药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/05/28 – 2024/06/03

Period
2024/05/28 to 2024/06/03, 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
263
Drugs with new generic filings (by drug name, de-duplicated)
55
Accepted this week, now under review
1

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

263filings, 73 of them generic

By application type

Application typeFilings
Supplement122
Generic73
New drug47
Import18
Import re-registration3

By drug type

Drug typeFilings
Chemical drug182
治疗用生物制品40
TCM37
预防用生物制品3
体外诊断试剂1

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

55 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

164 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

82 this week

AcceptedDrugApplicants
2024/06/03Import · Class 1 伊那利塞片JXHS2400038 Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche AG; Roche (China) Holding Ltd.
2024/06/03Import · Class 1 伊那利塞片JXHS2400037 Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche AG; Roche (China) Holding Ltd.
2024/06/01Import · Class 3.1 呼吸道合胞病毒疫苗JXSL2400107 Pfizer Inc.; Pfizer Investment CO Ltd.
2024/06/01Import · Class 2.2;2.4 克拉屈滨胶囊JXHL2400125 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd
2024/06/01Import · Class 2.2;2.4 克拉屈滨胶囊JXHL2400124 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd
2024/06/01Generic · Class 3 依帕司他片CYHS2401651 中美华世通生物医药科技(武汉)股份有限公司; 湖北华世通生物医药科技有限公司
2024/06/01Generic · Class 3 氯化钾颗粒CYHS2401648 山东普瑞曼药业有限公司
2024/06/01Generic · Class 3 维生素B6注射液CYHS2401646 北京远方通达医药技术有限公司; 河南科伦药业有限公司
2024/06/01Generic · Class 3 布美他尼注射液CYHS2401641 北京民康百草医药科技有限公司; 山西诺成制药有限公司
2024/06/01Generic · Class 3 布美他尼注射液CYHS2401640 北京民康百草医药科技有限公司; 山西诺成制药有限公司
2024/06/01New drug · Class 1 CS060380片CXHL2400553 凯思凯迪(上海)医药科技有限公司
2024/06/01New drug · Class 1 CS060380片CXHL2400552 凯思凯迪(上海)医药科技有限公司
2024/06/01New drug · Class 1 CS060380片CXHL2400551 凯思凯迪(上海)医药科技有限公司
2024/05/31Import · Class 2.2 Dostarlimab注射液JXSL2400106 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd.
2024/05/31Import · Class 1 VAY736注射液JXSL2400105 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/05/31Generic · Class 3 氨磺必利口服溶液CYHS2401638 常州四药制药有限公司
2024/05/31Generic · Class 3 氯化钙注射液CYHS2401634 河北千康医药科技有限责任公司; 山东齐都药业有限公司
2024/05/31Generic · Class 3 异烟肼注射液CYHS2401633 漯河市汇创医药有限公司; 裕松源药业有限公司
2024/05/31Generic · Class 3 维生素K1注射液CYHS2401632 合肥亿帆生物制药有限公司
2024/05/31Generic · Class 3 维生素K1注射液CYHS2401631 合肥亿帆生物制药有限公司
2024/05/31New drug · Class 1 夫那奇珠单抗注射液CXSL2400363 苏州盛迪亚生物医药有限公司
2024/05/31New drug · Class 1 夫那奇珠单抗注射液CXSL2400362 苏州盛迪亚生物医药有限公司
2024/05/31New drug · Class 1 夫那奇珠单抗注射液CXSL2400361 苏州盛迪亚生物医药有限公司
2024/05/31New drug · Class 1 注射用LNF2007双特异性抗体CXSL2400360 山东新时代药业有限公司
2024/05/31New drug · Class 1 SHR-2106注射液CXSL2400359 广东恒瑞医药有限公司
2024/05/31New drug · Class 1 注射用HS-20093CXSL2400358 上海翰森生物医药科技有限公司; 常州恒邦药业有限公司
2024/05/31New drug · Class 1 注射用HS-20093CXSL2400357 上海翰森生物医药科技有限公司; 常州恒邦药业有限公司
2024/05/31New drug · Class 1 HS-20117注射液CXSL2400356 上海翰森生物医药科技有限公司; 常州恒邦药业有限公司
2024/05/31New drug · Class 1 XMVA09注射液CXSL2400355 合肥星眸生物科技有限公司
2024/05/31New drug · Class 1 BGB-45035片CXHL2400550 百济神州(苏州)生物科技有限公司

52 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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