圳信立泰药业股份有限公司
2024/06/07Generic · Class 3 氨磺必利口服溶液CYHS2401713 宏越科技(湖州)有限公司; 浙江莎普爱思药业股份有限公司
2024/06/07Generic · Class 3 盐酸丙卡特罗口服溶液CYHS2401710 黑龙江澳利达奈德制药有限公司
2024/06/07Generic · Class 3 盐酸丙卡特罗口服溶液CYHS2401709 黑龙江澳利达奈德制药有限公司
2024/06/07Generic · Class 3 盐酸甲氧氯普胺注射液CYHS2401705 嘉实(湖南)医药科技有限公司; 康普药业股份有限公司
2024/06/07New drug · Class 1 注射用泽尼达妥单抗CXSS2400056 百济神州(苏州)生物科技有限公司; 无锡药明生物技术股份有限公司
2024/06/07New drug · Class 2.2;2.4 注射用重组A型肉毒毒素CXSL2400373 君合盟生物制药(通化)有限公司
2024/06/07New drug · Class 1 PreS1胶束注射液(冻干)CXSL2400372 普瑞斯万(武汉)生物科技有限公司

65 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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