药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2025/11/11 – 2025/11/17

Period
2025/11/11 to 2025/11/17, 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
384
Drugs with new generic filings (by drug name, de-duplicated)
50
Accepted this week, now under review
77

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

384filings, 67 of them generic

By application type

Application typeFilings
Supplement212
Generic67
New drug67
Import24
Import re-registration9
Unspecified5

By drug type

Drug typeFilings
Chemical drug240
TCM106
治疗用生物制品29
预防用生物制品8
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

50 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

205 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

115 this week

AcceptedDrugApplicants
2025/11/17New drug · Class 1 JNJ-95597528注射液CXSL2500974 强生(中国)投资有限公司
2025/11/17New drug · Class 1 YKYY032注射液CXHL2501263 北京悦康科创医药科技股份有限公司; 杭州天龙药业有限公司
2025/11/17New drug · Class 2.1;2.4 AP-2202片CXHL2501262 杭州安元生物医药科技有限公司
2025/11/15Import · Class 1 EPX-100口服溶液JXHL2500354 Epygenix Therapeutics Inc.; Tenacia Biotechnology (Shanghai) Co. Ltd
2025/11/15Generic · Class 3 呋塞米片CYHS2503971 珠海润都制药股份有限公司
2025/11/15Generic · Class 3 注射用拉氧头孢钠CYHS2503970 山东鲁抗三叶制药有限公司
2025/11/15New drug · Class 1 SYS6010CXSL2500973 石药集团巨石生物制药有限公司
2025/11/15New drug · Class 2.5 冻干人用狂犬病疫苗(人二倍体细胞)CXSL2500972 浙江普康生物技术股份有限公司
2025/11/15New drug · Class 1 JMT108注射液CXSL2500971 上海津曼特生物科技有限公司
2025/11/15New drug · Class 1 HLX701注射液CXSL2500970 上海复宏瑞霖生物技术有限公司; 上海市复宏汉霖生物医药有限公司
2025/11/15New drug · Class 1 ASN-8639片CXHL2501257 江苏亚虹医药科技股份有限公司
2025/11/15New drug · Class 1 ASN-8639片CXHL2501256 江苏亚虹医药科技股份有限公司
2025/11/14Import · Class 2.2 Mirikizumab注射液JXSL2500223 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/11/14Import · Class 2.2 Mirikizumab注射液JXSL2500222 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/11/14Import · Class 1 LY4268989胶囊JXHL2500353 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/11/14Generic · Class 3 氨溴特罗口服溶液CYHS2503967 江西远盛药业有限公司; 湖南九典制药股份有限公司
2025/11/14Generic · Class 3 氨溴特罗口服溶液CYHS2503966 江西远盛药业有限公司; 湖南九典制药股份有限公司
2025/11/14Generic · Class 3 右酮洛芬氨丁三醇注射液CYHS2503963 中润药业有限公司; 山西普德药业有限公司
2025/11/14Generic · Class 3 二羟丙茶碱注射液CYHS2503961 大玮(安徽)药业有限公司; 安徽威尔曼制药有限公司
2025/11/14Generic · Class 3 盐酸奥洛他定颗粒CYHS2503958 海南赛立克药业有限公司
2025/11/14Generic · Class 3 复方聚乙二醇(3350)电解质口服溶液CYHS2503955 赤峰源生药业有限公司
2025/11/14New drug · Class 2.4 YFZ-003CXZL2500116 四川凯京制药有限公司
2025/11/14New drug · Class 2.4 YFZ-003CXZL2500115 四川凯京制药有限公司
2025/11/14New drug · Class 2.4 YFZ-003CXZL2500114 四川凯京制药有限公司
2025/11/14New drug · Class 2.4 YFZ-003CXZL2500113 四川凯京制药有限公司
2025/11/14New drug · Class 2.2 B群脑膜炎球菌OMV疫苗CXSL2500969 上海羽冠生物技术有限公司
2025/11/14New drug · Class 2.2 B群脑膜炎球菌OMV疫苗CXSL2500968 上海羽冠生物技术有限公司
2025/11/14New drug · Class 2.2 B群脑膜炎球菌OMV疫苗CXSL2500967 上海羽冠生物技术有限公司
2025/11/14New drug · Class 1 IBI343CXSL2500966 信达生物制药(苏州)有限公司
2025/11/14New drug · Class 2.2 玛舒拉沙韦干混悬剂CXHS2500136 江西科睿药业有限公司

85 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.