A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Dose Phase 2 Study to Evaluate the Efficacy and Safety of BMS-986263 in Adults With Compensated Cirrhosis From Nonalcoholic Steatohepatitis (NASH)

The purpose of this randomized study is to assess safety and effectiveness of BMS-986263 in adults with compensated cirrhosis (chronic liver disease) from nonalcoholic steatohepatitis (fatty liver disease) (NASH).

开始日期2021-03-17

申办/合作机构

Bristol Myers Squibb Co.

NCT04225936

/ Completed临床1期

An Open-label, Two-Part, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986263 in Participants With Varying Degrees of Hepatic Impairment

The primary purpose of this study is to evaluate the effect of liver impairment on the safety and pharmacokinetics (PK) of BMS-986263

开始日期2020-01-16

申办/合作机构

Bristol Myers Squibb Co.

NCT03538301

/ Completed临床2期

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Biological Activity, and PK of ND-L02-s0201 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

A phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, biological activity, and pharmacokinetics (PK) of ND-L02-s0201 for Injection in subjects with IPF.

开始日期2018-06-18

申办/合作机构

日东电工株式会社

100 项与 BMS-986263 相关的临床结果

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100 项与 BMS-986263 相关的转化医学

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100 项与 BMS-986263 相关的专利（医药）

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项与 BMS-986263 相关的文献（医药）

2023-10-01·Clinical and translational science

Pharmacokinetics, safety, and tolerability of BMS-986263, a lipid nanoparticle containing HSP47 siRNA, in participants with hepatic impairment.

Article

作者: de Oliveira, Claudia H M C ; Cizza, Giovanni ; Tirucherai, Giridhar S ; Lawitz, Eric J ; Charles, Edgar D ; Wetherington, Jeffrey ; Qosa, Hisham ; Colletti, Nicholas

BMS-986263 is a retinoid-conjugated lipid nanoparticle delivering small interfering RNA designed to inhibit synthesis of HSP47 protein, a collagen-specific chaperone protein involved in fibrosis development. This is a phase I, open-label, two-part study evaluating pharmacokinetics and safety of BMS-986263 in participants with hepatic impairment (HI). Part 1 (n = 24) of this study enrolled two cohorts with mild and moderate HI and a separate cohort of age- and body mass index (BMI)-matched participants with normal hepatic function. Part 2 enrolled eight participants with severe HI and eight age- and BMI-matched participants with normal hepatic function. All participants received a single intravenous 90 mg BMS-986263 infusion. Compared with normal-matched participants, geometric mean area under the plasma concentration-time curve time zero to the time of the last quantifiable concentration (AUC_(0-T) ) and AUC from zero to infinity (AUC_(INF) ) of HSP47 siRNA were similar in participants with mild HI and 34% and 163% greater in those with moderate and severe HI, respectively, whereas the maximum plasma concentration was ~25% lower in mild and moderate HI groups but 58% higher in the severe HI group than in the normal group. Adverse events were reported by two of eight, four of eight, and three of eight participants with mild, moderate, or severe HI, respectively; none were reported in the normal-matched group. Overall, single-dose BMS-986263 was generally safe and well-tolerated and dose adjustment is not considered necessary for participants with mild or moderate HI. Although available data do not indicate that dose adjustment should be performed in patients with severe HI; the optimal posology of BMS-986263 in patients with severe HI may be determined later in its clinical development when additional data to establish exposure-safety/efficacy relationship becomes available.

2022-04-01·Hepatology1区 · 医学

BMS‐986263 in patients with advanced hepatic fibrosis: 36‐week results from a randomized, placebo‐controlled phase 2 trial

1区 · 医学

Article

作者: Kavita, Uma ; Lawitz, Eric J. ; Charles, Edgar D. ; Shevell, Diane E. ; Tirucherai, Giridhar S. ; Karsdal, Morten ; Poordad, Fred ; Chen, Warner ; Coste, Angie ; Nielsen, Mette ; Goodman, Zachary ; Du, Shuyan

