药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2025/02/18 – 2025/02/24

Period
2025/02/18 to 2025/02/24, 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
282
Drugs with new generic filings (by drug name, de-duplicated)
53
Accepted this week, now under review
15

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

282filings, 72 of them generic

By application type

Application typeFilings
Supplement142
Generic72
New drug47
Import14
Import re-registration4
Unspecified3

By drug type

Drug typeFilings
Chemical drug194
TCM46
治疗用生物制品38
预防用生物制品4

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

53 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

178 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
2025/02/22Generic · Class 3 盐酸舍曲林口服浓缩液CYHS2500823 海南海灵化学制药有限公司; 合肥诚志生物制药有限公司
2025/02/22Generic · Class 3 葡萄糖酸钙氯化钠注射液CYHS2500820 石家庄四药有限公司
2025/02/22Generic · Class 3 盐酸异丙肾上腺素注射液CYHS2500819 成都瑞尔医药科技有限公司; 成都市海通药业有限公司
2025/02/22Generic · Class 3 盐酸异丙肾上腺素注射液CYHS2500818 成都瑞尔医药科技有限公司; 成都市海通药业有限公司
2025/02/22Generic · Class 3 维生素K滴剂CYHS2500817 合肥科大生物技术有限公司; 安徽威尔曼制药有限公司
2025/02/22Generic · Class 3 帕拉米韦注射液CYHS2500816 安徽丰原药业股份有限公司
2025/02/22Generic · Class 3 腺苷钴胺胶囊CYHS2500814 湖南柏齐鹤药物研发有限公司; 浙江康恩贝制药股份有限公司
2025/02/22Generic · Class 3 注射用甲磺酸萘莫司他CYHL2500050 浙江同伍生物医药有限公司
2025/02/22Generic · Class 3 注射用甲磺酸萘莫司他CYHL2500049 浙江同伍生物医药有限公司
2025/02/22New drug · Class 2.2 伊匹木单抗注射液CXSS2500032 信达生物医药科技(杭州)有限公司; 信达生物制药(苏州)有限公司
2025/02/22New drug · Class 2.2 信迪利单抗注射液CXSS2500031 信达生物制药(苏州)有限公司
2025/02/22New drug · Class 1 注射用QLS5132CXSL2500173 齐鲁制药有限公司
2025/02/22New drug · Class 2.2;2.4 优替德隆胶囊CXHL2500214 成都华昊中天药业有限公司; 北京华昊中天生物医药股份有限公司
2025/02/22New drug · Class 2.2 X001 干混悬剂CXHL2500213 辽宁海一制药有限公司
2025/02/22New drug · Class 1 TFX06片CXHL2500212 浙江扬厉医药技术有限公司
2025/02/22New drug · Class 1 TFX06片CXHL2500211 浙江扬厉医药技术有限公司
2025/02/21Import · Class 3.1 Tremelimumab注射液JXSS2500016 AstraZeneca AB; Vetter Pharma-Fertigung GmbH & Co. KG; AstraZeneca Global R&D (China) Co. Ltd.
2025/02/21Import · Class 3.1 Tremelimumab注射液JXSS2500015 AstraZeneca AB; Vetter Pharma-Fertigung GmbH & Co. KG; AstraZeneca Global R&D (China) Co. Ltd.
2025/02/21Import · Class 3.1 度伐利尤单抗注射液JXSS2500014 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/02/21Import · Class 3.1 度伐利尤单抗注射液JXSS2500013 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/02/21Generic · Class 3 乙酰半胱氨酸注射液CYHS2500813 远大医药(中国)有限公司
2025/02/21Generic · Class 3 草酸艾司西酞普兰口服溶液CYHS2500812 成都倍特得诺药业有限公司
2025/02/21Generic · Class 3 草酸艾司西酞普兰口服溶液CYHS2500811 成都倍特得诺药业有限公司
2025/02/21Generic · Class 3 盐酸缬更昔洛韦颗粒CYHS2500808 湖北唯森制药有限公司
2025/02/21New drug · Class 1 TAEST1901注射液CXSL2500172 香雪生命科学技术(广东)有限公司
2025/02/21New drug · Class 2.2 吸附无细胞百白破(组分)b型流感嗜血杆菌(结合)联合疫苗CXSL2500171 北京智飞绿竹生物制药有限公司
2025/02/21New drug · Class 1 Afuresertib片CXHL2500210 来凯制药(宁波)有限公司
2025/02/21New drug · Class 1 Afuresertib片CXHL2500209 来凯制药(宁波)有限公司
2025/02/21New drug · Class 1 WXSH0493片CXHL2500208 江苏康缘药业股份有限公司
2025/02/20Import · Class 2.4 硫酸氢司美替尼胶囊JXHS2500026 ASTRAZENECA UK LIMITED; PATHEON PHARMACEUTICALS INCORPORATED; AstraZeneca Investment (China) Co. Ltd

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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