Efficacy and Safety of Bezafibrate 400 mg and Bezafibrate 200 mg as Adjunctive Treatments in Patients With Primary Biliary Cholangitis and Non-optimal Biochemical Response to Ursodeoxycholic Acid Therapy: a 12-month, Double-blind, Randomized, Placebo-controlled Trial With a 12-month, Double-blind, Placebo-free Extension Phase.

Primary biliary cholangitis (PBC) is a rare chronic, progressive, cholestatic liver disease that leads to cirrhosis and its life-threatening complications if undertreated. Ursodeoxycholic acid (UDCA) is the standard-of-care therapy for PBC. However, patients with an inadequate biochemical response to UDCA according to the Paris-2 criteria are still at high-risk of poor clinical outcome. In this situation of biochemical resistance to UDCA, bezafibrate 400 mg/d given in association with UDCA has been shown to improve the symptoms, biochemical response (BEZURSO study), histologic features, and possibly long-term clinical outcome. However, it has been shown that even patients with an adequate response to UDCA but persistent elevation in biochemical markers of cholestasis or liver inflammation, including alkaline phosphatases (ALP), gamma-glutamyl transpeptidase (GGT), transaminases, or total bilirubin (i.e., non-optimal biochemical response) have still an increased risk of death or liver transplantation in the long term, thus defining the complete normalization of these markers as the new clinically-relevant target for PBC treatment. In parallel to these findings, bezafibrate 400 mg/d as a second-line therapy for PBC could be associated with potentially dose-related, muscle, kidney, or liver toxic effects, and whether bezafibrate 200 mg/d could have a better benefit/risk ratio in this disease-setting remains to be determined. Therefore, our aim is to evaluate the efficacy and safety of bezafibrate 400 mg and bezafibrate 200 mg as adjunctive treatments in PBC patients with non-optimal biochemical response to UDCA.

开始日期2024-09-01

申办/合作机构

Assistance Publique des Hôpitaux de Paris SA

NCT06488911 / Enrolling by invitation临床3期

A Phase 3, Open-Label, Long-Term Safety Extension Study Evaluating the Safety and Tolerability of the Fixed-Dose Combination of Obeticholic Acid and Bezafibrate in Subjects With Primary Biliary Cholangitis

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of the Fixed-Dose Combination (FDC) of Obeticholic Acid (OCA) and Bezafibrate (BZF) tablet in Subjects with Primary Biliary Cholangitis (PBC).

开始日期2024-07-01

申办/合作机构

Intercept Pharmaceuticals, Inc.

NCT05239468 / Active, not recruiting临床2期

A Phase 2a, Double-Blind, Randomized, Active Controlled, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Bezafibrate Administered in Combination With Obeticholic Acid in Subjects With Primary Biliary Cholangitis

Study to determine the effect of the investigational drug bezafibrate (BZF) alone and in combination with the investigational drug obeticholic acid (OCA) in participants with Primary Biliary Cholangitis (PBC).

开始日期2022-03-21

申办/合作机构

Intercept Pharmaceuticals, Inc.

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100 项与苯扎贝特相关的转化医学

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100 项与苯扎贝特相关的专利（医药）

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1,801

项与苯扎贝特相关的文献（医药）

2024-11-01·ZEITSCHRIFT FUR GASTROENTEROLOGIE

Sub-optimal therapy of patients with primary biliary cholangitis (PBC) in the real-life stetting of the German PBC cohort

Article

作者: Müller, Tobias ; Hinz, Matthias ; Dikopoulos, Nektarios ; Kremer, Andreas E. ; Roeb, Elke ; Wiegand, Johannes ; Schattenberg, Jörn M. ; Reuken, Philipp A. ; Denk, Gerald ; Muche, Marion ; Greinert, Robin ; Tacke, Frank ; Michl, Patrick ; Bantel, Heike ; Grümmer, Harald ; Stein, Kerstin ; Piotrowski, Katja ; Trebicka, Jonel ; Naumann, Uwe ; Weber, Andreas ; Teufel, Andreas ; Böttler, Tobias ; Behrens, Rüdiger ; Ringelhan, Marc ; Hofmann, Wolf Peter ; Simon, Karl-Georg ; Berg, Christoph ; Sarrazin, Christoph ; Kautz, Achim ; Günther, Rainer ; Franke, Annegret ; Berg, Thomas ; Keitel, Verena ; Marquardt, Jens U. ; Köppe-Bauernfeind, Nicole ; Wissniowski, Thaddäus Till ; Zeuzem, Stefan ; Trautwein, Christian

Abstract:

