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

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: Quimbo, Alistair ; Liu, Yun ; 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）

2024-03-21

·医药魔方

2023年全球药企研发投入TOP10

于制药界而言，2023年应该是旧潮退去和新潮涌起的一年。随着新冠疫情威胁的不断弱化，相关产品逐渐失去市场空间和舆论的主导权，ADC、减肥的研发热潮席卷了制药行业。据医药魔方Nextpharma数据库统计，2023年ADC药物领域达成了58项合作/许可/收购交易，总交易金额高达563亿美元，而2022年这两个数字分别为49项和252亿美元。于GLP-1赛道而言，2023年进入申报临床（IND）和临床阶段的GLP-1项目已达到171个，举目望去已是“红海”一片。与之相对的，研发热点的轮动也会影响一家药企的研发资源分配，例如默沙东、辉瑞、阿斯利康等公司已声势浩大地加码ADC投资。而从更多MNC制药巨头的研发投入数据上，我们也更能感受到产业热点的变化以及各家药企的战略应对。2023年制药巨头研发投入TOP10NO.1 默沙东2023年，默沙东在财报中报告的研发投入为305.31亿美元，相比去年上涨了126%。这样的数据是令人震惊的，但绝不是计算有误，而是因为默沙东在2023年完成了3宗金额较大的合作及收购交易。以220亿美元引进第一三共的3款ADC产品，其中首付款55亿美元已支付，计入当年研发投入费用；以103亿美元（拟定金额为108亿美元）收购Prometheus Biosciences，于2023年6月16日完成收购；以11亿美元（拟定金额为13.5亿美元）收购Imago Biosciences，于2023年1月11日完成收购。若去除这些成本，默沙东在2023年的研发投入则为136亿美元，占总收入23%，与2022年数字接近。默沙东的内部和外部举措表明，寻找Keytruda（简称K药）之外的业绩增长点是其目前及未来的业务焦点。从近两年的交易来看，默沙东今后的肿瘤业务重心将聚焦于抗体偶联药物（ADC）。目前，默沙东至少已吸纳9款临床前及临床ADC，其中5款已进入后期开发阶段，包括已申报上市的HER3 ADC和TROP2 ADC、处于III期阶段的B7-H3 ADC以及处于II/III期阶段的CDH6 ADC和ROR1 ADC。来源：默沙东2023年财报PPT“单抗+ADC”策略已成为当下热门的抗肿瘤药物组合方向，默沙东亦在探索将ADC药物与K药联用对各类癌症的治疗效果。2023年12月，“维恩妥尤单抗（商品名Padcev）+K药”获FDA常规批准用于治疗局部晚期或转移性尿路上皮癌成人患者，这是默沙东在“ADC+K药”联用策略上顺利迈出的一大步。除了维恩妥尤单抗以外，默沙东还在尝试将K药与其它ADC药物进行联用，如维迪西妥单抗、戈沙妥珠单抗和Datopotamab deruxtecan。但以新一代抗肿瘤产品替代如今的“药王”K药并不是默沙东的全部想法，毕竟过于依赖一款产品容易导致其跌入独木难支的困境。且不谈供不应求的九价HPV疫苗产品Gardasil 9，在肿瘤领域之外，心血管疾病和免疫性疾病已成为默沙东瞄准的新投资方向。Sotatercept、Enlicitide（MK-0616）和Tulisokibart（PRA-023）即是默沙东即将在这两大领域推出的重磅产品。NO.2 强生2023年，强生正式完成了消费者健康业务的拆分，其分拆公司Kenvue于2023年5月4日在纳斯达克上市，其股价首日即大涨22%，市值也达到了410亿美元。分拆业务后的强生致力于成为一家更为纯粹的制药企业，其在药物开发上的投入也有所增加，达到了150.85亿美元（+6.7%），创下新纪录。若非默沙东在合作及并购上掷下百亿美金，强生仍将蝉联MNC研发投入费用榜首。2023年，强生为自身划定了三大重点进击方向：神经科学、肿瘤学和免疫学。