药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2023/02/28 – 2023/03/06

Period
2023/02/28 to 2023/03/06, 7 days inclusive
Data as of
2026/11/07 06:00
Cached records
94,440 acceptance records, 11,686 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
232
Drugs with new generic filings (by drug name, de-duplicated)
33
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

232filings, 48 of them generic

By application type

Application typeFilings
Supplement124
Generic48
New drug28
Import11
Import re-registration11
Unspecified10

By drug type

Drug typeFilings
Chemical drug158
TCM40
治疗用生物制品24
预防用生物制品6
Biologic3
体外诊断试剂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

33 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

153 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

63 this week

AcceptedDrugApplicants
2023/03/06New drug · Class 2.2;2.4 注射用辅酶ICXHL2300269 合肥康诺生物制药有限公司
2023/03/04Import · Class 2.2 Upadacitinib口服溶液JXHL2300042 AbbVie Inc.
2023/03/04Generic · Class 3 对乙酰氨基酚甘露醇注射液CYHS2300699 吉林康乃尔药业有限公司
2023/03/04Generic · Class 3 富马酸酮替芬鼻喷雾剂CYHS2300696 山东泰合医药科技有限公司; 山东京卫制药有限公司
2023/03/04Generic · Class 3 氨茶碱注射液CYHS2300685 北京百美特生物制药有限公司
2023/03/04Generic · Class 3 氨茶碱注射液CYHS2300684 北京百美特生物制药有限公司
2023/03/04New drug · Class 1.1 健脾益肾丸CXZL2300016 深圳市中医院
2023/03/04New drug · Class 1 BSI-060T注射液CXSL2300171 博奥信生物技术(南京)有限公司
2023/03/04New drug · Class 1 XH101注射液CXSL2300170 深圳市新合生物医疗科技有限公司
2023/03/04New drug · Class 1 靶向BCMA-CD19的安全型嵌合抗原受体T细胞注射液CXSL2300169 湖南思为康医药有限公司
2023/03/04New drug · Class 1 9MW3911注射液CXSL2300168 南京诺艾新生物技术有限公司
2023/03/03Import · Class 3.1 九价人乳头瘤病毒疫苗(酿酒酵母)JXSS2300020 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd.
2023/03/03Import · Class 3.1 九价人乳头瘤病毒疫苗(酿酒酵母)JXSS2300019 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd.
2023/03/03Import · Class 1 Milvexian片JXHL2300041 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/03/03Generic · Class 3 盐酸去氧肾上腺素注射液CYHS2300680 广州维奥康药业科技有限公司; 广东星昊药业有限公司
2023/03/03Generic · Class 3 米诺地尔外用溶液CYHS2300679 济南中海医药科技有限公司; 烟台鲁银药业有限公司
2023/03/03Generic · Class 3 米诺地尔外用溶液CYHS2300678 济南中海医药科技有限公司; 烟台鲁银药业有限公司
2023/03/03Generic · Class 3 琥珀酸美托洛尔缓释胶囊CYHS2300677 福建省宝诺医药研发有限公司; 浙江京新药业股份有限公司
2023/03/03Generic · Class 3 盐酸去氧肾上腺素注射液CYHS2300675 成都瑞尔医药科技有限公司; 四川美大康佳乐药业有限公司
2023/03/03Generic · Class 3 盐酸去氧肾上腺素注射液CYHS2300674 成都瑞尔医药科技有限公司; 四川美大康佳乐药业有限公司
2023/03/03Generic · Class 3 托拉塞米注射液CYHS2300673 北京元延医药科技股份有限公司; 西安汉丰药业有限责任公司
2023/03/03Generic · Class 3 托拉塞米注射液CYHS2300672 北京元延医药科技股份有限公司; 西安汉丰药业有限责任公司
2023/03/03New drug · Class 1 重组人源化抗HER2双特异性抗体注射液CXSL2300166 上海津曼特生物科技有限公司
2023/03/03New drug · Class 1 BRL-186616片CXHL2300268 厦门市博瑞来医药科技有限公司
2023/03/03New drug · Class 1 BRL-186616片CXHL2300267 厦门市博瑞来医药科技有限公司
2023/03/03New drug · Class 2.2 注射用阿立哌唑缓释微球CXHL2300266 辉粒药业(苏州)有限公司
2023/03/03New drug · Class 2.4 注射用多西他赛(白蛋白结合型)CXHL2300265 石药集团中奇制药技术(石家庄)有限公司
2023/03/03New drug · Class 1 WXSH0102片CXHL2300264 辰欣药业股份有限公司
2023/03/03New drug · Class 1 WXSH0102片CXHL2300263 辰欣药业股份有限公司
2023/03/03New drug · Class 2.4 奥布替尼片CXHL2300262 北京诺诚健华医药科技有限公司

33 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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