药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2026/09/22 – 2026/09/28

Period
2026/09/22 to 2026/09/28, 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
345
Drugs with new generic filings (by drug name, de-duplicated)
37
Accepted this week, now under review
287

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

345filings, 47 of them generic

By application type

Application typeFilings
Supplement183
New drug54
Generic47
Import34
Import re-registration16
Unspecified11

By drug type

Drug typeFilings
Chemical drug185
TCM91
治疗用生物制品62
Biologic5
预防用生物制品2

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

37 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

219 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

102 this week

AcceptedDrugApplicants
2026/09/28Import · Class 1 AMG 732JXSL2600261 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2026/09/28Import · Class 1 PF-07220060JXHL2600428 Pfizer Inc.; Pfizer Investment Co. Ltd.
2026/09/28Import · Class 1 PF-07220060JXHL2600427 Pfizer Inc.; Pfizer Investment Co. Ltd.
2026/09/28Import · Class 1 PF-07220060JXHL2600426 Pfizer Inc.; Pfizer Investment Co. Ltd.
2026/09/28Import · Class 1 Giredestrant胶囊JXHL2600425 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/09/28Import · Class 1 PF-07220060JXHL2600424 Pfizer Inc.; Pfizer Investment Co. Ltd.
2026/09/28Import · Class 1 Giredestrant胶囊JXHL2600423 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/09/28Import · Class 1 PF-07220060JXHL2600422 Pfizer Inc.; Pfizer Investment Co. Ltd.
2026/09/28Import · Class 1 PF-07220060JXHL2600421 Pfizer Inc.; Pfizer Investment Co. Ltd.
2026/09/28Import · Class 1 PF-07220060JXHL2600420 Pfizer Inc.; Pfizer Investment Co. Ltd.
2026/09/28Import · Class 1 PF-07220060JXHL2600419 Pfizer Inc.; Pfizer Investment Co. Ltd.
2026/09/28Import · Class 1 PF-07220060JXHL2600418 Pfizer Inc.; Pfizer Investment Co. Ltd.
2026/09/28Generic · Class 3 溴吡斯的明口服溶液CYHS2602419 宿州亿帆药业有限公司
2026/09/28Generic · Class 3 对乙酰氨基酚布洛芬片CYHS2602416 济南景笙科技有限公司; 潍坊中狮制药有限公司
2026/09/28Generic · Class 3 右酮洛芬氨丁三醇注射液CYHS2602415 山东达冠医药科技有限公司; 山东辉成制药有限公司
2026/09/28New drug · Class 1.1 消肿颗粒CXZL2600095 盈科瑞(天津)创新医药研究有限公司
2026/09/28New drug · Class 2.4 注射用重组A型肉毒毒素(150 kD)CXSS2600156 君合盟生物制药(通化)有限公司
2026/09/28New drug · Class 1 注射用AP308CXSL2601066 上海礼邦医药科技有限公司
2026/09/28New drug · Class 1 9MW2821CXSL2601065 迈威(上淘)生物科技股份有限公司
2026/09/28New drug · Class 1 YYSW001片CXHL2601211 一又生物(上海)有限公司; 中国药科大学; 梦阳药业(上海)有限公司
2026/09/28New drug · Class 1 注射用TNP-2092CXHL2601210 丹诺医药(苏州)股份有限公司
2026/09/28New drug · Class 1 BG-92505片CXHL2601209 百济神州(苏州)生物科技有限公司
2026/09/28New drug · Class 1 BG-92505片CXHL2601208 百济神州(苏州)生物科技有限公司
2026/09/28New drug · Class 1 注射用莱古比星CXHL2601207 上海亲合力生物医药科技股份有限公司
2026/09/28New drug · Class 1 YKYY018雾化吸入剂CXHL2601206 北京悦康科创医药科技股份有限公司
2026/09/28New drug · Class 1 YKYY018雾化吸入剂CXHL2601205 北京悦康科创医药科技股份有限公司
2026/09/24Import · Class 1 Duvakitug注射液JXSL2600260 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2026/09/24Import · Class 2.4 甲磺酸仑伐替尼胶囊JXHS2600123 Eisai Europe Limited; Eisai Co. Ltd.
2026/09/24Import · Class 2.4 甲磺酸仑伐替尼胶囊JXHS2600122 Eisai Europe Limited; Eisai Co. Ltd.
2026/09/24Import · Class 2.4 赛沃替尼片JXHL2600417 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.

72 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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