药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2022/06/21 – 2022/06/27

Period
2022/06/21 to 2022/06/27, 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
263
Drugs with new generic filings (by drug name, de-duplicated)
28
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

263filings, 42 of them generic

By application type

Application typeFilings
Supplement156
Generic42
New drug26
Import21
Unspecified9
Import re-registration9

By drug type

Drug typeFilings
Chemical drug176
TCM45
治疗用生物制品33
Biologic9

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

28 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

59 this week

AcceptedDrugApplicants
2022/06/24Generic · Class 3 盐酸多巴胺注射液CYHS2200949 海南倍特药业有限公司
2022/06/24Generic · Class 3 吡拉西坦注射液CYHS2200948 吉林省辉南长龙生化药业股份有限公司
2022/06/24Generic · Class 3 复方匹可硫酸钠颗粒CYHS2200947 海南万玮制药有限公司
2022/06/24Generic · Class 3 艾司奥美拉唑镁肠溶胶囊CYHS2200943 浙江永太药业有限公司
2022/06/24Generic · Class 3 艾司奥美拉唑镁肠溶胶囊CYHS2200941 浙江永太药业有限公司
2022/06/24New drug · Class 1 IMM40H注射液CXSL2200293 宜明昂科生物医药技术(上海)股份有限公司
2022/06/24New drug · Class 1 KM1溶瘤痘苗病毒注射液CXSL2200292 深圳市华药康明生物药业有限责任公司
2022/06/24New drug · Class 1 NCR100注射液CXSL2200291 安徽中盛溯源生物科技有限公司
2022/06/23Import · Class 3.1 注射用TeduglutideJXSS2200021 Takeda Pharmaceuticals International AG Ireland Branch; Patheon Italia S.p.A.
2022/06/23Import · Class 2.2 贝利尤单抗注射液(皮下注射)JXSL2200094 GlaxoSmithKline (Ireland) Limited; GlaxoSmithKline (China) Investment Co. LTD
2022/06/23Import · Class 1 BI 764198胶囊JXHL2200161 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2022/06/23Import · Class 1 BI 764198胶囊JXHL2200160 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2022/06/23Import · Class 1 BI 764198胶囊JXHL2200159 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2022/06/23Import · Class 2.4 Belzutifan片JXHL2200158 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D(China)Co. Ltd.
2022/06/23Generic · Class 3 卡谷氨酸片CYHS2200940 远大医药(中国)有限公司
2022/06/23Generic · Class 3 呋塞米口服溶液CYHS2200938 成都倍特得诺药业有限公司
2022/06/23Generic · Class 3 胞磷胆碱钠注射液CYHS2200933 华夏生生药业(北京)有限公司
2022/06/23Generic · Class 3 维A酸软胶囊CYHS2200932 山东良福制药有限公司
2022/06/23New drug · Class 1 LM-102注射液CXSL2200290 上海礼新医药研发有限公司
2022/06/23New drug · Class 1 重组抗IL-4Rα人源化单克隆抗体注射液CXSL2200289 三生国健药业(上海)股份有限公司
2022/06/23New drug · Class 1 重组抗IL-17A人源化单克隆抗体注射液CXSL2200288 三生国健药业(上海)股份有限公司
2022/06/23New drug · Class 2.2 恩沃利单抗注射液CXSL2200287 四川思路康瑞药业有限公司
2022/06/23New drug · Class 1 注射用SHR-A2102CXSL2200286 上海恒瑞医药有限公司
2022/06/23New drug · Class 1 JX7002注射液CXSL2200264 浙江京新药业股份有限公司
2022/06/23New drug · Class 1 TQ-B3101胶囊CXHS2200035 正大天晴药业集团南京顺欣制药有限公司
2022/06/23New drug · Class 1 TQ-B3101胶囊CXHS2200034 正大天晴药业集团南京顺欣制药有限公司
2022/06/23New drug · Class 1 MN-08片CXHL2200413 广州喜鹊医药有限公司
2022/06/23New drug · Class 1 WXSH0208片CXHL2200412 辰欣药业股份有限公司
2022/06/23New drug · Class 1 WXSH0208片CXHL2200411 辰欣药业股份有限公司
2022/06/23New drug · Class 2.2 注射用SAK2001CXHL2200410 慧禹康成(杭州)医药科技有限公司

29 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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