药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/10/08 – 2024/10/14

Period
2024/10/08 to 2024/10/14, 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
429
Drugs with new generic filings (by drug name, de-duplicated)
86
Accepted this week, now under review
2

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

429filings, 118 of them generic

By application type

Application typeFilings
Supplement198
Generic118
New drug57
Import31
Unspecified13
Import re-registration12

By drug type

Drug typeFilings
Chemical drug295
TCM69
治疗用生物制品59
Biologic4
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

86 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

258 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

123 this week

AcceptedDrugApplicants
2024/10/13Import · Class 3.1 伊匹木单抗注射液JXSS2400093 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2024/10/13Import · Class 3.1 伊匹木单抗注射液JXSS2400092 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2024/10/13Import · Class 3.1 纳武利尤单抗注射液JXSS2400091 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2024/10/13Import · Class 3.1 纳武利尤单抗注射液JXSS2400090 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2024/10/13Generic · Class 3 重酒石酸卡巴拉汀口服溶液CYHS2403448 山东百诺医药股份有限公司; 华益药业科技(安徽)有限公司
2024/10/13Generic · Class 3 呋塞米片CYHS2403447 上海理想制药有限公司
2024/10/13Generic · Class 3 盐酸丁螺环酮片CYHS2403446 重庆华森制药股份有限公司
2024/10/13Generic · Class 3 盐酸丁螺环酮片CYHS2403445 重庆华森制药股份有限公司
2024/10/13Generic · Class 3 苯磺贝他斯汀口崩片CYHS2403441 广东江正药业有限公司; 珠海润都制药股份有限公司
2024/10/13Generic · Class 3 盐酸纳美芬注射液CYHS2403434 广州市联瑞制药有限公司
2024/10/13Generic · Class 3 马来酸依那普利口服溶液CYHS2403433 北京远方通达医药技术有限公司; 太极集团四川太极制药有限公司
2024/10/13Generic · Class 3 注射用吲哚菁绿CYHS2403430 北京数字精准医疗科技股份有限公司; 悦康药业集团股份有限公司
2024/10/13New drug · Class 1 SYS6005CXSL2400692 石药集团巨石生物制药有限公司
2024/10/13New drug · Class 2.4 海曲泊帕乙醇胺片CXHS2400105 江苏恒瑞医药股份有限公司
2024/10/13New drug · Class 2.4 海曲泊帕乙醇胺片CXHS2400104 江苏恒瑞医药股份有限公司
2024/10/13New drug · Class 2.2 利拉鲁肽注射液CXHS2400103 深圳翰宇药业股份有限公司
2024/10/12Import · Class 3.1 布西珠单抗注射液JXSS2400089 Novartis Pharma Schweiz AG; Novartis Pharma Stein AG; Beijing Novartis Pharma Co. Ltd.
2024/10/12Import · Class 3.1 布西珠单抗注射液JXSS2400088 Novartis Pharma Schweiz AG; Alcon-Couvreur N.V.; Beijing Novartis Pharma Co. Ltd.
2024/10/12Import · Class 1 Mezagitamab注射剂JXSL2400193 Takeda Development Center Americas Inc.; Takeda APAC Biopharmaceutical Research and Development Company Limited
2024/10/12Import · Class 1 HCB301注射液JXSL2400192 FBD Biologics Limited; Shanghai Hanchor Biotech Inc.
2024/10/12Import · Class 2.4 甲磺酸仑伐替尼胶囊JXHS2400083 Eisai Europe Limited; Eisai Co. Ltd.
2024/10/12Import · Class 2.4 甲磺酸仑伐替尼胶囊JXHS2400082 Eisai Europe Limited; Eisai Co. Ltd.
2024/10/12Generic · Class 3 注射用氨苄西林钠CYHS2403423 湖南柏齐鹤药物研发有限公司; 湖南科伦制药有限公司
2024/10/12Generic · Class 3 氯化钙注射液CYHS2403421 广州大光制药有限公司; 湖南科伦制药有限公司
2024/10/12Generic · Class 3 西咪替丁注射液CYHS2403418 大理药业股份有限公司
2024/10/12Generic · Class 3 布瑞哌唑口崩片CYHS2403414 华益泰康药业股份有限公司
2024/10/12Generic · Class 3 布瑞哌唑口崩片CYHS2403412 华益泰康药业股份有限公司
2024/10/12Generic · Class 3 西格列汀二甲双胍缓释片CYHS2403411 江苏谦仁生物科技有限公司
2024/10/12Generic · Class 3 西格列汀二甲双胍缓释片CYHS2403408 江苏谦仁生物科技有限公司
2024/10/12Generic · Class 3 依帕司他片CYHS2403407 浙江东亚药业股份有限公司

93 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.