为此，强生痛定思痛，毅然决然舍弃了部分缺乏市场竞争力的研发项目（主要是传染病和疫苗领域的在研药物），如已进入III期阶段的RSV疫苗VAC18193（JNJ-64400141）。此外，强生还宣布退出乙型肝炎和丁型肝炎领域。2024年，强生将有多款产品或其新适应症迎来监管批准决定：Aprocitentan（商品名Opsumit）治疗肺动脉高血压患者（今日已批准）；马昔腾坦他达拉非复方（商品名Opsynvi）治疗肺动脉高血压患者；兰泽替尼+埃万妥单抗一线及二线治疗EGFR突变型非小细胞肺癌（NSCLC）患者；达雷妥尤单抗皮下注射剂型（商品名Darzalex Faspro）+硼替佐米+地塞米松治疗适合接受造血干细胞移植的新诊断多发性骨髓瘤患者；西达基奥仑赛（商品名Carvykti）二线治疗复发或难治性多发性骨髓瘤患者。NO.3 罗氏罗氏是2022年在研发方面上支出最多的MNC，与强生的研发投入费用差距不到1亿美元。2023年，罗氏的研发支出下调至132.37亿瑞士法郎（约为147.95亿美元），相比去年（140.53亿瑞士法郎）下降了5.8%。在经历了一系列临床失利后，罗氏选择谨慎一些前进，“钱需花在刀刃上”。罗氏首席执行官Thomas Schinecker曾在2023年9月举办的制药日活动（Pharma Day 2023）上表示，只有在充分评估在研药物的研发成功可能性后才会将其推进至III期阶段，以防止重蹈2022年多项临床失败的覆辙。罗氏近15年研发成功率（来源：罗氏2023制药日PPT）自2023年至今，罗氏有多款后期产品取得了积极进展，包括Crovalimab（可伐利单抗）、Inavolisib、Tiragolumab等产品。可伐利单抗是罗氏在阵发性睡眠性血红蛋白尿症（PNH）领域推出的第一款产品，其已在两项III期研究中取得了非劣效于一代C5抑制剂依库珠单抗（商品名Soliris）的积极结果。今年2月，该产品已率先在中国上市，加入与依库珠单抗的市场竞争。Inavolisib可能是目前选择性最高的PI3Kα抑制剂，其对PI3Kα的选择性比PI3Kβ/δ/γ高300倍。在III期INAVO120研究中，Inavolisib联合哌柏西利和氟维斯群可将PIK3CA突变型HR+/HER2-乳腺癌患者的无进展生存期（PFS）延长至15个月，将疾病进展风险降低了57%。来源：SABCS 2023大会PPT在阴雨连绵的TIGIT赛道，罗氏也为提振行业的信心贡献了一个积极信号。今年1月，Tiragolumab联合阿替利珠单抗和化疗治疗食管鳞状细胞癌的III期SKYSCRAPER-08研究达到了主要终点。此外，在I/II期MORPHEUS-liver研究中看到希望后，罗氏已迅速启动了Tiragolumab联合阿替利珠单抗和贝伐珠单抗治疗肝细胞癌的III期IMbrave152研究。默沙东和强生看中的难治性高血压和自免疾病领域，罗氏亦有所动作。2023年，罗氏先后以28亿美元和71亿美元获得了高血压RNAi疗法Zilebesiran和TL1A单抗RVT-3101的权益。NO.4 诺华2023年，诺华在财报中报告的研发投入为113.71亿美元，相比去年上涨了13.8%。2023年4月，诺华在公布Q1业绩时透露，将其产品管线削减10%（150→134），意在将预算集中在5大治疗领域：心血管疾病、血液学、实体瘤、免疫学和神经科学。对此，诺华首席执行官Vas Narasimhan博士解释道：“我们的项目比同行多，这导致每个项目的投资比同行少。在临床前或临床早期阶段进行大量投资可以帮助我们走得更快，并尽可能探索更多的治疗线以及更多的适应症。”重点方向确定后，诺华也加大了在放射性药物赛道的投资，例如与Bicycle Therapeutics达成了一项17亿美元的合作协议，进一步巩固其领导地位。市场潜力隐藏多年的IgAN肾病领域也进入了诺华的视野，该公司出手32亿美元并购了Chinook Therapeutics，获得了包括增殖诱导配体（APRIL）单抗Zigakibart在内的多款产品。诺华预计在今年向FDA递交加速批准Zigakibart上市的申请。在公布2023年财报时，诺华再次调整了其重点开发领域——心血管-肾脏-代谢疾病、免疫学、神经科学和肿瘤学。