药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2026/08/25 – 2026/08/31

Period
2026/08/25 to 2026/08/31, 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
402
Drugs with new generic filings (by drug name, de-duplicated)
42
Accepted this week, now under review
314

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

402filings, 61 of them generic

By application type

Application typeFilings
Supplement247
Generic61
New drug54
Import31
Import re-registration5
Unspecified4

By drug type

Drug typeFilings
Chemical drug185
TCM133
治疗用生物制品77
预防用生物制品7

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

42 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

224 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

106 this week

AcceptedDrugApplicants
2026/08/31Import · Class 1 注射用MK-2750JXSL2600235 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2026/08/31Import · Class 1 FUB523注射液JXSL2600234 Novartis Pharma AG
2026/08/31Import · Class 1 RO7795068注射液JXHL2600378 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/31Import · Class 1 RO7795068注射液JXHL2600377 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/31Import · Class 1 RO7795068注射液JXHL2600376 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/31Import · Class 1 RO7795068注射液JXHL2600375 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/31Import · Class 1 RO7795068注射液JXHL2600374 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/31Import · Class 1 RO7795068注射液JXHL2600373 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/31Import · Class 2.4 盐酸阿曲生坦片JXHL2600372 Novartis Pharma AG
2026/08/31Generic · Class 3 依巴斯汀口服溶液CYHS2602166 南昌立健药业有限公司
2026/08/31Generic · Class 3 二硫化硒洗剂CYHS2602163 景时(杭州)药业有限公司; 裕松源药业有限公司
2026/08/31Generic · Class 3 二硫化硒洗剂CYHS2602162 景时(杭州)药业有限公司; 裕松源药业有限公司
2026/08/31Generic · Class 3 依普利酮片CYHS2602158 北京诚济制药股份有限公司
2026/08/31Generic · Class 3 依普利酮片CYHS2602157 北京诚济制药股份有限公司
2026/08/31New drug · Class 1 JUR-003注射液CXSL2600939 烁磊生物医药(上海)有限公司
2026/08/31New drug · Class 1 JUR-003注射液CXSL2600938 烁磊生物医药(上海)有限公司
2026/08/31New drug · Class 1 Cizutamig注射液(皮下注射)CXSL2600937 上海坦蒂生物医药科技有限公司
2026/08/31New drug · Class 1 AZD7003CXSL2600936 阿斯利康投资(中国)有限公司
2026/08/31New drug · Class 1 沃拉德单抗注射液CXSL2600935 北京科信美德生物医药科技有限公司
2026/08/31New drug · Class 1 沃拉德单抗注射液CXSL2600934 北京科信美德生物医药科技有限公司
2026/08/31New drug · Class 3.3 冻干人用狂犬病疫苗(ZFB-3细胞)CXSL2600933 安徽智飞龙科马生物制药有限公司
2026/08/31New drug · Class 1 注射用BL-M08D1CXSL2600932 成都百利多特生物药业有限责任公司; 四川百利药业有限责任公司
2026/08/31New drug · Class 1 MWX205注射液CXHL2601057 上海民为生物技术有限公司
2026/08/28Import · Class 3.1 马塔西单抗注射液JXSL2600233 Pfizer Inc.; Pfizer Investment Co. Ltd.
2026/08/28Import · Class 1 ABBV-901注射用粉末JXSL2600232 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2026/08/28Import · Class 1 PFL-721片JXHL2600371 PIERRE FABRE MEDICAMENT; Pierre Fabre (Shanghai) Medical Co. Ltd.
2026/08/28Import · Class 1 PFL-721片JXHL2600370 PIERRE FABRE MEDICAMENT; Pierre Fabre (Shanghai) Medical Co. Ltd.
2026/08/28Import · Class 2.4 贝组替凡片JXHL2600369 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2026/08/28Import · Class 1 ATL-101鞘内注射液JXHL2600368 Atalanta Therapeutics Inc.; Tenacia Biopharmaceuticals (Shanghai) Co. Ltd.
2026/08/28Generic · Class 3 二硫化硒洗剂CYHS2602151 湖北午时药业股份有限公司

76 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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