A Phase 2, Multicenter, Open-Label, Single-arm Study to Evaluate the Efficacy and Safety of TAK-226 for Transfusion-Dependent Anemia in Japanese Patients With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes

The main aim of the study is to evaluate how TAK-226 improves symptoms of transfusion-dependent anemia in Japanese patients with lower-risk myelodysplastic syndromes.
The study consists of Screening Period (up to 6 weeks), Treatment Period , Safety Follow-Up Period (8 weeks), and Long-Term Follow-Up Period (5 years from the first dose of the study drug or 3 years after the last dose, whichever is longer).
Participants of this study will be administered TAK-226 during Treatment Period. Subsequently, the participants will be monitored for side effects related to the study treatment during Safety Follow-Up Period and Long-Term Follow-Up Period. The approximate duration of participation for a participant is up to approximately 6 years.
During the study period, participants will visit the study clinic/hospital multiple times as per the study schedule. During Treatment Period, the participants will come to the clinic/hospital approximately every two to four weeks.

开始日期2026-02-06

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

NCT06499285

/ Recruiting临床3期

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elritercept (KER-050) for the Treatment of Transfusion-Dependent Anemia in Adult Participants With Very Low-, Low-, or Intermediate-Risk Myelodysplastic Syndromes (MDS) (RENEW)

The main aim of this study is to find out how well elritercept works in lowering the need for RBC transfusions. Other aims are to learn how well elritercept works in reducing the need for RBC transfusions over longer periods of time or in adults with high transfusion needs. The study will also check on how safe elritercept is and how well it is tolerated.

开始日期2025-05-06

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

CTR20242732

/ Recruiting临床2期

HS-20106在IPSS-R极低危、低危或中危骨髓增生异常综合征（MDS）贫血受试者中的有效性、安全性和药代动力学的II期临床研究

评估HS-20106皮下注射（SC）给药治疗在IPSS-R极低危、低危或中危MDS导致贫血的受试者中的有效性。

开始日期2024-11-14

申办/合作机构

上海翰森生物医药科技有限公司

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100 项与艾利西普相关的临床结果

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100 项与艾利西普相关的转化医学

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100 项与艾利西普相关的专利（医药）

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项与艾利西普相关的文献（医药）

2025-12-01·Current Hematologic Malignancy Reports

Emerging Therapeutic Approaches for Anemia in Myelofibrosis

Review

作者: Harrington, Patrick ; Palumbo, Giuseppe A ; Chifotides, Helen T ; Duminuco, Andrea ; Torre, Elena ; Bose, Prithviraj ; Vetro, Calogero

PURPOSE OF REVIEW:

In this review, we highlight conventional agents and novel emerging therapeutic strategies to treat anemia in MF.

RECENT FINDINGS:

Anemia is a common and challenging feature of myelofibrosis (MF). The pathobiology of anemia is multifactorial, including progressive bone marrow fibrosis, decreased erythropoiesis due to high hepcidin levels leading to iron sequestration in the reticuloendothelial system, hypersplenism, erythropoiesis inhibition by myelosuppressive JAK inhibitors (ruxolitinib, fedratinib), and others. MF-associated anemia has a negative impact on survival. Conventional agents to manage anemia include erythropoiesis-stimulating agents, danazol, corticosteroids, and immunomodulatory agents, but responses are infrequent and lack durability. Notable advancements have emerged in developing novel treatments for anemia in MF, including the regulatory approval of momelotinib (ACVR1/JAK1/2 inhibitor) in 2023 and development of novel promising agents targeting hemojuvelin and activins. Momelotinib and pacritinib (ACVR1/JAK2 inhibitor) are the preferred JAK inhibitors for patients with cytopenias (anemia, thrombocytopenia). Luspatercept and elritercept are activin receptor ligand traps, promoting erythroid maturation and late-stage erythropoiesis. Currently, luspatercept is being evaluated in a phase 3 trial (INDEPENDENCE™) for anemia in MF patients who are on a JAK2 inhibitor and require transfusions, and in a phase 2 trial (ODYSSEY) in combination with momelotinib in MF patients who are transfusion dependent, whether or not on a JAK inhibitor. Interim results of the RESTORE trial demonstrated that elritercept significantly decreased transfusions in MF patients. DISC-0974 is a first-in-class anti-hemojuvelin (positive hepcidin regulator) monoclonal antibody that decreased hepcidin expression, increased serum iron, and enhanced erythropoiesis in anemic patients with MF in a phase 1b/2 study. Burgeoning studies of novel anemia-targeted agents and combinations are significantly improving the quality of life and outcomes of patients with MF. The recent approval of momelotinib to treat MF with anemia and the emerging novel anemia-directed strategies in early and advanced clinical development have ushered in a new era in the treatment of MF-related anemia.

2025-06-01·AMERICAN JOURNAL OF HEMATOLOGY

Emerging Pathogenetic Mechanisms and New Drugs for Anemia in Myelofibrosis and Myelodysplastic Syndromes

Review

作者: Tefferi, Ayalew ; Gangat, Naseema

ABSTRACT:

Anemia in myeloid neoplasms is multifaceted, with heterogeneous pathogenetic mechanisms that include ineffective erythropoiesis, hepcidin‐induced iron‐restricted erythropoiesis, and abnormal inflammatory cytokine production. Current management of anemia is challenged by limited approved drugs that specifically treat anemia in myelofibrosis (MF) and myelodysplastic syndrome (MDS). Newer therapies target the transforming growth factor beta (TGF‐β)‐bone morphogenic protein/sons of mothers against decapentaplegic (BMP‐SMAD) signaling pathway, which plays a significant role in ineffective erythropoiesis (SMAD 2/3) and abnormal hepcidin production (SMAD 1/5/8). These include TGF‐β ligand traps (luspatercept, elritercept), activin A receptor type 1 (ACVR1)/activin receptor‐like kinase 2 (ALK2) inhibitors (momelotinib, zilurgisertib), and anti‐hemojuvelin antibody‐based therapies (DISC‐0974). Luspatercept and momelotinib are approved for anemia related to lower‐risk MDS and MF, respectively, and represent an important addition to the treatment armamentarium, along with imetelstat, a telomerase inhibitor, recently ratified for anemia in lower‐risk MDS. A promising strategy to overcome the limitations of existing anemia‐directed therapies includes the use of drug combinations with complementary mechanisms (luspatercept + erythropoiesis stimulating agents, luspatercept + momelotinib, DISC‐0974 + momelotinib), and harnessing the erythropoietic potential of sodium‐glucose co‐transporter‐2 inhibitors (SGLT‐2I). Future research should address the complex pathophysiology of anemia, standardize definitions for anemia with gender‐specified cutoffs, implement uniform erythroid response criteria, and consider early therapeutic intervention in clinical trials for anemia‐directed therapies.