NO.5 阿斯利康2023年，阿斯利康在财报中报告的研发投入为109.35亿美元，相比去年上涨了12%。阿斯利康表示，这是因为有多款产品在2023年取得了出乎预料的进展，决定继续推进其开发工作。据阿斯利康2023年财报，已启动了多达27项III期临床试验，其中10项临床试验将证明其产品具有成为“重磅炸弹”药物的潜力。来源：阿斯利康2023年财报PPT除了产品，阿斯利康也在持续投资技术平台，以提高其研发能力。去年，阿斯利康大举进军细胞疗法赛道，在增加外部合作的基础上，还接连出手并购了Quell Therapeutics和亘喜生物，顺道开启了MNC并购中国Biotech的新潮流。来源：阿斯利康2023年财报PPT作为心血管-肾脏-代谢领域的领军企业，阿斯利康同样也在持续关注高血压领域的研发进展。2023年初，阿斯利康以18亿美元收购CinCor Pharma，获得了新型降压药物——醛固酮合成酶（ALDOS）抑制剂Baxdrostat。该药物已于2023年11月推进至III期阶段。阿斯利康首席执行官Pascal Soriot表示，公司将基于科学制定新的研发战略。“我们相信，公司的管线将会在未来10年内愈加丰富，这当然也会促进业绩的增长。我们正在投资新的科学，这些科学将塑造医学的未来，并塑造阿斯利康的未来。”NO.6 辉瑞2023年，新冠产品对业绩的buff加成进入倒计时，辉瑞的业绩也因此大幅下跌。重新审视管线后，辉瑞调整了战略重点，再度将精力集中于肿瘤领域。以430亿美元收购Seagen便是辉瑞为争夺肿瘤领域市场份额下的一步先行棋。在完成对Seagen的收购后，辉瑞的研发管线增加了36款抗肿瘤产品，其今后的产品重心也将以ADC、双抗和小分子药物为主。辉瑞肿瘤学部门首席科学官Jeff Settleman博士表示：“我们现在具有独特的优势，可以推出业内最广泛的ADC产品组合，其中包括各种新颖和具有差异化优势的项目。”为支持战略调整计划，辉瑞进行了大裁员，也削减了研发支出。2023年，辉瑞报告的全年研发投入为106.79亿美元，相比去年下降了6.6%。与此同时，辉瑞在下半年也摒弃了5个早期项目，包括1款酪氨酸蛋白激酶7（PTK7）ADC、1款小分子磷酸二酯酶（PDE4）抑制剂、1款CD47/PD-L1双抗、1款小分子HPK1抑制剂以及1款ROBO2-Fc融合蛋白。在抗肿瘤药物之外，辉瑞仍然会抽出一部分精力开发疫苗和自免产品。在流感肆虐的当下，辉瑞正在与BioNTech合作开发一款mRNA疫苗PF-07252220以降低流感发生率。辉瑞会否通过流感疫苗再创千亿美元营收辉煌，倒是可以再期待一下。前面提到的TL1A单抗RVT-3101也是辉瑞持有部分权益的产品。在炎症性疾病领域，辉瑞已推出Etrasimod和阿布昔替尼两款潜力产品为后续产品铺路。目前，辉瑞管线中至少有9款自免产品处于II期或III期阶段。NO.7 礼来2023年，礼来的研发支出为93.13亿美元，相比2022年上涨了29%。这主要是因为礼来在Q4推进了多款后期产品和早期产品的开发。接下来，礼来打算继续加速推进研发项目。在2023年财报电话会议上，礼来首席财务官Anat Ashkenazi表示，预计2024年的研发费用增长比例将高于营销、销售和管理费用的增长比例。2023年是礼来凭借GLP-1药物怒刷存在感的一年。这一年，GLP-1R/GIPR激动剂替尔泊肽接连在4项减肥III期研究中取胜，并顺利在2023年11月获批减肥适应症（新增商品名Zepbound）。在不到两个月的时间内，该产品即大卖1.749亿美元。礼来的另一款减肥产品——GLP-1R/GCGR激动剂Mazdutide（玛仕度肽）目前处于II期阶段，不过其合作伙伴信达生物推进得更快，已在中国提前其上市申请。此外，礼来也正在开发可口服的GLP-1药物。与从递送途径解决口服需求的诺和诺德不同的是，礼来选择的突破方向为小分子GLP-1R激动剂——Orforglipron目前正在开展3项减肥III期临床和4项降糖III期临床。总是能站上研发风口的礼来，自然也看到了放射性药物的潜力。2023年10月，礼来以14亿美元收购了放射性药物公司POINT Biopharma，打响加入赛道竞争的第一枪。