AbstractBackground and AimsHepatic fibrosis secondary to HCV infection can lead to cirrhosis and hepatic decompensation. Sustained virologic response (SVR) is possible with direct‐acting antiviral drug regimens; however, patients with advanced fibrosis have an increased risk for HCC. Heat shock protein 47 (HSP47), a key collagen chaperone, has been implicated in fibrosis development. We evaluated the efficacy and safety of BMS‐986263, a lipid nanoparticle delivering small interfering RNA designed to degrade HSP47 mRNA, for the treatment of advanced fibrosis.Approach and ResultsNCT03420768 was a Phase 2, randomized (1:1:2), placebo‐controlled trial conducted at a hepatology clinic in the United States. Patients with HCV‐SVR (for ≥ 1 year) and advanced fibrosis received once‐weekly i.v. infusions of placebo or BMS‐986263 (45 or 90 mg) for 12 weeks. The primary endpoint was ≥ 1 METAVIR stage improvement at Week 12; key secondary endpoints included Ishak score improvement, pharmacokinetics, fibrosis biomarkers, and safety. All 61 patients completed treatment, and 2/15 (13%, placebo), 3/18 (17%, 45 mg), and 6/28 (21%, 90 mg) had METAVIR improvements of ≥ 1 stage at Week 12. Five patients in the 90‐mg arm had Ishak improvements by ≥ 2 stages. BMS‐986263 plasma concentrations increased in a generally dose‐proportional fashion between BMS‐986263 doses, with no notable accumulation with weekly dosing. All adverse events (AEs) were mild or moderate in intensity; most treatment‐related AEs were infusion‐related reactions in the BMS‐986263 arms. At baseline, collagen levels were low, indicating low levels of fibrogenesis in these patients.ConclusionsIn patients with HCV‐SVR, BMS‐986263 administration was generally well tolerated through Week 36 and resulted in METAVIR and Ishak score improvements. Further evaluation of BMS‐986263 in patients with active fibrogenesis is warranted.

2021-04-01·ERJ Open Research

Anti-HSP47 siRNA lipid nanoparticle ND-L02-s0201 reverses interstitial pulmonary fibrosis in preclinical rat models

Article

作者: Liu, Yun ; Quimbo, Alistair ; Clamme, Jean-Pierre ; Zhang, Jun ; Liu, Jian ; Zabludoff, Sonya ; Yao, Jiping ; Xia, Fengcheng ; Ying, Wenbin

ND-L02-s0201 is a lipid nanoparticle encapsulating an siRNA which inhibits expression of heat shock protein 47 (HSP47), a collagen-specific chaperone. Accumulated evidence demonstrates a close association between increased level of HSP47 and excessive accumulation of collagen in fibrotic diseases. Our objective was to test ND-L02-s0201 efficacy in preclinical lung fibrosis models and characterise the downstream histological and functional consequences of inhibiting the expression of HSP47.Comprehensive optimisation and characterisation of bleomycin (BLM) and silica-induced rat lung fibrosis models were conducted, which ensured progressive pathological changes were sustained throughout the study during evaluation of the anti-fibrotic potential of ND-L02-s0201.In the BLM model, we demonstrated dose-dependent and statistically significant reduction in the relative lung weight, collagen deposition and histology, and fibrosis scores following ND-L02-s0201 treatment. Lung tissue mRNA profiling demonstrated that 11 out of 84 fibrosis-relevant genes were upregulated following BLM induction and were downregulated by approximately 4.5-fold following ND-L02-s0201 treatment. Epithelial–mesenchymal transition was characterised in the BLM model following ND-L02-s0201 treatment. Cell enrichment demonstrated that myofibroblasts contained the highest HSP47 mRNA expression. BLM led to more than a five-fold increase in myofibroblasts and ND-L02-s0201 treatment reduced the myofibroblasts to sham levels. Statistically significant improvement in lung function was noted in the BLM model which was determined by running endurance capacity using a 7-minute treadmill test. Comparable anti-fibrotic efficacy was also observed in the silica model.Results from two robust chronic rodent models of pulmonary fibrosis demonstrated significant anti-fibrotic effects and improved lung function which support the evaluation of ND-L02-s0201 in subjects with idiopathic pulmonary fibrosis.

