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

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·Hepatology (Baltimore, Md.)1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 ; Coste, Angie ; Shevell, Diane E. ; Chen, Warner ; Du, Shuyan ; Karsdal, Morten ; Nielsen, Mette ; Poordad, Fred ; Tirucherai, Giridhar S. ; Charles, Edgar D. ; Goodman, Zachary ; Lawitz, Eric J.

Abstract:

Background and Aims:

Hepatic 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 Results:

NCT03420768 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.

Conclusions:

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

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

2023-11-18

·蒲公英Ouryao

扛不住了！武田也砍掉四个管线！

转自：蒲公英Ouryao 整理：蒿山君近日，武田制药公布了上半年数据，砍掉了4条管线，业绩预期下调了高达71%。财报显示增长遇到一定的瓶颈。武田砍掉了4条管线2023年武田上半年总销售约138.71亿美元，同比增长1.4%，但利润却大幅下滑，下降了53%，约为17.87亿美元。武田产品管线可以分为五大部分，分别是：消化道产品、罕见病、血浆制品、精神疾病和抗肿瘤线。其中，消化道产品是他们的核心管线，上半年实现同比增长9.2%，报告显示，由于一系列不可控因素，导致了公司的净亏损增长，并且宣布砍掉4款研发产品管线，分别是： 1.Exkivity：治疗晚期非小细胞肺癌的产品，因III期临床试验无疗效获益而终止。 2.TAK-920/DNL-919：治疗AD类产品，因出现"中度、可逆的血液学效应"，停止了阿尔茨海默氏症（AD）药物的开发。 3.TAK-611：显示在在治疗异染性脑白质营养不良（MLD）的II期试验中未达到主要终点和次要终点而放弃研发。 4.TAK-105：由于数据表现不佳，治疗恶心和呕吐的候选药物TAK-105将停止研发。一款新药的问世绝非易事，面对新药研发困难、销售业绩下滑等压力冲击，药企巨头也不得不做出管线调整的决定，看看各大外企每年在研发领域的投入以及每年宣布放弃的产品线就可想而知。多家药企砍管线辉瑞砍5条管线：10月31日，第三季度财报的同一天，辉瑞宣布将削减5项临床项目，包括两个II期项目和三个I期项目，涉及癌症和皮肤病等领域。GSK砍3条管线：11月1日，公司财报显示，对其一期肿瘤项目进行了两项削减，中止了一个LAG-3靶向抗体和一个小分子STING激动剂-后者被称为GSK3745417。葛兰素史克还放弃了一个重组蛋白项目，该项目正处于治疗艰难梭菌的一期开发阶段。今年，GSK还结束对细胞基因疗法领域的投入。罗氏又砍掉4条管线：罗氏在近期公布的第三季度最新财报中透露，基于“全部疗效和安全性数据以及治疗领域不断变化的治疗格局”，放弃cibisatamab的实体瘤I期试验，Cibisatamab是一种与癌胚抗原结合的T细胞双特异性抗体。因在TWAINI试验中的无效性分析失败，在TWAINII试验中也没有达到主要终点，放弃治疗精神分裂症的TAAR1激动剂ralmitaront的II期项目。因在对中重度至重度非增殖性糖尿病视网膜病变患者进行的CANBERRAII期研究中，未能达到主要终点，放弃了治疗糖尿病视网膜病变的vicasinabin的II期项目。因上个月的III期试验结果不及预期，罗氏还放弃了其BCL-2抑制剂Venclexta联合地塞米松治疗复发或难治性多发性骨髓瘤的研究，但Venclexta联合阿扎胞苷治疗一线骨髓增生异常综合征的III期试验仍在进行中。值得注意的是，罗氏在一季度砍掉6条管线，半年报中提到，将终止几款候选药物开发，包括处于III期阶段的替奈普酶治疗卒中适应症，II期阶段血友病A基因疗法RG6358，以及4款尚处于I期研究阶段的新分子实体药物。艾伯维，删除2条管线：8月23日，艾伯维更新了管线，从其产品线中删除了2条ADC管线，包括ABBV-011和与辉瑞合作的ABBV-647。百时美施贵宝，削减6个项目：9月14日，百时美施贵宝在其研发日公布削减研发管线，包括两个2期临床项目（HSP47和一个TIGIT实体瘤项目）和四个1期临床项目。 Moderna，删减4个管线：靠新冠疫苗暴富的Moderna，其将“在需要时”进行管道优先排序而剔除。其中包括两个阿斯利康合作后放弃的管线AZD8601、MEDI1191以及mRNA-1653、mRNA-1703。另外，今年以来，赛诺菲结束了BTK抑制剂atuzabrutinib的开发，停止度普利尤单抗的过敏性真菌性鼻炎和无鼻息肉的慢性鼻窦炎两个项目；诺华则砍去了在研管线中10%的非核心项目等。参考：公司财报华夏日报

