药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2022/11/08 – 2022/11/14

Period
2022/11/08 to 2022/11/14, 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
302
Drugs with new generic filings (by drug name, de-duplicated)
54
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

302filings, 81 of them generic

By application type

Application typeFilings
Supplement156
Generic81
New drug36
Import13
Unspecified12
Import re-registration4

By drug type

Drug typeFilings
Chemical drug207
TCM68
治疗用生物制品25
Biologic1
预防用生物制品1

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

54 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

166 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

71 this week

AcceptedDrugApplicants
2022/11/14Generic · Class 3 盐酸利多卡因注射液CYHS2201979 北京世桥生物制药有限公司
2022/11/14Generic · Class 3 盐酸利多卡因注射液CYHS2201978 北京世桥生物制药有限公司
2022/11/14Generic · Class 3 盐酸利多卡因注射液CYHS2201977 北京世桥生物制药有限公司
2022/11/14Generic · Class 3 羟苯磺酸钙片CYHS2201974 浙江视方极医药科技有限公司; 宁夏康亚药业股份有限公司
2022/11/14New drug · Class 1 SIM0270胶囊CXHL2200894 先声药业有限公司
2022/11/13Import · Class 2.2;2.4 INOpulseJXHL2200334 Bellerophon Pulse Technologies LLC; Baylor Biosciences Inc
2022/11/12Import · Class 1 Remternetug注射液(静脉注射)JXSL2200200 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2022/11/12Import · Class 1 Remternetug注射液JXSL2200199 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2022/11/12Import · Class 1 注射用OregovomabJXSL2200198 OncoQuest Pharmaceuticals Inc.; IQVIA RDS (Shanghai) Co. Ltd.
2022/11/12Generic · Class 3 氨溴特罗口服溶液CYHS2201970 上海葆隆生物科技有限公司; 上海美优制药有限公司
2022/11/12Generic · Class 3 布洛芬注射液CYHS2201969 山东罗欣药业集团股份有限公司
2022/11/12Generic · Class 3 镥[177Lu]氧奥曲肽注射液CYHL2200102 天津恒瑞医药有限公司
2022/11/12New drug · Class 1 SM3321注射液CXSL2200572 北京烁星生物医药科技有限公司
2022/11/12New drug · Class 1 NMM肿瘤治疗性DNA疫苗裸质粒注射液CXSL2200571 固安鼎泰海规生物科技有限公司
2022/11/12New drug · Class 1 注射用IMM01CXSL2200570 宜明昂科生物医药技术(上海)股份有限公司
2022/11/12New drug · Class 1 莫非赛定利托那韦片CXHL2200893 广东东阳光药业有限公司
2022/11/12New drug · Class 1 注射用贺普拉肽CXHL2200892 上海贺普药业股份有限公司
2022/11/12New drug · Class 2.2 HECB1701001缓释片CXHL2200891 广东东阳光药业有限公司
2022/11/12New drug · Class 2.2 HECB1701001缓释片CXHL2200890 广东东阳光药业有限公司
2022/11/11Generic · Class 3 磷酸奥司他韦干混悬剂CYHS2201959 海南斯达制药有限公司; 天津汉瑞药业有限公司
2022/11/11Generic · Class 3 钠钾镁钙葡萄糖注射液CYHS2201956 宜昌人福药业有限责任公司; 宜昌三峡制药有限公司
2022/11/11Generic · Class 3 布洛氢可酮片CYHS2201954 宜昌人福药业有限责任公司
2022/11/11Generic · Class 3 布洛氢可酮片CYHS2201953 宜昌人福药业有限责任公司
2022/11/11Generic · Class 3 酮咯酸氨丁三醇注射液CYHS2201947 吉林振澳制药有限公司
2022/11/11Generic · Class 3 盐酸非索非那定干混悬剂CYHS2201943 济川药业集团有限公司
2022/11/11Generic · Class 3 盐酸非索非那定干混悬剂CYHS2201942 济川药业集团有限公司
2022/11/11New drug · Class 1.1 风叶咳喘平口服液CXZS2200014 卓和药业集团股份有限公司; 亚宝药业四川制药有限公司
2022/11/11New drug · Class 1.1 止得咳颗粒CXZL2200049 广西中医药大学附属瑞康医院; 广西中医药大学
2022/11/11New drug · Class 1 GC001溶瘤痘苗病毒注射液CXSL2200569 杭州功楚生物科技有限公司
2022/11/10Generic · Class 3 注射用尼可地尔CYHS2201940 科贝园(北京)医药科技有限公司; 山西普德药业有限公司

41 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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