Real-world data on the management of patients with primary biliary cholangitis (PBC) are so far scarce in Germany. Therefore, we aimed to establish a nationwide registry and describe the clinical characteristics and therapy of PBC patients.Three different cohorts defined as ursodeoxycholic acid (UDCA) responders, as inadequate responders according to Paris II criteria, and as newly diagnosed patients were prospectively recruited.This manuscript includes the baseline data of the project.In total, 33/77 (43%) contacted centres (58% of university hospitals, 38% of non-university hospitals, and 24% of private practices) recruited 515 patients including 204 UDCA responders, 221 inadequate responders to UDCA, and 90 newly diagnosed patients.All patients were treated with UDCA; however, a UDCA dosage below the recommended dosage of 13 mg/kg/d was observed in 38.5% of individuals after 12 months of treatment. UDCA dosages were lower in nonacademic compared to academic centres.Only 75/219 (38.5%) of inadequate responders to UDCA received a second-line therapy with obeticholic acid (OCA) and/or bezafibrate (BZF). OCA (13% vs. 4.5%) and BZF (14% vs. 6.5%) were significantly more often prescribed by academic vs. nonacademic centres.Pruritus (27% vs. 15.5%), fatigue (23% vs. 4.5%), and sicca syndrome (14% vs. 1%) were significantly more often reported by academic centres.The German PBC registry could be established, which indicates suboptimal therapy in a relevant proportion of patients and shows significant differences between academic and nonacademic centres. Results are fundamental to improving clinical management at different levels of care.

2024-11-01·INTERNATIONAL JOURNAL OF PHARMACEUTICS

Fabrication of osmotic pump tablets utilizing semisolid extrusion three-dimensional printing technology

Article

作者: Wang, Xiangyu ; Ji, Yang ; Fang, Dongyang ; Chen, Hao ; Gong, Ye ; Pan, Hao

The utilization of three-dimensional (3D) printing technology is prevalent in the fabrication of oral sustained release preparations; however, there is a lack of research on 3D-printed osmotic pump tablets. A 3D-printed core-shell structure bezafibrate osmotic pump tablet was developed based on the characteristics of rapid absorption and short half-life of bezafibrate, utilizing semisolid extrusion (SSE) 3D printing technology. First, the properties of different shell materials were investigated to define the composition of the shell, and ultimately, the optimal formulation was found to be ethyl cellulose:cellulose acetate:polyethylene glycol = 2:1:2. The formulation of the tablet core was defined based on the printing performance and release behavior. The formulation consisted of bezafibrate, lactis anhydrous, sodium bicarbonate, sodium alginate, polyethylene oxide and sodium dodecyl sulfate at a ratio of 400:400:300:80:50:50. The tablet was capable of achieving zero-order release. The physicochemical properties were also characterized. The pharmacokinetic data analysis indicated that there were no statistically significant differences in the pharmacokinetic parameters between the 3D-printed tablets and the reference listed drugs. There was a strong correlation between the in vitro and in vivo results for the 3D-printed tablets. The results showed that SSE printing is a practical approach for manufacturing osmotic pump tablets.

2024-10-15·Aging-US

Bezafibrate mitigates cardiac injury against coronary microembolization by preventing activation of p38 MAPK/NF-κB signaling

Article

作者: Wang, Wenfang ; Liu, Ruijie ; Li, Wenfeng

Coronary microembolization (CME)-induced inflammatory response and cardiomyocyte apoptosis are the main contributors to CME-associated myocardial dysfunction. Bezafibrate, a peroxisome proliferator-activated receptors (PPARs) agonist, has displayed various benefits in different types of diseases. However, it is unknown whether Bezafibrate possesses a protective effect in myocardial dysfunction against CME. In this study, we aimed to investigate the pharmacological function of Bezafibrate in CME-induced insults in myocardial injury and progressive cardiac dysfunction and explore the underlying mechanism. A CME model was established in rats, and cardiac function was detected. The levels of injury biomarkers in serum including CK-MB, AST, and LDH were determined using commercial kits, and pro-inflammatory mediators including TNF-α and IL-6 were detected using ELISA kits. Our results indicate that Bezafibrate improved cardiac function after CME induction. Bezafibrate reduced the release of myocardial injury indicators such as CK-MB, AST, and LDH in CME rats. We also found that Bezafibrate ameliorated oxidative stress by increasing the levels of the antioxidant GPx and the activity of SOD and reducing the levels of TBARS and the activity of NOX. Bezafibrate inhibited the expression of pro-inflammatory cytokines such as TNF-α and IL-6. Importantly, Bezafibrate was found to mitigate CME-induced myocardial apoptosis by increasing the expression of Bcl-2 and reducing the levels of Bax and cleaved caspase-3. Mechanistically, Bezafibrate could prevent the activation of p38 MAPK/NF-κB signaling. These findings suggest that Bezafibrate may be a candidate therapeutic agent for cardioprotection against CME in clinical applications.