2025-03-01·HEMATOLOGICAL ONCOLOGY

Managing Myelofibrosis: Matching Advances in Treatments With Clinical Unmet Needs

Review

作者: Chan, Tze Wei ; Than, Hein ; Huang, Feng‐Ju ; Billa, Gauri ; Lee, Lai Heng

ABSTRACT:

Myelofibrosis (MF) is characterized by anemia, constitutional symptoms, hepatosplenomegaly and bone marrow fibrosis, and is associated with poor survival. The janus kinase inhibitor (JAKi) ruxolitinib has been the mainstay of treatment for over a decade. Despite demonstrated symptomatic and quality of life improvement, unmet clinical needs persist. A literature review identified promising novel targeted treatment options in MF using pre‐set selection criteria (available Phase 2 or 3 data, minimum enrollment of 50 patients, trial end date within the last 5 years). Available data for novel and approved therapies were extracted, tabulated, and analyzed for clinical relevancy. From an initial shortlist of 48, 16 retained molecules were selected for inclusion. Other JAKi (pacritinib, momelotinib, jaktinib) address treatment‐related cytopenia, expanding the therapeutic utility of this class of agents to patients with baseline anemia or thrombocytopenia. Novel candidates exploit multiple molecular pathways, and offer the potential to improve the management of MF‐associated cytopenia (imetelstat, pelabresib, navitoclax, selinexor, luspatercept, sotatercept, elritercept, LCL161, bomedemstat) and recover bone marrow fibrosis (imetelstat, pelabresib, navitoclax and bomedemstat). It remains to be seen if these newer agents can induce any remission in MF and enable patients to come off therapy, but the future is beginning to look much brighter.

