药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2022/05/24 – 2022/05/30

Period
2022/05/24 to 2022/05/30, 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
284
Drugs with new generic filings (by drug name, de-duplicated)
40
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

284filings, 57 of them generic

By application type

Application typeFilings
Supplement129
Generic57
New drug47
Import27
Unspecified13
Import re-registration11

By drug type

Drug typeFilings
Chemical drug201
治疗用生物制品45
TCM30
Biologic7
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

40 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

161 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

87 this week

AcceptedDrugApplicants
2022/05/28Import · Class 3.1 Netakimab注射液JXSL2200066 Joint Stock Company “BIOCAD”,(JSC “BIOCAD”); SPH-Biocad Biopharmaceuticals (SH) Co. Ltd.
2022/05/28Import · Class 2.2 二氟泼尼酯滴眼液JXHL2200123 SUN PHARMACEUTICAL INDUSTRIES LTD.
2022/05/28Import · Class 1 EnpatoranJXHL2200122 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd.
2022/05/28Import · Class 1 EnpatoranJXHL2200121 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd.
2022/05/28Generic · Class 3 依帕司他片CYHS2200799 浙江恒研医药科技有限公司; 浙江赛默制药有限公司
2022/05/28New drug · Class 1 伊基仑赛注射液CXSL2200234 南京驯鹿生物医药有限公司
2022/05/28New drug · Class 1 伊基仑赛注射液CXSL2200233 南京驯鹿生物医药有限公司
2022/05/28New drug · Class 1 EOC202注射液CXSL2200232 泰州亿腾景昂药业股份有限公司
2022/05/28New drug · Class 2.2 盐酸多奈哌齐口溶膜CXHL2200341 浙江和泽医药科技股份有限公司
2022/05/28New drug · Class 2.2 恩扎卢胺片CXHL2200339 四川科伦药物研究院有限公司
2022/05/27Import · Class 3.1 司美格鲁肽片JXSS2200018 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2022/05/27Import · Class 3.1 司美格鲁肽片JXSS2200017 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2022/05/27Import · Class 3.1 司美格鲁肽片JXSS2200016 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2022/05/27Import · Class 1 VAY736注射液JXSL2200067 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/05/27Generic · Class 3 盐酸多巴胺注射液CYHS2200790 呋欧医药科技(湖州)有限公司; 安徽长江药业有限公司
2022/05/27Generic · Class 3 盐酸多巴胺注射液CYHS2200789 呋欧医药科技(湖州)有限公司; 安徽长江药业有限公司
2022/05/27Generic · Class 3 氨溴特罗口服溶液CYHS2200783 成都利尔药业有限公司
2022/05/27Generic · Class 3 依帕司他片CYHS2200777 石家庄四药有限公司
2022/05/27Generic · Class 3 阿立哌唑口服溶液CYHS2200776 西洲医药科技(浙江)有限公司; 浙江赛默制药有限公司
2022/05/27Generic · Class 3 厄贝沙坦氨氯地平片CYHL2200045 湖南慧泽生物医药科技有限公司
2022/05/27Generic · Class 3 厄贝沙坦氨氯地平片CYHL2200044 湖南慧泽生物医药科技有限公司
2022/05/27New drug · Class 3.4 人凝血因子ⅧCXSS2200054 深圳市卫光生物制品股份有限公司
2022/05/27New drug · Class 1 泽美洛韦玛佐瑞韦单抗注射液CXSS2200053 兴盟生物医药(苏州)有限公司
2022/05/27New drug · Class 1 泽美洛韦玛佐瑞韦单抗注射液CXSS2200052 兴盟生物医药(苏州)有限公司
2022/05/27New drug · Class 3.2 外用重组人凝血酶CXSS2200051 苏州泽璟生物制药股份有限公司
2022/05/27New drug · Class 1 赫基仑赛注射液CXSL2200231 合源生物科技(天津)有限公司
2022/05/27New drug · Class 3.2 静注人免疫球蛋白CXSL2200230 深圳市卫光生物制品股份有限公司
2022/05/27New drug · Class 3.2 静注人免疫球蛋白CXSL2200229 深圳市卫光生物制品股份有限公司
2022/05/27New drug · Class 1 B1962注射液CXSL2200226 天士力生物医药股份有限公司
2022/05/27New drug · Class 1 HR20014注射液CXSL2200225 江苏恒瑞医药股份有限公司

57 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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