药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2025/11/04 – 2025/11/10

Period
2025/11/04 to 2025/11/10, 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
362
Drugs with new generic filings (by drug name, de-duplicated)
44
Accepted this week, now under review
83

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

362filings, 59 of them generic

By application type

Application typeFilings
Supplement194
Generic59
New drug50
Import22
Import re-registration19
Unspecified18

By drug type

Drug typeFilings
Chemical drug194
TCM91
治疗用生物制品63
Biologic11
预防用生物制品3

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

44 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

220 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

90 this week

AcceptedDrugApplicants
2025/11/10New drug · Class 1 SPGL008注射液CXSL2500957 深圳赛保尔生物药业有限公司
2025/11/08Import · Class 1 ABBV-706注射用冻干粉JXSL2500213 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2025/11/08Import · Class 1 CID-103注射液JXSL2500212 CASI Pharmaceuticals Inc.; CASI Pharmaceuticals (China) Co. Ltd.
2025/11/08Import · Class 1 Frexalimab注射液JXSL2500211 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2025/11/08Generic · Class 3 美沙拉秦缓释颗粒CYHS2503907 石药集团中诺药业(石家庄)有限公司
2025/11/08Generic · Class 3 美沙拉秦缓释颗粒CYHS2503906 石药集团中诺药业(石家庄)有限公司
2025/11/08New drug · Class 1 SHR-1049注射液CXSL2500956 江苏恒瑞医药股份有限公司
2025/11/08New drug · Class 3.3 度普利尤单抗注射液CXSL2500955 江苏景行医药科技有限公司
2025/11/08New drug · Class 1 IBI343CXSL2500954 信达生物制药(苏州)有限公司
2025/11/08New drug · Class 3.3 KH816注射液CXSL2500953 成都康弘生物科技有限公司
2025/11/08New drug · Class 1 OB756片CXHL2501223 杭州邦顺制药股份有限公司
2025/11/07Import · Class 1 CagriSema注射液JXSL2500218 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2025/11/07Import · Class 1 CagriSema注射液JXSL2500217 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2025/11/07Import · Class 1 CagriSema注射液JXSL2500216 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2025/11/07Import · Class 1 CagriSema注射液JXSL2500215 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2025/11/07Import · Class 1 CagriSema注射液JXSL2500214 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2025/11/07Import · Class 2.4 左炔诺孕酮宫内释放系统JXHL2500344 Bayer Yakuhin Ltd.
2025/11/07Generic · Class 3 盐酸昂丹司琼口服溶液CYHS2503895 北京柏雅联合药物研究所有限公司; 广东众生药业股份有限公司
2025/11/07Generic · Class 3 注射用德拉沙星CYHL2500197 成都明德至远医药科技有限公司
2025/11/07New drug · Class 3.3 司美格鲁肽注射液CXSS2500122 复星万邦(江苏)医药集团有限公司
2025/11/07New drug · Class 3.3 司美格鲁肽注射液CXSS2500121 复星万邦(江苏)医药集团有限公司
2025/11/07New drug · Class 3.3 司美格鲁肽注射液CXSS2500120 复星万邦(江苏)医药集团有限公司
2025/11/07New drug · Class 3.3 司美格鲁肽注射液CXSS2500119 复星万邦(江苏)医药集团有限公司
2025/11/07New drug · Class 1 注射用重组酰化胰高血糖素样肽2类似物CXSL2500952 重庆派金生物科技有限公司
2025/11/07New drug · Class 1 人脐带间充质干细胞注射液CXSL2500951 杭州易文赛生物技术有限公司
2025/11/07New drug · Class 1 注射用YKYY031CXSL2500950 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
2025/11/07New drug · Class 1 IPG11406片CXHL2501222 南京艾美斐生物医药科技股份有限公司
2025/11/07New drug · Class 1 IPG11406片CXHL2501221 南京艾美斐生物医药科技股份有限公司
2025/11/07New drug · Class 1 IPG11406片CXHL2501220 南京艾美斐生物医药科技股份有限公司
2025/11/07New drug · Class 1 西奥罗尼胶囊CXHL2501219 深圳微芯生物科技股份有限公司; 成都微芯药业有限公司

60 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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