129

项与艾利西普相关的新闻（医药）

2025-12-04

·药研碎碎念

武田（Takeda）肿瘤管线观察笔记2.0

数据与信息整理截至 2025 年 12 月；若与官方披露有出入，以官方披露为准。监管状态因地区而异（FDA / EMA / PMDA / NMPA 等），适应症、给药方案、警示及限制可能不同；如与本文描述不一致，请以当地最新标签（USPI / SmPC / PMDA 批准文件等）为准。HTA 与定价报销结论（NICE / G-BA / HAS 等）不等同于监管批准。导读要点（Overview）从“十几种模态”收缩到 3 种核心模态2024–2025 年，武田完成约 9 亿美元规模的研发重组，将整体 R&D 模态从 10–12 种收窄至：小分子、生物制剂、ADC，原本作为核心之一的同种异体细胞治疗被逐步“边缘化”，并在 2025-10 正式决定退出肿瘤细胞治疗，转而寻求对外打包合作。 “小而密集”的 BD 风格：区域+技术拼图Shire 大并购之后，武田在肿瘤领域明显偏好中等体量的技术/区域性交易：以 400M 美元首付拿下 HUTCHMED 的 fruquintinib 海外权（FRUZAQLA）；支付 300M 美元首付从 Protagonist 引进 hepcidin 模拟物 rusfertide；支付 200M 美元首付从 Keros 引进 activin 抑制剂 elritercept； 2025-10 与 Innovent 达成最高约 114 亿美元的多产品合作（IBI363 / IBI343 + 1 个期权资产）。重组后的“六大晚期项目”里，肿瘤占据一席截至 2025-10，官方披露的“精选晚期肿瘤管线”核心为：elritercept、mirvetuximab soravtansine（日本权益）、rusfertide、TAK-168（KQB168）四个项目。武田希望它们能构成新一轮 100–200 亿美元峰值销售组合中的关键一环。细胞治疗：高位进入，高位撤出过去 5 年内，武田通过收购 GammaDelta / Adaptate、收购 Maverick 等动作，构建了 γδT、CAR-NK、COBRA 条件激活双抗等平台，但在 2024–2025 年的优先级重排中，TAK-007 等细胞项目从肿瘤领域“被迁出”或停掉，2025 年彻底宣布退出肿瘤细胞治疗临床。区域协同：日本 / 亚洲 + 中国合作的“杠杆位”Fruquintinib（FRUZAQLA）与 Ascentage 的 olverembatinib、HUTCHMED / Innovent 等合作，显示武田在 “以日本 / 亚洲商业化经验 + 全球渠道”换取来自中国的 FIC / 明显差异化资产的意愿与能力。观察：武田现在更像一个“干净资本纪律+多区域拼图”型买家：喜欢已经过 PoC 或接近注册的资产、清晰肿瘤领域（胸部肿瘤 / 消化道 / 血液恶性肿瘤）、以及可以嵌入其现有商业通路的产品，而不是再去“豪赌一个全新模态”。01｜交易战略画像：资本纪律与“区域+模态”配比1.1 从扩张到“资本纪律” Shire 并购之后，武田在肿瘤方向更强调 ROIC 与现金流约束：不再追求 Immunomedics 式 200 亿美元级单笔收购；转向 3–4 亿美元级首付 + 里程碑/分成的 BD 结构（Fruquintinib、oliverembatinib、rusfertide、elritercept 等均属此类）。 2024–2025 年 R&D 重组后，肿瘤板块被要求在更高门槛下“自证价值”：多个中期项目（modakafusp alfa、subasumstat、TAK-007 等）被下调或转向其他适应症；新引进资产必须在潜在峰值、差异化、组合空间三者间给出清晰故事。1.2 典型交易样式（2021–2025）平台或关键品种引进（全球或除中国） Fruquintinib（HUTCHMED）：400M 美元首付 + 里程碑；FRUZAQLA 于 2023 获 FDA 批准治疗经治 mCRC；2024 年获欧盟批准。 Rusfertide（Protagonist）：300M 美元首付，polycythemia vera 用 hepcidin 模拟物，2025 年 VERIFY III 期达到主要终点，计划 2025 年底向 FDA 递交 NDA。 Elritercept（Keros）：200M 美元首付 + 里程碑，针对 MDS / MF 相关贫血，2025 年 RENEW III 期启动。: 中国合作（双向）与 HUTCHMED：fruquintinib 海外权；与 Ascentage：最高 13 亿美元 biobucks 的 olverembatinib 许可期权；与 Innovent：1.2B 美元前期（含 100M 股权）+ 最高约 10.2B 里程碑，用于 IBI363、IBI343 及一项早期管线的海外开发与商业化。模态/平台收购 2021–2022 收购 GammaDelta / Adaptate / Maverick，搭建 γδT、T 细胞 engager（COBRA）平台； 2024–2025 年在细胞治疗和部分双抗上Write-down / Write-off，并宣布退出自研肿瘤细胞治疗临床，准备将平台整体打包寻求合作方。观察：武田当前偏好的是： “后期+清晰商业化路径”的资产（如 rusfertide / fruquintinib），配合其重点瘤种（血液 / 胸部 / GI）的差异化 FIC / BIC，以及可通过日本 / 亚洲 or 全球通路迅速兑现的产品。对“平台型早期技术”，除非能直接嵌入现有模态（ADC / 生物制剂 / 小分子），否则门槛明显抬高。02｜战略需求与“缺口” 结合公开讲话与管线，可以大致拆成三块：2.1 血液肿瘤：守住 Millennium 传统 + 新一代骨髓与骨髓增殖性疾病过去优势集中在多发性骨髓瘤（Velcade / Ninlaro）、CML（Iclusig），现在押注 PV / MDS / MF 等慢性/骨髓疾病： rusfertide（PV）、elritercept（MDS / MF 贫血）被视作下一代“血液基础疗法”。观察：可以与 rusfertide / elritercept 组合或序贯的小分子 / 抗体 / ADC；针对骨髓环境、纤维化、铁代谢等的新机制，使其血液板块不只是“老产品延伸”。2.2 胸部 / 消化道实体瘤：FRUZAQLA 之后的“第二层楼” Fruquintinib（FRUZAQLA）在经治 mCRC 打开局面之后，武田需要：更多 GI / 胆胰 / 肝癌方向的靶向药 & IO，以及围绕 FRUZAQLA 的联合策略（如与 IO / 抗血管其它药物的序贯/联合）。观察： GI 方向的 FIC 或“强 BIC”（例如新的 VEGFR / CLDN18.2 / FGFR / KRAS 周边组合）；能在日本 / 亚洲 + 全球同时落地的注册路径和真实世界数据设计。2.3 IO / 免疫微环境：STING / SUMO / TCE 的下一步武田仍保留 STING 激动剂（TAK-676 / TAK-500）与 SUMO E1 抑制剂 subasumstat（TAK-981）作为免疫微环境工具，但这些项目在 2024–2025 的重组中被“严格筛选”，节奏趋于谨慎。观察：能够明显提升当前 STING / SUMO 组合疗效 or 提供更清晰生物标志物分层的外部项目；在毒性 / 免疫相关 AE 方面有可见优势，便于和现有免疫组合拼接。小结：武田不缺项目，而在于缺能与既有基石资产（Ninlaro / Fruzaqla / 未来 rusfertide / elritercept）形成可信组合故事的项目。