药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2022/06/28 – 2022/07/04

Period
2022/06/28 to 2022/07/04, 7 days inclusive
Data as of
2026/11/08 06:00
Cached records
94,440 acceptance records, 11,586 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
315
Drugs with new generic filings (by drug name, de-duplicated)
39
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

315filings, 55 of them generic

By application type

Application typeFilings
Supplement130
New drug69
Generic55
Import25
Import re-registration23
Unspecified13

By drug type

Drug typeFilings
Chemical drug243
治疗用生物制品42
TCM24
预防用生物制品5
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

39 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

192 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

96 this week

AcceptedDrugApplicants
2022/07/04Import · Class 1 CetrelimabJXSL2200102 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/07/04Import · Class 1 BN301JXSL2200101 Sutro Biopharma Inc.; BioNova Pharmaceuticals (Shanghai) Limited
2022/07/04Import · Class 1 BN301JXSL2200100 Sutro Biopharma Inc.; BioNova Pharmaceuticals (Shanghai) Limited
2022/07/04Import · Class 2.4 Upadacitinib片JXHL2200169 AbbVie Inc.
2022/07/04Generic · Class 3 左乙拉西坦缓释片CYHS2200993 华润赛科药业有限责任公司
2022/07/04Generic · Class 3 左乙拉西坦缓释片CYHS2200992 华润赛科药业有限责任公司
2022/07/04New drug · Class 1 AC-003胶囊CXHL2200471 爱科诺生物医药(苏州)有限公司
2022/07/04New drug · Class 1 AC-003胶囊CXHL2200470 爱科诺生物医药(苏州)有限公司
2022/07/04New drug · Class 1 HE009片CXHL2200469 南昌弘益药业有限公司
2022/07/04New drug · Class 1 HE009片CXHL2200468 南昌弘益药业有限公司
2022/07/04New drug · Class 1 HE009片CXHL2200467 南昌弘益药业有限公司
2022/07/04New drug · Class 1 BGB-15025片CXHL2200466 百济神州(苏州)生物科技有限公司
2022/07/02Import · Class 3.3 贝伐珠单抗注射液JXSL2200099 Joint Stock Company“BIOCAD”,(JSC“BIOCAD”); SPH-Biocad Biopharmaceuticals (SH) Co. Ltd.
2022/07/02Import · Class 3.3 贝伐珠单抗注射液JXSL2200098 Joint Stock Company“BIOCAD”,(JSC“BIOCAD”); SPH-Biocad Biopharmaceuticals (SH) Co. Ltd.
2022/07/02Import · Class 2.2 Amivantamab注射液JXSL2200095 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/07/02New drug · Class 1 BA1106注射液CXSL2200307 山东博安生物技术股份有限公司
2022/07/02New drug · Class 1 LTC004CXSL2200306 北京志道生物科技有限公司
2022/07/02New drug · Class 1 注射用低分子量岩藻糖化糖胺聚糖钠CXSL2200305 牡丹江友搏药业有限责任公司
2022/07/02New drug · Class 1 靶向GPC3嵌合抗原受体自体T细胞注射液CXSL2200304 原启生物科技(上海)有限责任公司
2022/07/02New drug · Class 1 AK119注射液CXSL2200296 中山康方生物医药有限公司
2022/07/02New drug · Class 1 JBPOS0101胶囊CXHL2200463 浙江京新药业股份有限公司
2022/07/02New drug · Class 1 JBPOS0101胶囊CXHL2200462 浙江京新药业股份有限公司
2022/07/02New drug · Class 1 JBPOS0101胶囊CXHL2200461 浙江京新药业股份有限公司
2022/07/02New drug · Class 1 GW201片CXHL2200460 北京广为医药科技有限公司
2022/07/02New drug · Class 1 GW201片CXHL2200459 北京广为医药科技有限公司
2022/07/02New drug · Class 1 GW201片CXHL2200458 北京广为医药科技有限公司
2022/07/02New drug · Class 1 EVER001胶囊CXHL2200454 云顶新耀医药科技有限公司
2022/06/30Generic · Class 3 尼麦角林片CYHS2200980 福建海西新药创制股份有限公司; 浙江京新药业股份有限公司
2022/06/30Generic · Class 3 左氧氟沙星注射液CYHS2200978 长春海悦药业股份有限公司
2022/06/30Generic · Class 3 左氧氟沙星注射液CYHS2200977 长春海悦药业股份有限公司

66 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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