药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/01/16 – 2024/01/22

Period
2024/01/16 to 2024/01/22, 7 days inclusive
Data as of
2026/11/06 06:00
Cached records
94,364 acceptance records, 11,708 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
306
Drugs with new generic filings (by drug name, de-duplicated)
59
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

306filings, 77 of them generic

By application type

Application typeFilings
Supplement156
Generic77
New drug51
Import14
Unspecified4
Import re-registration4

By drug type

Drug typeFilings
Chemical drug203
TCM56
治疗用生物制品42
预防用生物制品3
Biologic2

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

179 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

95 this week

AcceptedDrugApplicants
2024/01/22Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液CYHS2400291 江苏康缘药业股份有限公司
2024/01/22New drug · Class 2.2 SHR-8068注射液CXSL2400050 苏州盛迪亚生物医药有限公司
2024/01/22New drug · Class 1 注射用SHR-A2102CXSL2400049 上海恒瑞医药有限公司
2024/01/22New drug · Class 2.2 阿得贝利单抗注射液CXSL2400048 上海盛迪医药有限公司
2024/01/22New drug · Class 2.4 羟乙磺酸达尔西利片CXHL2400093 江苏恒瑞医药股份有限公司
2024/01/22New drug · Class 2.4 羟乙磺酸达尔西利片CXHL2400092 江苏恒瑞医药股份有限公司
2024/01/22New drug · Class 1 HRS8807片CXHL2400091 上海恒瑞医药有限公司
2024/01/22New drug · Class 1 HRS8807片CXHL2400090 上海恒瑞医药有限公司
2024/01/22New drug · Class 2.4 羟乙磺酸达尔西利片CXHL2400089 江苏恒瑞医药股份有限公司
2024/01/20Import · Class 2.2 佩索利单抗注射液(皮下注射)JXSL2400021 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/01/20Import · Class 2.2 佩索利单抗注射液JXSL2400020 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/01/20Generic · Class 3 硫酸沙丁胺醇注射液CYHS2400290 湖南华纳大药厂股份有限公司
2024/01/20Generic · Class 3 西格列汀二甲双胍缓释片CYHS2400288 平光制药股份有限公司
2024/01/20Generic · Class 3 西格列汀二甲双胍缓释片CYHS2400287 平光制药股份有限公司
2024/01/20Generic · Class 3 依巴斯汀口服溶液CYHS2400286 山西同达药业有限公司
2024/01/20Generic · Class 3 复方聚乙二醇电解质散(Ⅱ)CYHS2400285 杨凌科森生物制药有限责任公司
2024/01/20Generic · Class 3 复方聚乙二醇电解质散(Ⅱ)CYHS2400284 杨凌科森生物制药有限责任公司
2024/01/20Generic · Class 3 盐酸曲唑酮片CYHS2400283 西安远大科创医药科技有限公司; 西安远大德天药业股份有限公司
2024/01/20Generic · Class 3 无水甜菜碱散剂CYHS2400282 北京斯利安药业有限公司
2024/01/20Generic · Class 3 二羟丙茶碱注射液CYHS2400281 安徽美来药业股份有限公司; 马鞍山丰原制药有限公司
2024/01/20Generic · Class 3 盐酸美金刚口服溶液CYHS2400280 沈阳天邦药业有限公司
2024/01/20New drug · Class 3.1 枇杷清肺颗粒CXZS2400004 仲景宛西制药股份有限公司
2024/01/20New drug · Class 3.3 b型流感嗜血杆菌结合疫苗CXSS2400014 罗益(无锡)生物制药有限公司
2024/01/20New drug · Class 2.2 注射用卡瑞利珠单抗CXSL2400047 苏州盛迪亚生物医药有限公司
2024/01/20New drug · Class 1 注射用BL-M07D1CXSL2400046 成都百利多特生物药业有限责任公司; 四川百利药业有限责任公司
2024/01/20New drug · Class 1 注射用BL-M07D1CXSL2400045 成都百利多特生物药业有限责任公司; 四川百利药业有限责任公司
2024/01/20New drug · Class 1 XNW5004片CXHL2400088 苏州信诺维医药科技股份有限公司
2024/01/20New drug · Class 1 XNW5004片CXHL2400087 苏州信诺维医药科技股份有限公司
2024/01/20New drug · Class 2.4 盐酸伊立替康脂质体注射液CXHL2400086 石药集团欧意药业有限公司
2024/01/19Import · Class 1 BI 456906 注射液JXHL2400020 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.

65 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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