要是讲清楚“如何与这些基石药协同，而不是抢饭碗”，会更符合它的内在需求结构。03｜技术平台版图：已掌握 vs. 正在修补3.1 已掌握 1）传统靶向与蛋白酶体抑制剂 Ninlaro（ixazomib）：口服蛋白酶体抑制剂，多发性骨髓瘤维持治疗的重要一环。 Alunbrig（brigatinib）：源自 ARIAD 并购的 ALK TKI，布局 ALK+ NSCLC。 Iclusig（ponatinib）：BCR-ABL TKI，针对 T315I 等耐药突变人群。 2）抗体 / ADC 与合作产品 Adcetris（brentuximab vedotin）：与 Seagen 合作的 CD30 ADC，用于霍奇金淋巴瘤 / 外周 T 淋等，已进入成熟品种管理阶段。 FRUZAQLA（fruquintinib）：VEGFR1/2/3 TKI，经治 mCRC；是武田近年在实体瘤上最重要的新品种之一。 3）“精选晚期肿瘤管线” Rusfertide：PTG-300，hepcidin 模拟物，针对 PV；III 期 VERIFY 已达主要终点，计划 2025 Q4 提交 NDA。 Elritercept（TAK-226）：activin 受体配体抑制剂，针对 MDS / MF 相关贫血；III 期 RENEW 开展中。 Mirvetuximab soravtansine：Folate receptor α ADC，日本权益在武田；作为局部桥接/注册策略的一部分。 TAK-168（KQB168）：源自 Kumquat 的小分子肿瘤项目，仍处于 I 期，但被列入“重点晚期管线”，反映管理层对其潜力的看重。3.2 正在修补 1）细胞治疗：从“自有平台”到“寻求外部接盘” 通过 GammaDelta / Adaptate 收购建立的 γδT & 相关 engager 平台，以及基于 TAK-007 等项目的 CAR-NK 开发，曾被视作第四大模态。但 2024–2025 的重组 + 投资者压力下，武田宣布退出肿瘤细胞治疗研究，并不再维持相关临床试验，转而希望将该平台整体与前期管线打包给外部伙伴。观察：武田有细胞治疗 IP / 生产资产，等待合适买家；在可预见的未来，几乎不会是 CAR-T / CAR-NK 等新项目的积极出价方。 2）COBRA 条件激活 T 细胞偶联平台通过收购 Maverick 获得，理论卖点是“肿瘤局部激活 + 外周低毒性”； 2024–2025 管线精简中，部分 COBRA 项目被关停，平台本身仍在评估“保留哪些资产继续推进”。 3）免疫微环境小分子：STING / SUMO TAK-676 / TAK-500：系统性/局部 STING 激动剂；在 ASCO 等会议上披露早期数据，仍处于 I/II 期探索。 Subasumstat（TAK-981）：SUMO E1 抑制剂，在 R&D 优先级重排中受到影响，节奏趋缓，但仍作为一个选项存在。整体看：武田已经把肿瘤管线缩减到少数“可以讲清楚商业故事的晚期品种 + 少数还在下注的免疫平台”，所有“模糊不清的早期多模态故事”都在 2024–2025 年中被强行剪掉。04｜重点资产与管线（精选）4.1 已上市 / 商业阶段名称机制 / 类型适应症 / 区域战略 / 商业备注Adcetris（brentuximab vedotin） CD30 ADC 霍奇金淋巴瘤、外周 T 淋（与 Seagen 合作）成熟品种，重点在于生命周期管理与新进入者竞争。Ninlaro（ixazomib）口服蛋白酶体抑制剂多发性骨髓瘤作为 Velcade 之后的口服延伸，维系血液肿瘤现金流。Alunbrig（brigatinib） ALK TKI ALK+ NSCLC ARIAD 并购资产之一，在头部竞争者林立背景下保持细分地位。Iclusig（ponatinib） BCR-ABL TKI CML / Ph+ ALL 聚焦耐药突变人群，更多承接难治患者。FRUZAQLA（fruquintinib） VEGFR1/2/3 TKI 经治 mCRC（中国外）与 HUTCHMED 合作的成功范例，为 GI 板块提供里程碑式新品。4.2 晚期 / 注册向管线名称机制 / 类型适应症阶段 / 要点战略备注Rusfertide Hepcidin 模拟肽 Polycythemia vera III 期 VERIFY 已达到主要终点；计划 2025 Q4 提交 NDA。被视作潜在 10–20 亿美元峰值资产之一，有望成为 PV 管理新基石。Elritercept（TAK-226） Activin 信号通路调节剂 MDS / MF 相关贫血 II 期数据积极，III 期 RENEW 进行中。武田试图在“超越 Reblozyl”的贫血治疗空间中占据一席。Mirvetuximab soravtansine FRα ADC 卵巢癌等 FRα 高表达肿瘤（日本）全球已上市，武田负责日本开发与商业化，定位为区域性高价值品种。体现“引入成熟 ADC → 区域放大”的策略。TAK-168（KQB168）小分子（来自 Kumquat 平台）实体瘤 I 期早期研究，但被官方放入“精选晚期肿瘤管线”图中。代表武田对合成致死 / 代谢 / 新通路小分子的中长期押注。4.3 中国合作名称合作方机制 / 类型进展要点战略备注FRUZAQLA（fruquintinib） HUTCHMED VEGFR TKI 2023 美国获批、2024 欧盟获批，经治 mCRC。 “中国原创药 → 全球”的标杆式合作，验证武田在 GI + 区域协同上的玩法。Olverembatinib Ascentage 第三代 BCR-ABL TKI 中国已批准用于特定 CML 人群，武田拥有全球其他地区潜在许可权（biobucks 约 13 亿美元）。与 Iclusig 形成代际/毒性结构上的互补。IBI363 / IBI343（+1 期权资产） Innovent PD-1/IL-2α-bias 融合蛋白 & CLDN18.2 ADC 2025-10 公告：Takeda 付 12 亿美元前期（含 1 亿股权）+ 最高约 102 亿美元里程碑，获得除大中华区外全球权益。这是武田 2025 年最重磅 BD，为其中/长期胃癌 / 胰腺 / 肺等实体瘤组合增加大量“弹药”。关于 IBI363 的战略卡位（补充）：从机制上看，IBI363 是一款 PD-1/IL-2α-bias 双特异抗体融合蛋白，既阻断 PD-1/PD-L1 通路，又选择性激活 IL-2 通路，优先扩增同时表达 PD-1 和 IL-2Rα 的肿瘤特异性 T 细胞，理论上有望同时解决 “PD-1 耐药” + “冷肿瘤不应答” 两个问题。从对价结构看，12 亿美元前期付款（含 1 亿美元股权）+ 最高 102 亿美元里程碑，在已披露的武田肿瘤 BD 中，是目前前期金额最高的一笔 IO 类交易之一，也被多家媒体解读为“押注 2030 年代增长曲线的关键拼图”。推断：武田在内部 STING / SUMO 等早期 IO 平台进展不及预期的背景下，通过一次高额前期对价，引入一个有潜力作为全球 IO backbone（“主干药”）的资产，用于补足实体瘤 IO 版图，而不是继续依赖自研早期平台来撑起整个 IO 故事（这一点是基于交易规模与公开管线优先级的推断，而非公司明示表态）。05｜交易历史（仅列与肿瘤相关、且对后续趋势有代表性的交易）时间对象 / 资产类型公开对价 / 结构战略要义 2025-10 Innovent（IBI363 / IBI343 + 期权资产）全球合作（除大中华） 1.2B 美元前期 + 最高约 10.2B 里程碑以多产品包的方式“锁定”中国新一代 IO+ADC 资源，强化中长期 GI / 胸部肿瘤组合。 