药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2025/08/26 – 2025/09/01

Period
2025/08/26 to 2025/09/01, 7 days inclusive
Data as of
2026/11/05 06:00
Cached records
94,245 acceptance records, 11,689 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
382
Drugs with new generic filings (by drug name, de-duplicated)
70
Accepted this week, now under review
94

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

382filings, 101 of them generic

By application type

Application typeFilings
Supplement172
Generic101
New drug69
Import28
Unspecified8
Import re-registration4

By drug type

Drug typeFilings
Chemical drug256
TCM63
治疗用生物制品55
Biologic7
预防用生物制品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

70 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

216 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 whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

129 this week

AcceptedDrugApplicants
2025/09/01Generic · Class 3 氟[18F]代雌二醇注射液CYHL2500160 江苏华益科技有限公司
2025/08/30Import · Class 3.1 注射用Rurioctocog alfa pegolJXSS2500115 Takeda Canada Inc; Baxalta Manufacturing S.a.r.l.; Takeda (China) International Trading Co. Ltd
2025/08/30Import · Class 3.1 注射用Rurioctocog alfa pegolJXSS2500114 Takeda Canada Inc; Baxalta Manufacturing S.a.r.l.; Takeda (China) International Trading Co. Ltd
2025/08/30Import · Class 3.1 注射用Rurioctocog alfa pegolJXSS2500113 Takeda Canada Inc; Baxalta Manufacturing S.a.r.l.; Takeda (China) International Trading Co. Ltd
2025/08/30Import · Class 3.1 注射用Rurioctocog alfa pegolJXSS2500112 Takeda Canada Inc; Baxalta Manufacturing S.a.r.l.; Takeda (China) International Trading Co. Ltd
2025/08/30Import · Class 3.1 注射用Rurioctocog alfa pegolJXSS2500111 Takeda Canada Inc; Baxalta Manufacturing S.a.r.l.; Takeda (China) International Trading Co. Ltd
2025/08/30Import · Class 1 [225Ac]Ac-FL-020注射液JXHL2500250 Full-Life Technologies GmbH; Shanghai Full-life Technologies Co. Ltd.
2025/08/30Import · Class 1 [111In]In-FL-020注射液JXHL2500249 Full-Life Technologies GmbH; Shanghai Full-life Technologies Co. Ltd.
2025/08/30Import · Class 1 Brenipatide注射液JXHL2500248 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/30Import · Class 1 Brenipatide注射液JXHL2500247 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/30Import · Class 1 Brenipatide注射液JXHL2500246 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/30Generic · Class 3 盐酸二甲双胍口服溶液CYHS2503201 安徽四环科宝制药有限公司
2025/08/30Generic · Class 3 盐酸二甲双胍口服溶液CYHS2503200 安徽四环科宝制药有限公司
2025/08/30Generic · Class 3 磷酸奥司他韦颗粒CYHS2503199 山东朗诺制药有限公司
2025/08/30Generic · Class 3 磷苯妥英钠注射液CYHS2503195 武汉华尔生物科技有限公司; 武汉启瑞药业有限公司
2025/08/30Generic · Class 3 磷苯妥英钠注射液CYHS2503194 武汉华尔生物科技有限公司; 武汉启瑞药业有限公司
2025/08/30Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G2.5%)CYHS2503187 海南爱科制药有限公司; 上海长征富民金山制药有限公司
2025/08/30Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G1.5%)CYHS2503186 海南爱科制药有限公司; 上海长征富民金山制药有限公司
2025/08/30Generic · Class 3 中性腹膜透析液(碳酸氢盐-G2.5%)CYHS2503185 海南爱科制药有限公司; 上海长征富民金山制药有限公司
2025/08/30Generic · Class 3 中性腹膜透析液(碳酸氢盐-G1.5%)CYHS2503184 海南爱科制药有限公司; 上海长征富民金山制药有限公司
2025/08/30New drug · Class 1 注射用ZG006CXSL2500753 苏州泽璟生物制药股份有限公司; 上海泽璟医药技术有限公司
2025/08/30New drug · Class 1 注射用戈氏梭菌芽孢冻干粉CXSL2500752 施慧达药业集团(吉林)有限公司
2025/08/30New drug · Class 1 9MW3811注射液CXSL2500751 迈威(上海)生物科技股份有限公司
2025/08/30New drug · Class 1 SCTC21C注射液CXSL2500750 神州细胞工程有限公司
2025/08/30New drug · Class 2.2 吡仑帕奈口溶膜CXHS2500105 上海欣峰制药有限公司
2025/08/30New drug · Class 2.2 吡仑帕奈口溶膜CXHS2500104 上海欣峰制药有限公司
2025/08/30New drug · Class 1 HH101785片CXHL2500933 上海海和药物研究开发股份有限公司
2025/08/30New drug · Class 1 HH101785片CXHL2500932 上海海和药物研究开发股份有限公司
2025/08/30New drug · Class 2.4 硫酸艾玛昔替尼片CXHL2500931 江苏恒瑞医药股份有限公司
2025/08/30New drug · Class 2.2 P-0264直服颗粒CXHL2500930 华益泰康药业股份有限公司

99 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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