项与苯扎贝特相关的新闻（医药）

2024-10-02

·PRNewswire

Ipsen's IQIRVO Approval Has Intensified the Primary Biliary Cholangitis Market Space | DelveInsight

The European Commission has granted conditional approval for Ipsen's IQIRVO (elafibranor) for the treatment of primary biliary cholangitis in adults, marking the first new therapy for this condition to be approved in the EU in almost ten years. With this approval, other companies such as CymaBay Therapeutics, Zydus Therapeutics, GlaxoSmithKline, and others also geared up to bring their candidates into the primary biliary cholangitis market. LAS VEGAS, Oct. 2, 2024 /PRNewswire/ -- Primary biliary cholangitis (PBC), previously referred to as primary biliary cirrhosis, is a long-term liver condition characterized by the gradual destruction of the small bile ducts within the liver, known as intrahepatic bile ducts. Over time, prolonged bile flow obstruction can result in cirrhosis and the development of portal hypertension. As per DelveInsight analysis, in 2023, the total diagnosed prevalent cases of primary biliary cholangitis in the 7MM were approximately 298K. These cases are projected to increase further during the forecast period (2024–2034). In 2023, the United States had the highest proportion of diagnosed prevalent cases of primary biliary cholangitis among the 7MM, comprising approximately 48% of the total cases. DelveInsight's epidemiology model for primary biliary cholangitis estimates a higher prevalence among females across the 7MM. Specifically, in the US in 2023, it suggests approximately 25K cases among males and 117K cases among females, indicating a female predominance. The primary treatment objectives are to reduce the progression rate of the disease and manage symptoms such as itching, osteoporosis, and dry eye/mouth (sicca syndrome). Liver transplantation remains the only life-saving option. Ursodeoxycholic acid (UDCA) is the main medication used to slow disease progression. Patients in the early stages often experience clinical, biochemical, and histological improvements. Studies suggest UDCA postpones the need for liver transplantation and extends survival, though its effectiveness in advanced stages like cirrhosis is uncertain. While initially approved by the US FDA for treating primary biliary cholangitis, UDCA now has generic versions available. The use of corticosteroids in patients without signs of autoimmune hepatitis remains a subject of ongoing research. Studies have shown that combining UDCA with dexamethasone can enhance the activity of the anion exchanger from two alternate promoters in liver cells in vitro. Budesonide is being considered due to its extensive first-pass hepatic metabolism, which may help minimize side effects. Corticosteroids may help relieve symptoms and improve biochemical and histological outcomes, though corticosteroid-induced osteoporosis is a major concern. The criteria for liver transplantation in patients with primary biliary cholangitis are generally the same as those for other chronic liver diseases. However, severe and unmanageable itching is a unique reason for considering a transplant. Fatigue, which may continue after transplantation, is not regarded as an indication for the procedure. Liver transplantation for PBC patients typically offers a better prognosis than for most other chronic liver diseases, with a 5-year survival rate of 84–87% and a 10-year survival rate of 79–84%. In May 2016, the US FDA granted accelerated approval for OCALIVA (obeticholic acid) as a treatment for primary biliary cholangitis. It is approved for use alongside UDCA in adults who do not respond adequately to UDCA, or as a standalone treatment for those who cannot tolerate UDCA. OCALIVA is a semi-synthetic bile acid analog with the chemical structure 6α-ethyl-chenodeoxycholic acid. OCALIVA remains the only approved second-line therapy for this condition. Later, in December 2016, the European Commission gave conditional approval for OCALIVA for the same uses—either in combination with UDCA or as monotherapy for adults unable to tolerate UDCA. Learn more about the FDA-approved primary biliary cholangitis drugs @ Drugs for Primary Biliary Cholangitis Treatment Recently, the European Commission has granted conditional approval for IQIRVO (elafibranor) 80mg tablets for treating primary biliary cholangitis. It can be used alongside ursodeoxycholic acid in adults who have an inadequate response to UDCA or as a standalone therapy for those who cannot tolerate UDCA. This decision follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on July 26, 2024, and the US FDA's Accelerated Approval granted on June 10, 2024. Elafibranor, a pioneering molecule, has been marketed and commercialized in the US by Ipsen under the brand name IQIRVO since June 2024. It was originally developed by GENFIT, from its discovery through the completion of a 52-week Phase III clinical trial. In 2021, Ipsen obtained exclusive global rights to elafibranor, except for China, Hong Kong, Taiwan, and Macau, through a licensing agreement with GENFIT. The EU approval was based on favorable outcomes from the Phase III ELATIVE trial, which demonstrated a 47% clinical benefit of IQIRVO combined with UDCA compared to placebo plus UDCA on the composite primary endpoint. The main objective for cholestasis response was defined as alkaline phosphatase (ALP) being less than 1.67 times the upper limit of normal (ULN), with a ≥15% reduction in ALP and total bilirubin levels within the normal range after one year. Additionally, the treatment showed a reduction in pruritus when compared to placebo. Additionally, in August 2024, Gilead Sciences, Inc. announced that the FDA has granted accelerated approval for LIVDELZI (seladelpar) to treat primary biliary cholangitis. This treatment can be used