A Phase 3, Randomized, Open-Label, Active-Controlled, Multicenter, Non-Inferiority Study to Evaluate the Efficacy and Safety of Pegol-Sihematide for Anemia in Patients With Non-Dialysis-Dependent Chronic Kidney Disease

The primary objective of this study is to evaluate the safety and efficacy of Pegol-Sihematide, as compared with recombinant human erythropoietin injection (CHO Cell), ESPO, in anemia treatment in patients with non-dialysis-dependent chronic kidney disease.

开始日期2019-06-20

申办/合作机构

江苏豪森药业集团有限公司

CTR20190234 / Active, not recruiting临床3期

培化西海马肽注射液治疗慢性肾脏病非透析患者贫血的有效性和安全性多中心随机开放阳性对照非劣效性Ⅲ期研究

1) 评价培化西海马肽对比重组人促红细胞生成素（利血宝®）治疗CKD非透析患者贫血的有效性； 2) 评价培化西海马肽对比重组人促红细胞生成素（利血宝®）治疗CKD非透析患者贫血的安全性； 3) 进一步研究培化西海马肽在CKD非透析贫血患者中的量效关系。

开始日期2019-05-22

申办/合作机构

上海翰森生物医药科技有限公司

[+1]

CTR20190209 / Completed临床3期

培化西海马肽注射液在接受过透析治疗的慢性肾脏病贫血患者中的多中心随机开放阳性对照非劣效性Ⅲ期临床研究

1) 评价培化西海马肽对比重组人促红细胞生成素（利血宝®）治疗接受过促红细胞生成素类药物（ESAs）治疗的 CKD 透析患者贫血的有效性； 2) 评价培化西海马肽对比重组人促红细胞生成素（利血宝®）治疗接受过 ESAs 治疗的 CKD 透析患者贫血的安全性； 3) 进一步研究培化西海马肽在接受过 ESAs 治疗的 CKD 透析贫血患者中的量效关系。

开始日期2019-05-15

申办/合作机构

上海翰森生物医药科技有限公司

[+1]

100 项与培莫沙肽相关的临床结果

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100 项与培莫沙肽相关的转化医学

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100 项与培莫沙肽相关的专利（医药）

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项与培莫沙肽相关的文献（医药）

2023-11-01·EClinicalMedicine

Pegmolesatide for the treatment of anemia in patients undergoing dialysis: a randomized clinical trial

Article

作者: Jiang, Hongli ; Li, Shaomei ; Liu, Bicheng ; Zhang, Shiying ; Xu, Chengyun ; Zhou, Hua ; Ren, Yueqin ; Luo, Qun ; Zhao, Zhanzheng ; Li, Chuan ; Lu, Guoyuan ; Qiu, Hongyu ; Pan, Chao ; He, Wei ; Zhang, Weili ; Luo, Ping ; Xu, Chunping ; Sun, Mindan ; Chen, Menghua ; Du, Shutong ; Wang, Xiaoling ; Lv, Lu ; He, Liangliang ; Chen, Qinkai ; Li, Guisen ; Yan, Tiekun ; Chen, Jianghua ; Yang, Xiao ; Zhang, Ping ; Wang, Xiaoxia ; Tang, Shuifu ; Zheng, Hongguang ; Xie, Deqiong ; Sun, Bengui ; Huang, Xiangyang ; Zhou, Linghui ; Yang, Aicheng ; Qin, Shuguang ; Guo, Minghao ; Wang, Cheng ; Jiang, Yan ; Xia, Yu'ou ; Wu, Qiong ; Zhong, Aimin ; Liu, Hong ; Li, Jing ; Wang, Qin

Background:

Pegmolesatide, a synthetic peptide-based erythropoietin (EPO) receptor agonist, is being evaluated as an alternative to epoetin alfa for treating anemia of chronic kidney disease (CKD) in Chinese dialysis patients. There is a critical need for a long-acting, cost-effective erythropoiesis-stimulating agent that does not produce EPO antibodies.

Methods:

A randomized, open-label, active-comparator, non-inferiority phase three trial was conducted at 43 dialysis centers in China between May 17th, 2019, and March 28th, 2022. Eligible patients aged 18-70 years were randomly assigned (2:1) to receive pegmolesatide once every four weeks or epoetin alfa one to three times per week, with doses adjusted to maintain a hemoglobin level between 10.0 and 12.0 g/dL. The primary efficacy endpoint was the mean change in hemoglobin level from baseline to the efficacy evaluation period in the per-protocol set (PPS) population. Non-inferiority of pegmolesatide to epoetin alfa was established if the lower limit of the two-sided 95% confidence interval for the between-group difference was ≥ -1.0 g/dL. Safety assessment included adverse events and potential anaphylaxis reactions. This trial is registered at ClinicalTrials.gov, NCT03902691.

