药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2026/03/31 – 2026/04/06

Period
2026/03/31 to 2026/04/06, 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
364
Drugs with new generic filings (by drug name, de-duplicated)
27
Accepted this week, now under review
92

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

364filings, 37 of them generic

By application type

Application typeFilings
Supplement253
New drug43
Generic37
Import18
Unspecified7
Import re-registration6

By drug type

Drug typeFilings
TCM159
Chemical drug148
治疗用生物制品56
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

27 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

197 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

67 this week

AcceptedDrugApplicants
2026/04/04Import · Class 2.2 帕博利珠单抗注射液(皮下注射)JXSS2600031 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2026/04/04Import · Class 2.2 帕博利珠单抗注射液(皮下注射)JXSS2600030 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2026/04/04Import · Class 3.1 帕博利珠单抗注射液(皮下注射)JXSS2600029 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2026/04/04Import · Class 3.1 帕博利珠单抗注射液(皮下注射)JXSS2600028 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2026/04/04Generic · Class 3 盐酸奥洛他定颗粒CYHS2600785 九华华源药业(桂林)有限公司; 成都天台山制药股份有限公司
2026/04/04New drug · Class 2.3 椿乳凝胶CXZL2600034 株洲千金药业股份有限公司
2026/04/04New drug · Class 1 SK-NK注射液CXSL2600380 赛奥斯博生物科技(北京)有限公司; 赛奥斯博生物科技(郑州)有限公司
2026/04/03Import · Class 2.2 注射用维恩妥尤单抗JXSL2600091 Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd.
2026/04/03Import · Class 2.2 注射用维恩妥尤单抗JXSL2600090 Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd.
2026/04/03Import · Class 1 Baxdrostat片JXHL2600099 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/04/03Generic · Class 3 富马酸酮替芬口服溶液CYHS2600784 安徽远望乐桓药业有限公司
2026/04/03New drug · Class 1 GT307注射液CXSL2600379 北京沙砾生物医药股份有限公司
2026/04/03New drug · Class 1 SAR445877注射用浓溶液CXSL2600378 赛诺菲(中国)投资有限公司
2026/04/03New drug · Class 1 ATTO-1310注射液CXSL2600377 艾拓维医药(上海)有限公司
2026/04/03New drug · Class 1 9MW5211注射液CXSL2600376 迈威(上海)生物科技股份有限公司
2026/04/03New drug · Class 1 注射用DXC018CXSL2600375 杭州多禧生物科技有限公司
2026/04/03New drug · Class 1 注射用SIM0689CXSL2600374 上海先纬医药科技有限公司
2026/04/03New drug · Class 1 艾普美妥司他片CXHS2600047 上海海和药物研究开发股份有限公司; 江苏宣泰药业有限公司
2026/04/03New drug · Class 1 艾普美妥司他片CXHS2600046 上海海和药物研究开发股份有限公司; 江苏宣泰药业有限公司
2026/04/03New drug · Class 1 伊托法替布软膏CXHS2600045 明慧医药(杭州)有限公司; 广州玻思韬控释药业有限公司
2026/04/03New drug · Class 1 D-0120-NA片CXHL2600406 益方生物科技(上海)股份有限公司
2026/04/03New drug · Class 1 VC005凝胶CXHL2600405 江苏威凯尔医药科技股份有限公司
2026/04/03New drug · Class 2.2 优替德隆胶囊CXHL2600404 成都华昊中天药业有限公司; 北京华昊中天生物医药股份有限公司
2026/04/02Import · Class 3.1 帕博利珠单抗注射液(皮下注射)JXSS2600027 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S. p. A.; MSD R&D (China) Co. Ltd
2026/04/02Import · Class 3.1 帕博利珠单抗注射液(皮下注射)JXSS2600026 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2026/04/02Import · Class 2.2 奥妥珠单抗注射液JXSS2600025 Roche Pharma (Schweiz) AG; Roche Diagnostics GmbH; Roche (China) Holding Ltd.
2026/04/02Import · Class 2.2 注射用德曲妥珠单抗JXSS2600024 Daiichi Sankyo Europe GmbH; Simtra Deutschland GmbH; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD.
2026/04/02Import · Class 1 PF-08634404JXSL2600089 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/04/02Import · Class 1 AZD8965片JXHL2600098 AstraZeneca AB; -
2026/04/02Import · Class 1 AZD8965片JXHL2600097 AstraZeneca AB; -

37 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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