财报基因疗法临床3期临床1期

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	日本	Bristol Myers Squibb Co.	2021-03-17
纤维化	临床2期	阿根廷	Bristol Myers Squibb Co.	2021-03-17
纤维化	临床2期	比利时	Bristol Myers Squibb Co.	2021-03-17
纤维化	临床2期	巴西	Bristol Myers Squibb Co.	2021-03-17
纤维化	临床2期	加拿大	Bristol Myers Squibb Co.	2021-03-17
纤维化	临床2期	法国	Bristol Myers Squibb Co.	2021-03-17
纤维化	临床2期	德国	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	意大利	Bristol Myers Squibb Co.	2021-03-17
纤维化	临床2期	波多黎各	Bristol Myers Squibb Co.	2021-03-17

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临床结果

适应症

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	廠艱廠顧製願觸醖憲鹽(餘襯膚鹽糧願醖餘糧艱) = 簾衊製網艱壓築窪範齋顧積獵顧鏇觸繭願繭鹹 (憲積衊淵鑰衊餘鏇鹹簾, 餘憲選膚窪餘遞願衊襯 ~ 淵遞壓簾廠夢糧淵鬱範) 更多	-	2024-09-04
NCT03538301 (CTgov)	临床2期	特发性肺纤维化	123	Other: Placebo	繭襯獵壓遞鏇網淵蓋鹹(構壓壓製積壓鏇獵壓鹽) = 衊鬱壓壓壓鹹壓醖願襯觸餘襯積廠遞夢壓觸壓 (鬱鹹壓遞壓膚艱夢糧鹽, 鬱衊鹹鑰齋膚醖遞窪糧 ~ 築鏇醖鑰鏇窪窪膚鏇鏇) 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	製簾廠積繭鏇構糧齋鹽(選遞襯繭遞夢積鹽鹹衊) = 1 in BMS-986263, 0 in normal-matched 遞製鏇範鹹鬱顧淵範獵 (遞鹹鹹鑰顧艱艱鏇願觸 ) 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))	壓鑰範選廠夢衊簾淵鏇(窪壓鹹廠襯襯窪遞鏇簾) = 鬱蓋憲壓鬱鏇糧憲觸蓋鏇選夢蓋顧鬱製繭顧願 (壓鹹廠選範壓鹹築鬱遞, 壓獵鹹齋願遞鹹糧艱鹹 ~ 鹽繭鏇糧選衊鹹憲願遞) 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))	壓鑰範選廠夢衊簾淵鏇(窪壓鹹廠襯襯窪遞鏇簾) = 餘齋鬱繭醖壓襯壓鏇遞鏇選夢蓋顧鬱製繭顧願 (壓鹹廠選範壓鹹築鬱遞, 選網鹽製膚衊糧夢製鹹 ~ 壓範構範選壓獵襯網網) 更多	-	2022-02-04
NCT03420768 (Pubmed) 人工标引	临床2期	肝纤维化	61	BMS-986263	鏇觸醖範觸壓鹽廠衊鹽(遞鹽餘衊壓範觸餘製衊) = 願襯糧鹽簾夢襯鹽夢遞淵窪膚齋築窪衊餘壓鹹 (齋壓鏇襯顧糧鏇淵齋繭 ) 更多	积极	2021-10-04
NCT03420768 (Pubmed) 人工标引	临床2期	肝纤维化	61	Placebo	鏇觸醖範觸壓鹽廠衊鹽(遞鹽餘衊壓範觸餘製衊) = 襯艱廠獵鑰鏇繭衊鑰簾淵窪膚齋築窪衊餘壓鹹 (齋壓鏇襯顧糧鏇淵齋繭 )	积极	2021-10-04