Findings:

Three hundreds and seventy-two patients were randomly assigned to the pegmolesatide group (248 patients) or the epoetin alfa group (124 patients). A total of 347 patients (233 in the pegmolesatide group and 114 in the epoetin alfa group) were included in the PPS population. In the PPS, the mean change (standard deviation, SD) in hemoglobin level from baseline to the efficacy evaluation period was 0.07 (0.92) g/dL in the pegmolesatide group and -0.22 (0.97) g/dL in the epoetin alfa group. The between-group difference was 0.29 g/dL (95% confidence interval: 0.11-0.47), verifying non-inferiority of pegmolesatide to epoetin alfa. Adverse events occurred in 231 (94%) participants in the pegmolesatide group and in 110 (89%) in the epoetin alfa group. Hypertension was the most common treatment-related adverse event. No fatal cases of anaphylaxis or hypotension were reported.

Interpretation:

Monthly subcutaneously injection of pegmolesatide was as effective and safe as conventional epoetin alfa administrated one to three times a week in treating anemia in Chinese dialysis patients.

Funding:

The study was supported by Hansoh Medical Development Group.

2017-05-01·European journal of cancer (Oxford, England : 1990)1区 · 医学

Health-related quality of life in patients with locally recurrent or metastatic breast cancer treated with etirinotecan pegol versus treatment of physician's choice: Results from the randomised phase III BEACON trial

1区 · 医学

Article

作者: Moreno-Aspitia, Alvaro ; O'Shaughnessy, Joyce ; Zhao, Carol ; Yardley, Denise A ; Mailliez, Audrey ; Hoch, Ute ; Hannah, Alison L ; Ahn, Jin-Seok ; Im, Seock-Ah ; Cortés, Javier ; Gómez-Pardo, Patricia ; Twelves, Chris ; Potter, David A ; Rugo, Hope S ; Perez, Edith A ; Awada, Ahmad ; Tagliaferri, Mary ; Schwartzberg, Lee S ; Diéras, Véronique

BACKGROUND:

Health-related quality of life (HRQoL) enhances understanding of treatment effects that impact clinical decision-making. Although the primary end-point was not achieved, the BEACON (BrEAst Cancer Outcomes with NKTR-102) trial established etirinotecan pegol, a long-acting topoisomerase-1 (TOP1) inhibitor, as a promising therapeutic for patients with advanced/metastatic breast cancer (MBC) achieving clinically meaningful benefits in median overall survival (OS) for patients with stable brain metastases, with liver metastases or ≥ 2 sites of metastatic disease compared to treatment of physician's choice (TPC). Reported herein are the findings from the preplanned secondary end-point of HRQoL.

PATIENTS AND METHODS:

HRQoL, assessed by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) (version 3.0) supplemented by the breast cancer-specific Quality of Life Questionnaire (QLQ-BR23), was evaluated post randomisation in 733 of 852 patients with either anthracycline-, taxane- and capecitabine-pretreated locally recurrent or MBC randomised to etirinotecan pegol (n = 378; 145 mg/m² every 3 weeks (q3wk)) or single-agent TPC (n = 355). Patients completed assessments at screening, every 8 weeks (q8wk) during treatment, and end-of-treatment. Changes from baseline were analysed, and the proportions of patients achieving differences (≥5 points) in HRQoL scores were compared.

RESULTS:

Differences were seen favouring etirinotecan pegol up to 32 weeks for global health status (GHS) and physical functioning scales (P < 0.02); numerical improvement was reported in other functional scales. The findings from HRQoL symptom scales were consistent with adverse event profiles; etirinotecan pegol was associated with worsening gastrointestinal symptoms whereas TPC was associated with worsened dyspnoea and other systemic side-effects. Analysis of GHS and physical functioning at disease progression showed a decline in HRQoL in both treatment arms, with a mean change from baseline of -9.4 and -10.8 points, respectively.

CONCLUSION:

There was evidence of benefit associated with etirinotecan pegol compared with current standard of care agents in multiple HRQoL measurements, including global health status and physical functioning, despite worse gastrointestinal symptoms (e.g. diarrhoea). Patients in both arms had a decline in HRQoL at disease progression.

STUDY NUMBER:

NCT01492101.

2016-09-01·Toxicology and applied pharmacology3区 · 医学

Chronic preclinical safety evaluation of EPO-018B, a pegylated peptidic erythropoiesis-stimulating agent in monkeys and rats

3区 · 医学

Article

作者: Zhu, Hai ; Gu, Xiao-Lei ; Li, Jian-Zhong ; Lu, Guo-Cai ; Chen, Yong-Chun ; Gong, Xue-Lian ; Xia, Zhen-Na

