药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2022/11/01 – 2022/11/07

Period
2022/11/01 to 2022/11/07, 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
244
Drugs with new generic filings (by drug name, de-duplicated)
37
Accepted this week, now under review
1

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

244filings, 45 of them generic

By application type

Application typeFilings
Supplement108
Generic45
New drug40
Import29
Import re-registration19
Unspecified3

By drug type

Drug typeFilings
Chemical drug175
治疗用生物制品39
TCM29
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

37 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

149 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

79 this week

AcceptedDrugApplicants
2022/11/07New drug · Class 1 EMB-07注射液CXSL2200562 岸迈生物科技(苏州)有限公司
2022/11/07New drug · Class 1 HLX23CXSL2200561 上海复宏汉霖生物技术股份有限公司
2022/11/07New drug · Class 1 重组抗PD-1全人源单克隆抗体注射液CXSL2200560 上海昀怡健康科技发展有限公司
2022/11/06Generic · Class 3 盐酸溴己新口服溶液CYHS2201901 江西亿友药业有限公司; 精诚徽药药业股份有限公司
2022/11/05Import · Class 1 注射用SAR443216JXSL2200195 Sanofi-Aventis Recherche & Développement; SANOFI (CHINA) INVESTMENT CO. LTD
2022/11/05Import · Class 1 注射用SAR443216JXSL2200194 Sanofi-Aventis Recherche & Développement; SANOFI (CHINA) INVESTMENT CO. LTD
2022/11/05Import · Class 1 AZD2936JXSL2200193 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2022/11/05Import · Class 1 VAY736注射液JXSL2200192 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/11/05Import · Class 1 MEDI5752JXSL2200191 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2022/11/05Generic · Class 3 己酮可可碱注射液CYHS2201898 安徽恒星制药有限公司
2022/11/05Generic · Class 3 盐酸西替利嗪注射液CYHS2201895 北京四环科宝药业有限公司; 北京四环科宝制药股份有限公司
2022/11/05New drug · Class 2.2 注射用维迪西妥单抗CXSL2200559 荣昌生物制药(烟台)股份有限公司
2022/11/04Import · Class 1 Omecamtiv Mecarbil缓释片JXHS2200102 Cytokinetics Incorporated; Patheon Inc.; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd
2022/11/04Import · Class 1 Omecamtiv Mecarbil缓释片JXHS2200101 Cytokinetics Incorporated; Patheon Inc.; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd
2022/11/04Import · Class 1 Omecamtiv Mecarbil缓释片JXHS2200100 Cytokinetics Incorporated; Patheon Inc.; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd
2022/11/04Import · Class 2.2 诺西那生钠注射液JXHL2200330 Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd
2022/11/04Import · Class 2.2 诺西那生钠注射液JXHL2200329 Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd
2022/11/04Generic · Class 3 注射用哌拉西林钠CYHS2201894 河北东圣科宇医药科技有限公司; 华北制药股份有限公司
2022/11/04Generic · Class 3 盐酸艾司氯胺酮注射液CYHS2201893 扬子江药业集团有限公司
2022/11/04Generic · Class 3 枸橼酸西地那非干混悬剂CYHS2201889 南京海纳医药科技股份有限公司; 南京海纳制药有限公司
2022/11/04Generic · Class 3 吡拉西坦注射液CYHS2201888 华夏生生药业(北京)有限公司
2022/11/04Generic · Class 3 吡拉西坦注射液CYHS2201887 华夏生生药业(北京)有限公司
2022/11/04New drug · Class 1 PE0116注射液CXSL2200558 上海怀越生物科技有限公司
2022/11/04New drug · Class 3.3 德谷门冬双胰岛素注射液CXSL2200557 东莞市东阳光生物药研发有限公司; 广东东阳光药业有限公司
2022/11/04New drug · Class 2.4 ASC10片CXHL2200867 歌礼生物科技(杭州)有限公司
2022/11/04New drug · Class 2.4;2.1 ASC10片CXHL2200866 歌礼生物科技(杭州)有限公司
2022/11/03Generic · Class 3 尼莫地平口服溶液CYHS2201882 上海奥全生物医药科技有限公司; 华益药业科技(安徽)有限公司
2022/11/03New drug · Class 2.3 阿利沙坦酯氨氯地平片CXHS2200061 深圳信立泰药业股份有限公司
2022/11/03New drug · Class 1 BPI-452080 片CXHL2200865 贝达药业股份有限公司
2022/11/03New drug · Class 1 BPI-452080 片CXHL2200864 贝达药业股份有限公司

49 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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