药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/11/26 – 2024/12/02

Period
2024/11/26 to 2024/12/02, 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
392
Drugs with new generic filings (by drug name, de-duplicated)
67
Accepted this week, now under review
11

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

392filings, 89 of them generic

By application type

Application typeFilings
Supplement198
Generic89
New drug50
Import re-registration27
Import18
Unspecified10

By drug type

Drug typeFilings
Chemical drug265
TCM81
治疗用生物制品40
Biologic5
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

67 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

221 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

92 this week

AcceptedDrugApplicants
2024/12/02Generic · Class 3 布美他尼注射液CYHS2404137 石家庄四药有限公司
2024/12/02Generic · Class 3 草酸艾司西酞普兰口服溶液CYHS2404136 海南广升誉制药有限公司; 江苏欧歌制药有限公司
2024/12/02Generic · Class 3 钠钾镁钙注射用浓溶液CYHS2404135 成都欣捷高新技术开发股份有限公司; 山东华鲁制药有限公司
2024/12/02Generic · Class 3 磷酸奥司他韦干混悬剂CYHS2404133 江西药都仁和制药有限公司
2024/12/02New drug · Class 1.2 冻干呼吸道合胞病毒(RSV)mRNA疫苗CXSL2400812 北京科兴中维生物技术有限公司
2024/12/02New drug · Class 1 JYB1904注射液CXSL2400811 江苏济烨生物制药有限公司
2024/11/30Import · Class 1 镥[177Lu]Lu-NeoB注射液JXHL2400281 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/11/30Import · Class 1 用于制备放射性药物[68Ga]Ga-NeoB注射液的药盒JXHL2400280 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/11/30Import · Class 1 注射用JX10JXHL2400279 Corxel Pharmaceuticals Inc.; Corxel Pharmaceuticals (Shanghai) Co. Ltd
2024/11/30Generic · Class 3 铝碳酸镁混悬液CYHS2404126 合肥远志医药科技开发有限公司; 安徽永生堂药业有限责任公司
2024/11/30Generic · Class 3 盐酸美金刚口崩片CYHS2404125 重庆苯立方医药科技有限公司; 山西同达药业有限公司
2024/11/30Generic · Class 3 碳酸镧颗粒CYHS2404124 海南皇隆制药股份有限公司
2024/11/30Generic · Class 3 马来酸依那普利口服溶液CYHS2404123 北京海一药业有限公司; 江苏欧歌制药有限公司
2024/11/30Generic · Class 3 酮咯酸氨丁三醇注射液CYHS2404122 广东南国药业有限公司
2024/11/30Generic · Class 3 对乙酰氨基酚颗粒(直接服用)CYHS2404121 上海上药信谊药厂有限公司
2024/11/30Generic · Class 3 吲哚美辛凝胶贴膏CYHL2400238 深圳珐玛易药品科技有限公司
2024/11/30Generic · Class 3 利多卡因丙胺卡因气雾剂CYHL2400237 北京中泰邦医药科技有限公司
2024/11/30New drug · Class 1 LYN101注射液CXSL2400810 上海才致药成生物科技有限公司
2024/11/30New drug · Class 1 NKC007细胞注射液CXSL2400809 广州蒽恺赛生物科技有限公司
2024/11/30New drug · Class 1 KYS202002A注射液CXSL2400808 江苏康缘药业股份有限公司
2024/11/30New drug · Class 1 Sonrotoclax薄膜包衣片CXHL2401304 百济神州(苏州)生物科技有限公司
2024/11/30New drug · Class 1 Sonrotoclax薄膜包衣片CXHL2401303 百济神州(苏州)生物科技有限公司
2024/11/30New drug · Class 1 Sonrotoclax薄膜包衣片CXHL2401302 百济神州(苏州)生物科技有限公司
2024/11/30New drug · Class 1 Sonrotoclax薄膜包衣片CXHL2401301 百济神州(苏州)生物科技有限公司
2024/11/30New drug · Class 1 HS-10502片CXHL2401300 江苏豪森药业集团有限公司; 上海翰森生物医药科技有限公司
2024/11/30New drug · Class 1 HS-10502片CXHL2401299 江苏豪森药业集团有限公司; 上海翰森生物医药科技有限公司
2024/11/30New drug · Class 2.4 泽布替尼胶囊CXHL2401298 百济神州(苏州)生物科技有限公司
2024/11/30New drug · Class 2.4 泽布替尼胶囊CXHL2401297 百济神州(苏州)生物科技有限公司
2024/11/30New drug · Class 1 F1F3软膏CXHL2401296 中奥生物医药技术(广东)有限公司
2024/11/30New drug · Class 1 F1F3软膏CXHL2401295 中奥生物医药技术(广东)有限公司

62 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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