药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/03/05 – 2024/03/11

Period
2024/03/05 to 2024/03/11, 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
220
Drugs with new generic filings (by drug name, de-duplicated)
46
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

220filings, 59 of them generic

By application type

Application typeFilings
Supplement107
Generic59
New drug33
Import15
Import re-registration4
Unspecified2

By drug type

Drug typeFilings
Chemical drug144
治疗用生物制品42
TCM32
Biologic1
预防用生物制品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

46 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

134 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

71 this week

AcceptedDrugApplicants
2024/03/09New drug · Class 1 注射用MK-2870CXSL2400175 默沙东研发(中国)有限公司
2024/03/09New drug · Class 1 EB160片CXHL2400263 中山优理生物医药有限公司
2024/03/09New drug · Class 1 EB160片CXHL2400262 中山优理生物医药有限公司
2024/03/09New drug · Class 1 EB160片CXHL2400261 中山优理生物医药有限公司
2024/03/08Import · Class 3.1 注射用隆培促生长素JXSS2400025 Ascendis Pharma Endocrinology Division A/S; Vetter Pharma-Fertigung GmbH & Co. KG; VISEN Pharmaceuticals (Shanghai) Co. Ltd.
2024/03/08Import · Class 3.1 注射用隆培促生长素JXSS2400024 Ascendis Pharma Endocrinology Division A/S; Vetter Pharma-Fertigung GmbH & Co. KG; VISEN Pharmaceuticals (Shanghai) Co. Ltd.
2024/03/08Import · Class 3.1 注射用隆培促生长素JXSS2400023 Ascendis Pharma Endocrinology Division A/S; Vetter Pharma-Fertigung GmbH & Co. KG; VISEN Pharmaceuticals (Shanghai) Co. Ltd.
2024/03/08Import · Class 3.1 注射用隆培促生长素JXSS2400022 Ascendis Pharma Endocrinology Division A/S; Vetter Pharma-Fertigung GmbH & Co. KG; VISEN Pharmaceuticals (Shanghai) Co. Ltd.
2024/03/08Import · Class 3.1 注射用隆培促生长素JXSS2400021 Ascendis Pharma Endocrinology Division A/S; Vetter Pharma-Fertigung GmbH & Co. KG; VISEN Pharmaceuticals (Shanghai) Co. Ltd.
2024/03/08Import · Class 3.1 注射用隆培促生长素JXSS2400020 Ascendis Pharma Endocrinology Division A/S; Vetter Pharma-Fertigung GmbH & Co. KG; VISEN Pharmaceuticals (Shanghai) Co. Ltd.
2024/03/08Import · Class 3.1 注射用隆培促生长素JXSS2400019 Ascendis Pharma Endocrinology Division A/S; Vetter Pharma-Fertigung GmbH & Co. KG; VISEN Pharmaceuticals (Shanghai) Co. Ltd.
2024/03/08Import · Class 3.1 注射用隆培促生长素JXSS2400018 Ascendis Pharma Endocrinology Division A/S; Vetter Pharma-Fertigung GmbH & Co. KG; VISEN Pharmaceuticals (Shanghai) Co. Ltd.
2024/03/08Import · Class 3.1 注射用隆培促生长素JXSS2400017 Ascendis Pharma Endocrinology Division A/S; Vetter Pharma-Fertigung GmbH & Co. KG; VISEN Pharmaceuticals (Shanghai) Co. Ltd.
2024/03/08Import · Class 1.1 呼吸道合胞病毒减毒活疫苗JXSL2400058 Sanofi Pasteur Inc.; Shenzhen Sanofi Pasteur Biological Products Co. Ltd
2024/03/08Generic · Class 3 复方氨基酸(16)双肽(1)注射液CYHS2400802 内蒙古白医制药股份有限公司
2024/03/08Generic · Class 3 复方氨基酸(16)双肽(1)注射液CYHS2400801 内蒙古白医制药股份有限公司
2024/03/08New drug · Class 1 SPH7450片CXHL2400260 上海医药集团股份有限公司
2024/03/08New drug · Class 1 SPH7450片CXHL2400259 上海医药集团股份有限公司
2024/03/08New drug · Class 1 SPH7450片CXHL2400258 上海医药集团股份有限公司
2024/03/08New drug · Class 1 SPH7450片CXHL2400257 上海医药集团股份有限公司
2024/03/08New drug · Class 1 HRS9531片CXHL2400256 福建盛迪医药有限公司
2024/03/08New drug · Class 1 HRS9531片CXHL2400255 福建盛迪医药有限公司
2024/03/08New drug · Class 1 HRS9531片CXHL2400254 福建盛迪医药有限公司
2024/03/08New drug · Class 1 HRS9531片CXHL2400253 福建盛迪医药有限公司
2024/03/08New drug · Class 1 HRS9531片CXHL2400252 福建盛迪医药有限公司
2024/03/07Generic · Class 3 腺苷钴胺胶囊CYHS2400793 湖南千金湘江药业股份有限公司
2024/03/07Generic · Class 3 盐酸溴己新注射液CYHS2400788 安徽新世纪药业有限公司; 平光制药股份有限公司
2024/03/07Generic · Class 3 盐酸艾司洛尔注射液CYHS2400786 河北龙海药业有限公司; 石家庄凯达生物工程有限公司
2024/03/07New drug · Class 1.1 母苏颗粒CXZL2400013 瑞阳制药股份有限公司
2024/03/07New drug · Class 1 SYS6002CXSL2400174 石药集团巨石生物制药有限公司

41 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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