主要研究目的：以持证商：Mitsubishi Tanabe Pharma Corporation，ニプロESファーマ株式会社生产的吡嘧司特钾片（规格：10mg，商品名：Alegysal）为参比制剂，以国药集团国瑞药业有限公司生产的吡嘧司特钾片（规格：10mg)为受试制剂，采用随机、开放、单剂量、两周期双交叉设计，评价两种制剂在中国健康受试者中空腹和餐后状态下的生物等效性。次要研究目的：观察健康受试者口服受试制剂吡嘧司特钾片（规格：10mg）和参比制剂吡嘧司特钾片（规格：10mg，商品名：Alegysal）的安全性。

开始日期2022-07-08

申办/合作机构

国药集团国瑞药业有限公司

CTR20220169 / CompletedN/A

吡嘧司特钾片人体生物等效性预试验

主要研究目的：按有关生物等效性试验的规定，选择持证商：Mitsubishi Tanabe Pharma Corporation，ニプロESファーマ株式会社生产的吡嘧司特钾片（规格：10mg，商品名：Alegysal）为参比制剂，对国药集团国瑞药业有限公司生产的受试制剂吡嘧司特钾片（规格：10mg）进行空腹和餐后给药人体生物等效性试验，比较受试制剂和参比制剂中药物的吸收速度和吸收程度，考察关键药动学参数的个体内变异度，为正式试验样本量确定及试验方案优化提供依据。次要研究目的：观察健康受试者口服受试制剂吡嘧司特钾片（规格：10mg）和参比制剂吡嘧司特钾片（规格：10mg，商品名：Alegysal）的安全性。

开始日期2022-02-17

申办/合作机构

国药集团国瑞药业有限公司

100 项与吡嘧司特钾相关的临床结果

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100 项与吡嘧司特钾相关的转化医学

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100 项与吡嘧司特钾相关的专利（医药）

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107

项与吡嘧司特钾相关的文献（医药）

2024-12-01·ENVIRONMENTAL POLLUTION

Brominated flame retardant in animal feeds from Poland

Article

作者: Pietron, Wojciech Jerzy ; Warenik-Bany, Malgorzata

The safety of food of animal origin is closely related to feed quality. Feed pollution by brominated flame retardants (BFRs) leads to the exposure of animals and consumers of food of animal origin to these substances. The study aimed to assess the concentration of ten PBDE (BDE-28, 47, 49, 99, 100, 138, 153, 154, 183, and 209) congeners and eight nBFRs (TBX, PBT, HBB, PBEB, EH-TBB, BTBPE, BEH-TBPH, and DBDPE) in 59 feed and feed materials from six different feed categories (277/2012/EU). The quantification of analytes was based on isotopic dilution and gas chromatography-high-resolution mass spectrometry (GC-HRMS). All 59 feed samples were contaminated with at least one of the analytes. PBDEs and nBFRs were found in 78% and 91% of the samples, respectively. BFR content ranged from 0.18 to 5.87 μg kg^-1 in feed with a 12% moisture content, and the most contaminated category was vegetable oils, followed by fishmeal, feeds for fish, animal fats, and compound feeds for pigs. The least contaminated samples turned out to be compound feeds for chickens. This study confirms the general trend of decreasing PBDE concentrations in fishmeal. In the investigated samples, BDE-47 and BDE-209 contributed the most to the ∑PBDE content. DBDPE, HBB, and PBT contributed the most to the investigated ∑nBFRs. The widespread occurrence of nBFRs in feed seems disturbing because these compounds have replaced PBDEs. Their concentrations in the feed may most likely exceed those of PBDEs in the coming years.

2024-10-01·BREAST CANCER RESEARCH AND TREATMENT

Comprehensive genomic profiling of ESR1, PIK3CA, AKT1, and PTEN in HR(+)HER2(−) metastatic breast cancer: prevalence along treatment course and predictive value for endocrine therapy resistance in real-world practice

Article

作者: Quintanilha, Julia C F ; Bhave, Manali A ; McArthur, Heather ; Kalinsky, Kevin ; Tukachinsky, Hanna ; Graf, Ryon P ; Huang, Richard S P ; Li, Gerald ; Ross, Jeffrey S ; Levy, Mia A ; Scott, Takara ; Pasquina, Lincoln

Abstract:

Background:

The treatment landscape for HR(+)HER2(−) metastatic breast cancer (MBC) is evolving for patients with ESR1 mutations (mut) and PI3K/AKT pathway genomic alterations (GA). We sought to inform clinical utility for comprehensive genomic profiling (CGP) using tissue (TBx) and liquid biopsies (LBx) in HR(+)HER2(−) MBC.