alongside ursodeoxycholic acid in adults who have not responded adequately to UDCA or as a standalone therapy for those unable to tolerate UDCA. Livdelzi is not advised for patients with or who develop decompensated cirrhosis. Seladelpar (MBX-8025) is a potent and selective PPARδ agonist, administered orally, and is currently being developed for patients with PBC who either do not respond to or cannot tolerate UDCA. In March 2024, Gilead Sciences completed its acquisition of CymaBay and announced the validation of a Marketing Authorization Application (MAA) for Seladelpar by the European Medicines Agency (EMA). Seladelpar has been granted Breakthrough Therapy Designation (BTD) by the US FDA, PRIME status by the EMA, and Orphan Drug Designation (ODD) from both agencies, which may accelerate the approval process. To know more about primary biliary cholangitis treatment options, visit @ New Treatment for Primary Biliary Cholangitis With this approval, several companies have also geared up to bring their lead assets into the market. The expected launch of emerging therapies, such as Saroglitazar Magnesium (Zydus Therapeutics), Linerixibat (GlaxoSmithKline), Setanaxib (Calliditas Therapeutics AB), Bezafibrate + obeticholic acid (Intercept Pharmaceuticals/Alfasigma), Volixibat (Mirum Pharmaceuticals), EP547 (Escient Pharmaceuticals), and others are expected to create a positive impact on the market. Other therapies in the early stages of the trial are also being developed. Discover which therapies are expected to grab major primary biliary cholangitis market share @ Primary Biliary Cholangitis Market Report Saroglitazar (LIPAGLYN) comprises two primary types of PPAR agonists: PPARα (alpha) and PPARγ (gamma). This medication simultaneously reduces lipid and glucose levels, effectively decreasing elevated triglycerides and blood sugar while enhancing insulin sensitivity. The US FDA has awarded Saroglitazar orphan drug designation (ODD) and fast track designation (FTD) for primary biliary cholangitis (PBC). It is presently undergoing Phase II/III trials for this condition. Linerixibat (GSK2330672) is a medication under development for patients with primary biliary cholangitis who suffer from itching. It is a small molecule inhibitor of the ileal bile acid transporter (IBAT) that is minimally absorbed and taken as an oral tablet. By preventing the reabsorption of bile acids in the small intestine, linerixibat lowers the levels of pruritic bile acids in the bloodstream. In 2019, the FDA designated it as an orphan drug (ODD). It is currently being evaluated in a Phase III trial for treating cholestatic pruritus in individuals with PBC. Discover more about drugs for primary biliary cholangitis in development @ Primary Biliary Cholangitis Clinical Trials The anticipated launch of these emerging therapies for primary biliary cholangitis are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the primary biliary cholangitis market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the primary biliary cholangitis market saw a significant emergence of a dominant treatment modality, valued at USD 1.1 billion in the 7MM. This modality likely reflects advancements in therapeutic approaches such as first-line agents like UDCA, second-line treatments like obeticholic acid, and potentially emerging biologics or combination therapies aiming to address the complex pathophysiology of PBC, thus enhancing patient outcomes and market share. DelveInsight's latest published market report titled as Primary Biliary Cholangitis Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the primary biliary cholangitis country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The primary biliary cholangitis market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent cases of Primary Biliary Cholangitis Gender-specific Diagnosed Prevalent cases of Primary Biliary Cholangitis Age-specific Diagnosed Prevalent cases of Primary Biliary Cholangitis The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM primary biliary cholangitis market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis up to 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this primary biliary cholangitis market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the primary biliary cholangitis market. Also, stay abreast of the mitigating factors to improve your market position in the primary biliary cholangitis therapeutic space. Related Reports Primary Biliary Cholangitis Pipeline Primary Biliary Cholangitis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key PBC companies, including Genfit, Zydus Discovery, Ohara Pharmaceutical, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Novartis, CymaBay Therapeutics, among others. Primary Biliary Cholangitis Epidemiology Forecast Primary Biliary Cholangitis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and PBC epidemiology trends. Liver Cirrhosis Market Liver Cirrhosis Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key liver cirrhosis companies, including Madrigal Pharmaceuticals, Inc., Galectin Therapeutics Inc., Grifols Therapeutics LLC, CymaBay Therapeutics, Akero Therapeutics, Inc., NGM Biopharmaceuticals, Inc., Gilead Sciences, Novo Nordisk A/S, Cellaion, Promethera Therapeutics, Lipocine Inc., Bristol Myers Squibb, Prism Pharma, Ohara Pharmaceutical, Shionogi, among others. Liver Cirrhosis Pipeline Liver Cirrhosis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key liver cirrhosis companies, including Versantis AG, Mirum Pharmaceuticals, Sagimet Biosciences, TenNor Therapeutics, Prism Pharma, Vedanta Biosciences, Intercept Pharmaceuticals, Boehringer Ingelheim, Ohara Pharmaceutical, Ocelot Bio, Calliditas Therapeutics, Galecto Biotech, Pharmicell, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床3期上市批准孤儿药临床结果突破性疗法

