药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2022/02/15 – 2022/02/21

Period
2022/02/15 to 2022/02/21, 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
262
Drugs with new generic filings (by drug name, de-duplicated)
40
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

262filings, 57 of them generic

By application type

Application typeFilings
Supplement141
Generic57
New drug39
Import12
Unspecified11
Import re-registration2

By drug type

Drug typeFilings
Chemical drug196
治疗用生物制品35
TCM30
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

40 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

60 this week

AcceptedDrugApplicants
2022/02/21Import · Class 1 SAR443820JXHL2200039 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2022/02/21Import · Class 1 注射用WCK5222JXHL2200038 Wockhardt Bio AG; Labcorp Pharmaceutical Research and Development (Beijing) Co. Ltd.
2022/02/21Generic · Class 3 吡拉西坦注射液CYHS2200363 珠海和凡医药股份有限公司; 山东威高药业股份有限公司
2022/02/21Generic · Class 3 吡拉西坦注射液CYHS2200362 珠海和凡医药股份有限公司; 山东威高药业股份有限公司
2022/02/21Generic · Class 3 吡拉西坦注射液CYHS2200361 珠海和凡医药股份有限公司; 山东威高药业股份有限公司
2022/02/21Generic · Class 3 注射用头孢哌酮钠舒巴坦钠/氯化钠注射液CYHS2200360 北京锐业制药有限公司
2022/02/21Generic · Class 3 注射用头孢哌酮钠舒巴坦钠/氯化钠注射液CYHS2200359 北京锐业制药有限公司
2022/02/21New drug · Class 2.2 SHR-8068注射液CXSL2200100 苏州盛迪亚生物医药有限公司
2022/02/21New drug · Class 1 阿得贝利单抗注射液CXSL2200099 上海盛迪医药有限公司
2022/02/21New drug · Class 1 RA1115-B1滴眼液CXHL2200116 苏州锐明新药研发有限公司
2022/02/21New drug · Class 1 RA1115-B1滴眼液CXHL2200115 苏州锐明新药研发有限公司
2022/02/21New drug · Class 1 RA1115-B1滴眼液CXHL2200114 苏州锐明新药研发有限公司
2022/02/21New drug · Class 1 RA1115-B1滴眼液CXHL2200113 苏州锐明新药研发有限公司
2022/02/21New drug · Class 1 RA1115-B1滴眼液CXHL2200112 苏州锐明新药研发有限公司
2022/02/21New drug · Class 2.3 复方果糖电解质注射液CXHL2200108 上海致真生物科技有限公司
2022/02/21New drug · Class 1 ZL-82片CXHL2200107 成都赜灵生物医药科技有限公司
2022/02/21New drug · Class 1 ZL-82片CXHL2200106 成都赜灵生物医药科技有限公司
2022/02/21New drug · Class 1 ZL-82片CXHL2200105 成都赜灵生物医药科技有限公司
2022/02/21New drug · Class 1 HS-10386片CXHL2200104 江苏豪森药业集团有限公司; 上海翰森生物医药科技有限公司
2022/02/21New drug · Class 1 HS-10386片CXHL2200103 江苏豪森药业集团有限公司; 上海翰森生物医药科技有限公司
2022/02/18Import · Class 1 Olvi-Vec注射液JXSL2200020 Genelux Corporation; Newsoara Biopharma Co. Ltd.
2022/02/18Generic · Class 3 硫酸特布他林注射液CYHS2200341 成都利尔药业有限公司
2022/02/18Generic · Class 3 泊马度胺胶囊CYHL2200021 常州制药厂有限公司
2022/02/18Generic · Class 3 泊马度胺胶囊CYHL2200020 常州制药厂有限公司
2022/02/18Generic · Class 3 泊马度胺胶囊CYHL2200019 常州制药厂有限公司
2022/02/18Generic · Class 3 泊马度胺胶囊CYHL2200018 常州制药厂有限公司
2022/02/18New drug · Class 2.3 苁蓉总苷胶囊CXZL2200011 江苏康缘药业股份有限公司
2022/02/18New drug · Class 3.4 注射用重组人凝血因子ⅧCXSS2200014 成都蓉生药业有限责任公司
2022/02/18New drug · Class 1 人脐带间充质干细胞注射液CXSL2200098 上海爱萨尔生物科技有限公司
2022/02/18New drug · Class 1 人脐带间充质干细胞注射液CXSL2200097 上海爱萨尔生物科技有限公司

30 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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