药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2026/10/27 – 2026/11/02

Period
2026/10/27 to 2026/11/02, 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
268
Drugs with new generic filings (by drug name, de-duplicated)
30
Accepted this week, now under review
268

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

268filings, 42 of them generic

By application type

Application typeFilings
Supplement147
Generic42
New drug41
Import28
Import re-registration9
Unspecified1

By drug type

Drug typeFilings
Chemical drug135
TCM77
治疗用生物制品52
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

30 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

157 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
346
Left review this week (approved or terminated, to be verified)
268

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

74 this week

AcceptedDrugApplicants
2026/10/30Import · Class 2.2类 特泽利尤单抗注射液JXSS2600101 AstraZeneca AB; Amgen Manufacturing Limited LLC; AstraZeneca Investment (China) Co. Ltd.
2026/10/30Import · Class 2.2类 特泽利尤单抗注射液JXSS2600100 AstraZeneca AB; Amgen Manufacturing Limited LLC; AstraZeneca Investment (China) Co. Ltd.
2026/10/30Import · Class 1 LY4086940片JXHL2600479 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/10/30Import · Class 1 LY4086940片JXHL2600478 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/10/30Import · Class 1 LY4086940片JXHL2600477 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/10/30Import · Class 1 LY4086940片JXHL2600476 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/10/30Import · Class 1 LY4086940片JXHL2600475 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/10/30Import · Class 1 LY4086940片JXHL2600474 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/10/30Import · Class 1 LY4086940片JXHL2600473 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/10/30Import · Class 1 LY4086940片JXHL2600472 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/10/30Import · Class 1 LY4086940片JXHL2600471 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/10/30Generic · Class 3 富马酸酮替芬口服溶液CYHS2602662 大连百利天华制药有限公司; 河南华雒康润药业有限公司
2026/10/30Generic · Class 3 复方氨基酸注射液(17AA-SF)CYHS2602661 远大医学营养科学(武汉)有限公司
2026/10/30Generic · Class 3 复方氨基酸注射液(17AA-SF)CYHS2602660 远大医学营养科学(武汉)有限公司
2026/10/30Generic · Class 3 吡非尼酮片CYHS2602658 山东新时代药业有限公司
2026/10/30New drug · Class 3.1 三痹汤颗粒CXZS2600059 广西中医药大学百年乐制药有限公司
2026/10/30New drug · Class 3.1 蠲痹汤颗粒CXZS2600058 广西中医药大学百年乐制药有限公司
2026/10/30New drug · Class 1类 注射用MHB039ACXSL2601191 明慧医药(上海)有限公司
2026/10/30New drug · Class 1 注射用MHB046CCXSL2601190 明慧医药(上海)有限公司
2026/10/30New drug · Class 1类 HRS-4642注射液CXHL2601331 上海恒瑞医药有限公司; 江苏恒瑞医药股份有限公司
2026/10/29Import · Class 2.4 Seladelpar胶囊JXHL2600470 Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2026/10/29Import · Class 1 Cilofexor片JXHL2600469 Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2026/10/29Import · Class 1 Cilofexor片JXHL2600468 Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2026/10/29Import · Class 1 Casdatifan 片JXHL2600467 Arcus Biosciences Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd.
2026/10/29Import · Class 1 Casdatifan 片JXHL2600466 Arcus Biosciences Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd.
2026/10/29Generic · Class 3 硫酸锌注射液CYHS2602647 山东齐都药业有限公司
2026/10/29Generic · Class 3 阿仑膦酸钠口服溶液CYHS2602641 江苏贝佳制药有限公司
2026/10/29New drug · Class 2.2;2.3 小儿清热消炎宁颗粒CXZS2600057 天地恒一制药股份有限公司
2026/10/29New drug · Class 3.3 度拉糖肽注射液CXSS2600176 乐普药业股份有限公司; 乐普(北京)生物科技有限公司
2026/10/29New drug · Class 3.3 度拉糖肽注射液CXSS2600175 乐普药业股份有限公司; 乐普(北京)生物科技有限公司

44 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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