2024-08-22

·米内网

中药龙头发威！2个独家品种涨逾100%，25款1类新药来势汹汹，10款新药冲线在即

精彩内容日前，天士力开发的创新药注射用重组人尿激酶原新适应症报产。作为国内现代中药龙头企业，天士力坚持创新驱动，目前有16款中药新药、13款化药/生物药新药步入临床阶段，其中有10款已处于III期临床及以上阶段，上市可期；仿制药方面，22个品种过评/视同过评，8个品种以新分类申报在审（3个暂无首仿）。手握22个独家品种！2个中成药涨超100% 以中药产品起家的天士力成立于1994年，2002年8月在上海证券所挂牌上市。通过多年布局，公司围绕心脑血管、消化代谢、抗肿瘤三大治疗领域，构建涵盖现代中药、化学药及生物药的完善的多层次的产品组合，并快速推进研发创新转型。米内网数据显示，目前国内仅天士力拥有生产批文的品种有22个（以药品名称计，不含原料药），涉及17个中成药，4个化学药以及1个生物药，涵盖心脑血管系统、消化系统、呼吸系统、妇科、儿科等多个治疗领域。国内仅天士力拥有批文的品种注：标*为国家医保品种来源：米内网中国上市药品（MID）数据库天士力以复方丹参滴丸带动了养血清脑颗粒（丸）、芪参益气滴丸、注射用益气复脉、注射用丹参多酚酸等系列独家品种，构建了以心脑血管用药为主的现代中药大药体系。米内网数据显示，近年来在中国三大终端六大市场（统计范围详见本文末）在心脑血管中成药厂家排名中，天士力均名列前茅。在呼吸系统中成药领域，天士力拥有3款独家品种，其中穿心莲内酯滴丸、痰咳净滴丸2024第一季度在中国零售药店终端（城市实体药店+网上药店）的销售额增速均超过100%。作为国内现代中药龙头企业，近年来天士力产品管线逐渐步入收获期。近五年来（2019-2023年），公司有芍麻止痉颗粒、坤心宁颗粒2款中药1类新药（按新版中药注册管理办法，下同）获批生产，安体威颗粒、九味化斑丸、芪苓温肾消囊颗粒3款中药1类新药以及TSL-0319胶囊、JS1-1-01片、TSL-1806胶囊、B1962注射液、重组抗EGFR全人单克隆抗体注射液、培重组人成纤维细胞生长因子21注射液6款化药/生物药1类新药获批临床，复方丹参滴丸、芪参益气滴丸新适应症获批临床；此外，他达拉非片、吉非替尼片、米诺膦酸片、苯扎贝特缓释片、注射用替莫唑胺、盐酸美金刚缓释胶囊、注射用硼替佐米、注射用尼可地尔、利伐沙班片9个品种获批生产并视同过评，其中米诺膦酸片、苯扎贝特缓释片为首仿+首家过评。 2024年以来，天士力研发进展不断：中药新药方面，枇杷清肺饮颗粒、温经汤颗粒2款3.1类新药（古代经典名方中药复方制剂）提交NDA，其中枇杷清肺饮颗粒为国内首家；注射用重组人尿激酶原新适应症提交NDA，推测适应症为急性缺血性脑卒中。化学药方面，1类新药人脐带间充质干细胞注射液获批临床；盐酸达泊西汀片获批生产并视同过评，碳酸司维拉姆片、米诺地尔搽剂、硫酸氨基葡萄糖胶囊3个品种以新分类报产；富马酸酮替芬片、尼可地尔片2个品种通过一致性评价，注射用盐酸地尔硫卓提交一致性评价补充申请。猛攻3大千亿市场！10款新药上市可期近年来，天士力坚定实施创新驱动战略，持续加大研发投入。2023年公司研发投入13.15亿元，同比增长29.49%，占医药工业收入比例为17.73%。2024年第一季度研发费用（不含资本化投入）接近2亿元，同比增长超过20%。通过多年布局，天士力围绕心脑血管、消化代谢、抗肿瘤三大治疗领域，稳步推动现代中药、生物药、化学药研发进展。米内网数据显示，2023年中国三大终端六大市场心脑血管（化药+生物药+中成药）、消化代谢（化药+生物药+中成药）、肿瘤免疫（化药+生物药+中成药）3大类药物销售额合计均超过2000亿元。目前天士力有29款新药（不含已有批文品种开展新适应症，不含终止或暂停临床品种）在国内处于获批临床及以上阶段。