药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/02/27 – 2024/03/04

Period
2024/02/27 to 2024/03/04, 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
344
Drugs with new generic filings (by drug name, de-duplicated)
44
Accepted this week, now under review
1

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

344filings, 57 of them generic

By application type

Application typeFilings
Supplement199
Generic57
New drug43
Import24
Unspecified13
Import re-registration8

By drug type

Drug typeFilings
Chemical drug203
TCM87
治疗用生物制品50
预防用生物制品3
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

44 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

92 this week

AcceptedDrugApplicants
2024/03/04Import · Class 1 PF-07220060JXHL2400059 Pfizer Inc.; Pfizer Investment CO. Ltd
2024/03/04Import · Class 1 PF-07220060JXHL2400058 Pfizer Inc.; Pfizer Investment CO. Ltd
2024/03/04Import · Class 1 PF-07220060JXHL2400057 Pfizer Inc.; Pfizer Investment CO. Ltd
2024/03/04Import · Class 1 Lu AF28996 胶囊JXHL2400056 H. Lundbeck A/S
2024/03/04Import · Class 1 Lu AF28996 胶囊JXHL2400055 H. Lundbeck A/S
2024/03/04Import · Class 1 Lu AF28996 胶囊JXHL2400054 H. Lundbeck A/S
2024/03/04Import · Class 1 Lu AF28996 胶囊JXHL2400053 H. Lundbeck A/S
2024/03/04Import · Class 1 ARV-471(PF-07850327)片JXHL2400052 Pfizer Inc; Pfizer Investment CO. Ltd.
2024/03/04Generic · Class 3 甲硫酸新斯的明注射液CYHS2400752 南京海辰药业股份有限公司
2024/03/04Generic · Class 3 甲硫酸新斯的明注射液CYHS2400751 南京海辰药业股份有限公司
2024/03/04Generic · Class 3 甲硫酸新斯的明注射液CYHS2400750 南京海辰药业股份有限公司
2024/03/04Generic · Class 3 醋酸地非法林注射液CYHL2400051 齐鲁制药(海南)有限公司
2024/03/04New drug · Class 1 己二酸他雷替尼胶囊CXHS2400020 葆元生物医药科技(杭州)有限公司; 凯莱英生命科学技术(天津)有限公司
2024/03/02Import · Class 3.1 注射用利纳西普JXSS2400016 Kiniksa Pharmaceuticals (UK) Ltd.; Jubilant HollisterStier LLC; HANGZHOU ZHONGMEI HUADONG PHARMACEUTICALS CO. LTD
2024/03/02Import · Class 1 RO7435846片JXHL2400051 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2024/03/02Import · Class 1 RO7435846片JXHL2400050 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2024/03/02Import · Class 1 RO7435846片JXHL2400049 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2024/03/02Generic · Class 3 注射用德拉沙星CYHS2400746 江苏奥赛康药业有限公司
2024/03/02Generic · Class 3 复方电解质注射液(V)CYHS2400745 河北天成药业股份有限公司
2024/03/02Generic · Class 3 盐酸维洛沙秦缓释胶囊CYHL2400050 江苏恩华药业股份有限公司; 苏州恩华生物医药科技有限公司
2024/03/02Generic · Class 3 盐酸维洛沙秦缓释胶囊CYHL2400049 江苏恩华药业股份有限公司; 苏州恩华生物医药科技有限公司
2024/03/02New drug · Class 1 SSGJ-707注射液CXSL2400171 沈阳三生制药有限责任公司; 三生国健药业(上海)股份有限公司
2024/03/02New drug · Class 1 盐酸去甲乌药碱注射液CXHS2400019 珠海润都制药股份有限公司
2024/03/01Import · Class 2.4 米罗那非片JXHL2400048 AriBio Co. Ltd.; Panacro (Hefei) Pharmaceutical Technology Co. Ltd.
2024/03/01Import · Class 2.4 米罗那非片JXHL2400047 AriBio Co. Ltd.; Panacro (Hefei) Pharmaceutical Technology Co. Ltd.
2024/03/01Generic · Class 3 二羟丙茶碱注射液CYHS2400741 扬州中宝药业股份有限公司
2024/03/01Generic · Class 3 地氯雷他定口服溶液CYHS2400738 江苏开元药业有限公司; 南京海纳制药有限公司
2024/03/01Generic · Class 3 磷酸奥司他韦干混悬剂CYHS2400734 哈药集团技术中心
2024/03/01Generic · Class 3 维生素B6注射液CYHS2400733 海南元盈医药科技有限公司; 酒泉大得利制药股份有限公司
2024/03/01Generic · Class 3 托吡酯口服溶液CYHS2400730 重庆华森制药股份有限公司; 华益药业科技(安徽)有限公司

62 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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