药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/06/11 – 2024/06/17

Period
2024/06/11 to 2024/06/17, 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
320
Drugs with new generic filings (by drug name, de-duplicated)
59
Accepted this week, now under review
3

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

320filings, 77 of them generic

By application type

Application typeFilings
Supplement160
Generic77
New drug56
Import12
Unspecified9
Import re-registration6

By drug type

Drug typeFilings
Chemical drug223
TCM50
治疗用生物制品38
Biologic5
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

59 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

177 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
2024/06/17New drug · Class 1.2 SCTV04C注射液CXSL2400397 神州细胞工程有限公司
2024/06/17New drug · Class 1.2 SCTV04C注射液CXSL2400396 神州细胞工程有限公司
2024/06/17New drug · Class 1 SYSA1801注射液CXSL2400395 石药集团巨石生物制药有限公司
2024/06/17New drug · Class 1 PG-033片CXHL2400607 北京普祺医药科技股份有限公司
2024/06/17New drug · Class 1 PG-033片CXHL2400606 北京普祺医药科技股份有限公司
2024/06/17New drug · Class 1 TY751注射液CXHL2400605 天津药物研究院有限公司
2024/06/15Import · Class 1 BAY 2927088片JXHL2400140 Bayer AG; Bayer Healthcare Company Ltd.
2024/06/15Import · Class 2.4 Capivasertib片JXHL2400139 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2024/06/15Import · Class 2.4 Capivasertib片JXHL2400138 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2024/06/15Import · Class 1 AZD9833片JXHL2400137 AstraZeneca AB; AstraZeneca Investment (China) Co. Limited
2024/06/15Generic · Class 3 盐酸昂丹司琼片CYHS2401808 成都通德药业有限公司
2024/06/15Generic · Class 3 米诺地尔搽剂CYHS2401807 贵州瑞和制药有限公司; 中山万汉制药有限公司
2024/06/15Generic · Class 3 米诺地尔搽剂CYHS2401806 贵州瑞和制药有限公司; 中山万汉制药有限公司
2024/06/15Generic · Class 3 复方聚乙二醇(3350)电解质散CYHS2401805 四川信拓医药技术有限公司; 成都天台山制药股份有限公司
2024/06/15New drug · Class 3.1 五味消毒饮颗粒CXZS2400022 瑞阳制药股份有限公司
2024/06/15New drug · Class 3.3 司美格鲁肽注射液CXSL2400394 惠升生物制药股份有限公司
2024/06/15New drug · Class 3.3 司美格鲁肽注射液CXSL2400393 惠升生物制药股份有限公司
2024/06/15New drug · Class 1 GR1802注射液CXSL2400392 重庆智翔金泰生物制药股份有限公司
2024/06/15New drug · Class 1 GR1802注射液CXSL2400391 重庆智翔金泰生物制药股份有限公司
2024/06/15New drug · Class 1 SCTB41注射液CXSL2400390 神州细胞工程有限公司
2024/06/14Import · Class 2.2 Efgartigimod注射液JXSL2400113 argenx BV; Zai Lab (Shanghai) Co. Ltd.
2024/06/14Generic · Class 3 维生素B6注射液CYHS2401798 南京思聆医药科技有限公司; 金陵药业股份有限公司南京金陵制药厂
2024/06/14Generic · Class 3 复方聚乙二醇电解质散(儿童型)CYHS2401797 亚宝药业集团股份有限公司
2024/06/14Generic · Class 3 瑞加诺生注射液CYHL2400112 珠海润都制药股份有限公司
2024/06/14Generic · Class 3 盐酸西替利嗪注射液CYHL2400111 中孚药业股份有限公司
2024/06/14New drug · Class 1.1 益智安脑颗粒CXZL2400033 北京京师脑力科技有限公司
2024/06/14New drug · Class 1 SCT520FF注射液CXSL2400389 神州细胞工程有限公司
2024/06/14New drug · Class 1 SCT520FF注射液CXSL2400388 神州细胞工程有限公司
2024/06/14New drug · Class 1 SCT520FF注射液CXSL2400387 神州细胞工程有限公司
2024/06/14New drug · Class 3.3 重组抗PD-1人源化单克隆抗体注射液CXSL2400386 复星汉霖(深圳)生物技术有限公司; 上海复宏汉霖生物技术股份有限公司

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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