从药物类型看，16款为中成药，8款为治疗用生物制品，5款为化学药；从注册分类看（按新版药品注册管理办法），1类新药有25款，2类改良型新药有2款，古代经典名方中药复方制剂有2款。天士力国内在研新药来源：米内网综合数据库在中药新药方面，古代经典名方中药复方制剂枇杷清肺饮颗粒及温经汤颗粒均已申报上市，安神滴丸（失眠症）、脊痛宁片（脊柱关节炎）、青术颗粒（原发性急性痛风性关节炎）、安体威颗粒（风寒感冒）、香橘乳癖宁胶囊（乳腺增生）、苏苏小儿止咳颗粒（儿童感冒咳嗽）、连夏消痞颗粒（功能性消化不良）均处于III期临床试验阶段，上市可期。在化学药及生物药新药方面，PXT3003治疗腓骨肌萎缩症已完成III期全部病例入组，上市可期。此外，安美木单抗（EGFR单抗）、TSL-1502胶囊（PARP抑制剂）、TG1050、JS1-1-01片已处于II期临床试验阶段。仿制药方面，截至目前，天士力有21个品种过评/视同过评，其中7个为首家过评，米诺膦酸片、苯扎贝特缓释片为国内首仿，且目前仍为独家品种。国采方面，公司有5个品种中选，他达拉非片、吲达帕胺片、注射用替莫唑胺等品种在国采落地执行后市场份额攀升。天士力已过评品种注：带*为首家/独家过评，加粗为国采中标来源：米内网一致性评价进度数据库目前天士力还有8个品种以新分类申报在审（含联合申报），其中巴氯芬口服溶液、酒石酸匹莫范色林胶囊、左舒必利片暂无国产仿制药获批，盐酸丙卡特罗口服溶液仅3家企业拥有生产批文。天士力新分类申报且在审的品种来源：米内网中国申报进度（MED）数据库强强联合！天士力易主华润变身国企 8月4日晚间，天士力公告称，公司控股股东天士力集团及其一致行动人，拟通过协议转让的方式，向华润三九转让所持有天士力28%的股份，转让总价为62.12亿元。同时，天士力集团拟通过协议转让的方式，向国新投资转让其所持有天士力5%的股份，转让总价为11.09亿元。交易完成后，天士力控股股东将由天士力集团变更为华润三九，实际控制人将变更为中国华润。 8月5日，天士力复牌，开盘涨停，收涨5.68%，这是资本市场对此次交易的积极反应。有业内人士表示，中药作为我国独特的医疗资源，具有悠久的历史和丰富的临床经验，天士力作为一家以中药为主的企业，与华润三九有着良好的合作基础，这使得华润医药能够进一步扩大其在中药领域的市场份额和影响力。在公告中，华润三九明确表示，此次交易有利于其加快补充创新中药管线，持续深耕中药全流程开发体系，且交易双方也将因此发挥中药产业链协同效应，在中药材种植、创新研发、智能制造、渠道营销等领域相互赋能，增强全产业链核心竞争力。对于天士力来说，公司拥有多个独家品种，在医院端和学术营销方面具有一定优势，而华润三九在医药制造和商业领域处于行业领先地位，双方战略布局优势互补，产业链协同效应有望显现，推进新产品上市和研发成果市场化进程。同时，与国新投资的合作将优化资源配置，有望推动拓宽创新中药管线布局。近年来，国资入主民营中药企业的情况并不鲜见，目前中药上市公司市值TOP10中，高达70%的企业具有国资背景，包括片仔癀、云南白药、华润三九、同仁堂、白云山、东阿阿胶等。在业内看来，一方面，近年来国家出台了系列利好中医药发展的政策，中医药产业的战略价值不断提升；另一方面，中医药企业因国家保护品种、保密配方、老字号、专利等因素具备相当高的进入门槛，其本身掌握着一些稀缺资源，构建了强大的竞争力；此外，中医药产品生命周期长，有些还具有消费品特性，经营波动性小，更易受到偏好稳健的国资青睐。资料来源：米内网数据库、公司公告等注：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8月21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