2023–2024 Protagonist（rusfertide）许可 300M 美元首付 + 里程碑血液肿瘤方向最重要的 in-licensing，锚定 PV 领域。 2024-12 Keros（elritercept）许可 200M 美元首付 + 里程碑通过 activin 通路补强 MDS / MF 贫血治疗布局。 2022–2023 HUTCHMED（fruquintinib 海外权）许可 400M 美元首付 + 里程碑高度成功的“中国产品全球化”合作，为后续中国 BD 树立模板。 2021–2022 GammaDelta / Adaptate 并购未披露构建 γδT + engager 平台，后来在 2025 细胞治疗退出中部分减值。 2021 Maverick（COBRA）收购（期权行权）最高约 5.25 亿美元获取 COBRA 条件激活 T 细胞偶联平台，现处于“项目筛减后精简推进”阶段。小结：武田愿意为验证性强、可预见商业化路径的项目付出明显首付（300–400M 量级）；对中国合作对象，典型模式是：对方贡献 FIC / BIC 资产 + 中国开发；武田提供 ex-China 开发+商业化；细胞治疗 / γδT / 早期双抗收购则是“反例教材”，表明其现在对早期平台的容忍度显著下降。06｜未来关键观测点（What to Watch） Rusfertide：NDA 递交与审评节奏若 2026 年获批并顺利放量，将为武田血液板块提供新的“基石药”，也会强化其对 hepcidin / 铁代谢方向的外部兴趣。 Elritercept：与 Reblozyl 的对位关系 III 期 RENEW 结果、贫血缓解深度与安全性，将决定其是否能在 MDS / MF 领域形成差异化。 FRUZAQLA 的联合策略与适应症扩展武田是否会推动与 IO / 其它靶向药的联合试验，以及在结直肠癌以外 GI 肿瘤的布局。 Innovent 资产的全球转化能力 IBI343（CLDN18.2 ADC）能否在全球 CLDN18.2 竞赛中脱颖而出； IBI363 的 IL-2α 偏向机制能否在安全性/耐受上形成差异化。细胞治疗资产如何“出清” 武田何时、以何种方式把 γδT / CAR-NK 平台打包给外部公司，将决定其在细胞治疗赛道上的“谢幕方式”。07｜关键风险 1）晚期管线相对单薄虽然官方宣传“历史上最强的晚期管线”，但就肿瘤板块而言，真正进入注册视野的项目（rusfertide / elritercept / FRUZAQLA 联合）数量有限，一旦出现重大挫折，板块波动会放大。 2）细胞治疗“高位撤退”的后遗症连续收购 GammaDelta / Adaptate / Maverick 后退出肿瘤细胞治疗，既有财务减值，也会让市场质疑其对新模态的耐心；外部合作方对“长期承诺”的信心需要重新建立。 3）监管与区域差异Exkivity（mobocertinib）在美国撤回加速批准、在日本和若干亚洲市场继续确证，是一个典型范例：不同地区对终点和安全性的偏好差异会带来时间差与标签差异。 4）中国合作的“政策与情绪风险”虽然武田高层公开强调“不能忽视来自中国的创新”，但同时也提到需要在 BIOSECURE 等政策背景下“谨慎前行”——这意味着合作更看重合规、数据可追溯与供应链安全。小结：重心应放在 GI / 血液恶性肿瘤 / 胸部肿瘤，模态以小分子 / 抗体 / ADC 为主；需备好跨区域 CMC、数据完整性、合规说明，降低“中国风险”在内部决策中的阻力。版权说明：本文基于公开资料整理，供行业交流，不构成投资或医疗建议。转载请注明出处。【免责声明 (Disclaimer)】本文所含信息和观点仅供参考，纯属作者基于公开信息的分析与推演，不构成任何形式的要约、招揽、推荐、承诺或保证。非专业意见：本文不构成任何投资、法律、会计、税务或医疗建议。读者不应将本文内容作为任何决策的唯一依据。信息时效性与准确性：本文信息均来源于截至 [2025年12月] 作者认为可靠的公开资料。作者不对此类信息的准确性、完整性或时效性作任何明示或暗示的保证。文中所含信息或意见可能会在不发出通知的情况下做出更改。所有信息请以相关实体的官方公告为最终依据。前瞻性陈述：本文可能包含基于作者当前预期、假设和预测的“前瞻性陈述”。此类陈述本质上具有不确定性和风险，实际结果可能与预期大相径庭。责任限制：在任何情况下，作者均不对任何人因使用或依赖本文任何内容所引致的任何损失（无论是直接的、间接的、后果性的）承担任何责任。来源(节选)： https://assets-dam.takeda.com/image/upload/v1761317469/Oncology/Science/Pipeline/Oncology_Pipeline.pdf https://www.takedaoncology.com/science/pipeline/ https://www.takeda.com/newsroom/newsreleases/2025/positive-topline-results-from-verify-study/ https://www.takeda.com/newsroom/newsreleases/2025/polycythemia-vera-rusfertide-study/ https://clin.larvol.com/trial-detail/NCT05210790 https://www.takeda.com/newsroom/newsreleases/2024/elritercept-licensing-agreement/ https://www.takedaoncology.com/newsroom/news-releases/2024/elritercept-licensing/ https://ir.kerostx.com/news-releases/news-release-details/keros-therapeutics-announces-global-license-agreement-takeda https://ir.kerostx.com/news-releases/news-release-details/keros-therapeutics-announces-effectiveness-global-license https://www.takeda.com/newsroom/newsreleases/2023/takeda-to-acquire-exclusive-worldwide-ex-china-license-of-hutchmeds-fruquintinib-a-highly-selective-oral-vegfr123-tyrosine-kinase-inhibitor/ https://www.hutch-med.com/closing-of-fruquintinib-license-to-takeda-outside-china/ https://www.hutch-med.com/fruquintinib-outside-china-partnership-with-takeda/ https://www.biospace.com/hutchmed-reports-2024-interim-results-and-provides-business-updates https://www.takeda.com/newsroom/newsreleases/2025/innovent/ 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并购细胞疗法抗体药物偶联物免疫疗法申请上市