项与 BMS-986263 相关的新闻（医药）

2024-01-03

·Pharmaceutical Technology

Boehringer reinforces interest in NASH with new $2bn deal

Boehringer will use Ribo’s RIBO-GalSTAR platform to identify and develop therapies for NASH. Credit: Michael Vi via Shutterstock. Boehringer Ingelheim is intensifying efforts to combat non-alcoholic steatohepatitis (NASH) through a new multi-target collaboration with Suzhou Ribo Life Science and Ribocure Pharmaceuticals (Ribo), where it plans to develop small interfering RNA (siRNA)-based treatments. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report. Go deeper with GlobalData Reports NPVM: Bristol-Myers Squibb Co's BMS-986263 Reports Non-Alcoholic Steatohepatitis - Epidemiology Forecast to 2029 Premium Insights The gold standard of business intelligence. Find out more Related Company Profiles Boehringer Ingelheim International GmbH Dicerna Pharmaceuticals Inc Novo Nordisk AS Zealand Pharma AS View all The agreement’s value is set to potentially exceed $2bn and will allow Boehringer to capitalise on Ribo’s RIBO-GalSTAR platform for targeted siRNA therapeutics in liver cells. This collaboration comes six years after Boehringer joined forces with Dicerna Pharmaceuticals to discover and develop new therapeutics using Dicerna’s GalXC technology platform, for the treatment of liver diseases including NASH. Under the terms of the deal, Dicerna received over $200m from Boehringer, including an upfront payment, and development and commercial milestone payments. In May 2021, Dicerna announced that an siRNA candidate called DCR-LIV2 conjugated with a hepatocyte-targeting ligand was accepted by Boehringer for development, but the latter company has not announced any updates on its progress since then. Later, in November 2021, Novo Nordisk acquired Dicerna in a $3.3bn transaction that gave Novo access to Dicerna’s RNAi platform. Earlier in 2017, Boehringer signed an agreement with MiNA Therapeutics, developing compounds to target NASH. At the time, MiNA received an upfront payment of $307m from Boehringer. As per GlobalData, MiNA has a small activating RNA (saRNA) therapeutic in the discovery stage for NASH. GlobalData is the parent company of Pharmaceutical Technology . NASH is a form of non-alcoholic fatty liver disease characterised by inflammation and liver cell damage, often associated with the accumulation of fat in the liver. Unlike simple fatty liver, NASH can progress into more severe conditions including cirrhosis and liver cancer. Historically, it has been challenging to develop any effective treatments for NASH with the field being littered with several high-profile failures. Still, there is a limited, but steady pipeline of candidates that continue to be explored. In the statement accompanying the partnership, senior vice president and global head of cardiometabolic diseases research at Boehringer Søren Tullin said: “This new partnership is part of our commitment to collaborate with peers worldwide to address the interconnected nature of CRM diseases. Our goal is to develop the next wave of innovative medicines that will lead to a holistic health gain for patients.” In addition to NASH, Boehringer is targeting obesity, with the German company releasing positive Phase II data for survodutide, a subcutaneous long-acting dual glucagon and GLP-1 agonist which is being developed in partnership with Zealand Pharma , in June of last year. The drug is meant to treat individuals with a body mass index (BMI) above 27kg/m², and NASH. According to a patient-based forecast on GlobalData’s Pharma Intelligence Center, survodutide is predicted to generate $707m in 2030. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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British (+1284) Virgin Islands - US (+1340) Wallis & Futuna (+681) Yemen (North)(+969) Yemen (South)(+967) Zambia (+260) Zimbabwe (+263) Country * UK USA Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos Islands Colombia Comoros Congo Democratic Republic of the Congo Cook Islands Costa Rica Côte d"Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati North Korea South Korea Kuwait Kyrgyzstan Lao Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, The Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestinian Territory Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Réunion Romania Russian Federation Rwanda Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Saint Vincent and The Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and The South Sandwich Islands Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates US Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela Vietnam British Virgin Islands US Virgin Islands Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Kosovo By downloading this case study, you acknowledge that GlobalData may share your information with GlobalData and that your personal data will be used as described in their Privacy Policy Submit Visit our Privacy Policy for more information about our services, how GlobalData may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report.

并购临床2期

2023-09-18

·药研发

【药研发0919】亚虹MetAP2抑制剂早期临床积极 | 深圳福沃口服SERD上Ⅰ期临床...

