药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2023/03/07 – 2023/03/13

Period
2023/03/07 to 2023/03/13, 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
334
Drugs with new generic filings (by drug name, de-duplicated)
58
Accepted this week, now under review
9

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

334filings, 79 of them generic

By application type

Application typeFilings
Supplement175
Generic79
New drug46
Import14
Import re-registration12
Unspecified8

By drug type

Drug typeFilings
Chemical drug250
TCM43
治疗用生物制品36
Biologic3
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

58 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

195 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

94 this week

AcceptedDrugApplicants
2023/03/13Import · Class 1 LY3454738注射液JXSL2300050 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/03/13Generic · Class 3 头孢丙烯干混悬剂CYHS2300773 国药集团致君(深圳)制药有限公司
2023/03/13Generic · Class 3 奥贝胆酸片CYHL2300036 杭州民生药业股份有限公司
2023/03/13Generic · Class 3 奥贝胆酸片CYHL2300035 杭州民生药业股份有限公司
2023/03/13New drug · Class 2.2 替格瑞洛缓释片CXHL2300303 越洋医药开发(广州)有限公司
2023/03/11Import · Class 3.1 度伐利尤单抗注射液JXSS2300025 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca Investment (China) Co. Ltd.
2023/03/11Import · Class 3.1 度伐利尤单抗注射液JXSS2300024 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca Investment (China) Co. Ltd.
2023/03/11Import · Class 1 elranatamabJXSL2300049 Pfizer Inc; Pfizer Investment CO. Ltd.
2023/03/11Import · Class 1 Zavegepant鼻喷雾剂JXHL2300044 Pfizer Inc.; Pfizer Investment CO. Ltd
2023/03/11Generic · Class 3 恩格列净利格列汀片CYHS2300770 齐鲁制药(海南)有限公司
2023/03/11Generic · Class 3 恩格列净利格列汀片CYHS2300769 齐鲁制药(海南)有限公司
2023/03/11Generic · Class 3 法莫替丁注射液CYHS2300763 南京恒道医药科技股份有限公司; 江苏九旭药业有限公司
2023/03/11New drug · Class 1 HH-012注射液CXSL2300182 华辉安健(北京)生物科技有限公司
2023/03/11New drug · Class 2.4 氟维司群注射液CXHL2300302 正大天晴药业集团股份有限公司
2023/03/11New drug · Class 2.4 氟维司群注射液CXHL2300301 正大天晴药业集团股份有限公司
2023/03/11New drug · Class 1 替拉扎明注射液CXHL2300300 杭州瑞臻医药有限公司
2023/03/11New drug · Class 1 VC004凝胶CXHL2300299 江苏威凯尔医药科技有限公司
2023/03/11New drug · Class 1 VC004凝胶CXHL2300298 江苏威凯尔医药科技有限公司
2023/03/11New drug · Class 1 VC004凝胶CXHL2300297 江苏威凯尔医药科技有限公司
2023/03/11New drug · Class 1 VC004凝胶CXHL2300296 江苏威凯尔医药科技有限公司
2023/03/11New drug · Class 1 NRT6008注射液CXHL2300295 成都纽瑞特医疗科技股份有限公司
2023/03/10Import · Class 3.1 注射用维恩妥尤单抗JXSS2300023 Astellas Pharma Europe B.V.; Baxter Oncology GmbH; Astellas (China) Investment Co. Ltd.
2023/03/10Import · Class 3.1 注射用维恩妥尤单抗JXSS2300022 Astellas Pharma Europe B.V.; Baxter Oncology GmbH; Astellas (China) Investment Co Ltd.
2023/03/10Generic · Class 3 法莫替丁注射液CYHS2300762 合肥亿帆生物制药有限公司
2023/03/10Generic · Class 3 盐酸多巴酚丁胺注射液CYHS2300761 沈阳双鼎制药有限公司
2023/03/10Generic · Class 3 盐酸多巴酚丁胺注射液CYHS2300760 沈阳双鼎制药有限公司
2023/03/10Generic · Class 3 艾司奥美拉唑镁肠溶胶囊CYHS2300759 通化万通药业股份有限公司
2023/03/10Generic · Class 3 艾司奥美拉唑镁肠溶胶囊CYHS2300758 通化万通药业股份有限公司
2023/03/10Generic · Class 3 奥沙利铂注射液CYHS2300754 吉斯美(武汉)制药有限公司
2023/03/10Generic · Class 3 重酒石酸卡巴拉汀口服溶液CYHS2300753 山东朗诺制药有限公司

64 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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