2025-11-20

·谈医说药

2025年11月20日药品临床试验默示许可

序号受理号药品名称申请人名称适应症注册分类 1 CXSL2500783 FS-8002注射液上海菩莳医药科技有限公司本品联合JS212±化疗治疗恶性实体瘤。 1 2 JXSB2500131 Mezagitamab注射剂 Takeda Development Center Americas, Inc. 原发性免疫性血小板减少症 1 3 JXHB2500134 BI 1291583 片 Boehringer Ingelheim International GmbH 治疗支气管扩张症 1 4 CXHL2500994 伯瑞替尼肠溶胶囊北京浦润奥生物科技有限责任公司用于一线治疗具有间质-上皮转化因子（MET）蛋白过表达的局部晚期或转移性非鳞非小细胞肺癌（NSCLC）患者 2.4 5 CXSL2500780 注射用JS212 上海君实生物医药科技股份有限公司本品联合用药（JS207或特瑞普利单抗或AWT020或FS-8002)±化疗或联合AP-L1898或联合化疗治疗恶性实体瘤。 1 6 CXSL2500786 注射用HS-20110 上海翰森生物医药科技有限公司;常州恒邦药业有限公司本品联合贝伐珠单抗联合化疗用于晚期结直肠癌患者的治疗。 1 7 CXSL2500784 注射用HMPL-A251 和记黄埔医药（上海）有限公司 HMPL-A251拟用于不可切除的、局部晚期或转移性的HER2表达的实体瘤成人患者。 1 8 CXSL2500779 注射用GEN1184 金麦安博生物制药（苏州）有限公司局部晚期或转移性非小细胞肺癌. 1 9 CXSL2500787 帕博利珠单抗注射液上海宏成药业有限公司黑色素瘤；非小细胞肺癌；食管癌；头颈部鳞状细胞癌；结直肠癌；肝细胞癌；胆道癌；三阴性乳腺癌；微卫星高度不稳定型或错配修复基因缺陷型肿瘤；胃癌；宫颈癌；尿路上皮癌。 3.3 10 CXSL2500781 SHR-A1811(sc)注射液苏州盛迪亚生物医药有限公司本品拟用于实体瘤的治疗。 2.1 11 JXHL2500269 PF-07799933片 Pfizer Inc. 携带BRAF V600突变的实体瘤患者（黑色素瘤和结直肠癌除外） 1 12 JXHL2500268 PF-07799933片 Pfizer Inc. 携带BRAF V600突变的实体瘤患者（黑色素瘤和结直肠癌除外） 1 13 JXHL2500267 PF-07799544片 Pfizer Inc. 携带BRAF V600突变的实体瘤患者（黑色素瘤和结直肠癌除外） 1 14 JXHL2500266 PF-07799544片 Pfizer Inc. 携带BRAF V600突变的实体瘤患者（黑色素瘤和结直肠癌除外） 1 15 JXHL2500265 PF-07799544片 Pfizer Inc. 携带BRAF V600突变的实体瘤患者（黑色素瘤和结直肠癌除外） 1 16 CXSL2500782 AWT020注射用无菌粉末上海君实生物医药科技股份有限公司本品联合JS212±化疗治疗恶性实体瘤。 1 17 CXSB2500167 豚草花粉点刺液浙江我武生物科技股份有限公司用于皮肤点刺试验，辅助诊断与豚草花粉致敏相关的I型变态反应性疾病治疗用生物制品 18 CXHL2500976 注射用莱古杉醇上海亲合力生物医药科技股份有限公司非肌层浸润性膀胱癌 1 19 CXHL2500977 注射用MFS-16 成都麻沸散医药科技有限公司全身麻醉的诱导与维持 1 20 JXSB2500118 HS-20106注射液 Keros Therapeutics, Inc. 本品拟用于治疗各种原因导致的血细胞减少 1 21 CXHL2500975 D-2570片益方生物科技（上海）股份有限公司本品拟用于系统性红斑狼疮的治疗。 1 22 JXSL2500171 [111In]-FPI-2107 AstraZeneca AB 晚期实体瘤患者。 1 23 CXSL2500777 PLB-002 普灵生物医药（深圳）有限公司晚期实体瘤 1 24 JXSL2500172 FPI-2053 AstraZeneca AB 晚期实体瘤患者。 1 25 JXHL2500264 ETX-636 Ensem Therapeutics, Inc. 携带PIK3CA突变的晚期实体瘤患者 1 26 JXHL2500263 ETX-636 Ensem Therapeutics, Inc. 携带PIK3CA突变的晚期实体瘤患者 1 27 CXHL2500963 阿贝西利片齐鲁制药有限公司本品拟联合药物用于治疗ER+/HER2-局部晚期或转移性乳腺癌患者。 2.4 28 CXHL2500962 阿贝西利片齐鲁制药有限公司本品拟联合药物用于治疗ER+/HER2-局部晚期或转移性乳腺癌患者。 2.4 29 CXHL2500961 阿贝西利片齐鲁制药有限公司本品拟联合药物用于治疗ER+/HER2-局部晚期或转移性乳腺癌患者。 2.4 30 CXHL2500967 QLS1304片齐鲁制药有限公司与内分泌治疗联合用于ER+/HER2-局部晚期/转移性乳腺癌患者。 1 31 CXHL2500966 QLS1304片齐鲁制药有限公司与内分泌治疗联合用于ER+/HER2-局部晚期/转移性乳腺癌患者。 1 32 CXHL2500965 QLS1304片齐鲁制药有限公司与内分泌治疗联合用于ER+/HER2-局部晚期/转移性乳腺癌患者。 1 33 CXHL2500964 QLC1401片齐鲁制药有限公司本品拟联合药物用于治疗晚期/转移性ER+/HER2-乳腺癌 1 34 CXHL2500957 SYH2056片上海翊石医药科技有限公司本品用于治疗抑郁症。 1 35 CXHL2500956 SYH2056片上海翊石医药科技有限公司本品用于治疗抑郁症。 1 36 CXHL2500947 HP518片海创药业股份有限公司 HP518联合醋酸阿比特龙片和泼尼松片或联合多西他赛和泼尼松片或联合他拉唑帕利用于治疗晚期前列腺癌患者。 1 37 JXHL2500228 Brenipatide注射液 Eli Lilly and Company 本品适用于成人抑郁症（MDD）预防复发的辅助治疗。 1 38 JXHL2500227 Brenipatide注射液 Eli Lilly and Company 本品适用于成人抑郁症（MDD）预防复发的辅助治疗。 1 39 JXHL2500226 Brenipatide注射液 Eli Lilly and Company 本品适用于成人抑郁症（MDD）预防复发的辅助治疗。 1

