药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2026/08/18 – 2026/08/24

Period
2026/08/18 to 2026/08/24, 7 days inclusive
Data as of
2026/11/03 06:00
Cached records
94,050 acceptance records, 11,694 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
458
Drugs with new generic filings (by drug name, de-duplicated)
54
Accepted this week, now under review
305

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

458filings, 77 of them generic

By application type

Application typeFilings
Supplement242
Generic77
New drug68
Import49
Unspecified14
Import re-registration8

By drug type

Drug typeFilings
Chemical drug230
TCM136
治疗用生物制品78
预防用生物制品12
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

54 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

261 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 no longer on the under-review list whose last snapshot sighting falls in this week, meaning approved or terminated, to be verified. Companies are counted by first applicant.

Class 3 and new-drug acceptances

137 this week

AcceptedDrugApplicants
2026/08/24Import · Class 1 依赛弗酶α注射液(皮下注射)JXSS2600078 Alexion Europe SAS; Alexion Pharma International Operations Limited Alexion Athlone Manufacturing Facility (AAMF); AstraZeneca Global R&D (China) Co. Ltd.
2026/08/24Import · Class 1 依赛弗酶α注射液(皮下注射)JXSS2600077 Alexion Europe SAS; Alexion Pharma International Operations Limited Alexion Athlone Manufacturing Facility (AAMF); AstraZeneca Global R&D (China) Co. Ltd.
2026/08/24Import · Class 1 依赛弗酶α注射液(皮下注射)JXSS2600076 Alexion Europe SAS; Alexion Pharma International Operations Limited Alexion Athlone Manufacturing Facility (AAMF); AstraZeneca Global R&D (China) Co. Ltd.
2026/08/24Import · Class 3.1 13价肺炎球菌多糖结合疫苗JXSL2600227 Pfizer Europe MA EEIG; Pfizer Investment CO. Ltd.
2026/08/24Import · Class 3.1 20价肺炎球菌多糖结合疫苗JXSL2600226 Pfizer Europe MA EEIG; Pfizer Investment CO. Ltd.
2026/08/24Import · Class 1 ARVN901JXSL2600225 Arctic Vision (Hong Kong) Limited; Arctic Vision (Shanghai) Biotechnology Co. Ltd.
2026/08/24Import · Class 1 DS-3939aJXSL2600224 Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2026/08/24Import · Class 1 AZD8205JXSL2600223 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/08/24Import · Class 1 Telisotuzumab Adizutecan 注射用粉末JXSL2600222 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd
2026/08/24Import · Class 1 AZD9574JXHL2600362 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/08/24Import · Class 1 AZD9574JXHL2600361 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/08/24Import · Class 1 CBL-514注射液JXHL2600360 Caliway Biopharmaceuticals Co. Ltd.; Hangzhou Tigermed Consulting Co. Ltd.
2026/08/24Generic · Class 3 布洛芬注射液CYHS2602108 山东百诺医药股份有限公司; 中孚药业股份有限公司
2026/08/24Generic · Class 3 布洛芬注射液CYHS2602107 山东百诺医药股份有限公司; 中孚药业股份有限公司
2026/08/24Generic · Class 3 奥美拉唑碳酸氢钠干混悬剂(Ⅰ)CYHS2602102 常州瑞明药业股份有限公司
2026/08/24Generic · Class 3 盐酸去氧肾上腺素注射液CYHS2602101 江苏福邦药业有限公司
2026/08/24Generic · Class 3 盐酸去氧肾上腺素注射液CYHS2602100 江苏福邦药业有限公司
2026/08/24Generic · Class 3 叶酸片CYHS2602096 北京恒生药业有限公司
2026/08/24Generic · Class 3 注射用雷替曲塞CYHS2602095 四川双通医疗科技有限公司; 四川汇宇制药股份有限公司
2026/08/24Generic · Class 3 美索巴莫片CYHS2602094 乐声药业石家庄有限公司
2026/08/24Generic · Class 3 注射用盐酸罗沙替丁醋酸酯CYHS2602093 聊城高新生物技术有限公司; 晋城海斯制药有限公司
2026/08/24Generic · Class 3 达格列净沙格列汀片CYHL2600089 合肥合源药业有限公司
2026/08/24New drug · Class 1.1 芪珀生脉颗粒CXZL2600080 北京春风药业有限公司
2026/08/24New drug · Class 1 注射用ZL-1310CXSL2600904 再鼎医药(上海)有限公司
2026/08/24New drug · Class 1 GA002注射液CXSL2600903 健达九州(北京)生物科技有限公司
2026/08/24New drug · Class 2.2 奥妥珠单抗β注射液CXSL2600902 北京天广实生物技术股份有限公司
2026/08/24New drug · Class 1 重组NV-A01腺病毒注射液CXSL2600901 南京诺惟生物科技有限公司
2026/08/24New drug · Class 2.2 奥妥珠单抗β注射液CXSL2600900 北京天广实生物技术股份有限公司
2026/08/24New drug · Class 2.4 注射用重组A型肉毒毒素(Sf9细胞,150 kD天然氨基酸序列)CXSL2600899 苏州若弋生物科技有限公司
2026/08/24New drug · Class 1 RC148注射液CXSL2600898 荣昌生物制药(烟台)股份有限公司

107 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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