药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2022/06/14 – 2022/06/20

Period
2022/06/14 to 2022/06/20, 7 days inclusive
Data as of
2026/11/08 06:00
Cached records
94,440 acceptance records, 11,586 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
292
Drugs with new generic filings (by drug name, de-duplicated)
33
Accepted this week, now under review
0

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

292filings, 41 of them generic

By application type

Application typeFilings
Supplement157
New drug47
Generic41
Import19
Import re-registration18
Unspecified10

By drug type

Drug typeFilings
Chemical drug205
治疗用生物制品53
TCM29
预防用生物制品4
Biologic1

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

33 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

173 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

72 this week

AcceptedDrugApplicants
2022/06/20Import · Class 1 替拉扎明注射液JXHL2200140 Raygene Inc.; Hangzhou Taibo Pharmaceutical Company Ltd.
2022/06/20New drug · Class 1.1 AC591颗粒CXZL2200029 江苏省中医药研究院
2022/06/20New drug · Class 2.2 派安普利单抗注射液CXSL2200283 正大天晴康方(上海)生物医药科技有限公司
2022/06/20New drug · Class 1 CM369注射液CXSL2200282 北京天诺健成医药科技有限公司
2022/06/20New drug · Class 2.2 人干扰素α2b阴道泡腾胶囊CXSL2200281 科兴生物制药股份有限公司
2022/06/20New drug · Class 3.3 四价流感病毒裂解疫苗CXSL2200280 深圳康泰生物制品股份有限公司
2022/06/20New drug · Class 1 重组全人源抗EGFR单克隆抗体注射液CXSL2200279 上海赛远生物科技有限公司
2022/06/20New drug · Class 1 EVT-401片CXHL2200403 浙江金华康恩贝生物制药有限公司
2022/06/20New drug · Class 1 EVT-401片CXHL2200402 浙江金华康恩贝生物制药有限公司
2022/06/20New drug · Class 2.2 HRG2101吸入剂CXHL2200400 江苏恒瑞医药股份有限公司
2022/06/20New drug · Class 2.2 注射用左西孟旦CXHL2200397 海南倍特药业有限公司
2022/06/17Import · Class 2.1 Isatuximab注射液(皮下注射)JXSL2200088 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2022/06/17Import · Class 1 Bemarituzumab注射液JXSL2200087 Zai Lab (US) LLC; Zai Lab (Shanghai) CO. Ltd.
2022/06/17Import · Class 1 Bemarituzumab注射液JXSL2200086 Zai Lab (US) LLC; Zai Lab (Shanghai) CO. Ltd.
2022/06/17Import · Class 1 M1774胶囊JXHL2200151 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd
2022/06/17Import · Class 1 M1774胶囊JXHL2200150 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd
2022/06/17Import · Class 1 M1774胶囊JXHL2200149 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd
2022/06/17Generic · Class 3 铝碳酸镁混悬液CYHS2200912 四川益生智同医药生物科技发展有限公司; 太极集团四川太极制药有限公司
2022/06/17Generic · Class 3 多种微量元素注射液(Ⅰ)CYHS2200906 洋浦京泰药业有限公司; 内蒙古白医制药股份有限公司
2022/06/17Generic · Class 3 盐酸多巴酚丁胺注射液CYHS2200904 南京恒道医药科技股份有限公司; 海南灵康制药有限公司
2022/06/17Generic · Class 3 米诺地尔搽剂CYHS2200901 辰光(天津)制药有限公司
2022/06/17Generic · Class 3 米诺地尔搽剂CYHS2200900 辰光(天津)制药有限公司
2022/06/17New drug · Class 1.1 心阳片CXZL2200028 广州中医药大学第一附属医院
2022/06/17New drug · Class 1 6MW3511注射液CXSL2200278 迈威(上海)生物科技股份有限公司
2022/06/17New drug · Class 3.3 水痘减毒活疫苗CXSL2200273 辽宁成大生物股份有限公司; 成大生物(本溪)有限公司
2022/06/17New drug · Class 1 QA102 胶囊CXHL2200399 珠海岐微生物科技有限公司
2022/06/17New drug · Class 1 QA102 胶囊CXHL2200398 珠海岐微生物科技有限公司
2022/06/17New drug · Class 1 SPH3127片CXHL2200396 上海医药集团股份有限公司
2022/06/17New drug · Class 1 SPH3127片CXHL2200395 上海医药集团股份有限公司
2022/06/16Import · Class 3.1 注射用Susoctocog alfaJXSS2200020 Baxalta US Inc.; Vetter Pharma-Fertigung GmbH & Co. KG; Takeda (China) International Trading Co. Ltd

42 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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