药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2022/05/17 – 2022/05/23

Period
2022/05/17 to 2022/05/23, 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
37
Drugs with new generic filings (by drug name, de-duplicated)
3
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

37filings, 4 of them generic

By application type

Application typeFilings
New drug14
Supplement12
Generic4
Import re-registration4
Import3

By drug type

Drug typeFilings
Chemical drug24
治疗用生物制品8
TCM4
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

3 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1富马酸伏诺拉生片2158
2左乙拉西坦口服溶液113
3盐酸乌拉地尔注射液115

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

21 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

17 this week

AcceptedDrugApplicants
2022/05/20Import · Class 1 KarXT胶囊JXHL2200118 Karuna Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd.
2022/05/20Import · Class 1 KarXT胶囊JXHL2200117 Karuna Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd.
2022/05/20Import · Class 1 KarXT胶囊JXHL2200116 Karuna Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd.
2022/05/20New drug · Class 1.1 黄酯胶囊CXZL2200023 四川省中医药科学院(四川省中药研究所)
2022/05/20New drug · Class 1 MG-ZG122人源化单抗注射液CXSL2200218 上海麦济生物技术有限公司
2022/05/20New drug · Class 1 注射用YL201CXSL2200217 苏州宜联生物医药有限公司
2022/05/20New drug · Class 1 GR1501注射液CXSL2200216 重庆智翔金泰生物制药股份有限公司
2022/05/20New drug · Class 1 TQ-B3139胶囊CXHS2200026 正大天晴药业集团南京顺欣制药有限公司
2022/05/20New drug · Class 1 TQ-B3139胶囊CXHS2200025 正大天晴药业集团南京顺欣制药有限公司
2022/05/20New drug · Class 1 TQ-B3139胶囊CXHS2200024 正大天晴药业集团南京顺欣制药有限公司
2022/05/20New drug · Class 1 HRS-4642注射液CXHL2200313 江苏恒瑞医药股份有限公司
2022/05/20New drug · Class 1 HRS-5965片CXHL2200312 成都盛迪医药有限公司
2022/05/20New drug · Class 1 HRS-5965片CXHL2200311 成都盛迪医药有限公司
2022/05/20New drug · Class 1 SC0245片CXHL2200310 无锡智康弘义生物科技有限公司
2022/05/20New drug · Class 1 SC0245片CXHL2200309 无锡智康弘义生物科技有限公司
2022/05/20New drug · Class 1 氟[18F]思睿肽注射液CXHL2200308 上海蓝纳成生物技术有限公司
2022/05/18New drug · Class 2.2 冻干人用狂犬病疫苗(鸡胚细胞)CXSL2200214 深圳市卫光生物制品股份有限公司

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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