药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2025/07/08 – 2025/07/14

Period
2025/07/08 to 2025/07/14, 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
469
Drugs with new generic filings (by drug name, de-duplicated)
84
Accepted this week, now under review
109

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

469filings, 128 of them generic

By application type

Application typeFilings
Supplement192
Generic128
New drug107
Import30
Import re-registration10
Unspecified2

By drug type

Drug typeFilings
Chemical drug318
TCM79
治疗用生物制品68
Biologic2
预防用生物制品2

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

84 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

275 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

183 this week

AcceptedDrugApplicants
2025/07/14Import · Class 1 IcoSema 注射液JXSL2500122 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2025/07/14Generic · Class 3 盐酸普萘洛尔注射液CYHS2502518 德全药品(江苏)股份有限公司
2025/07/14New drug · Class 2.2 恩朗苏拜单抗注射液CXSL2500588 石药集团巨石生物制药有限公司
2025/07/14New drug · Class 2.2 QL2107注射液CXSL2500587 齐鲁制药有限公司
2025/07/14New drug · Class 1 KDTV001注射液CXSL2500586 武汉凯德基诺生物技术有限公司
2025/07/14New drug · Class 1 注射用QLC5508CXSL2500585 齐鲁制药有限公司
2025/07/14New drug · Class 1 EVM14注射液CXSL2500584 云顶新耀(北京)医药科技有限公司
2025/07/14New drug · Class 2.3 BTP4507CXHL2500698 江苏诺和必拓新药研发有限公司; 北京阳光诺和药物研究股份有限公司; 北京百奥药业有限责任公司
2025/07/12Import · Class 1 AZD5335JXSL2500121 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/07/12Import · Class 2.4 注射用六氟化硫微泡JXHL2500183 Bracco International B.V.; Bracco Imaging Medical Technologies (Shanghai) Co. Ltd
2025/07/12Import · Class 1 AZD9574JXHL2500182 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/07/12Import · Class 1 AZD9574JXHL2500181 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/07/12Import · Class 1 AZD9574JXHL2500180 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/07/12Import · Class 1 AZD9574JXHL2500179 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/07/12Generic · Class 3 盐酸西替利嗪干糖浆CYHS2502516 海南元盈医药科技有限公司; 海南海神同洲制药有限公司
2025/07/12Generic · Class 3 西咪替丁注射液CYHS2502505 森淼(山东)药业有限公司; 湖北津药药业股份有限公司
2025/07/12Generic · Class 3 复方聚乙二醇电解质散(Ⅱ)CYHS2502504 上海朝晖药业有限公司
2025/07/12Generic · Class 3 复方电解质醋酸钠葡萄糖注射液CYHS2502503 山东化药医药科技有限公司; 山东华鲁制药有限公司
2025/07/12Generic · Class 3 复方电解质醋酸钠葡萄糖注射液CYHS2502502 山东化药医药科技有限公司; 山东华鲁制药有限公司
2025/07/12Generic · Class 3 米诺地尔搽剂CYHS2502500 科笛生物医药(无锡)有限公司
2025/07/12Generic · Class 3 米诺地尔搽剂CYHS2502499 科笛生物医药(无锡)有限公司
2025/07/12Generic · Class 3 复方电解质醋酸钠葡萄糖注射液CYHS2502498 南京正大天晴制药有限公司
2025/07/12Generic · Class 3 复方电解质醋酸钠葡萄糖注射液CYHS2502497 南京正大天晴制药有限公司
2025/07/12Generic · Class 3 碳酸氢钠林格注射液(Ⅰ)CYHS2502496 南京正科医药股份有限公司; 山东华鲁制药有限公司
2025/07/12Generic · Class 3 米诺地尔搽剂CYHS2502494 湖北午时药业股份有限公司
2025/07/12Generic · Class 3 米诺地尔搽剂CYHS2502493 湖北午时药业股份有限公司
2025/07/12Generic · Class 3 注射用乳糖酸红霉素CYHS2502490 苏州朗科生物技术股份有限公司; 江苏海岸药业有限公司
2025/07/12Generic · Class 3 注射用乳糖酸红霉素CYHS2502489 苏州朗科生物技术股份有限公司; 江苏海岸药业有限公司
2025/07/12Generic · Class 3 吸入用盐酸氨溴索溶液CYHS2502485 北京韩美药品有限公司
2025/07/12Generic · Class 3 吸入用盐酸氨溴索溶液CYHS2502484 北京韩美药品有限公司

153 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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