药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2023/05/30 – 2023/06/05

Period
2023/05/30 to 2023/06/05, 7 days inclusive
Data as of
2026/11/07 06:00
Cached records
94,440 acceptance records, 11,686 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
304
Drugs with new generic filings (by drug name, de-duplicated)
59
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

304filings, 93 of them generic

By application type

Application typeFilings
Supplement144
Generic93
New drug40
Import16
Unspecified6
Import re-registration5

By drug type

Drug typeFilings
Chemical drug237
治疗用生物制品35
TCM32

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

180 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

88 this week

AcceptedDrugApplicants
2023/06/05Generic · Class 3 西咪替丁注射液CYHS2301528 山西诺成制药有限公司
2023/06/03Import · Class 3.1 司美格鲁肽注射液JXSS2300045 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2023/06/03Import · Class 3.1 司美格鲁肽注射液JXSS2300044 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2023/06/03Import · Class 3.1 司美格鲁肽注射液JXSS2300043 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2023/06/03Import · Class 3.1 司美格鲁肽注射液JXSS2300042 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2023/06/03Import · Class 3.1 司美格鲁肽注射液JXSS2300041 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2023/06/03New drug · Class 1 HW060015胶囊CXHL2300604 武汉人福创新药物研发中心有限公司
2023/06/03New drug · Class 1 HW060015胶囊CXHL2300603 武汉人福创新药物研发中心有限公司
2023/06/03New drug · Class 1 HW060015胶囊CXHL2300602 武汉人福创新药物研发中心有限公司
2023/06/03New drug · Class 1 TLL-018缓释片CXHL2300601 杭州高光制药有限公司
2023/06/03New drug · Class 1 TLL-018缓释片CXHL2300600 杭州高光制药有限公司
2023/06/03New drug · Class 1 TLL-018缓释片CXHL2300599 杭州高光制药有限公司
2023/06/03New drug · Class 1 TLL-018缓释片CXHL2300598 杭州高光制药有限公司
2023/06/03New drug · Class 1 TLL-018缓释片CXHL2300597 杭州高光制药有限公司
2023/06/02Import · Class 2.4 BMS-986165片JXHL2300136 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2023/06/02Import · Class 2.4 BMS-986165片JXHL2300135 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2023/06/02Generic · Class 3 枸橼酸钾缓释片CYHS2301506 成都硕德药业有限公司
2023/06/02Generic · Class 3 枸橼酸钾缓释片CYHS2301505 成都硕德药业有限公司
2023/06/02Generic · Class 3 帕拉米韦注射液CYHS2301504 山西阳和医药技术有限公司; 山西国润制药有限公司
2023/06/02Generic · Class 3 盐酸艾司洛尔注射液CYHS2301503 湖南赛隆药业(长沙)有限公司; 湖南赛隆药业有限公司
2023/06/02Generic · Class 3 盐酸西替利嗪注射液CYHL2300074 山东新时代药业有限公司
2023/06/02New drug · Class 1 伊努西单抗注射液CXSS2300043 康融东方(广东)医药有限公司
2023/06/02New drug · Class 1 伊努西单抗注射液CXSS2300042 康融东方(广东)医药有限公司
2023/06/02New drug · Class 1 伊努西单抗注射液CXSS2300041 康融东方(广东)医药有限公司
2023/06/02New drug · Class 1 伊努西单抗注射液CXSS2300040 康融东方(广东)医药有限公司
2023/06/02New drug · Class 1 重组抗PD-1全人源单克隆抗体注射液CXSL2300389 石药集团中奇制药技术(石家庄)有限公司
2023/06/02New drug · Class 1 BGB-A445注射液CXSL2300388 广州百济神州生物制药有限公司
2023/06/02New drug · Class 1 HRS-6209片CXHL2300596 江苏恒瑞医药股份有限公司
2023/06/02New drug · Class 1 HRS-6209片CXHL2300595 江苏恒瑞医药股份有限公司
2023/06/02New drug · Class 1 BGB-15025片CXHL2300594 百济神州(苏州)生物科技有限公司

58 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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