Methods:

Records from a de-identified breast cancer clinicogenomic database for patients who underwent TBx/LBx testing at Foundation Medicine during routine clinical care at ~ 280 US cancer clinics between 01/2011 and 09/2023 were assessed. GA prevalence [ESR1mut, PIK3CAmut, AKT1mut, PTENmut, and PTEN homozygous copy loss (PTENloss)] were calculated in TBx and LBx [stratified by ctDNA tumor fraction (TF)] during the first three lines of therapy. Real-world progression-free survival (rwPFS) and overall survival (rwOS) were compared between groups by Cox models adjusted for prognostic factors.

Results:

~ 60% of cases harbored 1 + GA in 1st-line TBx (1266/2154) or LBx TF ≥ 1% (80/126) and 26.5% (43/162) in LBx TF < 1%. ESR1mut was found in 8.1% TBx, 17.5% LBx TF ≥ 1%, and 4.9% LBx TF < 1% in 1st line, increasing to 59% in 3rd line (LBx TF ≥ 1%). PTENloss was detected at higher rates in TBx (4.3%) than LBx (1% in TF ≥ 1%). Patients receiving 1st-line aromatase inhibitor + CDK4/6 inhibitor (n = 573) with ESR1mut had less favorable rwPFS and rwOS versus ESR1 wild-type; no differences were observed for fulvestrant + CDK4/6 inhibitor (n = 348).

Conclusion:

Our study suggests obtaining TBx for CGP at time of de novo/recurrent diagnosis, followed by LBx for detecting acquired GA in 2nd + lines. Reflex TBx should be considered when ctDNA TF < 1%.

2024-10-01·European Urology Oncology

Regional Versus Systematic Biopsy in Addition to Targeted Biopsy: Results from a Systematic Review and Meta-analysis

Review

作者: Tedde, Alessandro ; Madonia, Massimo ; Roupret, Morgan ; Schoots, Ivo ; Sanguedolce, Francesco ; Giannarini, Gianluca ; Palou, Joan ; Chernysheva, Daria ; Basile, Giuseppe ; Uleri, Alessandro ; Panebianco, Valeria ; Padhani, Anwar R ; Budeaus, Lars ; Lauwers, Carol Nancy Gianna ; Padhani, Anwar R. ; Baboudjian, Michael ; Breda, Alberto

BACKGROUND AND OBJECTIVE:

Intensification of targeted biopsy (TBx) around a magnetic resonance imaging (MRI)-visible lesion with regional biopsy (RBx) could obviate the need for systematic biopsy (SBx). We aimed to compare the detection yields of clinically significant prostate cancer (csPCa)-defined as International Society of Urological Pathology (ISUP) grade group ≥2-between TBx + RBx and the reference standard (TBx + SBx).

METHODS:

RBx was defined as perilesional or ipsilateral biopsy. A literature search was conducted up to September 2023 using PubMed, Embase, and Web of Science databases. The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines were followed. Included studies were eligible when presenting data from SBx, TBx, and TBx + RBx cores and their detection yields. The Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) criteria were used to assess the risk of bias of the included studies.

KEY FINDINGS AND LIMITATIONS:

Twenty-one studies were included for a meta-analysis. The overall detection yield of csPCa was not statistically different between TBx + SBX and TBx + RBx (46.1% vs 44.2%; odds ratio [OR] 1.07, 95% confidence interval [CI] 0.99-1.16, p = 0.07); similar findings were found also for ISUP grade group ≥3 prostate cancer (PCa; OR 1.06, 95% CI 0.92-1.22, p = 0.43) and in different subgroup analyses. TBx + SBx was associated with higher cancer detection of ISUP grade group 1 PCa (OR 1.16, 95% CI 1.04-1.30, p = 0.008). The main limitations include the retrospective nature of most of the selected studies, heterogeneity of RBx definition, and template.

CONCLUSIONS AND CLINICAL IMPLICATIONS:

Our study supports the use of the TBx + RBx template in the early detection pathway for the detection of csPCa. SBx can be omitted when targeting lesions visible on MRI.

PATIENT SUMMARY:

A prostate biopsy strategy consisting of taking biopsy in and around an magnetic resonance imaging-visible lesion reduces the risk of detecting indolent prostate cancers without affecting the detection of aggressive tumours.