2025-11-19

·GlobeNewswire-Health Care

Keros Therapeutics Announces Preliminary Results of Tender Offer

LEXINGTON, Mass., Nov. 19, 2025 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. (“Keros” or the “Company”) (Nasdaq: KROS), today announced the preliminary results of its cash tender offer (the “Tender Offer”) to repurchase up to 10,950,165 shares of its common stock, at a fixed purchase price of $17.75 per share, for an aggregate purchase price of up to approximately $194.4 million. The Tender Offer expired at 5:00 p.m. Eastern Time on November 18, 2025. The expiration of the Tender Offer concludes the Company’s previously announced $375 million capital return program. Based on the preliminary count by Computershare Trust Company, N.A., the depositary for the Tender Offer (the “Depositary”), a total of approximately 16,659,732 shares of Keros common stock were validly tendered and not validly withdrawn. Additionally, approximately 1,186,829 shares were tendered through notice of guaranteed delivery. In accordance with the terms and conditions of the Tender Offer and based on the preliminary count by the Depositary, Keros expects to accept for payment an aggregate of 10,950,165 shares of its common stock, at a purchase price of $17.75 per share, for an aggregate purchase price of approximately $194.4 million, excluding fees and expenses relating to the Tender Offer. Because more than 10,950,165 shares were tendered in the Tender Offer, Keros expects to accept shares for purchase on a pro rata basis, except for conditional tenders that will automatically be regarded as withdrawn if the condition of the tender has not been met. The shares to be acquired pursuant to the Tender Offer represent approximately 35.91% of Keros’ outstanding common stock as of November 18, 2025. The number of shares expected to be purchased in the Tender Offer is preliminary and subject to change. The preliminary information contained in this press release is subject to confirmation by the Depositary and is based on the assumption that all shares tendered through notice of guaranteed delivery will be delivered within the one business day settlement period. The final number of shares to be purchased in the Tender Offer will be announced following the expiration of the guaranteed delivery period and the completion by the Depositary of the confirmation process. Payment for the shares accepted for purchase pursuant to the Tender Offer, and the return of all other shares tendered and not purchased, will occur promptly thereafter. Payment for shares will be made in cash, without interest. Stockholders with questions about the Tender Offer may contact MacKenzie Partners, Inc., the information agent for the Tender Offer, toll-free at (800) 322-2885, at (212) 929-5500 or in writing at 7 Penn Plaza, New York, NY 10001. Stockholders may also contact Goldman Sachs & Co. LLC, the dealer manager for the Tender Offer, at (212) 902-8556. About Keros Therapeutics, Inc. Keros is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the TGF-ß family of proteins. Keros is a leader in understanding the role of the TGF-ß family of proteins, which are master regulators of the growth, repair and maintenance of a number of tissues, including blood, bone, skeletal muscle, adipose and heart tissue. By leveraging this understanding, Keros has discovered and is developing protein therapeutics that have the potential to provide meaningful and potentially disease-modifying benefit to patients. Keros’ lead product candidate, KER-065, is being developed for the treatment of neuromuscular diseases, with an initial focus on Duchenne muscular dystrophy. Keros’ most advanced product candidate, elritercept, is being developed for the treatment of cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndrome and in patients with myelofibrosis. Cautionary Note Regarding Forward-Looking StatementsStatements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as “anticipates,” “believes,” “continue,” “expects,” “enable,” “intention,” “potential” and “will” or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: the number of shares to be purchased (including the number of shares tendered through notice of guaranteed delivery) and the aggregate purchase price of shares expected to be purchased in the Tender Offer. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: the final number of shares to be purchased in the Tender Offer, developments or changes in economic or market conditions; developments or changes in the securities markets, developments or changes in Keros’ business, financial condition or cash flows, and other risks detailed in Keros’ reports filed with the Securities and Exchange Commission (the “SEC”), including its quarterly report on Form 10-Q for the quarter ended September 30, 2025, filed with the SEC on November 5, 2025, and its other documents subsequently filed with or furnished to the SEC. Keros disclaims any intent or obligation to update these forward-looking statements. ContactsInvestor Contact: Justin Frantz jfrantz@kerostx.com 617-221-6042 Media Contact: Mahmoud Siddig / Adam Pollack / Brooks Hussey Joele Frank, Wilkinson Brimmer Katcher (212) 355-4449

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100 项与艾利西普相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
骨髓增生异常综合征	临床3期	美国	Takeda Pharmaceutical Co., Ltd.	2025-05-06
骨髓增生异常综合征	临床3期	澳大利亚	Takeda Pharmaceutical Co., Ltd.	2025-05-06
骨髓增生异常综合征	临床3期	巴西	Takeda Pharmaceutical Co., Ltd.	2025-05-06
骨髓增生异常综合征	临床3期	保加利亚	Takeda Pharmaceutical Co., Ltd.	2025-05-06
骨髓增生异常综合征	临床3期	加拿大	Takeda Pharmaceutical Co., Ltd.	2025-05-06
骨髓增生异常综合征	临床3期	智利	Takeda Pharmaceutical Co., Ltd.	2025-05-06
骨髓增生异常综合征	临床3期	捷克	Takeda Pharmaceutical Co., Ltd.	2025-05-06
骨髓增生异常综合征	临床3期	法国	Takeda Pharmaceutical Co., Ltd.	2025-05-06
骨髓增生异常综合征	临床3期	德国	Takeda Pharmaceutical Co., Ltd.	2025-05-06
骨髓增生异常综合征	临床3期	匈牙利	Takeda Pharmaceutical Co., Ltd.	2025-05-06

