药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/06/18 – 2024/06/24

Period
2024/06/18 to 2024/06/24, 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
267
Drugs with new generic filings (by drug name, de-duplicated)
53
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

267filings, 75 of them generic

By application type

Application typeFilings
Supplement130
Generic75
New drug31
Import12
Import re-registration11
Unspecified6
药械组合产品2

By drug type

Drug typeFilings
Chemical drug166
TCM51
治疗用生物制品40
预防用生物制品6
Biologic4

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

180 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

74 this week

AcceptedDrugApplicants
2024/06/24Import · Class 2.4 盐酸阿来替尼胶囊JXHL2400145 F.Hoffmann-La Roche Ltd
2024/06/22Generic · Class 3 阿达帕林过氧苯甲酰凝胶CYHS2401869 苏州高迈药业有限公司; 药源生物科技(启东)有限公司
2024/06/22Generic · Class 3 间苯三酚口崩片CYHS2401867 河北汇德旭盛医药科技有限公司; 河北创健药业有限公司
2024/06/22Generic · Class 3 恩格列净二甲双胍缓释片CYHS2401866 浙江昂利康制药股份有限公司
2024/06/22Generic · Class 3 盐酸卡利拉嗪胶囊CYHL2400125 成都奥邦药业有限公司
2024/06/22Generic · Class 3 盐酸卡利拉嗪胶囊CYHL2400124 成都奥邦药业有限公司
2024/06/22New drug · Class 1 注射用SSGJ-709CXSL2400408 沈阳三生制药有限责任公司
2024/06/22New drug · Class 1 TQC3721吸入粉雾剂CXHL2400625 正大天晴药业集团股份有限公司
2024/06/22New drug · Class 1 TQC3721吸入粉雾剂CXHL2400624 正大天晴药业集团股份有限公司
2024/06/22New drug · Class 1 CVL237片CXHL2400623 甫康(上海)健康科技有限责任公司; 浙江甫康制药有限公司
2024/06/22New drug · Class 2.3 BCM476胶囊CXHL2400622 上海云晟研新生物科技有限公司
2024/06/22New drug · Class 2.2 注射用醋酸曲普瑞林缓释微球CXHL2400621 南京恒生制药有限公司
2024/06/21Import · Class 3.1 注射用坦昔妥单抗JXSS2400050 Incyte Biosciences Distribution B.V.; Baxter Oncology GmbH; Beijing InnoCare Pharma Tech Co. Ltd.
2024/06/21Import · Class 3.1 司库奇尤单抗注射液JXSS2400049 Novartis Pharma Schweiz AG; Novartis Pharma Stein AG; Novartis Pharmaceutical Manufacturing GmbH
2024/06/21Import · Class 3.1 司库奇尤单抗注射液JXSS2400048 Novartis Pharma Schweiz AG; Novartis Pharma Stein AG
2024/06/21Import · Class 2.2 贝利尤单抗注射液(皮下注射)JXSL2400116 GlaxoSmithKline (Ireland) Limited; GlaxoSmithKline (China) Investment Company Limited
2024/06/21Import · Class 2.4 甲磺酸奥希替尼片JXHS2400042 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2024/06/21Import · Class 2.4 甲磺酸奥希替尼片JXHS2400041 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2024/06/21Generic · Class 3 吡格列酮二甲双胍片CYHS2401853 浙江江北药业有限公司
2024/06/21Generic · Class 3 注射用青霉素钠CYHS2401852 辽宁省连科药业有限公司; 江苏海宏制药有限公司
2024/06/21Generic · Class 3 注射用青霉素钠CYHS2401851 辽宁省连科药业有限公司; 江苏海宏制药有限公司
2024/06/21Generic · Class 3 注射用青霉素钠CYHS2401850 辽宁省连科药业有限公司; 江苏海宏制药有限公司
2024/06/21Generic · Class 3 注射用磷霉素钠CYHS2401849 广州艾奇西新药研究有限公司; 国药集团国瑞药业有限公司
2024/06/21Generic · Class 3 注射用磷霉素钠CYHS2401848 广州艾奇西新药研究有限公司; 国药集团国瑞药业有限公司
2024/06/21Generic · Class 3 盐酸米诺环素泡沫剂CYHL2400123 山西振东安欣生物制药有限公司
2024/06/21Generic · Class 3 盐酸米诺环素泡沫剂CYHL2400122 山西振东安欣生物制药有限公司
2024/06/21Generic · Class 3 去氧胆酸注射液CYHL2400121 北京藏卫信康医药研发有限公司
2024/06/21Generic · Class 3 立他司特滴眼液CYHL2400120 浙江莎普爱思药业股份有限公司
2024/06/21Generic · Class 3 氟[18F]妥司特注射液CYHL2400119 北京先通国际医药科技股份有限公司
2024/06/21New drug · Class 1 注射用HS-20089CXSL2400407 上海翰森生物医药科技有限公司; 常州恒邦药业有限公司

44 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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