申请上市临床3期上市批准

2024-07-26

·FierceBiotech

Calliditas' liver disease trial hits primary endpoint after sweeping changes to design

Calliditas Therapeutics’ press release lacks details of the next steps for setanaxib in primary biliary cholangitis. Calliditas Therapeutics’ slimmed-down, truncated and rethought primary biliary cholangitis (PBC) drug has hit its primary endpoint. But the biotech, which changed the midphase trial to cut costs, only saw a positive trend on liver stiffness and reported a higher rate of treatment-related dropouts on the study drug.The Stockholm-based biotech set out in 2021 to enroll more than 300 patients in a 52-week phase 2b/3 trial. Management rethought the study late last year, dropping the phase 3 part, cutting the enrollment target to 70 and the duration to 24 weeks and switching the primary endpoint to reduction in the liver enzyme ALP. Calliditas made the changes to reduce its R&D costs for the trial for 2024 and 2025.This morning, Calliditas reported that the study met its revised primary endpoint. The trial ultimately compared two doses of setanaxib to placebo in 76 patients with PBC and elevated liver stiffness. More than 40% of participants took ursodeoxycholic acid and either Intercept Pharmaceuticals’ Ocaliva or the PPAR agonist bezafibrate during the study. Thirteen percent of subjects were on all three drugs.From baseline, Calliditas tracked improvements in ALP of 19% on the high dose and 14% on the low dose. The biotech said the changes in ALP, a liver enzyme that is raised in PBC patients, were statistically significant versus placebo at both doses. Calliditas named liver stiffness and fatigue as the two other measures to look out for on an earnings call in May. The biotech reported “positive trends on liver stiffness” in the phase 2 readout. The top-line data release makes no mention of fatigue.Setanaxib was generally well tolerated, according to Calliditas, with similar rates of treatment emergent adverse events (TEAEs) in the placebo and treatment cohorts. The frequency of TEAEs leading to study discontinuation was higher in patients receiving setanaxib compared to placebo.Calliditas’ press release lacks details of the next steps for setanaxib in PBC. The biotech did highlight two upcoming readouts in other indications. A phase 2, investigator-led idiopathic pulmonary fibrosis trial is scheduled to report results around the end of the year. Calliditas’ phase 2 Alport syndrome study is set to deliver data in 2025.The studies form part of a multifront R&D program that has seen setanaxib tested in a range of settings including head and neck cancer. The breadth of the program reflects Calliditas’ belief that the potential anti-fibrotic effects of setanaxib have applications in a range of indications.

临床2期临床结果临床3期临床失败

100 项与苯扎贝特相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01366	苯扎贝特	C10AB02	DB01393

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
高脂血症	日本	Kissei Pharmaceutical Co., Ltd.	1991-03-15
高胆固醇血症	日本	Nipro Corp.	1978-01-01
家族性混合型高脂血症	日本	Nipro Corp.	1978-01-01
高甘油三酯血症	日本	Nipro Corp.	1978-01-01

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
原发性胆汁性胆管炎	临床3期	美国	Intercept Pharmaceuticals, Inc.	2024-07-01
原发性胆汁性胆管炎	临床3期	阿根廷	Intercept Pharmaceuticals, Inc.	2024-07-01
原发性胆汁性胆管炎	临床3期	澳大利亚	Intercept Pharmaceuticals, Inc.	2024-07-01
原发性胆汁性胆管炎	临床3期	比利时	Intercept Pharmaceuticals, Inc.	2024-07-01
原发性胆汁性胆管炎	临床3期	加拿大	Intercept Pharmaceuticals, Inc.	2024-07-01
原发性胆汁性胆管炎	临床3期	克罗地亚	Intercept Pharmaceuticals, Inc.	2024-07-01
原发性胆汁性胆管炎	临床3期	捷克	Intercept Pharmaceuticals, Inc.	2024-07-01
原发性胆汁性胆管炎	临床3期	爱沙尼亚	Intercept Pharmaceuticals, Inc.	2024-07-01
原发性胆汁性胆管炎	临床3期	法国	Intercept Pharmaceuticals, Inc.	2024-07-01
原发性胆汁性胆管炎	临床3期	德国	Intercept Pharmaceuticals, Inc.	2024-07-01

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临床结果

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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