项与吡嘧司特钾相关的新闻（医药）

2024-01-18

·米内网

【瞩目】立方制药拿下重磅首仿！百亿市场风云再起

精彩内容近日，立方制药全资子公司合肥诚志生物申报的4类仿制药伊曲康唑口服液获批生产，为国内国产首家获批。这是一款三唑类衍生物，也是立方制药首款获批的全身用抗真菌药。米内网数据显示，2023上半年中国三大终端六大市场（统计范围详见本文末）全身用抗真菌药销售额超过50亿元。伊曲康唑为三唑类衍生物，具有广谱抗真菌活性，主要用于治疗HIV阳性或免疫系统低下患者的口腔和/或食道念珠菌病。对血液系统肿瘤、骨髓移植患者和预期发生中性粒细胞减少症的患者，可预防侵袭性真菌感染的发生。国内已获批上市的伊曲康唑制剂来源：米内网一键检索国内已获批上市的伊曲康唑制剂主要有伊曲康唑胶囊、伊曲康唑分散片、伊曲康唑颗粒、伊曲康唑口服溶液、伊曲康唑注射液等。米内网数据显示，2022年中国三大终端六大市场伊曲康唑销售额接近6亿元。目前布局伊曲康唑口服溶液仿制药的企业不多，黄氏制药/华腾(天津)医药、合肥诚志生物的产品均以新注册分类报产，并于日前同日获批，同时拿下国内首仿+首家过评，此外江苏艾迪药业的产品以仿制4类报产，目前已获临床试验默示许可。伊曲康唑口服溶液新分类报产情况来源：米内网中国申报进度（MED）数据库在全身用抗真菌领域，伊曲康唑口服溶液为立方制药首款获批的产品。近年来中国三大终端六大市场全身用抗真菌药的销售额有所波动，2021年达100亿元，2022年有所回落，2023上半年超过50亿元，全年销售额有望重回百亿规模。近年来中国三大终端六大市场全身用抗真菌药销售情况（单位：万元）来源：米内网格局数据库目前立方制药还有5个品种以新注册分类申报在审，包括盐酸哌甲酯缓释片（暂无首仿）、盐酸丙美卡因滴眼液、帕利哌酮缓释片、吡嘧司特钾滴眼液及马来酸噻吗洛尔滴眼液，涵盖神经系统药物、感觉系统药物两大治疗领域。资料来源：米内网数据库、国家药监局等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至1月18日，如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

上市批准

2024-01-07

·米内网

12月14个1类新药报产，7个双抗、15个ADC报临床；4个生物类似药获批，15个品种首家过评

摘要abstract 14个1类新药报产，7个双抗、15个ADC报临床 10个改良型新药申报新适应症仿制申请有38个品种暂无国内获批 5个存量品种首次有企业申报一致性评价 4个生物类似药获批上市，2个品种获批适应症 15个品种有首家过评，其中4个为首仿CDE总体承办情况据米内网中国申报进度（MED）数据库统计，2023年12月CDE共承办药品注册申请1561件。其中上市申请435件，临床申请327件，存量品种一致性评价84件。2023年1-12月CDE承办药品注册申请情况（按受理号计）创新药品种申报情况2023年12月，162个创新药品种（药品注册分类为“1”的品种）获CDE承办。有14个1类新药申请上市，其中化药有6个，中药有2个，治疗用生物制品有5个。此外还有7个双抗、15个ADC药物申报临床。2023年12月创新药上市申请承办情况2023年12月创新药临床申请承办情况改良型新药品种申报情况2023年12月，42个改良型新药品种（药品注册分类为“2”的品种）获CDE承办，TAP-1503乳膏(上海泽德曼医药)、艾诺米替片(江苏艾迪药业)、艾诺韦林片(江苏艾迪药业)、琥珀酸瑞波西利片(诺华)、替戈拉生片(山东罗欣药业集团)、埃万妥单抗注射液(西安杨森)、帕博利珠单抗注射液(默沙东)、派安普利单抗注射液(正大天晴康方(上海)生物医药)、斯鲁利单抗注射液(上海复宏汉霖生物制药)、注射用卡瑞利珠单抗(苏州盛迪亚生物医药)为新适应症申请上市。2023年12月改良型新药上市申请承办情况2023年12月改良型新药临床申请承办情况仿制药品种申报情况2023年12月，241个品种的仿制申请获CDE承办，间苯三酚口崩片、卡泊三醇倍他米松软膏、克立硼罗软膏、膦甲酸钠注射液、硫酸阿巴卡韦片、替格瑞洛分散片、硝普钠氯化钠注射液、盐酸伐地那非口崩片、盐酸纳呋拉啡口崩片、盐酸他喷他多片、盐酸右哌甲酯缓释胶囊等38个品种目前暂无国内仿制药获批。2023年12月仿制药品种申报情况存量品种一致性评价申报情况2023年12月，50个品种的一致性评价补充申请获CDE承办。维生素B6注射液、腺苷钴胺片、亚叶酸钙注射液、注射用多种维生素(12)、注射用磷霉素钠等5个品种为首次申报。2023年12月存量品种一致性评价申报情况其他类型申请情况2023年12月，有13个进口原研药和3个生物类似药申请上市。2023年12月其他类型品种申请情况获批情况2023年12月有1个1类新药获批：索卡佐利单抗注射液(兆科(广州)肿瘤药物)。帕博利珠单抗注射液(默沙东)、舒格利单抗注射液(辉瑞)等获批新适应症。4个生物类似药获批，齐鲁制药占2个：阿柏西普眼内注射溶液(齐鲁制药)、甘精胰岛素注射液(辽宁博鳌生物制药)、利拉鲁肽注射液(通化东宝药业)、注射用依那西普(齐鲁制药)。84个仿制药获批，45个存量品种有企业过评，其中注射用盐酸兰地洛尔(南京海辰药业)、盐酸利多卡因凝胶(北京茗泽中和药物研究)、硫辛酸片(亚宝药业集团)、马来酸阿伐曲泊帕片(南京正大天晴制药)、盐酸米托蒽醌注射液(海南倍特药业)、平衡盐冲洗液(华仁药业)、琥珀酸地文拉法辛缓释片(石药欧意药业)、氨吡啶缓释片(Aurobindo)、吡嘧司特钾片(国药国瑞药业)、头孢克肟干混悬剂(深圳立健药业)、10%脂肪乳(OO)/5.5%氨基酸(15)/葡萄糖(20%)注射液(福建盛迪医药)、青霉素V钾片(山西好医生药业)、盐酸贝尼地平片(山东华素制药)、多巴丝肼片(浙江花园药业)、氨基酸葡萄糖注射液(四川科伦药业)等15个品种为首家过评。首家过评品种中：氨吡啶缓释片(Aurobindo)、多巴丝肼片(浙江花园药业)、琥珀酸地文拉法辛缓释片(石药欧意药业)、马来酸阿伐曲泊帕片(南京正大天晴制药)为国内首仿品种。2023年12月主要注册类型品种获批情况数据来源：米内网中国申报进度数据库（MED）、CDE、NMPA；相关统计字段按药品名称统计，时间截至2023年12月31日；获批品种按NMPA发布时间统计；药物作用靶点以及适应症整理自公开资料。本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

