药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2022/01/18 – 2022/01/24

Period
2022/01/18 to 2022/01/24, 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
265
Drugs with new generic filings (by drug name, de-duplicated)
50
Accepted this week, now under review
0

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

265filings, 69 of them generic

By application type

Application typeFilings
Supplement134
Generic69
New drug34
Import14
Import re-registration9
Unspecified5

By drug type

Drug typeFilings
Chemical drug193
TCM36
治疗用生物制品29
预防用生物制品7

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

50 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

150 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

69 this week

AcceptedDrugApplicants
2022/01/24Import · Class 1 MK-6024注射液JXSL2200014 Merck Sharp & Dohme Corp.; MSD R&D(China)Co. Ltd.
2022/01/24Import · Class 1 MK-6024注射液JXSL2200013 Merck Sharp & Dohme Corp.; MSD R&D(China)Co. Ltd.
2022/01/24Import · Class 1 注射用3D-189JXHL2200026 3D Medicines Inc.; 3D Medicines(Qingdao)Co. Limited
2022/01/24Generic · Class 3 福多司坦口服溶液CYHS2200169 浙江国镜药业有限公司
2022/01/24Generic · Class 3 福多司坦口服溶液CYHS2200168 浙江国镜药业有限公司
2022/01/24Generic · Class 3 西格列汀二甲双胍缓释片CYHS2200155 上海安必生制药技术有限公司; 江苏安必生制药有限公司
2022/01/24Generic · Class 3 阿立哌唑口服溶液CYHS2200104 成都苑东生物制药股份有限公司; 华北制药股份有限公司
2022/01/24Generic · Class 3 阿立哌唑口服溶液CYHS2200103 成都苑东生物制药股份有限公司; 华北制药股份有限公司
2022/01/24Generic · Class 3 羟考酮纳洛酮缓释片CYHS2200102 山东绿叶制药有限公司
2022/01/24Generic · Class 3 利多卡因凝胶贴膏CYHL2200009 南京海纳医药科技股份有限公司
2022/01/24New drug · Class 1 CM313注射液CXSL2200042 康诺亚生物医药科技(成都)有限公司
2022/01/24New drug · Class 1 注射用YK012CXSL2200041 益科思特(北京)医药科技发展有限公司
2022/01/24New drug · Class 1 斯鲁利单抗注射液CXSL2200040 上海复宏汉霖生物技术股份有限公司
2022/01/24New drug · Class 1 TQB2450注射液CXSL2200039 正大天晴药业集团股份有限公司
2022/01/24New drug · Class 1 BC008抗体注射液CXSL2200037 宝船生物医药科技(上海)有限公司
2022/01/24New drug · Class 1 IBI323CXSL2200036 信达生物制药(苏州)有限公司
2022/01/24New drug · Class 1 TQB2618注射液CXSL2200035 正大天晴药业集团股份有限公司
2022/01/24New drug · Class 2.3 依折麦布匹伐他汀钙片CXHL2200044 乐普制药科技有限公司
2022/01/24New drug · Class 1 DC05F01CXHL2200043 北京双鹤润创科技有限公司
2022/01/24New drug · Class 1 ABSK043胶囊CXHL2200042 上海和誉生物医药科技有限公司
2022/01/24New drug · Class 1 ABSK043胶囊CXHL2200041 上海和誉生物医药科技有限公司
2022/01/21Generic · Class 3 羧甲司坦口服溶液CYHS2200153 广东华南药业集团有限公司; 广东众生药业股份有限公司
2022/01/21Generic · Class 3 羧甲司坦口服溶液CYHS2200152 广东华南药业集团有限公司; 广东众生药业股份有限公司
2022/01/21Generic · Class 3 依非韦伦拉米夫定替诺福韦片CYHS2200146 上海迪赛诺医药集团股份有限公司
2022/01/21Generic · Class 3 醋酸去氨加压素口服溶液CYHS2200141 杭州和泽坤元药业有限公司; 浙江康恩贝制药股份有限公司
2022/01/21New drug · Class 1 注射用重组人源化抗HER2单抗-AS269偶联物(ARX788)CXSL2200033 浙江新码生物医药有限公司
2022/01/21New drug · Class 1 IBI319CXSL2200030 信达生物制药(苏州)有限公司
2022/01/21New drug · Class 2.4 环泊酚注射液CXHS2200006 辽宁海思科制药有限公司
2022/01/21New drug · Class 2.4 硫酸阿托品滴眼液CXHL2200035 博瑞制药(苏州)有限公司
2022/01/21New drug · Class 2.4 硫酸阿托品滴眼液CXHL2200034 博瑞制药(苏州)有限公司

39 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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