NCT04594694 (747-213, GlobeNewswire) 人工标引	临床2期	原发性胆汁性胆管炎	75	bezafibrate 400 mg SR + OCA 5 mg titrated to 10 mg at week 4	蓋廠齋齋鹹齋簾襯願積(廠憲鹽糧簾鹽鹽願衊齋) = 夢簾顧鏇艱齋鏇夢糧蓋構醖鹹網築網構憲遞壓 (餘夢構繭鏇糧鹹製鬱夢 ) 更多	积极	2024-05-18
				bezafibrate 200 mg IR + OCA 5 mg titrated to 10 mg at week 4	蓋廠齋齋鹹齋簾襯願積(廠憲鹽糧簾鹽鹽願衊齋) = 憲構淵齋淵襯鹹鏇廠鬱構醖鹹網築網構憲遞壓 (餘夢構繭鏇糧鹹製鬱夢 ) 更多
NCT02548832 (CTgov)	临床3期	家族性混合型高脂血症	36	Berberine (Berberine)	衊顧壓衊鏇膚鏇壓鏇窪(鹽觸簾網積蓋選蓋醖鹹) = 膚鹹積簾餘醖襯糧選壓鬱鹹鹹顧遞醖鹽願積廠 (艱夢獵衊鹹獵顧夢膚衊, 願獵廠繭餘鑰膚鏇餘淵 ~ 積糧膚鑰範膚鏇遞構夢) 更多	-	2023-02-24
				Bezafibrate (Bezafibrate)	衊顧壓衊鏇膚鏇壓鏇窪(鹽觸簾網積蓋選蓋醖鹹) = 遞積壓鬱網構窪齋遞鬱鬱鹹鹹顧遞醖鹽願積廠 (艱夢獵衊鹹獵顧夢膚衊, 鏇襯壓願獵簾獵廠餘膚 ~ 憲壓選願憲膚醖鹽獵窪) 更多
Japan PBC Study Group (EASL2022)	N/A	albumin \| bilirubin	889	Bezafibrate and Ursodeoxycholic Acid	鹹範蓋範鑰窪簾鑰選膚(膚襯築艱襯鹽網遞製觸) = 膚壓衊鹽願簾製膚鹽觸繭製積醖鑰蓋衊夢網鬱 (選鑰範廠鹹齋鏇鏇鬱鏇 )	不佳	2022-06-23
WCLC2021	N/A	非小细胞肺癌	-	Fibrates	廠顧鑰齋積糧簾築鬱窪(餘製鹽齋醖願壓遞鏇積): HR = 0.86 (95% CI, 0.75 ~ 0.99), P-Value = 0.042	-	2021-09-08
				No Fibrates
EASD2020	N/A	葡萄糖耐受不良	-	Bezafibrate 400 mg/die	構願獵範衊範製膚淵選(艱鬱觸廠鹹廠廠衊鬱築) = 壓築顧觸窪遞顧獵繭齋選鏇蓋淵夢餘膚窪窪醖 (鑰願蓋艱構鬱選觸遞夢 ) 更多	-	2020-09-22
EASL2020	N/A	原发性胆汁性胆管炎追加	-	UDCA monotherapy	繭膚壓觸獵鏇築獵壓廠(夢廠壓顧積膚衊壓構繭): aHR = 0.52 (95% CI, 0.43 ~ 0.63), P-Value = < 0.0001 更多	-	2020-08-27
				UDCA and BZF combination therapy
NCT02984982 (ODYSSEY J-IVUS, CTgov)	临床4期	急性冠状动脉综合征 \| 冠心病 \| 高胆固醇血症	206	Antiplatelets+Atorvastatin+Rosuvastatin+Bezafibrate+Ezetimibe+Anticoagulants (Standard of Care)	夢鬱糧衊簾選醖積簾糧(醖夢夢範繭鑰觸網憲願) = 壓願壓遞窪夢餘廠壓蓋廠夢繭蓋網壓醖夢廠顧 (艱夢鹹衊鏇夢艱觸積簾, 醖遞壓願簾選築膚醖願 ~ 鏇廠鬱鹽選艱憲淵鹽鬱) 更多	-	2019-09-09
				Antiplatelets+Atorvastatin+Rosuvastatin+Alirocumab SAR236553+Bezafibrate+Ezetimibe+Anticoagulants (Alirocumab)	夢鬱糧衊簾選醖積簾糧(醖夢夢範繭鑰觸網憲願) = 夢齋衊觸獵齋鏇獵襯簾廠夢繭蓋網壓醖夢廠顧 (艱夢鹹衊鏇夢艱觸積簾, 膚繭鑰糧鬱窪醖鏇鹽廠 ~ 襯鏇膚觸鹹繭獵憲築壓) 更多
POISE (EASL2019)	N/A	原发性胆汁性胆管炎	16	Obeticholic acid	積繭鑰糧襯築鬱簾繭網(蓋積遞鹽鹹獵構積齋遞) = 廠醖淵繭積願繭鑰鬱選夢範窪壓夢製夢壓餘鬱 (淵鏇餘鬱夢壓壓範蓋鏇, 275.0 ~ 408.4) 更多	积极	2019-04-13
				Bezafibrate	積繭鑰糧襯築鬱簾繭網(蓋積遞鹽鹹獵構積齋遞) = 願鏇鏇網糧積廠糧膚簾夢範窪壓夢製夢壓餘鬱 (淵鏇餘鬱夢壓壓範蓋鏇, 275.0 ~ 408.4) 更多
EASL2019	N/A	原发性胆汁性胆管炎	54	UDCA	餘夢衊膚範簾築淵壓構(醖艱鹽廠餘積廠顧夢餘) = 齋獵積範鹹齋積衊獵糧夢獵願願網壓膚願廠範 (淵鏇夢範積窪鏇憲艱觸 ) 更多	不佳	2019-04-12
				Bezafibrate	餘夢衊膚範簾築淵壓構(醖艱鹽廠餘積廠顧夢餘) = 夢糧鑰網鹽窪顧餘醖遞夢獵願願網壓膚願廠範 (淵鏇夢範積窪鏇憲艱觸 ) 更多
EASL2019	N/A	原发性胆汁性胆管炎一线	307	Bezafibrate + Ursodeoxycholic acid	選夢壓鏇顧網蓋蓋夢廠(顧壓選蓋糧鑰遞糧醖鏇) = 築積範憲鏇醖製廠獵觸醖積築網鹹願構繭醖觸 (憲衊鬱鬱蓋廠廠鏇獵鹽, 309 ~ 141)	-	2019-04-12