药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/07/30 – 2024/08/05

Period
2024/07/30 to 2024/08/05, 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
355
Drugs with new generic filings (by drug name, de-duplicated)
75
Accepted this week, now under review
12

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

355filings, 100 of them generic

By application type

Application typeFilings
Supplement179
Generic100
New drug50
Import14
Unspecified8
Import re-registration4

By drug type

Drug typeFilings
Chemical drug228
TCM63
治疗用生物制品56
预防用生物制品6
Biologic2

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

75 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

230 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

105 this week

AcceptedDrugApplicants
2024/08/03Import · Class 2.2 佩索利单抗注射液JXSL2400145 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/08/03Import · Class 1 HDP-101JXSL2400144 Heidelberg Pharma AG; Hangzhou Zhongmei HuaDong Pharmaceutical Co. Ltd.
2024/08/03Import · Class 1 ASP2138注射液JXSL2400143 Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd.
2024/08/03Import · Class 1 JNJ-78278343注射液JXSL2400142 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/08/03Import · Class 1 JNJ-78278343注射液JXSL2400141 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/08/03Generic · Class 3 昂丹司琼口溶膜CYHS2402479 上海欣峰制药有限公司
2024/08/03Generic · Class 3 昂丹司琼口溶膜CYHS2402478 上海欣峰制药有限公司
2024/08/03Generic · Class 3 磷酸奥司他韦干混悬剂CYHS2402477 安徽济人药业股份有限公司
2024/08/03Generic · Class 3 氯化钾口服溶液CYHS2402475 浙江领创优品药业有限公司; 浙江凯润药业股份有限公司
2024/08/03Generic · Class 3 氯化钾口服溶液CYHS2402474 浙江领创优品药业有限公司; 浙江凯润药业股份有限公司
2024/08/03Generic · Class 3 头孢地尼干混悬剂CYHS2402472 上海金城素智药业有限公司
2024/08/03Generic · Class 3 依托泊苷注射液CYHS2402468 成都瑞尔医药科技有限公司; 山东新时代药业有限公司
2024/08/03Generic · Class 3 阿巴帕肽注射液CYHL2400159 齐鲁制药有限公司
2024/08/03New drug · Class 1 GQ1005注射液CXSL2400522 启德医药科技(苏州)有限公司
2024/08/03New drug · Class 1 注射用PTX-912CXSL2400521 博致生物科技(上海)有限公司
2024/08/03New drug · Class 3.3 司美格鲁肽注射液CXSL2400520 北京质肽生物医药科技有限公司; 北京诺博特生物科技有限公司
2024/08/03New drug · Class 3.3 司美格鲁肽注射液CXSL2400519 北京质肽生物医药科技有限公司; 北京诺博特生物科技有限公司
2024/08/03New drug · Class 3.3 司美格鲁肽注射液CXSL2400518 北京质肽生物医药科技有限公司; 北京诺博特生物科技有限公司
2024/08/03New drug · Class 3.3 司美格鲁肽注射液CXSL2400517 北京质肽生物医药科技有限公司; 北京诺博特生物科技有限公司
2024/08/03New drug · Class 1 YFQLXB-UC01注射液CXSL2400516 山东省齐鲁细胞治疗工程技术有限公司
2024/08/03New drug · Class 1 ZM001注射液CXSL2400515 厦门再妙生物科技有限公司
2024/08/02Import · Class 3.1 elranatamabJXSL2400140 Pfizer Inc.; Pfizer Investment Co. Ltd.
2024/08/02Import · Class 3.1 注射用sotaterceptJXSL2400139 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2024/08/02Import · Class 3.1 注射用sotaterceptJXSL2400138 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2024/08/02Generic · Class 3 膦甲酸钠注射液CYHS2402461 赤峰源生药业有限公司
2024/08/02Generic · Class 3 氨磺必利口服溶液CYHS2402458 万特制药(海南)有限公司
2024/08/02Generic · Class 3 盐酸溴己新注射液CYHS2402451 北京双鹭药业股份有限公司
2024/08/02Generic · Class 3 布美他尼片CYHS2402450 新乡市常乐制药有限责任公司
2024/08/02New drug · Class 1.2 冻干带状疱疹mRNA疫苗CXSL2400514 武汉瑞佶生物科技有限公司; 深圳瑞吉生物科技有限公司
2024/08/02New drug · Class 1 IHS002赋能人脐带间充质干细胞注射液CXSL2400513 无锡华泰创新药技术研究院有限公司

75 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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