药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/07/16 – 2024/07/22

Period
2024/07/16 to 2024/07/22, 7 days inclusive
Data as of
2026/11/05 06:00
Cached records
94,245 acceptance records, 11,689 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
415
Drugs with new generic filings (by drug name, de-duplicated)
81
Accepted this week, now under review
4

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

415filings, 128 of them generic

By application type

Application typeFilings
Supplement170
Generic128
New drug72
Import16
Unspecified15
Import re-registration14

By drug type

Drug typeFilings
Chemical drug279
TCM63
治疗用生物制品55
预防用生物制品13
Biologic5

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

81 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

268 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

137 this week

AcceptedDrugApplicants
2024/07/22Generic · Class 3 盐酸丙卡特罗口服溶液CYHS2402298 安徽瑞旗药业有限公司; 安徽新世纪药业有限公司
2024/07/22New drug · Class 3.2 MVA株猴痘减毒活疫苗CXSL2400473 上海生物制品研究所有限责任公司
2024/07/22New drug · Class 1 镓[68Ga]PSMA-0057注射液CXHL2400742 苏州瑞核医药科技有限公司
2024/07/22New drug · Class 1 镥[177Lu]PSMA-0057注射液CXHL2400741 苏州瑞核医药科技有限公司
2024/07/20Import · Class 1 注射用BRII-693JXHL2400182 Brii Biosciences Limited; Brii Biosciences (Beijing) Co. Limited
2024/07/20Generic · Class 3 硝酸甘油注射液CYHS2402294 成都瑞尔医药科技有限公司; 四川汇宇制药股份有限公司
2024/07/20Generic · Class 3 硝酸甘油注射液CYHS2402293 成都瑞尔医药科技有限公司; 四川汇宇制药股份有限公司
2024/07/20Generic · Class 3 醋酸钙口服溶液CYHS2402291 沈阳欣瑞制药有限公司
2024/07/20Generic · Class 3 对乙酰氨基酚片CYHS2402290 江苏贝佳制药有限公司
2024/07/20Generic · Class 3 丁酸氯维地平注射用乳剂CYHS2402285 上海上药第一生化药业有限公司; 上海医药集团(本溪)北方药业有限公司
2024/07/20Generic · Class 3 丁酸氯维地平注射用乳剂CYHS2402284 上海上药第一生化药业有限公司; 上海医药集团(本溪)北方药业有限公司
2024/07/20Generic · Class 3 氨磺必利口服溶液CYHS2402279 江苏长泰药业股份有限公司
2024/07/20New drug · Class 1 普基仑赛注射液CXSS2400076 重庆精准生物技术有限公司
2024/07/20New drug · Class 1 普基仑赛注射液CXSS2400075 重庆精准生物技术有限公司
2024/07/20New drug · Class 1 QL1706注射液CXSL2400472 齐鲁制药有限公司
2024/07/20New drug · Class 1 注射用XTL6001CXSL2400471 上海西泰利生物医药科技有限公司
2024/07/20New drug · Class 3.2 人抗凝血酶ⅢCXSL2400470 四川远大蜀阳药业有限责任公司
2024/07/20New drug · Class 1 GD-N1801外用溶液CXHL2400740 四川好医生攀西药业有限责任公司
2024/07/20New drug · Class 1 GD-N1801外用溶液CXHL2400739 四川好医生攀西药业有限责任公司
2024/07/20New drug · Class 1 BGB-26808片CXHL2400738 百济神州(苏州)生物科技有限公司
2024/07/20New drug · Class 1 BGB-26808片CXHL2400737 百济神州(苏州)生物科技有限公司
2024/07/20New drug · Class 1 BGB-26808片CXHL2400736 百济神州(苏州)生物科技有限公司
2024/07/20New drug · Class 1 富马酸奥比特嗪肠溶微丸胶囊CXHL2400735 深圳市真兴医药技术有限公司
2024/07/20New drug · Class 1 HY-1608注射液CXHL2400734 北京君科华元医药科技有限公司
2024/07/19Import · Class 2.2 纳武利尤单抗注射液JXSS2400062 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2024/07/19Import · Class 2.2 纳武利尤单抗注射液JXSS2400061 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2024/07/19Generic · Class 3 氨氯地平贝那普利胶囊CYHS2402277 江西施美药业股份有限公司
2024/07/19Generic · Class 3 氨溴特罗口服溶液CYHS2402269 翎耀生物科技(上海)有限公司; 安徽新世纪药业有限公司
2024/07/19Generic · Class 3 盐酸布比卡因注射液CYHS2402267 广州合和医药有限公司; 扬州中宝药业股份有限公司
2024/07/19Generic · Class 3 盐酸布比卡因注射液CYHS2402266 广州合和医药有限公司; 扬州中宝药业股份有限公司

107 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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