药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/03/12 – 2024/03/18

Period
2024/03/12 to 2024/03/18, 7 days inclusive
Data as of
2026/11/05 06:00
Cached records
94,245 acceptance records, 11,689 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
246
Drugs with new generic filings (by drug name, de-duplicated)
47
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

246filings, 62 of them generic

By application type

Application typeFilings
Supplement106
Generic62
New drug43
Import re-registration15
Import12
Unspecified8

By drug type

Drug typeFilings
Chemical drug168
TCM35
治疗用生物制品32
Biologic7
预防用生物制品4

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

47 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

144 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

70 this week

AcceptedDrugApplicants
2024/03/18Generic · Class 3 氯化钙注射液CYHS2400865 广州艾格生物科技有限公司; 广东星昊药业有限公司
2024/03/18Generic · Class 3 硫酸沙丁胺醇注射液CYHS2400862 江苏开元药业有限公司; 康普药业股份有限公司
2024/03/18Generic · Class 3 盐酸普萘洛尔片CYHS2400861 合肥国药诺和药业有限公司; 华益药业科技(安徽)有限公司
2024/03/16Import · Class 1 注射用Datopotamab DeruxtecanJXSS2400026 Daiichi Sankyo Europe GmbH; Baxter Oncology GmbH; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2024/03/16Import · Class 1 ABBV-400注射用粉末JXSL2400060 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/03/16New drug · Class 2.2 聚乙二醇干扰素α-2b注射液CXSS2400026 厦门特宝生物工程股份有限公司
2024/03/16New drug · Class 2.2 聚乙二醇干扰素α-2b注射液CXSS2400025 厦门特宝生物工程股份有限公司
2024/03/16New drug · Class 2.2 聚乙二醇干扰素α-2b注射液CXSS2400024 厦门特宝生物工程股份有限公司
2024/03/16New drug · Class 2.2 聚乙二醇干扰素α-2b注射液CXSS2400023 厦门特宝生物工程股份有限公司
2024/03/16New drug · Class 1 注射用苏维西塔单抗CXSS2400022 江苏先声生物制药有限公司
2024/03/16New drug · Class 1 BAT6005注射液CXSL2400189 百奥泰生物制药股份有限公司
2024/03/16New drug · Class 1 BAT1308注射液CXSL2400188 百奥泰生物制药股份有限公司
2024/03/16New drug · Class 1.2 呼吸道合胞病毒IN006二价mRNA疫苗CXSL2400187 深圳深信生物科技有限公司
2024/03/16New drug · Class 1 ABP1618片CXHL2400285 上海爱博医药科技有限公司
2024/03/16New drug · Class 1 ABP1618片CXHL2400284 上海爱博医药科技有限公司
2024/03/15Import · Class 2.2;2.4 TAR-210JXHL2400065 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/03/15Import · Class 1 Balcinrenone达格列净胶囊JXHL2400064 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/03/15Import · Class 1 Balcinrenone达格列净胶囊JXHL2400063 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/03/15Generic · Class 3 硫酸阿托品注射液CYHS2400853 江苏开元药业有限公司; 康普药业股份有限公司
2024/03/15Generic · Class 3 普仑司特干糖浆CYHS2400849 济川药业集团有限公司
2024/03/15Generic · Class 3 西咪替丁注射液CYHS2400845 苏州朗科生物技术股份有限公司; 扬州中宝药业股份有限公司
2024/03/15Generic · Class 3 复方聚乙二醇电解质散(儿童型)CYHS2400838 四川科伦药业股份有限公司
2024/03/15New drug · Class 1 SHR-4849注射液CXSL2400186 苏州盛迪亚生物医药有限公司; 上海恒瑞医药有限公司
2024/03/15New drug · Class 1 FC084CSA片CXHL2400283 中山医诺维申新药研发有限公司
2024/03/15New drug · Class 1 FC084CSA片CXHL2400282 中山医诺维申新药研发有限公司
2024/03/14Import · Class 1 BI 1839100 片JXHL2400062 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/03/14Generic · Class 3 溴吡斯的明缓释片CYHS2400832 上海上药中西制药有限公司
2024/03/14Generic · Class 3 小儿复方氨基酸注射液(19AA-I)CYHS2400830 湖北民康药业集团有限公司; 津药和平(天津)制药有限公司
2024/03/14Generic · Class 3 小儿复方氨基酸注射液(19AA-I)CYHS2400829 湖北民康药业集团有限公司; 津药和平(天津)制药有限公司
2024/03/14Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液CYHS2400827 石家庄四药有限公司

40 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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