「本文共：16条资讯，阅读时长约：3分钟」今‍日‍头条亚虹MetAP2抑制剂早期临床积极。亚虹医药口服可逆性MetAP2抑制剂APL-1202联合替雷利珠单抗对比替雷利珠单抗单药，用于新辅助治疗肌层浸润性膀胱癌（MIBC）的I/II期临床结果积极。APL-1202具有抗血管生成、抗肿瘤活性及调节肿瘤免疫微环境的作用。期中分析显示，联用治疗组和单药组均达到Simon二阶段试验最优设计对第一阶段疗效的要求，该试验进入第二阶段。‍‍‍国‍‍‍‍‍‍‍‍‍内‍‍‍‍药‍‍讯‍‍‍‍1.昂科免疫CTLA-4抗体启动Ⅲ期临床。昂科免疫CTLA-4单抗ONC-392登记启动一项Ⅲ期临床，拟评估与多西他赛头对头比较，用于治疗经PD-1/PD-L1抑制剂治疗后进展的转移性非小细胞肺癌受试者的有效性与安全性。这是国际Ⅲ期临床的中国部分，将由广东省人民医院吴一龙教授担任主要研究者。2023年3月，BioNTech公司与昂科免疫达成合作，共同开发和商业化ONC-392用于（单药或联合用药）治疗多种实体瘤。2.礼来FGFR3抑制剂中国报IND。礼来1类化药LOXO-435片的临床试验申请获CDE受理。LOXO-435是一款选择性FGFR3抑制剂，可避免因抑制FGFR1和FGFR2导致的剂量限制性毒性，避免出现高磷酸血症和其他慢性不耐受的不良事件。目前全球尚无FGFR3抑制剂获批上市。在海外，LOXO-435正在I期临床中评估用于治疗尿路上皮癌的安全性与有效性。3.恒瑞源正HPV18靶向TCR-T上Ⅰ期临床。恒瑞源正靶向HPV18的TCR-T疗法HRYZ-T101登记启动一项Ⅰ期临床，拟评估用于治疗HPV18阳性实体瘤的安全性和有效性。该项试验主要研究者由复旦大学附属肿瘤医院吴小华医学博士和张剑医学博士共同担任。今年5月，恒瑞源正已完成超2亿元C轮融资，紫金港资本作为本轮主要投资机构继续加投，其他主要投资机构包括恒瑞医药、中科科创等。4.深圳福沃口服SERD上Ⅰ期临床。福沃药业自主研发的口服选择性雌激素受体降解剂（SERD）FWD1802，在首次人体Ⅰ期临床中完成首例受试者给药。该项试验旨在评估FWD1802单药治疗，和与哌柏西利联合治疗用于ER+/HER2-不可切除的局部晚期或转移性乳腺癌受试者中安全性和有效性，主要研究者由复旦大学附属肿瘤医院肿瘤内科主任医师张剑副教授担任。5.诺诚健华SHP2抑制剂获批肺癌临床。诺诚健华新型SHP2变构抑制剂ICP-189获国家药监局临床许可，拟开展单药治疗晚期实体瘤，以及联合EGFR抑制剂甲磺酸伏美替尼片用于治疗EGFR突变的局部晚期或转移性非小细胞肺癌（NSCLC）的临床研究。SHP2是一种非受体蛋白酪氨酸磷酸酶，在MAPK信号通路和免疫检查点通路中发挥作用，可调节细胞增殖和存活。此前，该新药已在美国获临床批件。6.康方CLDN18.2/CD47双抗国内获批临床。康方生物CLDN18.2/CD47双抗AK132注射液获国家药监局批准开展用于治疗晚期恶性肿瘤的临床研究。AK132能同时特异性结合CLDN18.2和CD47分子，具有协同抗肿瘤的潜力。此前，全球已有3款同类药物在研，分别是宝船生物BC007、尚健生物SG1906和Phanes公司PT886；BC007和SG1906正在中美两国同步进行临床开发，分别评估用于晚期实体瘤的治疗潜力。‍‍‍‍国‍‍‍‍‍‍‍‍‍‍际‍‍‍‍药‍讯‍‍1.缬苯那嗪颗粒剂报NDA。Neurocrine公司VMAT2抑制剂新剂型缬苯那嗪（Valbenazine，Ingrezza）颗粒剂的上市申请获FDA受理，旨在寻求覆盖Valbenazine胶囊所获批的适应症，包括迟发性运动障碍和亨廷顿病的舞蹈症状，PDUFA日期为明年4月30日。Valbenazine能够通过降低突触前的多巴胺水平来减少不可自控行为的发生。Ingrezza的颗粒剂配方有望为吞咽困难的迟发性运动障碍和亨廷顿病舞蹈症患者提供替代治疗选择。2.口服非肽类偏向性激动剂Ⅲ期临床成功。Crinetics公司口服非肽类偏向性激动剂Paltusotine（CRN00808）治疗肢端肥大症的Ⅲ期临床PATHFNDR-达到主要终点和所有次要终点。与安慰剂相比，paltusotine治疗组第36周时达到IGF-1（胰岛素样生长因子1）水平保持在正常值上限的1.0倍以下的患者比例更高（83%vs4%，p<0.0001）；paltusotine的耐受性良好。此前，该新药已获FDA授予治疗肢端肥大症的孤儿药资格。3.GPR119激动剂上NASH Ⅱ期临床。