药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2023/11/14 – 2023/11/20

Period
2023/11/14 to 2023/11/20, 7 days inclusive
Data as of
2026/11/06 06:00
Cached records
94,364 acceptance records, 11,708 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
351
Drugs with new generic filings (by drug name, de-duplicated)
53
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

351filings, 68 of them generic

By application type

Application typeFilings
Supplement204
Generic68
New drug44
Import23
Import re-registration7
Unspecified5

By drug type

Drug typeFilings
Chemical drug239
TCM69
治疗用生物制品39
Biologic2
预防用生物制品2

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

53 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

204 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

91 this week

AcceptedDrugApplicants
2023/11/20Import · Class 1 AZD3470薄膜衣片JXHL2300292 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/11/20Import · Class 1 AZD3470薄膜衣片JXHL2300291 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/11/20Generic · Class 3 醋酸葡萄糖维持液CYHS2303177 仁合益康集团有限公司; 河北仁合益康药业有限公司
2023/11/20Generic · Class 3 醋酸葡萄糖维持液CYHS2303176 仁合益康集团有限公司; 河北仁合益康药业有限公司
2023/11/20Generic · Class 3 普瑞巴林口服溶液CYHS2303172 北京索普兴大医药研究有限公司; 青岛国信制药有限公司
2023/11/20Generic · Class 3 盐酸非索非那定口服混悬液CYHS2303171 浙江普利药业有限公司
2023/11/20New drug · Class 3.1 桃红四物汤颗粒CXZS2300023 海南康茂信医药科技有限公司; 国药集团德众(佛山)药业有限公司
2023/11/20New drug · Class 1.1 四仙颗粒CXZL2300071 四川省中医药科学院
2023/11/20New drug · Class 2.2 阿得贝利单抗注射液CXSL2300794 上海盛迪医药有限公司
2023/11/20New drug · Class 1 TQB2223 注射液CXSL2300793 正大天晴(广州)医药有限公司
2023/11/20New drug · Class 1 IMC001注射液CXSL2300792 成都易慕峰生物科技有限公司; 苏州易慕峰生物科技有限公司
2023/11/20New drug · Class 2.4 镥[177Lu]氧奥曲肽注射液CXHL2301284 北京先通国际医药科技股份有限公司
2023/11/18Generic · Class 3 盐酸阿比多尔片CYHS2303169 武汉人福利康药业有限公司
2023/11/18Generic · Class 3 西咪替丁注射液CYHS2303168 广州市联瑞制药有限公司
2023/11/18New drug · Class 2.3 小儿热速清口服液CXZL2300070 吉林一正药业集团有限公司
2023/11/18New drug · Class 1 BW-20507注射液CXHL2301283 杭州舶临医药科技有限公司
2023/11/18New drug · Class 2.1;2.2;2.4 盐酸(R)-氯胺酮鼻喷雾剂CXHL2301282 四川普锐特药业有限公司
2023/11/18New drug · Class 2.1;2.2;2.4 盐酸(R)-氯胺酮鼻喷雾剂CXHL2301281 四川普锐特药业有限公司
2023/11/17Import · Class 2.3 注射用氨曲南阿维巴坦钠JXHS2300103 Pfizer Europe MA EEIG; Hospira Australia Pty Ltd; Pfizer Investment Co. Ltd.
2023/11/17Generic · Class 3 盐酸甲氧氯普胺注射液CYHS2303156 朗天医药科技(武汉)有限公司; 朗天药业(湖北)有限公司
2023/11/17Generic · Class 3 聚乙烯醇滴眼液CYHS2303155 浙江视方极医药科技有限公司; 浙江赛默制药有限公司
2023/11/17Generic · Class 3 重酒石酸去甲肾上腺素注射液CYHS2303150 河北科源药业有限公司; 河北仁合益康药业有限公司
2023/11/17Generic · Class 3 美洛昔康纳米晶注射液CYHL2300139 江苏慧聚药业股份有限公司
2023/11/17New drug · Class 2.3 八宝丹胶囊CXZL2300069 厦门中药厂有限公司
2023/11/17New drug · Class 1 ZVS203e 注射液CXSL2300790 北京中因制药有限公司
2023/11/17New drug · Class 1 注射用重组酰化胰高血糖素样肽2类似物CXSL2300789 重庆派金生物科技有限公司
2023/11/17New drug · Class 1 靶向CD19的嵌合抗原受体基因修饰的NK细胞注射液CXSL2300788 上海先博生物科技有限公司
2023/11/17New drug · Class 1 靶向CD19的嵌合抗原受体基因修饰的NK细胞注射液CXSL2300787 上海先博生物科技有限公司
2023/11/17New drug · Class 1 靶向CD19的嵌合抗原受体基因修饰的NK细胞注射液CXSL2300786 上海先博生物科技有限公司
2023/11/17New drug · Class 1 ZHB103注射液CXSL2300785 江苏众红生物工程创药研究院有限公司

61 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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