药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2026/10/20 – 2026/10/26

Period
2026/10/20 to 2026/10/26, 7 days inclusive
Data as of
2026/11/02 06:00
Cached records
93,950 acceptance records, 11,657 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
384
Drugs with new generic filings (by drug name, de-duplicated)
46
Accepted this week, now under review
384

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

384filings, 60 of them generic

By application type

Application typeFilings
Supplement228
Generic60
New drug51
Import31
Import re-registration9
Unspecified5

By drug type

Drug typeFilings
Chemical drug187
TCM121
治疗用生物制品67
Biologic6
预防用生物制品2
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

46 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

258 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

Entered review this week
149
Left review this week (approved or terminated, to be verified)
426

Data collected since 2026/10/22: this week counts snapshots from 2026/10/23 only.

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

90 this week

AcceptedDrugApplicants
2026/10/26Import · Class 1 ABBV-901注射用粉末JXSL2600285 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2026/10/26Import · Class 1 Azenosertib片JXHL2600463 K-Group Beta Inc.; Hangzhou Tigermed Consulting Co. Ltd.
2026/10/26Import · Class 1 Azenosertib片JXHL2600462 K-Group Beta Inc.; Hangzhou Tigermed Consulting Co. Ltd.
2026/10/26Import · Class 2.4 注射用WCK 5222JXHL2600461 Wockhardt Bio AG; Fortrea Pharmaceutical Research and Development (Beijing) Co. Ltd.
2026/10/26Generic · Class 3 亚硒酸钠注射液CYHS2602625 仁合益康汇泽药业河北有限公司
2026/10/26Generic · Class 3 苯磺酸美洛加巴林口崩片CYHS2602617 天方药业有限公司
2026/10/26Generic · Class 3 苯磺酸美洛加巴林口崩片CYHS2602616 天方药业有限公司
2026/10/26Generic · Class 3 苏沃雷生片CYHL2600124 广东豪瑞恩制药有限公司
2026/10/26Generic · Class 3 苏沃雷生片CYHL2600123 广东豪瑞恩制药有限公司
2026/10/26Generic · Class 3 苏沃雷生片CYHL2600122 广东豪瑞恩制药有限公司
2026/10/26New drug · Class 2.3 黄葵胶囊CXZL2600108 苏中药业集团股份有限公司
2026/10/26New drug · Class 2.2 信迪利单抗注射液CXSS2600170 信达生物制药(苏州)有限公司
2026/10/26New drug · Class 1 诺吉仑赛注射液CXSS2600169 上海君赛生物药业有限公司
2026/10/26New drug · Class 1 CM398注射液CXSL2601172 康诺亚生物医药科技有限公司
2026/10/26New drug · Class 1 SPGL008注射液CXSL2601171 深圳赛保尔生物药业有限公司
2026/10/26New drug · Class 1 SSGJ-706注射液CXSL2601170 沈阳三生制药有限责任公司
2026/10/23Import · Class 2.2 萨特利珠单抗注射液JXSS2600098 Roche Pharma (Schweiz) AG; Utsunomiya Plant of Chugai Pharma Manufacturing Co. Ltd.; Roche (China) Holding Ltd.
2026/10/23Import · Class 1 AZD0486JXSL2600284 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/10/23Import · Class 1 AZD0486JXSL2600283 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/10/23Import · Class 1 注射用ABBV-969JXSL2600282 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2026/10/23Import · Class 1 579 - 痤疮 mRNA 注射液JXSL2600281 Sanofi Vaccines US Inc.; Shenzhen Sanofi Biological Products Co. Ltd.
2026/10/23Import · Class 2.4 甲苯磺酸利特昔替尼胶囊JXHS2600132 Pfizer Inc.; Pfizer Manufacturing Deutschland GmbH; Pfizer Investment Co. Ltd.
2026/10/23Import · Class 2.4 甲苯磺酸利特昔替尼胶囊JXHS2600131 Pfizer Inc.; Pfizer Manufacturing Deutschland GmbH; Pfizer Investment Co. Ltd.
2026/10/23Generic · Class 3 盐酸倍他司汀片CYHS2602608 卡文迪许(泰州)药业有限公司; 山东齐都药业有限公司
2026/10/23Generic · Class 3 双氯芬酸依泊胺凝胶贴膏CYHL2600121 杭州端本医药科技有限公司
2026/10/23New drug · Class 1.1 逍遥静音颗粒CXZL2600107 北京欣瑞元医药科技有限公司
2026/10/23New drug · Class 2.2 注射用伦康依隆妥单抗CXSS2600168 成都百利多特生物药业有限责任公司; 成都百利多特生物药业有限责任公司(有效载荷-连接子:成都精西药业有限责任公司)
2026/10/23New drug · Class 1 泰利奇拜单抗注射液(皮下注射)CXSS2600167 重庆智翔金泰生物制药股份有限公司
2026/10/23New drug · Class 1 IMM040811注射液CXSL2601169 北京免疫方舟医药科技有限公司
2026/10/23New drug · Class 1 IMM092注射液CXSL2601168 北京免疫方舟医药科技有限公司

60 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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