药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/08/13 – 2024/08/19

Period
2024/08/13 to 2024/08/19, 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
322
Drugs with new generic filings (by drug name, de-duplicated)
67
Accepted this week, now under review
6

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

322filings, 92 of them generic

By application type

Application typeFilings
Supplement144
Generic92
New drug58
Import17
Unspecified6
Import re-registration5

By drug type

Drug typeFilings
Chemical drug219
TCM52
治疗用生物制品42
预防用生物制品8
Biologic1

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

67 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

196 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

110 this week

AcceptedDrugApplicants
2024/08/19New drug · Class 1 RJMty19注射液CXSL2400553 浙江瑞加美生物科技有限公司
2024/08/17Import · Class 1 AZD5492JXSL2400149 AstraZeneca AB; AstraZeneca Global ll&U (China) Co. Ltd.
2024/08/17Generic · Class 3 布美他尼注射液CYHS2402684 四川沃翔生物医药有限公司; 成都第一制药有限公司
2024/08/17Generic · Class 3 十四烷基硫酸钠注射液CYHL2400167 上海上药第一生化药业有限公司
2024/08/17Generic · Class 3 十四烷基硫酸钠注射液CYHL2400166 上海上药第一生化药业有限公司
2024/08/17Generic · Class 3 利多卡因丙胺卡因气雾剂CYHL2400165 山东百诺医药股份有限公司
2024/08/17New drug · Class 1 SYS6026注射液CXSL2400552 石药集团巨石生物制药有限公司
2024/08/17New drug · Class 1 LAT010注射液CXSL2400551 徕特康(苏州)生物制药有限公司
2024/08/17New drug · Class 1 G01滴眼液CXSL2400550 青岛万明赛伯生物医药有限公司
2024/08/17New drug · Class 1 G01滴眼液CXSL2400549 青岛万明赛伯生物医药有限公司
2024/08/17New drug · Class 1 G01滴眼液CXSL2400548 青岛万明赛伯生物医药有限公司
2024/08/17New drug · Class 1 重组全人源抗PCSK9单克隆抗体注射液CXSL2400547 信立泰(成都)生物技术有限公司; 信立泰(苏州)药业有限公司; 深圳信立泰药业股份有限公司
2024/08/17New drug · Class 1 HRS-6208胶囊CXHL2400849 山东盛迪医药有限公司; 上海恒瑞医药有限公司
2024/08/17New drug · Class 1 HRS-6208胶囊CXHL2400848 山东盛迪医药有限公司; 上海恒瑞医药有限公司
2024/08/16Import · Class 2.2 度伐利尤单抗注射液JXSS2400067 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca Investment (China) Co. Ltd.
2024/08/16Import · Class 2.2 度伐利尤单抗注射液JXSS2400066 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca Investment (China) Co. Ltd.
2024/08/16Import · Class 2.4 阿昔替尼片JXHS2400055 Pfizer Europe MA EEIG; Pfizer Manufacturing Deutschland GmbH; Pfizer Investment Co. Ltd.
2024/08/16Import · Class 2.4 阿昔替尼片JXHS2400054 Pfizer Europe MA EEIG; Pfizer Manufacturing Deutschland GmbH; Pfizer Investment Co. Ltd.
2024/08/16Import · Class 1 KFA115JXHL2400206 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/08/16Import · Class 1 KFA115JXHL2400205 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/08/16Import · Class 1 KFA115JXHL2400204 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/08/16Import · Class 1 KFA115JXHL2400203 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/08/16Import · Class 1 HRO761JXHL2400202 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/08/16Import · Class 1 HRO761JXHL2400201 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/08/16Generic · Class 3 复方聚乙二醇(3350)电解质散CYHS2402675 蚌埠丰原涂山制药有限公司
2024/08/16Generic · Class 3 盐酸纳美芬注射液CYHS2402674 江苏瑜兴医药科技有限公司; 亚邦医药股份有限公司
2024/08/16Generic · Class 3 依托泊苷注射液CYHS2402672 海南倍特药业有限公司
2024/08/16Generic · Class 3 马来酸阿塞那平舌下片CYHS2402669 哈尔滨三联药业股份有限公司
2024/08/16Generic · Class 3 马来酸阿塞那平舌下片CYHS2402668 哈尔滨三联药业股份有限公司
2024/08/16Generic · Class 3 硝酸甘油注射液CYHS2402667 陕西顿斯制药有限公司

80 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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