药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2022/05/31 – 2022/06/06

Period
2022/05/31 to 2022/06/06, 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
229
Drugs with new generic filings (by drug name, de-duplicated)
33
Accepted this week, now under review
2

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

229filings, 43 of them generic

By application type

Application typeFilings
Supplement124
Generic43
New drug33
Import19
Unspecified7
Import re-registration3

By drug type

Drug typeFilings
Chemical drug155
TCM47
治疗用生物制品21
预防用生物制品4
Biologic2

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

132 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

61 this week

AcceptedDrugApplicants
2022/06/06Generic · Class 3 甘露醇山梨醇注射液CYHS2200836 南京恩泰医药科技有限公司; 江苏大红鹰恒顺药业有限公司
2022/06/06New drug · Class 1 伊基仑赛注射液CXSS2200055 南京驯鹿生物医药有限公司
2022/06/06New drug · Class 1 阴道用四联乳杆菌活菌胶囊CXSL2200246 四川厌氧生物科技有限责任公司
2022/06/06New drug · Class 3.3 司美格鲁肽注射液CXSL2200245 重庆宸安生物制药有限公司; 上海博唯生物科技有限公司
2022/06/06New drug · Class 3.3 司美格鲁肽注射液CXSL2200244 重庆宸安生物制药有限公司; 上海博唯生物科技有限公司
2022/06/06New drug · Class 1 XNW1011胶囊CXHL2200359 杏联药业(苏州)有限公司
2022/06/03Import · Class 1 DS-1062aJXSL2200072 Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited
2022/06/03Import · Class 2.2 司库奇尤单抗注射液JXSL2200070 Novartis Pharma Schweiz AG; Beijing Novartis Pharma Co. Ltd.
2022/06/03Import · Class 2.2 注射用罗特西普JXSL2200069 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2022/06/03Import · Class 2.2 注射用罗特西普JXSL2200068 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2022/06/03Import · Class 1 AMG 193JXHL2200132 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2022/06/03Import · Class 1 AMG 193JXHL2200131 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2022/06/03Import · Class 1 AMG 193JXHL2200130 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2022/06/03Import · Class 1 Paltusotine片JXHL2200129 Crinetics Pharmaceuticals Inc.; WuXi Clinical Development Services (Shanghai) Co. Ltd.
2022/06/03Import · Class 1 CapivasertibJXHL2200128 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2022/06/03Import · Class 1 CapivasertibJXHL2200127 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2022/06/03Import · Class 1 MRTX849片JXHL2200126 Mirati Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd.
2022/06/03Import · Class 1 LNP023胶囊JXHL2200125 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/06/03Import · Class 1 LNP023胶囊JXHL2200124 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/06/03Generic · Class 3 盐酸氨溴索口服溶液CYHS2200834 国药集团致君(深圳)制药有限公司; 国药集团致君(深圳)坪山制药有限公司
2022/06/03Generic · Class 3 氟比洛芬钠滴眼液CYHS2200829 武汉先路医药科技股份有限公司; 成都普什制药有限公司
2022/06/03New drug · Class 3.3 德谷胰岛素注射液CXSL2200241 南京赛诺生物制药有限公司; 南京赛诺生物技术有限公司
2022/06/03New drug · Class 2.2 四价流感病毒裂解疫苗(MDCK细胞)CXSL2200240 武汉生物制品研究所有限责任公司; 兰州百灵生物技术有限公司; 西北民族大学
2022/06/03New drug · Class 2.2 苯甲酸氨氯地平干混悬剂CXHS2200032 广州一品红制药有限公司
2022/06/03New drug · Class 2.2 苯甲酸氨氯地平干混悬剂CXHS2200031 广州一品红制药有限公司
2022/06/03New drug · Class 1 AC-003胶囊CXHL2200358 爱科诺生物医药(苏州)有限公司
2022/06/03New drug · Class 1 AC-003胶囊CXHL2200357 爱科诺生物医药(苏州)有限公司
2022/06/03New drug · Class 1 TQB3702片CXHL2200356 正大天晴药业集团股份有限公司
2022/06/03New drug · Class 1 VCT220片CXHL2200355 苏州闻泰医药科技有限公司
2022/06/03New drug · Class 1 VCT220片CXHL2200354 苏州闻泰医药科技有限公司

31 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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