EPO-018B, a synthetic peptide-based erythropoiesis stimulating agent (ESA), is mainly designed for treatment of anemia caused by chronic renal failure and chemotherapy against cancer. It overcomes the deficiencies of currently approved ESA, including the frequent administration of temperature-sensitive recombinant protein and anti-EPO antibody-mediated pure red cell aplasia (PRCA). This study was designed to evaluate the potential chronic toxicity of EPO-018B. Subcutaneous administration doses were designed as 0, 0.2, 1 and 10mg/kg for six months for 160 rats (20/gender/group) and 0, 0.3, 3 and 20mg/kg for nine months for 32 monkeys (4/gender/group) once every three weeks. The vehicles received the same volume of physiological saline injection. All animals survived to the scheduled necropsies after six weeks (for rats) and fourteen weeks (for monkeys) recovery period, except for the two high-dose female rats and two high-dose male monkeys, which were considered related to the increased RBCs, chronic blood hyperviscosity and chronic cardiac injury. EPO-018B is supposed to be subcutaneously injected once every month and the intended human therapeutic dose is 0.025mg/kg. The study findings at 0.2mg/kg for rats and 0.3mg/kg for monkeys were considered to be the study NOAEL (the no observed adverse effect level), which were more than ten times the intended human therapeutic dose. Higher doses caused adverse effects related to the liver toxicity, cardiotoxicity, appearance of neutralizing antibodies of EPO-018B and the decrease of serum glucose and cholesterol. Most treatment-induced effects were reversible or revealed ongoing recovery upon the discontinuation of treatment. The sequelae occurred in rats and monkeys were considered secondary to exaggerated pharmacology and would less likely occur in the intended patient population. As to the differences between human beings and animals, the safety of EPO-018B need to be further confirmed in the future clinical studies.