NeuroBo公司新型G-蛋白偶联受体119（GPR119）激动剂DA-1241治疗非酒精性脂肪性肝炎（NASH）的Ⅱa期临床首例患者给药。DA-1241可促进关键肠肽GLP-1、GIP和PYY的释放，对肝脏炎症、脂质代谢、体重减轻和葡萄糖代谢具有潜在益处。在NASH和2型糖尿病临床前动物模型中，DA-1241已显示出可减少肝脏脂肪变性、肝脏炎症和肝纤维化，同时改善血糖控制。4.新型IL-2偶联物皮炎早期临床积极。Nektar公司新型IL-2偶联物rezpegaldesleukin治疗特应性皮炎的Ⅰb期临床结果积极。rezpegaldesleukin能剂量依赖性地改善ESAI评分；24µg/kg剂量组在受影响的体表面积（BSA）、皮肤科生活质量指数调查表（DLQI）以及患者湿疹自我评估（POEM）等临床疗效终点上也具有统计学上显著的改善。此外，药物的安全性良好。5.BMS终止多款新药临床开发。百时美施贵宝在研发日上透露，公司终止TIGIT单抗BMS-986207、RNAi疗法BMS-986263、RIPK1抑制剂、CC-90009、CD47/CD20双抗等新药的开发。BMS-986207（ONO-4686）是一款TIGIT单抗，在O药+Y药+TIGIT的三免疫检查点抑制剂联合方案治疗IV期未接受全身抗癌治疗的非小细胞肺癌（NSCLC）患者的Ⅱ期临床中，由于毒性太大，还没披露结果就直接终止。6.AlveoGene融资开发AATD吸入式基因疗法。AlveoGene公司宣布正式成立并完成种子轮融资。AlveoGene由OSE、Harrington和OCC与英国呼吸基因治疗联盟（GTC）的六位顶尖科学家合作创建，该公司将利用GTC开发的下一代慢病毒递送平台，开发吸入式基因疗法用于罕见呼吸系统疾病的治疗。AlveoGene公司先导候选药物AVG-001是一种新型的吸入式基因疗法，预计2-3年内将进入临床开发，用于治疗α-1抗胰蛋白酶缺乏症（AATD）患者。‍‍‍‍‍‍‍‍‍医‍‍‍‍‍‍药‍‍‍‍‍‍‍‍‍‍‍‍‍热‍‍‍‍‍‍‍点‍‍‍。1.山东中医药大学党委书记履新。9月14日下午，山东中医药大学召开干部会议，宣布省委关于学校党委主要领导调整的决定：张立祥同志任山东中医药大学党委书记，武继彪同志不再担任山东中医药大学党委书记职务。根据公开资料，张立祥，男，汉族，1966年9月生，省委党校研究生，公共卫生硕士，中共党员。张立祥曾任山东省卫生厅办公室主任，山东中医药高等专科学校校长、党委副书记、党委书记，山东省卫生健康委员会党组成员、副主任等职务。2.中国中医科学院西苑医院济宁医院挂牌。9月15日，中国中医科学院西苑医院济宁医院挂牌仪式举行。西苑医院济宁医院新院区总投资32.3亿元，建筑面积26.1万平方米，规划床位1300张，停车位2253个，配置国内一流医疗设备及信息化系统。医院将重点建设心脑血管病科等六大专科，打造一流的国家区域医疗中心，助力国家中医药综合改革示范区建设。3.孟加拉国暴发严重登革热疫情。孟加拉国卫生服务总局16日发布数据显示，截至当日，该国今年以来已累计报告登革热病例164562例，死亡病例804例，其中9月死亡病例211例。世界卫生组织称，这是该国有记录以来最严重的登革热疫情。目前，孟加拉国所有8个专区下的64个县均报告了登革热病例。‍‍‍‍‍‍‍评‍‍‍‍‍审‍‍‍‍动‍‍态‍‍‍‍‍‍‍ 1. CDE新药受理情况（09月17日) 2. FDA新药获批情况（北美09月15日）股市资讯上个交易日 A 股医药板块 +1.06%涨幅前三跌幅前三双成药业+9.97% *ST吉药-9.02%通化金马+7.82% *ST太安-4.85%亚虹医药+6.81% 珍宝岛-3.80%【浙江医药】下属子公司浙江新码生物收到NMPA下发的关于公司在研药物注射用NCB003的《药物临床试验批准通知书》，同意本品单药在晚期实体瘤开展临床试验。【泽璟制药】注射用重组人促甲状腺激素(rhTSH)用于分化型甲状腺癌患者术后辅助诊断的I期临床试验达到了方案预设的主要终点，公司将向CDE提交 Pre-BLA的沟通交流申请。【我武生物】公司的“烟曲霉点刺液”在华科大同济医学院附属同济医院完成了“一项在中国志愿者中探索烟曲霉点刺液安全性及有效性的临床研究--单中心、开放的I期临床研究”的首例受试者入组，正式进入该临床试验。【常山药业】控股子公司常山凯捷健收到艾本那肽Ⅲ期临床研究总结报告。- The End -戳“阅读原文”，了解更多医药研发及股市资讯。

