药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2023/01/17 – 2023/01/23

Period
2023/01/17 to 2023/01/23, 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
261
Drugs with new generic filings (by drug name, de-duplicated)
51
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

261filings, 76 of them generic

By application type

Application typeFilings
Supplement115
Generic76
New drug45
Import12
Import re-registration7
Unspecified6

By drug type

Drug typeFilings
Chemical drug202
治疗用生物制品35
TCM24

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

51 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

155 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

74 this week

AcceptedDrugApplicants
2023/01/21New drug · Class 1 CT041自体CAR T细胞注射液CXSL2300059 上海科济制药有限公司
2023/01/20Import · Class 1 VSA003注射液JXHL2300013 Visirna Therapeutics HK Limited; Visirna Therapeutics (Shanghai) Co Ltd.
2023/01/20Import · Class 1 Milvexian片JXHL2300012 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/01/20Generic · Class 3 己酮可可碱注射液CYHS2300207 平光制药股份有限公司
2023/01/20Generic · Class 3 倍他米松磷酸钠注射液CYHS2300203 津药和平(天津)制药有限公司
2023/01/20Generic · Class 3 地氯雷他定口服溶液CYHS2300199 海南斯达制药有限公司
2023/01/20New drug · Class 2.2;2.3 HYR0201颗粒CXZL2300003 天地恒一制药股份有限公司
2023/01/20New drug · Class 1 注射用SHR-4602CXSL2300058 苏州盛迪亚生物医药有限公司; 上海盛迪医药有限公司
2023/01/20New drug · Class 1 注射用AP026CXSL2300057 安源医药科技(上海)有限公司
2023/01/20New drug · Class 1 甲磺酸贝福替尼胶囊CXHS2300016 贝达药业股份有限公司
2023/01/20New drug · Class 1 甲磺酸贝福替尼胶囊CXHS2300015 贝达药业股份有限公司
2023/01/20New drug · Class 2.4 甲磺酸伏美替尼片CXHL2300110 上海艾力斯医药科技股份有限公司
2023/01/20New drug · Class 1 QHRD107胶囊CXHL2300109 常州千红生化制药股份有限公司
2023/01/20New drug · Class 1 QHRD107胶囊CXHL2300108 常州千红生化制药股份有限公司
2023/01/20New drug · Class 1 QHRD107胶囊CXHL2300107 常州千红生化制药股份有限公司
2023/01/20New drug · Class 2.2 苯磺酸氨氯地平颗粒CXHL2300103 广东东阳光药业有限公司
2023/01/20New drug · Class 2.2 苯磺酸氨氯地平颗粒CXHL2300102 广东东阳光药业有限公司
2023/01/20New drug · Class 2.2 苯磺酸氨氯地平颗粒CXHL2300101 广东东阳光药业有限公司
2023/01/20New drug · Class 1 G201-Na胶囊CXHL2300100 石家庄以岭药业股份有限公司
2023/01/20New drug · Class 1 G201-Na胶囊CXHL2300099 石家庄以岭药业股份有限公司
2023/01/19Import · Class 1 VSA001注射液JXHL2300011 Visirna Therapeutics HK Limited; Visirna Therapeutics (Shanghai) Co Ltd.
2023/01/19Import · Class 1 BRM421 滴眼液JXHL2300010 BRIM Biotechnology Inc.; Grandpharma (China) Co. Ltd.
2023/01/19Generic · Class 3 奥硝唑注射液CYHS2300196 沈阳双鼎制药有限公司
2023/01/19Generic · Class 3 奥硝唑注射液CYHS2300195 沈阳双鼎制药有限公司
2023/01/19Generic · Class 3 盐酸肾上腺素注射液CYHS2300192 海南倍特药业有限公司
2023/01/19Generic · Class 3 醋酸维持液(含葡萄糖)CYHS2300190 南京赛瑞谱顿制药有限公司; 江苏大红鹰恒顺药业有限公司
2023/01/19Generic · Class 3 醋酸维持液(含葡萄糖)CYHS2300189 南京赛瑞谱顿制药有限公司; 江苏大红鹰恒顺药业有限公司
2023/01/19Generic · Class 3 帕拉米韦注射液CYHS2300186 石药集团中诺药业(石家庄)有限公司
2023/01/19Generic · Class 3 尼莫地平口服溶液CYHS2300185 成都倍特得诺药业有限公司
2023/01/19Generic · Class 3 倍他米松磷酸钠注射液CYHS2300183 成都倍特得诺药业有限公司

44 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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