项与培莫沙肽相关的新闻（医药）

2024-10-24

·翰森制药

ASN 2024 | 翰森制药培莫沙肽Ⅲ期研究事后分析结果发布

Lancet子刊eClinicalMedicine发表过一项培莫沙肽针对CKD透析贫血患者的Ⅲ期临床研究成果1；为探讨培莫沙肽对于CKD透析贫血患者是否具有进一步获益，研究者针对上述Ⅲ期研究开展了一项事后分析；事后分析结果于2024ASN年会发布，证实培莫沙肽相比短效促红素更能实现血红蛋白达标，且安全性更佳2。 2024年美国肾脏病学会年会（ASN Kindey Week）于当地时间10月23-27日在美国圣地亚哥会议中心举行。翰森制药自主研发的1类创新药培莫沙肽（商品名：圣罗莱®）治疗慢性肾脏病（CKD）透析贫血患者的Ⅲ期研究事后分析结果以壁报形式在大会发布2。 ASN年会是全球首屈一指的肾脏病学术会议，旨在分享讨论肾脏病领域的最新研究进展与前沿热点。2024年该会议共吸引全球12,000余名肾脏领域专业人士参加3。培莫沙肽是一种新型长效聚乙二醇（PEG）化促红细胞生成素（EPO）模拟肽，于2023年6月获国家药品监督管理局（NMPA）批准上市，用于治疗因慢性肾脏病（CKD）引起的贫血4，并于当年纳入国家医保目录。既往Lancet子刊eClinicalMedicine发表过一项培莫沙肽针对CKD透析贫血患者的Ⅲ期临床研究1，这项随机、多中心、开放标签、非劣效性研究证实培莫沙肽在治疗CKD透析患者贫血中具有确切疗效和良好安全性，患者仅需一月一次皮下注射就能实现血红蛋白稳定达标1。本次ASN年会发布的培莫沙肽治疗CKD透析贫血患者的Ⅲ期事后分析结果进一步证实，培莫沙肽相比短效促红素更能实现血红蛋白达标，且安全性更佳2。具体信息如下：研究成果培莫沙肽治疗透析CKD患者贫血：一项随机、阳性、对照Ⅲ期研究的事后分析展示形式：壁报展示时间：当地时间2024年10月24日展示地点：圣地亚哥会展中心展览厅作者：陈江华（浙江大学医学院附属第一医院）周凌辉（厦门大学附属第一医院） …… 向上滑动阅览【研究背景】培莫沙肽是一种新型长效聚乙二醇化促红细胞生成素模拟肽，一项随机、多中心、开放标签、非劣效性Ⅲ期研究 (NCT03902691)已证明其与阿法依泊汀具有相当的疗效和安全性。这项事后分析旨在探讨培莫沙肽治疗透析患者贫血的进一步获益。【研究方法】共有372例接受透析的慢性肾脏病 (CKD) 患者被随机 (2:1) 分配接受培莫沙肽或阿法依泊汀治疗，为期52周。采用事后分析，计算疗效评估期间不同血红蛋白（Hb）水平的患者比例。【研究结果】在接受培莫沙肽治疗的患者中，达到平均Hb≥11 g/dL的比例高于接受阿法依泊汀治疗的患者（63.9% vs 44.7%，P=0.0003）。与使用阿法依伯汀的患者相比，培莫沙肽组有更多的患者维持Hb水平在11-12 g/dL（35.2% vs 22.8%，P=0.0164）和11-13 g/dL（57.5% vs 36.8%，P=0.0002）的目标范围。在不同基线特征亚组分析中，包括年龄≤65岁、原发性高血压、CKD 5期≥12个月、CRP≤11.5 mg/L、血清铁蛋白介于100-500 ng/mL以及转铁蛋白饱和度≥20%，培莫沙肽在维持Hb水平达到11-12 g/dL方面也显示出更好的效果。这些亚组在实现Hb达到11-13 g/dL的目标范围方面也具有类似的结果。特别关注的治疗相关不良事件的发生率，包括高血压（4.5% vs 6.5%）、肝毒性（0.8% vs 2.4%）和高钾血症（2.4% vs 4.0%），培莫沙肽组在数值上均更低。【研究结论】与阿法依伯汀相比，培莫沙肽更可能维持血红蛋白水平处于指南推荐的目标范围，并且具有更佳的安全性特征。参考资料：【1】Zhang P, et al. Pegmolesatide for the treatment of anemia in patients undergoing dialysis: a randomized clinical trial. EClinicalMedicine. 2023 Oct 28;65:102273. 【2】Chen Jianghua,et al.Pegmolesatide for the Treatment of Anemia in Patients with CKD Undergoing Dialysis: Insights from a Randomized Active-Controlled Phase 3 Study. ASN 2024. ABSTRACT: TH-PO888 【3】American Society of Nephrology （ASN）. https://www.asnonline.org/education/kidneyweek/ 【4】国家药监局批准培莫沙肽注射液上市. https://www.nmpa.gov.cn/yaowen/ypjgyw/ypyw/20230630195113151.html（发布时间：2023-06-30）关于翰森翰森制药是中国领先的创新驱动型制药企业，下属豪森药业、常州恒邦药业、翰森生物医药等子公司，重点关注抗肿瘤、抗感染、中枢神经系统、代谢及自身免疫等重大疾病治疗领域，致力于通过持续创新提高人类生命质量。截至2024上半年，公司已上市7款创新药，创新产品营收占比达77.4%。公司连续多年位居全球制药企业百强、中国医药研发产品线最佳工业企业前3强，是国家重点高新技术企业、国家技术创新示范企业。公司于2019年6月在香港联交所挂牌上市（股票代码：03692.HK）。更多信息请访问：https://cn.hspharm.com/。声明：1、翰森制药不推荐任何未获批药品使用或未获批适应症用药。 2、本新闻稿中的医疗信息仅供信息和新闻报道使用，不用于广告目的，不要将其用于医疗保健或诊断建议。前瞻性说明本新闻稿旨在提供关于翰森制药集团有限公司及其附属公司（包括其子公司，统称为“翰森制药”）的信息。它不构成对翰森制药或任何投资建议的信息披露。本新闻稿包含的信息可能包括与翰森制药业务和产品前景、计划、信念、预期和策略相关的前瞻性声明。这些声明是基于推测性假设的预测，并不保证未来的表现。它们受到诸如科学、商业、政治、经济、财务、法律因素以及竞争环境和社会条件等风险和不确定性的影响，这些因素很多都是翰森制药无法控制且难以预测的，因此实际结果可能与此处所述有显著差异，且过去的证券价格趋势不应作为未来行情的指导。因此，投资者在使用这些信息进行投资决策时应谨慎行事。“致力于”“预期”“相信”“预测”“意图”“预计”“可能”“将”“应该”“计划”“继续”“目标”“考虑”“估计”“指导”“潜在”“追求”以及于任何未来计划、行动或事件的讨论中使用的类似词语和术语，均表示前瞻性声明。翰森制药不承诺或保证前瞻性信息的准确性、及时性或完整性，并且不承担更新或修订这些前瞻性声明的义务。无论是翰森制药还是其任何董事、员工或代理人，均不对任何证明不准确或无法实现的前瞻性声明负责，也不对因依赖本新闻稿中提供的信息而产生的任何损失或损害负责，包括但不限于直接、偶然、间接或惩罚性的损害。本新闻稿中的所有信息均为发布之日的最新信息。翰森制药不承担因新发展、未来事件或其他情况而更新或修订这些信息的责任，除非法律要求。此外，翰森制药保留在任何时候未经通知对本新闻稿的全部或部分内容进行更改、更正或中断的权利。对于特别与上市公司有关的信息，公司鼓励投资者参考翰森制药（03692.HK）的公告和财务报告。 END