2023年，礼来在GLP-1产品和新一代Aβ单抗的加持下，市值一路飞涨突破7000亿美元，跃居全球市值第一药企。有分析师预测，未来礼来的市值很有可能继续狂飙，最终破万亿市值大关。NO.8 百时美施贵宝2023年，百时美施贵宝（BMS）在财报中报告的研发投入为92.99亿美元，相比去年下降了2.2%。2023年，百时美施贵宝（BMS）的高管团队发生了一次大变动。自2019年BMS收购新基（Celgene）以来便任职执行副总裁兼研发总裁的Rupert Vessey宣布离开公司。在过去的4年中，他为整合并推进新基的产品作出了巨大贡献。在Rupert Vessey辞职后，BMS聘请了前免疫学、心血管和纤维化研究中心负责人兼转化医学负责人Robert Plenge博士接替其职位。自Plenge接手以来，BMS对其产品管线进行了调整，剔除了多项资产，其中包括II期产品TIGIT单抗BMS-986207和治疗MASH的RNAi疗法ND-L02-s0201。2023年，BMS也是有一些积极进展的。5月和9月，溶血磷脂酸受体1（LPA1）拮抗剂BMS-986278先后在特发性肺纤维化（IPF）和进行性肺纤维化（PPF）适应症上取得成功。值得注意的是，两项研究均有一定比例的受试者既往接受过吡非尼酮（商品名Esbriet，罗氏）或尼达尼布（商品名Ofev，勃林格殷格翰）等抗纤维化疗法治疗，这表明BMS-986278可能具有作为现有疗法的附加治疗的潜力。鉴于以上积极结果，BMS已启动了BMS-986278治疗IPF和PPF的III期临床试验。若这两项III期研究能顺利完成，吡非尼酮和尼达尼布将面临不小的市场竞争压力。不同于其它MNC的是，BMS在并购交易中选择的对象是持有抗精神分裂症药物的Karuna Therapeutics。不过，BMS也入局了放射性药物赛道，在去年1月末收购了RayzeBio，囊获一款III期产品RYZ101。NO.9 艾伯维2023年，艾伯维的研发投入明显增加，由2022年的65.10亿美元上涨至76.75亿美元。这主要是因为其支柱产品修美乐（阿达木单抗）正式遭受了多款生物类似药的夹击，销售额大幅下跌，以至于艾伯维不得不加大投资力度以快速推进在研产品的研发或寻找其它潜力产品。乌帕替尼（商品名Rinvoq）是艾伯维目前的重点产品之一。在逐渐覆盖类风湿性关节炎、特应性皮炎、溃疡性结肠炎等疾病后，艾伯维开始着手探索乌帕替尼在系统性红斑狼疮、斑秃、白癜风等患者基数大但难以攻克的适应症上的应用潜力。幸运的是，除了正在崛起的乌帕替尼和利生奇珠单抗（商品名Skyrizi），艾伯维也抓住机会吸收了多款重磅产品。2023年12月，艾伯维以101亿美元收购了ImmunoGen，获得了卵巢癌领域的重磅ADC产品索米妥昔单抗（商品名Elahere）。同月，艾伯维出手87亿美元拿下Cerevel Therapeutics，补充其神经科学管线。2023年，艾伯维在血液瘤领域取得了不错的成绩。其CD3/CD20双抗Epcoritamab虽不具备先发优势，但通过差异化的适应症开发策略开辟了另一条道路。此外，艾伯维已决定进一步拓展其应用空间，计划在今年晚些时候启动Epcoritamab二线治疗弥漫性大B细胞淋巴瘤（DLBCL）和一线治疗滤泡性淋巴瘤（FL）的III期临床试验，这两项适应症同样具备差异化优势。NO.10 赛诺菲2023年，赛诺菲的研发支出为93.13亿美元，相比2022年上涨了3.4%。2023年10月，赛诺菲在公布Q3业绩时宣布了“Play to Win”的全新战略篇章。赛诺菲首席执行官Paul Hudson表示，希望到2030年实现免疫学产品销售额超过220亿欧元和疫苗产品销售额超过100亿欧元的目标。为此，赛诺菲制定了一系列计划。一方面是剥离消费者健康业务，集中资源开发在研产品；另一方面是确定项目优先级，减少肿瘤学投资增加免疫学投资。在新的战略支持下，赛诺菲也推进了多款产品的加速开发：启动CD40L单抗Frexalimab治疗多发性硬化症的两项III期临床试验；启动AmlitelimabOX40L单抗治疗特应性皮炎的多项III期临床试验；启动鼻喷呼吸道合胞病毒（RSV）疫苗LID/ΔM2-2/1030s预防RSV感染的III期临床试验；启动C1s单抗Riliprubart治疗慢性炎症性脱髓鞘性多发性神经病（CIDP）的两项III期临床试验。