临床1期临床2期临床3期

2023-09-14

·FierceBiotech

BMS trims anti-TIGIT pipeline and a handful of other early- to midstage meds

Bristol Myers Squibb is ending development of a handful of new assets, including an anti-TIGIT med in phase 2. As the TIGIT class gets closer to finally seeing clinical success, Bristol Myers Squibb is trimming one of its candidates. The company disclosed development of a phase 2 anti-TIGIT is ending as part of its annual R&D day on Thursday. BMS is also halting work on a phase 2 nonalcoholic steatohepatitis (NASH) candidate licensed in 2016 from Nitto Denko Corporation and a handful of other phase 1 assets. "We regularly evaluate our pipeline to best prioritize resources where we see the potential for transformational effects on patients’ lives," a spokesperson said in a statement. BMS terminated a phase 2 study of the anti-TIGIT in solid tumors in late January due to “safety reasons, adverse change in the risk/benefit,” according to the clinical trial record. The record for a phase 1/2 multiple myeloma trial, sponsored by the Multiple Myeloma Research Consortium, was last updated in July to indicate it was active and recruitment had been completed. The decision comes as the class is potentially on the precipice of a bit of momentum, led by Roche's tiragolumab. Data released last year found that the asset in combination with Tecentriq did not improve progression-free survival in first-line non-small cell lung cancer patients, throwing into question the potential of the class that had garnered investments from numerous Big Pharmas. But an inadvertent data drop last month showed that treated patients did live longer compared to patients on just Tecentriq, though not by a statistically significant amount. Nonetheless, Roche's shared jump on the news. BMS is evidently pushing all of its TIGIT chips toward a bispecific candidate licensed from Agenus in May 2021 for $200 million upfront. Agenus also stands to earn $1.36 billion in milestone payments. The bispecific is in a phase 1 trial in patients with solid tumors as both a monotherapy and in combination with a PD-1 inhibitor. The NASH med was a siRNA asset targeting heat shock protein 47 that cost BMS $100 million to license in 2016. A phase 2 trial testing BMS-986263 in patients with advanced hepatic fibrosis that had been cured of hepatitis C wrapped up in February 2022. Data published in April last year showed that the most significant improvement in fibrosis was in patients at the 90-mg dose level, the highest in the trial, and that all adverse events were mild to moderate. The early-stage cuts include a cancer molecule aimed at an undisclosed target, a CD47 and CD20-targeting lymphoma med, a leukemia treatment and a RIPK1 inhibitor. Editor's note: This story was updated to include a statement from a BMS spokesperson.