临床3期临床终止ASCO会议

2024-10-12

·药渡Daily

翰森制药「熬出头了」

2019年之前，翰森制药还是一家以仿制药为主的传统制药企业，仿制药业务收入和利润增速的放缓，让其下定决心转型创新药。然而，创新转型并非一帆风顺。2022年，翰森制药创新药数量从2019年之前的1款增加到7款，创新药收入占比也首次超过了仿制药，达到了50.6%，但也就是在这一年，翰森制药营收和净利润首次出现负增长。直到2024年中报业绩出炉，营收65.06亿元，同比增长44.21%，净利润27.26亿元，同比增长111.47%，创新药收入占比高达77.34%。一切质疑烟消云散，翰森制药进化到了势不可挡的阶段。创新药价值兑现仿转创从来都不只是一句口号。成立于1995年的翰森制药，以仿制药起家，经过二十几年的发展，上市的药物超过五十款，拥有包括奥氮平片、注射用培美曲塞二钠、注射用盐酸吉西他滨等年销售额超10亿元的首仿药品。虽说船大难掉头，但翰森制药管理层意识到随着竞争加剧，仿制药业务高速增长的时代已经过去，创新转型是唯一的道路。截至目前，翰森制药共有8款创新药（含合作产品）获批上市，包括阿美乐（甲磺酸阿美替尼片）、豪森昕福（甲磺酸氟马替尼片）、迈灵达（吗啉硝唑氯化钠注射液）、孚来美（聚乙二醇洛塞那肽注射液）、恒沐（艾米替诺福韦片）、昕越（伊奈利珠单抗注射液）、圣罗莱（培莫沙肽注射液）、希维奥（塞利尼索），涵盖肿瘤、自免、慢性病、抗感染等多个领域。翰森制药已上市创新药图片来源：华源证券这8款成功商业化的创新药，直接撑起了翰森制药近八成的营收，是其成功“仿转创”的底气所在。其中，阿美乐（阿美替尼）无疑是翰森制药最核心的创新产品，是中国首个原研的三代EGFR-TKI类创新药，2020年3月获批二线治疗EGFR T790M，2021年12月二线前移至一线。作为国内首款第三代EGFR抑制剂，阿美替尼享受到了充足的先发优势，上市的第三年，即2022年销售收入就达到了24亿元，2023年虽未披露数据，但从样本医药销售数据来看，依旧保持了较快的增长速度，外界预测约为35亿元，成为带动翰森制药创新药销售收入增长的绝对主力。然而，目前国内已有6款第三代EGFR抑制剂获批上市，还有奥赛康的Limertinib、强生的兰泽替尼已在国内申请上市，预计今年年底或者明年将会有8款第三代EGFR-TKI同台竞技。激烈的竞争下，翰森制药选择继续开拓阿美替尼的适应症，目前包括术后辅助、一线化疗联用在内的多个适应症正处在临床III期，另有两个适应症分别于今年7月、8月NDA获受理。除此以外，翰森制药的其他创新药也即将迎来快速放量：豪森昕福是国内首个自主研发的新型二代Bcr-Abl TKI，是我国首个在疗效和安全性上进行“双向优化”的新型TKI，获得国家卫健委《慢性髓性白血病诊断与治疗指南》以及《恶性血液病诊疗指南》推荐；恒沐是首个中国原研口服抗乙型肝炎病毒（HBV）药物，目前迎来上市3周年，成为翰森制药抗感染药物主力；昕越是全球唯一获批用于AQP4抗体阳性的视神经脊髓炎谱系疾病（NMOSD）成人患者治疗的人源化抗CD19单抗，目前安进正在进行IgG4相关疾病及重症肌无力适应症的临床工作，有望提升销量天花板…… 创新药收入占比的提高，让翰森制药的销售毛利率得到提升，2024年上半年，毛利率达到91.1%，较2023年同期提高2.97个百分点。 “务实”的研发策略翰森制药能在短短五年时间完成产品结构的彻底改变，离不开持续的研发投入。2019年-2023年，翰森制药研发投入分别为11.21亿元、12.52亿元、17.97亿元、16.93亿元、20.97亿元，2024年上半年，研发投入继续保持增长达到11.96亿元，同比增长28.7%。翰森制药研发开支（2019年-2024H1）除了已上市产品之外，目前翰森制药还有超过30个处于临床不同阶段的创新药项目正在开展超过50项临床，数款在研产品进入关键临床阶段。其中，HS-20093是国产进度第一的靶向B7-H3 ADC药物，目前正在中国进行多项用于治疗小细胞肺癌、肉瘤、头颈鳞癌及其他实体瘤的II期临床研究。2024 ASCO公布的研究数据显示，HS-20093在既往充分治疗的复发或难治性骨与软组织肉瘤患者中表现出了较强的抗肿瘤活性，优于临床现有标准治疗历史数据，且安全耐受性良好。有望2027年在国内获批上市。除了传统的抗肿瘤优势板块，翰森制药的非肿瘤产品管线也日益丰满。 HS-20094是一款GLP-1受体和GIP受体双重激动剂，在GLP-1降糖减肥药火遍全球的背景下，唯一的双靶点GLP-1替尔泊肽2024年上半年销售额达到66.56亿美元，同比增长329%。目前HS-20094降糖及减重适应症研发均处于临床II期，进度全球领先。此外，针对银屑病的TYK2药物HS-10374、针对慢性咳嗽的P2X3药物HS-10383、针对IgA肾病的ETA/AT1双受体拮抗剂HS-10390、针对精神分裂症的HS-10380，均具备广阔的市场前景，临床研究进度在国内或全球处于领先地位。仿制药起家的翰森制药，能在短时间内拥有强大的创新药研发管线，一方面来自自主研发，另一方面多元化的BD战略也发挥了举足轻重的作用。自2019年以来，翰森制药就积极通过外部合作来拓宽管线，近五年累计达成超20项BD合作，其中既有已成熟的创新产品，也有早期高差异化的项目。 2024年上半年，翰森制药在BD方面的表现依旧抢眼，先后与普米斯、荃信生物、麓鹏制药就EGFR/cMet 双抗、IL-23单抗、BTK抑制剂达成总金额高达68.36亿元人民币的授权合作。与其在仿制药上坚持做“首仿”类似，翰森制药在创新药研发策略上也以“me to”和“me better”为主，争取通过“国内首创”来抢占国内市场份额，同时凭借手上充足的现金流，四处寻找有潜力的管线进行BD合作，降低新药研发风险。在这种“务实”的战略下，翰森制药形成了大量梯次合理的研发管线，预计未来3年公司每年将有8-10个IND申请，2-3个NDA申请，至2025年将有15款以上的创新药（含新适应症）上市，创新药收入占比也将超过80%。借船出海由于中美医药市场对创新药支付能力的差距短期内无法消除，在国内创新药越来越内卷的情况下，国产创新药只有走向海外，才能充分兑现价值。在必须“出海”的前提下，如何出海成为摆在创新药企面前一个选择，主要有“造船出海”和“借船出海”（License out）两种模式。与百济神州、君实生物在海外铺设大量团队人员推进临床、商业化不同，翰森制药尽管拥有丰厚的现金储备，但在吸取恒瑞医药出海的“教训”后，选择了更为保守的License out的方式。作为翰森制药创新药的核心，阿美替尼早在2020年7月，就以超1亿美元价格将海外开发及商业化权益转让给了美国EQRx公司。2022年6月和12月，一线治疗EGFR突变晚期或转移性NSCLC上市申请，分别在英国（MHRA）和欧洲（EMA）获得受理。但在2023年8月，EQRx公司被Revolution收购，EQRx原有管线被放弃，阿美替尼也随之被退货，翰森制药重新获得其海外权益。目前阿美替尼正在进行与奥希替尼的头对头III期临床试验，可见翰森制药对奥希替尼疗效的信心，未来海外权益仍有机会授权给更有商业化能力的海外药企。如果说与EQRx的合作只是翰森制药出海的小试牛刀，那么与GSK的合作则显得更成熟。 2023年10月，以8500万美元首付款以及最多14.85亿美元的里程碑付款将HS-20089的海外权益授权给GSK；2023年12月，又以1.85亿美元首付款以及15.25亿美元里程碑付款将HS-20093的海外权益授权给GSK。以上两款产品商业化后，还将获得海外地区的全球净销售额分级支付特许权使用费。这两笔对外授权，无论是合作对象还是合作金额都与阿美替尼授权EQRx相比进步极大。HS-20089和HS-20093是分别靶向B7-H4、B7-H3的ADC药物，与GSK的合作充分验证了翰森制药技术平台的优势，走在了国产ADC出海的第一梯队。未来在GSK全力推动下，翰森制药ADC产品将更快实现创新价值。结语作为一家成立近30年的药企，翰森制药的发展充分诠释了“稳健”的魅力，无论是仿制药时代的以“首仿”为主，还是创新药时代自研+BD的模式降低研发风险，都是以公司长期盈利为目的，在业绩没有较大波动的情况下，以惊人的速度实现了从传统仿制药企向创新药企的华丽转变，估值逻辑也发生了根本性的变化。参考资料翰森制药官网、年报《翰森制药：国内领先创新驱动型BigPharma，出海提升价值空间》，华源医药，2024年05月31日

