药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/07/09 – 2024/07/15

Period
2024/07/09 to 2024/07/15, 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
395
Drugs with new generic filings (by drug name, de-duplicated)
84
Accepted this week, now under review
1

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

395filings, 121 of them generic

By application type

Application typeFilings
Supplement171
Generic121
New drug72
Import21
Import re-registration8
Unspecified2

By drug type

Drug typeFilings
Chemical drug278
TCM71
治疗用生物制品45
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

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

224 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

148 this week

AcceptedDrugApplicants
2024/07/15New drug · Class 2.4 注射用重组人透明质酸酶CXSS2400067 上海宝济药业股份有限公司
2024/07/15New drug · Class 2.2 四价流感病毒裂解疫苗(MDCK细胞)CXSL2400449 深圳康泰生物制品股份有限公司; 兰州百灵生物技术有限公司
2024/07/15New drug · Class 1 GD-19乳状注射液CXHL2400711 天津谷堆生物医药科技有限公司
2024/07/13Import · Class 2.2 伊匹木单抗注射液JXSS2400056 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2024/07/13Import · Class 2.2 伊匹木单抗注射液JXSS2400055 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2024/07/13Generic · Class 3 利多卡因丁卡因乳膏CYHS2402174 科笛生物医药(无锡)有限公司
2024/07/13New drug · Class 2.2 索卡佐利单抗注射液CXSS2400065 兆科(广州)肿瘤药物有限公司; 无锡药明生物技术股份有限公司
2024/07/13New drug · Class 1 TQ05105片CXHS2400053 正大天晴药业集团股份有限公司
2024/07/12Import · Class 3.1 度普利尤单抗注射液JXSL2400123 Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd.
2024/07/12Import · Class 2.2 艾加莫德α注射液JXSL2400122 argenx BV; Zai Lab (Shanghai) Co. Ltd.
2024/07/12Import · Class 1 MK-3475A注射液JXSL2400121 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2024/07/12Import · Class 1 TAK-861片JXHL2400180 Takeda Development Center Americas Inc.
2024/07/12Import · Class 1 TAK-861片JXHL2400179 Takeda Development Center Americas Inc.
2024/07/12Import · Class 1 TAK-861片JXHL2400178 Takeda Development Center Americas Inc.
2024/07/12Import · Class 1 TAK-861片JXHL2400177 Takeda Development Center Americas Inc.
2024/07/12Import · Class 1 Bomedemstat胶囊JXHL2400176 Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2024/07/12Import · Class 1 Bomedemstat胶囊JXHL2400175 Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2024/07/12Import · Class 1 Bomedemstat胶囊JXHL2400174 Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2024/07/12Import · Class 1 Bomedemstat胶囊JXHL2400173 Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2024/07/12Import · Class 2.4 罗氟司特乳膏JXHL2400172 Arcutis Biotherapeutics INC
2024/07/12Import · Class 1 BI 1839100 片JXHL2400171 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/07/12Generic · Class 3 注射用比阿培南CYHS2402162 悦康药业集团股份有限公司
2024/07/12Generic · Class 3 西格列汀二甲双胍缓释片CYHS2402158 河南中杰药业有限公司
2024/07/12Generic · Class 3 西格列汀二甲双胍缓释片CYHS2402157 河南中杰药业有限公司
2024/07/12Generic · Class 3 注射用氢化可的松琥珀酸钠CYHS2402154 江苏江丰医药科技有限公司; 津药和平(天津)制药有限公司
2024/07/12Generic · Class 3 维生素B?注射液CYHS2402153 江苏宝东医药科技有限公司; 哈尔滨誉衡制药有限公司
2024/07/12Generic · Class 3 硫代硫酸钠注射液CYHS2402152 山东齐都药业有限公司
2024/07/12Generic · Class 3 硫代硫酸钠注射液CYHS2402151 山东齐都药业有限公司
2024/07/12Generic · Class 3 卡络磺钠注射液CYHS2402150 广州一品红制药有限公司; 河北凯威制药有限责任公司
2024/07/12Generic · Class 3 阿仑膦酸钠口服溶液CYHS2402149 苏州华健瑞达医药技术有限公司; 湖南九典制药股份有限公司

118 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.