药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/04/02 – 2024/04/08

Period
2024/04/02 to 2024/04/08, 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
211
Drugs with new generic filings (by drug name, de-duplicated)
41
Accepted this week, now under review
4

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

211filings, 48 of them generic

By application type

Application typeFilings
Supplement100
Generic48
New drug36
Import18
Unspecified5
Import re-registration4

By drug type

Drug typeFilings
Chemical drug131
TCM40
治疗用生物制品39
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

41 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

139 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

73 this week

AcceptedDrugApplicants
2024/04/08Import · Class 1 BAY 3018250JXSL2400068 Bayer AG; Bayer Healthcare Company Ltd.
2024/04/08Import · Class 2.4 Capivasertib片JXHL2400087 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2024/04/08Import · Class 2.4 Capivasertib片JXHL2400086 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2024/04/08Generic · Class 3 盐酸肾上腺素注射液CYHS2401032 湖南海誓生物医药有限公司; 康普药业股份有限公司
2024/04/08Generic · Class 3 腺苷钴胺胶囊CYHS2401029 杭州沐源生物医药科技有限公司; 广东安诺药业股份有限公司
2024/04/08Generic · Class 3 甲硫酸新斯的明注射液CYHS2401025 广州市联瑞制药有限公司
2024/04/08Generic · Class 3 注射用奥氮平CYHS2401024 齐鲁制药有限公司
2024/04/08Generic · Class 3 腺苷钴胺胶囊CYHS2401022 华北制药股份有限公司
2024/04/08Generic · Class 3 阿仑膦酸钠口服溶液CYHS2401018 山东朗诺制药有限公司
2024/04/08Generic · Class 3 复合磷酸氢钾注射液CYHS2401015 华夏生生药业(北京)有限公司
2024/04/08New drug · Class 2.2 信迪利单抗注射液CXSS2400038 信达生物制药(苏州)有限公司
2024/04/08New drug · Class 1 注射用人脐带间充质干细胞CXSL2400212 艾尔普再生医学科技(深圳)有限公司
2024/04/08New drug · Class 2.2 水合氯醛糖浆CXHS2400025 成都倍特得诺药业有限公司
2024/04/08New drug · Class 1 RS-C1001片CXHL2400340 青岛睿森生物科技有限公司
2024/04/08New drug · Class 1 RS-C1001片CXHL2400339 青岛睿森生物科技有限公司
2024/04/08New drug · Class 1 KY386注射用浓溶液CXHL2400338 深圳开悦生命科技有限公司
2024/04/07New drug · Class 1.1 益气消瘤颗粒CXZL2400019 广东方盛融大药业有限公司
2024/04/04Import · Class 3.1 帕博利珠单抗注射液JXSS2400034 Merck Sharp & Dohme LLC; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd
2024/04/04Import · Class 2.2 司美格鲁肽注射液JXHL2400085 Dr. Reddy's Laboratories Limited; Dr. Reddy's (Beijing) Pharmaceutical Co. Ltd.
2024/04/04Import · Class 1 Golcadomide胶囊JXHL2400084 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2024/04/04Import · Class 1 Golcadomide胶囊JXHL2400083 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2024/04/04Import · Class 1 Golcadomide胶囊JXHL2400082 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2024/04/04Import · Class 1 BAY 2862789口服溶液JXHL2400081 Bayer AG; Bayer Healthcare Company Ltd.
2024/04/04Generic · Class 3 地拉罗司片CYHS2401014 上海复星医药产业发展有限公司; 苏州二叶制药有限公司
2024/04/04Generic · Class 3 地拉罗司片CYHS2401013 上海复星医药产业发展有限公司; 苏州二叶制药有限公司
2024/04/04Generic · Class 3 钠钾镁钙注射用浓溶液CYHS2401011 华夏生生药业(北京)有限公司
2024/04/04Generic · Class 3 布美他尼注射液CYHS2401010 北京六环药业有限公司; 华夏生生药业(北京)有限公司
2024/04/04New drug · Class 1.1 龙七胶囊CXZS2400011 江苏康缘药业股份有限公司
2024/04/04New drug · Class 2.3 丹红化瘀口服液CXZL2400018 广州白云山和记黄埔中药有限公司
2024/04/04New drug · Class 1 注射用RAB001CXHL2400337 中山莱博瑞辰生物医药有限公司

43 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.