财报临床3期上市批准申请上市

2024-10-07

·PRNewswire

The Positive Topline Results From Phase III Study of UCB/Biogen's Dapirolizumab Pegol Brings a Ray of Hope in Systemic Lupus Erythematosus Therapeutic Space | DelveInsight

UCB and Biogen reported encouraging topline findings from the Phase III PHOENYCS GO trial, which assessed dapirolizumab pegol, a novel Fc-free anti-CD40L drug candidate, in individuals with moderate-to-severe SLE. The promising outcomes with dapirolizumab pegol signify significant advancements in creating treatments that can enhance the quality of life for individuals with lupus, a condition that continues to have considerable unmet medical needs, particularly impacting women. LAS VEGAS, Oct. 7, 2024 /PRNewswire/ -- Systemic lupus erythematosus is a long-lasting autoimmune disorder that can impact various areas of the body. Lupus arises when the immune system, typically responsible for defending against infections and illnesses, mistakenly targets the body's own tissues. This misguided response leads to inflammation and, in some instances, lasting damage to tissues, potentially affecting a wide range of organs including the skin, joints, heart, lungs, kidneys, blood cells, and brain. As per the estimates, the prevalence of systemic lupus erythematosus in the United States is approximately 500K cases in 2023. In females, prevalence rates are observed to be much greater than that of males, constituting more than 90% of the total prevalent cases in the US. In 2023, among the treated SLE patients, nearly 40% of patients became relapsed or refractory after the first line of therapy. The main goals of SLE treatment are to alleviate symptoms, prevent or reduce organ damage and disease flare-ups, minimize drug toxicity, and improve the patient's overall quality of life. The SLE treatment plan primarily includes antimalarial medications (like hydroxychloroquine), glucocorticoids (such as prednisone or similar), immunosuppressive drugs (including methotrexate, azathioprine, or mycophenolate), and biologics, in addition to nonsteroidal anti-inflammatory drugs (NSAIDs) for managing inflammation and pain. Biologics are specifically used for patients who do not respond to standard treatments or for those with severe, organ-threatening diseases. Currently, the biologics approved by the US FDA as adjunct therapies for SLE patients are BENLYSTA and SAPHNELO. In contrast, the use of rituximab for treating SLE is considered off-label. Learn more about the FDA-approved SLE drugs @ Drugs for Systemic Lupus Erythematosus Treatment BENLYSTA (belimumab) is a fully human monoclonal antibody that targets and inhibits BLyS (B-lymphocyte stimulator), a protein found at elevated levels in patients with systemic autoimmune diseases such as systemic lupus erythematosus and lupus nephritis. By binding to soluble BLyS, BENLYSTA prevents the prolonged survival of B cells, including autoreactive B cells, and reduces their differentiation into plasma cells that produce immunoglobulins. However, BENLYSTA does not directly bind to B cells. First approved by the US FDA in 2011, it is the only biologic therapy approved for the treatment of active SLE and LN in more than 50 years, including for pediatric patients. SAPHNELO (anifrolumab) is a fully human monoclonal antibody and the first of its kind, targeting subunit 1 of the type I interferon (IFN) receptor to inhibit type I IFN activity. Type I IFNs, including IFN-alpha, IFN-beta, and IFN-kappa, are cytokines that play a role in the inflammatory pathways associated with systemic lupus erythematosus. Most adults with SLE exhibit increased type I IFN signaling, which correlates with greater disease activity and severity. SAPHNELO has been approved for the treatment of SLE in over 60 countries, including the US, EU, and Japan, with ongoing reviews in additional regions. To know more about SLE treatment options, visit @ New Treatment for Systemic Lupus Erythematosus SLE pipeline possesses some drugs in mid and late-stage developments to be approved in the near future. The emerging landscape holds a diverse range of therapeutic alternatives for treatment, including Litifilimab (Biogen), Ianalumab (Novartis), Cenerimod (Idorsia/Viatris), Dapirolizumab pegol (UCB/Biogen), Telitacicept (RC18) (RemeGen), and others in different lines of treatment. The expected launch of these therapies shall further create a positive impact on the market. Discover which therapies are expected to grab major SLE market share @ Systemic Lupus Erythematosus Market Report Dapirolizumab pegol is a novel investigational treatment, consisting of a humanized, Fc-free antigen-binding (Fab') fragment conjugated with polyethylene glycol (PEG). It works by inhibiting CD40L signaling, which has been shown to reduce B cell activation, decrease autoantibody production, limit type 1 interferon (IFN) secretion, and suppress the activation of T cells and antigen-presenting cells (APCs). In September 2024, UCB and Biogen announced that the Phase III PHOENYCS GO trial achieved its primary goal, showing clinical