据赛诺菲所言，多款中后期在研免疫产品的销售额峰值均可达到20-50亿欧元，这将是促进其业绩增长的强大驱动力。Copyright © 2024 PHARMCUBE. All Rights Reserved.欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。医药魔方将于3月28日在上海举办2024医药投融资交易大会暨第二届医药魔方TOP15榜单发布。邀请参会，共议新周期下的医药投融资与交易。

抗体药物偶联物并购财报申请上市临床2期

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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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。

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100 项与 BMS-986263 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
非酒精性脂肪性肝炎	临床2期	以色列	Bristol Myers Squibb Co.	2021-03-17
非酒精性脂肪性肝炎	临床2期	巴西	Bristol Myers Squibb Co.	2021-03-17
非酒精性脂肪性肝炎	临床2期	德国	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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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	壓鏇餘構顧齋觸築選構(網願構膚夢顧夢鏇簾衊) = 鹽獵鹽鬱顧壓窪簾醖獵構築壓夢醖鏇繭醖築糧 (獵壓範築壓獵積選淵艱, 選觸觸夢構憲淵餘積壓 ~ 鹹顧簾醖築鑰鹹觸齋壓) 更多	-	2024-09-04
NCT03538301 (CTgov)	临床2期	特发性肺纤维化	123	Other: Placebo	鹽鑰餘夢齋鏇廠獵願獵(糧繭醖築獵鑰遞鹽糧簾) = 壓鑰顧膚繭繭窪餘顧窪艱鹹襯繭遞壓構遞窪觸 (範廠繭壓齋網鏇鹽糧鑰, 範製鹽獵獵淵築遞襯淵 ~ 餘鑰鹹選選淵積窪選觸) 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	餘鏇夢餘願願願襯網膚(繭襯積齋築鑰膚積齋顧) = 1 in BMS-986263, 0 in normal-matched 鹽繭網窪觸壓築獵顧築 (簾夢願鹽淵構繭範壓選 ) 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))	艱積鏇網鑰膚鏇醖簾鑰(範鏇憲築簾積網製範襯) = 製顧夢觸網繭築網顧製獵醖艱鏇構願築觸網艱 (窪鹽築壓餘蓋壓觸鹹醖, 壓憲範襯窪糧顧遞顧壓 ~ 衊範艱簾積膚衊襯製製) 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))	艱積鏇網鑰膚鏇醖簾鑰(範鏇憲築簾積網製範襯) = 網餘膚網夢鬱製醖遞憲獵醖艱鏇構願築觸網艱 (窪鹽築壓餘蓋壓觸鹹醖, 顧壓鏇襯壓齋鑰觸範繭 ~ 製糧願餘壓鬱鬱繭顧築) 更多	-	2022-02-04
NCT03420768 (Pubmed) 人工标引	临床2期	肝纤维化	61	BMS-986263	(築鹽艱遞網襯壓繭蓋鬱) = 願壓淵積鬱壓餘製鑰膚壓遞壓製選願齋衊簾簾 (鏇蓋構構蓋構顧鏇襯鏇 ) 更多	积极	2021-10-04
NCT03420768 (Pubmed) 人工标引	临床2期	肝纤维化	61	Placebo	(築鹽艱遞網襯壓繭蓋鬱) = 糧網淵範壓憲積鹽齋餘壓遞壓製選願齋衊簾簾 (鏇蓋構構蓋構顧鏇襯鏇 )	积极	2021-10-04