药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2025/04/01 – 2025/04/07

Period
2025/04/01 to 2025/04/07, 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
323
Drugs with new generic filings (by drug name, de-duplicated)
59
Accepted this week, now under review
28

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

323filings, 82 of them generic

By application type

Application typeFilings
Supplement172
Generic82
New drug42
Import17
Unspecified6
Import re-registration4

By drug type

Drug typeFilings
Chemical drug178
TCM93
治疗用生物制品51
预防用生物制品1

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

59 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

175 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

79 this week

AcceptedDrugApplicants
2025/04/07Import · Class 2.4 英克司兰钠注射液JXHS2500043 Novartis Europharm Limited; Novartis Pharmaceutical Manufacturing GmbH; Beijing Novartis Pharma Co. Ltd.
2025/04/07Import · Class 1 Lartesertib片剂JXHL2500071 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd
2025/04/07Import · Class 1 Tuvusertib片剂JXHL2500070 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd
2025/04/07Import · Class 1 Tuvusertib片剂JXHL2500069 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd
2025/04/07Import · Class 1 Tuvusertib胶囊JXHL2500068 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd
2025/04/07Import · Class 1 Tuvusertib胶囊JXHL2500067 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd
2025/04/07Generic · Class 3 阿昔洛韦钠注射液CYHS2501313 山东达冠医药科技有限公司; 河南普瑞药业有限公司
2025/04/07Generic · Class 3 阿昔洛韦钠注射液CYHS2501312 山东达冠医药科技有限公司; 河南普瑞药业有限公司
2025/04/07Generic · Class 3 维生素K滴剂CYHS2501309 重庆万霖生物医药科技有限公司; 大连美创药业有限公司
2025/04/07New drug · Class 3.1 开心散CXZS2500015 安徽华润金蟾药业有限公司
2025/04/07New drug · Class 1 CM512注射液CXSL2500275 康诺亚生物医药科技(成都)有限公司
2025/04/07New drug · Class 2.2 塔戈利单抗注射液CXSL2500271 四川科伦博泰生物医药股份有限公司
2025/04/07New drug · Class 1 注射用SKB315CXSL2500270 四川科伦博泰生物医药股份有限公司
2025/04/07New drug · Class 1 注射用SSGJ-612CXSL2500269 沈阳三生制药有限责任公司
2025/04/07New drug · Class 1 SSGJ-707注射液CXSL2500268 沈阳三生制药有限责任公司
2025/04/07New drug · Class 1 重组抗IL-1β人源化单克隆抗体注射液CXSL2500267 三生国健药业(上海)股份有限公司
2025/04/07New drug · Class 1 注射用TQB6411CXSL2500266 正大天晴药业集团南京顺欣制药有限公司
2025/04/07New drug · Class 1 68Ga-NRT6020注射液CXHL2500358 成都纽瑞特医疗科技股份有限公司
2025/04/07New drug · Class 2.1;2.2 JMHT05CXHL2500357 湖南九典制药股份有限公司
2025/04/07New drug · Class 2.1;2.2 JMHT05CXHL2500356 湖南九典制药股份有限公司
2025/04/03Import · Class 3.1 注射用德曲妥珠单抗JXSS2500041 Daiichi Sankyo Europe GmbH; Baxter Oncology GmbH; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD.
2025/04/03Import · Class 3.1 本瑞利珠单抗注射液JXSS2500040 AstraZeneca AB; -
2025/04/03Import · Class 3.1 本瑞利珠单抗注射液JXSS2500039 AstraZeneca AB; -
2025/04/03Import · Class 2.2 Ravulizumab注射液JXSL2500052 Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd.
2025/04/03Import · Class 2.2 Ravulizumab注射液JXSL2500051 Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd.
2025/04/03Import · Class 1 Bimagrumab注射液JXSL2500050 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/04/03Import · Class 1 Bimagrumab注射液JXSL2500049 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/04/03Import · Class 2.2 注射用佐妥昔单抗JXSL2500048 Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd.
2025/04/03Generic · Class 3 二羟丙茶碱注射液CYHS2501299 山东益健药业有限公司
2025/04/03Generic · Class 3 乙酰半胱氨酸片CYHS2501292 海南赛立克药业有限公司

49 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.