improvements in patients with moderate-to-severe systemic lupus erythematosus. Additionally, key secondary endpoints, assessing disease activity and flare-ups, also demonstrated clinical improvements. Following the positive results from the PHOENYCS GO study, UCB and Biogen are launching a second Phase 3 trial of dapirolizumab pegol in 2024, named PHOENYCS FLY. Participants from the PHOENYCS GO study will continue to be monitored in a long-term open-label extension. Biogen is working on developing Litifilimab (BIIB059), an experimental humanized monoclonal antibody. This antibody specifically targets and binds to blood dendritic cell antigen 2 (BDCA2), a receptor found on plasmacytoid dendritic cells (pDCs). When BDCA2 is engaged, it inhibits the production of type I interferons (IFN-I) and other inflammatory molecules. BDCA2 is exclusively expressed on the surface of human pDCs. Litifilimab acts as an inhibitor of B-cell lymphocyte stimulator. Currently, Biogen is conducting Phase III clinical trials to evaluate its use for treating SLE. Ianalumab, developed by Novartis, is an antibody aimed at the B-cell activating factor receptor (BAFF-R). It is designed to inhibit BAFF-R signaling and deplete B cells through antibody-dependent cellular cytotoxicity. The drug is currently undergoing a Phase III clinical trial for systemic lupus erythematosus, with the company expecting to submit it for approval by 2027, according to a recent presentation. Cenerimod is an oral, once-daily tablet that acts as a highly selective modulator of the sphingosine-1-phosphate receptor 1 (S1P1). Although the exact cause of systemic lupus erythematosus is not fully understood, T and B lymphocytes are believed to be the primary immune cells involved in the disease's progression. These cells express the S1P1 receptor on their surface. In February 2024, Idorsia Pharmaceuticals formed a major global research and development partnership with Viatris to advance and commercialize two Phase III assets, selatogrel and cenerimod, on a global scale. Discover more about drugs for SLE in development @ Systemic Lupus Erythematosus Clinical Trials The anticipated launch of these emerging therapies for SLE 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 SLE market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for SLE is expected to grow from USD 3.2 billion in 2023 with a significant CAGR by 2034. This growth is mainly driven by ongoing clinical research and better diagnostic tools that might improve the prognosis of the disease. DelveInsight's latest published market report titled as Systemic Lupus Erythematosus 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 SLE country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The SLE market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total SLE Diagnosed Prevalent Cases Total SLE Diagnosed Prevalent Cases by Gender Total SLE Diagnosed Prevalent Cases by Age SLE Severity-Based Diagnosed Prevalent Cases Total SLE Treated Cases The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM SLE market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this SLE 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 SLE market. Also, stay abreast of the mitigating factors to improve your market position in the SLE therapeutic space. Related Reports Systemic Lupus Erythematosus Pipeline Systemic Lupus Erythematosus Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key myasthenia gravis companies, including Yake Biotechnology, UCB, Sorrento Therapeutics, SinoMab Bioscience Ltd, Shanghai Junshi Biosciences, Sareum, Sanofi, Roche, Rheos Medicine, Resolve, Provention Bio, Pfizer, Novartis, Neovacs, Merck, Medsenic, Landos Biopharma, Kezar Life Sciences, Kangpu Biopharmaceuticals, Janssen Research & Development, Janssen, InnoCare, ImmuPharma, I-MAB Biopharma, ILTOO, Idorsia Pharmaceuticals, Horizon Therapeutics, Genovax, Exinda Thearapeutics, Equillium, Eli Lilly and Company, Eisai, Daiichi Sankyo Company, Corestem, Corbus Pharmaceuticals, Citryll BV, Chipscreen Biosciences, Carna Bioscience, Bristol-Myers Squibb, Brickell Biotech, Boston Pharmaceuticals, Biogen, Athos Therapeutics, Asahi Kasei Pharma, Aria Pharmaceuticals, Antengene Therapeutics, Amgen, Alpine Immune Sciences, Akeso Biopharma, AbbVie, among others. Systemic Lupus Erythematosus Epidemiology Systemic Lupus Erythematosus Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted SLE epidemiology in the 7MM. Lupus Nephritis Market Lupus Nephritis Market Insights, Epidemiology, and Market Forecast – 2034 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 lupus nephritis companies, including NOVARTIS, MORPHOSYS, ASTRAZENECA, ROCHE, KEZAR LIFE SCIENCES, ALEXION PHARMACEUTICALS, NOVARTIS, CABALETTA BIO, among others. Lupus Nephritis Pipeline Lupus Nephritis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key lupus nephritis companies, including Inflection Biosciences, Equillium, Roche, Horizon Therapeutics, BeiGene, Janssen Research & Development, ImmPACT Bio, 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