上市批准一致性评价生物类似药抗体药物偶联物

2023-07-19

·BioSpace

Redwood Scientific Technologies Inc., Announces Partnership Agreement with Silk Road Ent., Inc., for Retail Distribution of TBX FREE and TBX VAPE FREE

NEW YORK, July 19, 2023 /PRNewswire/ -- Redwood Scientific Technologies Inc. (RSCI. OTC. PK) announces a partnership with Silk Road Ent., Inc. (SKRJ, OTC, PK) for retail distribution of TBX FREE and TBX VAPE FREE, its smoking cessation products. Redwood will bring these nicotine-free solutions to the market to combat addiction to smoking and vaping. The partnership aims to leverage Silk Road's distribution network to reach pharmacies, grocery stores, and convenience stores in the US market. The finalized study for product efficacy and safety is expected to conclude by the end of 2023 before retail distribution begins. Redwood Scientific Technologies Inc. announces a partnership with Silk Road Ent., Inc. for retail distribution For media inquiries, please contact: Public Relations Info@redwoodsci.co 646-503-7884 Company Codes: OTC-BB:RSCI, OTC-BB:SKRJ, OTC-PINK:RSCI, OTC-PINK:SKRJ, OtherOTC:RSCI

100 项与吡嘧司特钾相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01088	吡嘧司特钾	R	DB00885

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
季节性过敏性鼻炎	日本	Santen Pharmaceutical Co., Ltd.	1995-01-20
哮喘	日本	Alfresa Pharma Corp.	1981-01-18
变应性结膜炎	日本	Santen Pharmaceutical Co., Ltd.	1981-01-18
过敏性鼻炎	日本	Alfresa Pharma Corp.	1981-01-18

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ARVO2003	N/A	季节性过敏性结膜炎	169	0.1% Pemirolast Potassium Ophthalmic Solution BID	糧鑰獵艱憲觸範淵構餘(觸鬱夢夢襯糧選簾觸窪) = 鹹構鏇簾願鹹獵鹹繭遞淵繭壓鹹膚獵鬱蓋製窪 (夢製網鬱觸鹽艱齋醖憲 ) 更多	积极	2003-05-01
				0.1% Pemirolast Potassium Ophthalmic Solution QID	糧鑰獵艱憲觸範淵構餘(觸鬱夢夢襯糧選簾觸窪) = 憲網鑰鏇壓製鹽餘艱夢淵繭壓鹹膚獵鬱蓋製窪 (夢製網鬱觸鹽艱齋醖憲 ) 更多