药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2022/07/19 – 2022/07/25

Period
2022/07/19 to 2022/07/25, 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
289
Drugs with new generic filings (by drug name, de-duplicated)
29
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

289filings, 44 of them generic

By application type

Application typeFilings
Supplement176
Generic44
New drug35
Import22
Unspecified7
Import re-registration5

By drug type

Drug typeFilings
Chemical drug190
TCM61
治疗用生物制品37
Biologic1

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

29 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

128 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

71 this week

AcceptedDrugApplicants
2022/07/25Import · Class 1 Mezigdomide(CC-92480)胶囊JXHL2200213 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2022/07/25Import · Class 1 Mezigdomide(CC-92480)胶囊JXHL2200212 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2022/07/25Import · Class 1 Mezigdomide(CC-92480)胶囊JXHL2200211 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2022/07/25Import · Class 1 Mezigdomide(CC-92480)胶囊JXHL2200210 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2022/07/25Import · Class 1 Mezigdomide(CC-92480)胶囊JXHL2200209 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2022/07/25Import · Class 1 Mezigdomide(CC-92480)胶囊JXHL2200208 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2022/07/25Generic · Class 3 地高辛注射液CYHS2201136 海口天行健药物研究有限公司; 海南合瑞制药股份有限公司
2022/07/25Generic · Class 3 阿齐沙坦片CYHS2201135 瑞阳制药股份有限公司
2022/07/25New drug · Class 1 注射用LB4330CXSL2200334 上海健信生物医药科技有限公司
2022/07/25New drug · Class 3.3 德谷胰岛素注射液CXSL2200319 通化东宝药业股份有限公司
2022/07/25New drug · Class 3.3 德谷胰岛素注射液CXSL2200318 通化东宝药业股份有限公司
2022/07/25New drug · Class 1 CL-197胶囊CXHL2200530 河南真实生物科技有限公司; 河南师范大学; 河南美泰宝生物制药有限公司
2022/07/25New drug · Class 1 CL-197胶囊CXHL2200529 河南真实生物科技有限公司; 河南师范大学; 河南美泰宝生物制药有限公司
2022/07/25New drug · Class 1 ABP1011T片CXHL2200528 上海爱博医药科技有限公司
2022/07/25New drug · Class 1 ABP1011T片CXHL2200527 上海爱博医药科技有限公司
2022/07/22Import · Class 1 Amlitelimab注射液JXSL2200128 Sanofi-Aventis Recherche & Développement; Sanofi(China) Investment Co. LTD
2022/07/22Generic · Class 3 头孢克肟片CYHS2201124 温岭市创新生物医药科技股份有限公司; 万邦德制药集团有限公司
2022/07/22New drug · Class 1.1 复方野菊花黄酮颗粒CXZL2200034 浙江中医药大学
2022/07/22New drug · Class 3.2 重组人促甲状腺素注射液CXSS2200069 苏州智核生物医药科技有限公司; 康宁杰瑞(吉林)生物科技有限公司
2022/07/22New drug · Class 1 IAH0968CXSL2200332 盛禾(中国)生物制药有限公司
2022/07/22New drug · Class 1 IAH0968CXSL2200331 盛禾(中国)生物制药有限公司
2022/07/22New drug · Class 1 注射用BAT8007CXSL2200330 百奥泰生物制药股份有限公司
2022/07/22New drug · Class 1 苯乙基异硫氰酸酯液体硬胶囊CXHL2200526 无锡杰西医药股份有限公司
2022/07/22New drug · Class 1 苯乙基异硫氰酸酯液体硬胶囊CXHL2200525 无锡杰西医药股份有限公司
2022/07/22New drug · Class 1 RX04胶囊CXHL2200524 上海日馨医药科技股份有限公司
2022/07/22New drug · Class 1 RX04胶囊CXHL2200523 上海日馨医药科技股份有限公司
2022/07/22New drug · Class 1 WXSH0176片CXHL2200522 辰欣药业股份有限公司; 天津辰欣药物研究有限公司
2022/07/22New drug · Class 1 WXSH0176片CXHL2200521 辰欣药业股份有限公司; 天津辰欣药物研究有限公司
2022/07/21Import · Class 1 Cendakimab注射液JXSL2200127 Celgene International II Sàrl; Bristol-Myers Squibb (China) Investment Co. Ltd.
2022/07/21Import · Class 1 MK-4280A注射液JXSL2200126 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.

41 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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