药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2025/09/23 – 2025/09/29

Period
2025/09/23 to 2025/09/29, 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
460
Drugs with new generic filings (by drug name, de-duplicated)
72
Accepted this week, now under review
112

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

460filings, 93 of them generic

By application type

Application typeFilings
Supplement228
Generic93
New drug88
Import28
Import re-registration14
Unspecified9

By drug type

Drug typeFilings
Chemical drug264
TCM106
治疗用生物制品83
预防用生物制品4
Biologic2
Unspecified1

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

72 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

279 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

133 this week

AcceptedDrugApplicants
2025/09/29Import · Class 1 注射用MK-2400JXSL2500192 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2025/09/29Import · Class 1 注射用MK-6070JXSL2500191 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2025/09/29Import · Class 1 NNC6019-0001注射液JXSL2500190 Novo Nordisk A/S; ICON Clinical Research (Beijing No. 2) Co. Ltd.
2025/09/29Generic · Class 3 布比卡因脂质体注射液CYHS2503587 齐鲁制药(海南)有限公司
2025/09/29Generic · Class 3 布比卡因脂质体注射液CYHS2503586 齐鲁制药(海南)有限公司
2025/09/29Generic · Class 3 呋塞米片CYHS2503564 海鸿恒隆(海南)生物科技有限公司; 江苏云阳集团药业有限公司
2025/09/29Generic · Class 3 氟轻松氢醌维A酸乳膏CYHL2500175 浙江昂利康制药股份有限公司
2025/09/29New drug · Class 3.1 泻白散颗粒CXZS2500043 西施兰(南阳)药业股份有限公司; 绵阳一康制药有限公司
2025/09/29New drug · Class 1.1 金防风袋泡茶CXZL2500090 江西守正药业有限公司
2025/09/29New drug · Class 1 重组人源化单克隆抗体MIL62注射液CXSS2500102 北京天广实生物技术股份有限公司; 北京华放天实生物制药有限责任公司
2025/09/29New drug · Class 3.3 GLR1044注射液CXSL2500849 甘李药业山东有限公司
2025/09/29New drug · Class 1 注射用SHR-9839(sc)CXSL2500848 苏州盛迪亚生物医药有限公司; 上海恒瑞医药有限公司
2025/09/29New drug · Class 2.2 贝伐珠单抗注射液CXSL2500847 苏州盛迪亚生物医药有限公司
2025/09/29New drug · Class 1 注射用MRG003CXSL2500846 乐普生物科技股份有限公司
2025/09/29New drug · Class 1 SHR-4375注射液CXSL2500845 苏州盛迪亚生物医药有限公司
2025/09/29New drug · Class 2.2 SHR-8068注射液CXSL2500844 苏州盛迪亚生物医药有限公司
2025/09/29New drug · Class 1 RJMty19注射液CXSL2500843 浙江瑞加美生物科技有限公司
2025/09/29New drug · Class 2.2 阿得贝利单抗注射液CXSL2500842 上海盛迪医药有限公司
2025/09/29New drug · Class 2.2 JMHT06CXHL2501056 湖南九典制药股份有限公司
2025/09/29New drug · Class 2.2 JMHT06CXHL2501055 湖南九典制药股份有限公司
2025/09/29New drug · Class 1 KR23343片CXHL2501054 江西科睿药业有限公司
2025/09/29New drug · Class 1 KR23343片CXHL2501053 江西科睿药业有限公司
2025/09/29New drug · Class 1 HRS-4642注射液CXHL2501052 上海恒瑞医药有限公司; 江苏恒瑞医药股份有限公司
2025/09/29New drug · Class 1 HRS-4642注射液CXHL2501051 上海恒瑞医药有限公司; 江苏恒瑞医药股份有限公司
2025/09/29New drug · Class 1 SGB-7342注射液CXHL2501050 苏州圣因生物医药有限公司
2025/09/29New drug · Class 1 MAX-10181片CXHL2501049 北京再极医药科技有限公司
2025/09/29New drug · Class 1 MAX-10181片CXHL2501048 北京再极医药科技有限公司
2025/09/28Import · Class 3.1 注射用维布妥昔单抗JXSS2500129 Takeda Pharma A/S; BSP Pharmaceuticals S.p.A.; Takeda (China) International Trading Co. Ltd
2025/09/28Import · Class 1 Ponsegromab注射液JXSL2500189 Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd.
2025/09/28Import · Class 1 AZD5335JXSL2500188 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.

103 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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