药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2021/06/15 – 2021/06/21

Period
2021/06/15 to 2021/06/21, 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
221
Drugs with new generic filings (by drug name, de-duplicated)
24
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

221filings, 32 of them generic

By application type

Application typeFilings
Supplement124
New drug36
Generic32
Import18
Unspecified9
Import re-registration2

By drug type

Drug typeFilings
Chemical drug166
治疗用生物制品39
TCM15
预防用生物制品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

24 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

130 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
2021/06/21Import · Class 1 Palovarotene胶囊JXHL2101099 IPSEN PHARMA; IPSEN(SHANGHAI)INNOVATION PHARMACEUTICAL CO. LTD.
2021/06/21Import · Class 1 Palovarotene胶囊JXHL2101098 IPSEN PHARMA; IPSEN(SHANGHAI)INNOVATION PHARMACEUTICAL CO. LTD.
2021/06/21Import · Class 1 Palovarotene胶囊JXHL2101097 IPSEN PHARMA; IPSEN(SHANGHAI)INNOVATION PHARMACEUTICAL CO. LTD.
2021/06/21Import · Class 1 Palovarotene胶囊JXHL2101096 IPSEN PHARMA; IPSEN(SHANGHAI)INNOVATION PHARMACEUTICAL CO. LTD.
2021/06/21Import · Class 1 Palovarotene胶囊JXHL2101095 IPSEN PHARMA; IPSEN(SHANGHAI)INNOVATION PHARMACEUTICAL CO. LTD.
2021/06/21Import · Class 1 Afuresertib片JXHL2101094 Laekna Limited; Laekna Therapeutics Shanghai Co. Ltd.
2021/06/21Import · Class 1 Afuresertib片JXHL2101093 Laekna Limited; Laekna Therapeutics Shanghai Co. Ltd.
2021/06/21Import · Class 1 Etrasimod片JXHL2101082 Arena Pharmaceuticals Inc.; Everest Medicines (China) Co. Ltd
2021/06/21Import · Class 1 Etrasimod片JXHL2101081 Arena Pharmaceuticals Inc.; Everest Medicines (China) Co. Ltd
2021/06/21Generic · Class 3 奥硝唑注射液CYHS2101322 山东华铂凯盛生物科技有限公司; 通化金马药业集团股份有限公司
2021/06/21New drug · Class 1 QX004N注射液CXSL2101142 江苏荃信生物医药有限公司
2021/06/21New drug · Class 1 BDB-001注射液CXSL2101141 舒泰神(北京)生物制药股份有限公司; 北京德丰瑞生物技术有限公司
2021/06/21New drug · Class 2.4 环泊酚注射液CXHS2101025 辽宁海思科制药有限公司
2021/06/21New drug · Class 1 OB756片CXHL2101216 杭州邦顺制药有限公司
2021/06/21New drug · Class 1 EN002凝胶CXHL2101215 恩康药业科技(广州)有限公司
2021/06/21New drug · Class 1 EN002凝胶CXHL2101214 恩康药业科技(广州)有限公司
2021/06/18Generic · Class 3 硝苯地平缓释片CYHS2101305 南京易亨制药有限公司
2021/06/18New drug · Class 1 EX101注射液CXSL2101140 广州爱思迈生物医药科技有限公司
2021/06/18New drug · Class 1 重组人源化抗表皮生长因子受体单克隆抗体注射液CXSL2101139 上海津曼特生物科技有限公司
2021/06/18New drug · Class 1 重组抗PD-1全人源单克隆抗体注射液CXSL2101138 石药集团中奇制药技术(石家庄)有限公司
2021/06/18New drug · Class 1 注射用IMM01CXSL2101109 宜明昂科生物医药技术(上海)有限公司
2021/06/18New drug · Class 1 SYHX1901片CXHL2101206 石药集团欧意药业有限公司
2021/06/18New drug · Class 1 SYHX1901片CXHL2101205 石药集团欧意药业有限公司
2021/06/18New drug · Class 2.4 注射用苏拉明钠CXHL2101187 广东康大制药有限公司
2021/06/17Import · Class 1 注射用STP705JXHL2101092 Sirnaomics Inc.; Sirnaomics Biopharmaceuticals (Suzhou) Co. Ltd.
2021/06/17Generic · Class 3 头孢克肟胶囊CYHS2101301 山东裕欣药业有限公司; 山东罗欣药业集团股份有限公司
2021/06/17Generic · Class 3 头孢克肟胶囊CYHS2101300 山东裕欣药业有限公司; 山东罗欣药业集团股份有限公司
2021/06/17Generic · Class 3 硫酸镁注射液CYHS2101298 石家庄杏泽医药科技有限公司; 山东华鲁制药有限公司
2021/06/17Generic · Class 3 硫酸镁注射液CYHS2101297 石家庄杏泽医药科技有限公司; 山东华鲁制药有限公司
2021/06/17Generic · Class 3 曲前列尼尔注射液CYHS2101273 江苏众强药业有限公司; 广东星昊药业有限公司

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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