100 项与培莫沙肽相关的药物交易

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适应症	国家/地区	公司	日期
伴随慢性肾病的贫血	中国	江苏豪森药业集团有限公司	2023-06-30

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适应症	最高研发状态	国家/地区	公司	日期
肾性贫血	临床3期	中国	江苏豪森药业集团有限公司	2019-05-15
慢性肾衰竭贫血	临床3期	中国	江苏豪森药业集团有限公司	2019-05-15
骨髓增生异常性贫血	临床1期	中国	江苏豪森药业集团有限公司	2014-06-20
骨髓增生异常综合征	临床1期	中国	江苏豪森药业集团有限公司	2014-06-01

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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


NCT03902691 (Literature) 人工标引	临床3期	慢性肾衰竭贫血	372	pegmolesatide	築築網積窪餘獵蓋艱窪(願齋鏇鬱積遞積糧衊襯) = 衊網願繭簾願衊網築壓壓餘簾糧築築襯淵窪構 (鹽鬱衊簾積憲壓鹹遞選, 0.92) 更多	非劣	2023-10-28
NCT03902691 (Literature) 人工标引	临床3期	慢性肾衰竭贫血	372	epoetin alfa	築築網積窪餘獵蓋艱窪(願齋鏇鬱積遞積糧衊襯) = 淵膚淵積壓築淵鹽鏇顧壓餘簾糧築築襯淵窪構 (鹽鬱衊簾積憲壓鹹遞選, 0.97) 更多	非劣	2023-10-28
ISN WCN2022	N/A	伴随慢性肾病的贫血	372	Pegmolesatide	鹹鹽顧衊膚廠醖鹽製憲(壓蓋選廠鑰壓膚顧鬱鬱) = 1.6% who received Pegmolesatide and 3.2% who received the Epoetin alfa 鑰鬱襯鹹憲觸壓觸夢齋 (選齋簾鏇築襯積壓選鹹 ) 更多	积极	2022-02-01