临床1期临床2期蛋白降解靶向嵌合体临床终止引进/卖出

100 项与 BMS-986263 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
纤维化	临床2期	以色列	Bristol Myers Squibb Co.	2021-03-17
纤维化	临床2期	以色列	Bristol Myers Squibb Co.	2021-03-17
纤维化	临床2期	西班牙	Bristol Myers Squibb Co.	2021-03-17
特发性肺纤维化	临床2期	英国	日东电工株式会社	2018-06-18
特发性肺纤维化	临床2期	德国	日东电工株式会社	2018-06-18
特发性肺纤维化	临床2期	美国	日东电工株式会社	2018-06-18
特发性肺纤维化	临床2期	日本	日东电工株式会社	2018-06-18
肝纤维化	临床2期	美国	Bristol Myers Squibb Co.	2018-02-14
丙型肝炎	临床2期	美国	Bristol Myers Squibb Co.	2018-02-14
肝硬化	临床2期	美国	Bristol Myers Squibb Co.	2018-02-14

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临床结果

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分期

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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


NCT04267393 (CTgov)	临床2期	非酒精性脂肪性肝炎 \| 纤维化 \| 肝硬化	124	Placebo	觸淵簾餘夢鏇蓋顧艱艱(餘憲蓋鏇願獵顧鏇憲鹽) = 簾淵鏇積鹹選艱夢遞襯簾襯鏇獵積選壓簾觸齋 (積顧夢餘衊構顧鏇網繭, 壓築衊壓製夢窪願網夢 ~ 夢顧艱夢積繭鑰憲製窪) 更多	-	2024-09-04
NCT03538301 (CTgov)	临床2期	特发性肺纤维化	123	Other: Placebo	築積醖艱網淵鑰顧齋齋(範鹹網遞觸艱餘鑰壓衊) = 廠獵淵餘窪蓋夢選衊鹽遞鏇襯簾鏇齋齋繭餘襯 (鹽膚觸鹽鹹艱壓鹹遞襯, 選鹽蓋廠淵憲獵獵範繭 ~ 齋衊願憲網餘壓網鏇遞) 更多	-	2023-12-11
NCT04225936 (part 2 of the hepatic impairment (HI) phase 1 study, EASL2022)	临床1期	肝病	8	BMS-986263	壓壓襯艱襯齋願製簾廠(觸獵簾廠網積淵獵觸範) = 1 in BMS-986263, 0 in normal-matched 鹽夢構願醖鹹蓋鬱餘糧 (構齋鏇窪膚願網齋鏇鏇 ) 更多	积极	2022-06-25
NCT03420768 (CTgov)	临床2期	肝纤维化 \| 丙型肝炎 \| 肝硬化	61	BMS-986263 (BMS-986263 45 mg QW (Once Weekly))	構蓋繭繭蓋繭廠鬱鬱獵(膚鑰網糧糧夢繭壓憲窪) = 簾糧築窪壓襯積夢廠膚鹹觸鑰積淵餘衊願廠繭 (觸選夢網構淵糧願淵膚, 鬱夢憲壓遞鑰壓鹽憲願 ~ 廠鏇餘網糧憲襯膚醖蓋) 更多	-	2022-02-04
NCT03420768 (CTgov)	临床2期	肝纤维化 \| 丙型肝炎 \| 肝硬化	61	BMS-986263 (BMS-986263 90 mg QW (Once Weekly))	構蓋繭繭蓋繭廠鬱鬱獵(膚鑰網糧糧夢繭壓憲窪) = 觸鹽襯襯憲選鹽窪範築鹹觸鑰積淵餘衊願廠繭 (觸選夢網構淵糧願淵膚, 衊願廠遞獵衊鏇選鹹艱 ~ 窪衊網網顧膚選觸艱醖) 更多	-	2022-02-04
NCT03420768 (Pubmed) 人工标引	临床2期	肝纤维化	61	BMS-986263	(願顧願願艱廠餘壓鑰壓) = 鬱鏇鑰構簾醖夢窪餘遞顧鹹鑰鑰鹹襯醖憲衊廠 (襯願蓋築顧廠鹽製簾顧 ) 更多	积极	2021-10-04
NCT03420768 (Pubmed) 人工标引	临床2期	肝纤维化	61	Placebo	(願顧願願艱廠餘壓鑰壓) = 鬱鹹鹹製艱膚衊獵衊鏇顧鹹鑰鑰鹹襯醖憲衊廠 (襯願蓋築顧廠鹽製簾顧 )	积极	2021-10-04