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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


NCT04419649 (ASH2025)	临床2期	SF3B1	78	Elritercept	簾憲構觸醖鑰蓋選鏇鑰(艱顧觸壓築觸醖廠廠襯) = 鑰製蓋製鏇醖繭餘艱齋鬱遞憲膚夢艱鏇鹹鑰廠 (願壓鏇壓選窪範鏇餘製 ) 更多	积极	2025-12-06
NCT05037760 (RESTORE, ASH2025)	临床2期	骨髓纤维化	38	Elritercept + ruxolitinib	廠鹹鬱觸願願願獵築蓋(遞顧製夢醖網鬱蓋廠膚) = The most common adverse events (AEs) were diarrhea (18.4%, all grade 1/2; median duration 5.5 days) and thrombocytopenia (13.2%, grade 3 in 10.5%). No pts discontinued elritercept due to an AE. 餘範齋選選餘廠齋築遞 (獵夢廠築網鑰繭鏇鏇築 )	积极	2025-12-06
NCT05037760 (RESTORE, EHA2025)	临床2期	骨髓纤维化	73	Elritercept monotherapy	鑰窪繭簾蓋簾衊壓齋襯(淵憲艱築艱齋糧顧鏇繭) = An asymptomatic Hgb increase in one participant required dose reduction per protocol and was deemed a dose-limiting toxicity 醖膚鏇壓觸範齋願餘夢 (鏇構艱糧顧顧糧鑰願餘 ) 更多	积极	2025-05-14
NCT05037760 (RESTORE, EHA2025)	临床2期	骨髓纤维化	73	Elritercept + Ruxolitinib combination therapy		积极	2025-05-14
NCT04419649 (PF635, EHA2025)	临床2期	骨髓增生异常综合征 non-RS	15	Elritercept	鏇窪壓製築構築艱遞衊(窪餘製衊壓壓衊餘鏇觸) = 鏇廠積築艱鏇蓋鹽願繭觸襯艱憲觸鬱築膚憲願 (願窪遞鹹齋網遞窪鹽衊, 190 ~ 1632) 更多	积极	2025-05-14
NCT04419649 (Phase 2 trial, EHA2025)	临床2期	骨髓增生异常综合征	95	Elritercept 3.75-5 mg/kg	壓窪鏇膚膚襯襯範簾衊(製壓襯鬱選網鑰醖鬱構) = Observed differences in FACT-An total score for TI≥24 wks responders vs non-responders were driven by greater improvements for responders in the Anemia subscale (AnS), especially the FACIT-Fatigue component. Improvements were observed across FACIT-Fatigue items including those related to both fatigue experience and impact. Moreover, FACIT-Fatigue scores improved over time in TI≥24 wks responders as did the proportion of participants with improvements meeting or exceeding the MCID 簾範廠選選壓糧獵網鑰 (廠鹽遞鹹鹹淵醖衊鬱襯 )	积极	2025-05-14
PB2774 (EHA2025)	临床1/2期	骨髓增生异常综合征	770	Rigosertib	齋襯簾簾膚範範糧繭鹹(齋鏇壓網窪積鹽艱獵艱) = 鹹鬱糧鹹鑰鏇觸壓蓋選蓋廠製艱選齋願淵願鏇 (襯遞獵夢壓積淵鬱選簾, 0.012 ~ 0.039) 更多	积极	2025-05-14
NCT04419649 (ASH2024) 人工标引	临床2期	骨髓增生异常性贫血	15	Elritercept (Non-Transfusion Dependent)	觸顧鬱構簾糧觸餘糧窪(鏇夢窪積壓遞繭遞醖憲) = 築衊鹽鏇簾製選範網夢網繭積願淵願獵淵築遞 (願鬱築獵衊鏇膚壓襯選 ) 更多	积极	2024-12-09
NCT05037760 (RESTORE, ASH2024) 人工标引	临床2期	骨髓纤维化	54	Elritercept monotherapyElritercept monotherapy	鹹鑰鑰憲積餘窪積顧膚(範簾鹽鹹鏇蓋積夢遞顧) = 夢構艱範蓋顧鬱簾積襯鹽鹽築選醖淵繭憲觸憲 (遞願壓衊繭艱醖蓋積觸 ) 更多	积极	2024-12-09
NCT05037760 (RESTORE, ASH2024) 人工标引	临床2期	骨髓纤维化	54	Elritercept + Ruxolitinib	鹹鑰鑰憲積餘窪積顧膚(範簾鹽鹹鏇蓋積夢遞顧) = 醖遞夢繭窪繭齋鹽襯襯鹽鹽築選醖淵繭憲觸憲 (遞願壓衊繭艱醖蓋積觸 ) 更多	积极	2024-12-09
ASH2024	N/A	骨髓增生异常综合征	-	Elritercept 3.75-5 mg/kg	遞壓鬱遞鬱醖淵鏇繭網(糧簾壓糧餘齋積醖鑰壓) = 襯獵製積壓構衊鹽繭窪製鏇範膚製製淵糧齋觸 (憲廠鹹觸顧醖積醖繭鏇 ) 更多	-	2024-12-07
NCT05037760 (RESTORE, Biospace) 人工标引	临床2期	骨髓纤维化	54	elritercept with or without ruxolitinib	醖齋鬱壓蓋齋顧壓願積(廠襯築醖願簾艱網簾構) = 範鏇獵鹽選艱憲衊壓廠鬱夢餘襯願蓋築構衊艱 (網積壓製網鬱鹽願鹽積 ) 更多	积极	2024-06-17
NCT05037760 (RESTORE, Biospace) 人工标引	临床2期	骨髓纤维化	54	elritercept with or without ruxolitinib (3.0 mg/kg of elritercept or higher in combination with ruxolitinib)	鏇願淵蓋選憲鑰衊築選(願艱顧積選憲廠餘簾壓) = 築窪窪觸範壓簾壓餘製顧繭觸觸淵繭鹹憲齋構 (憲壓繭網憲顧築鏇醖醖 ) 更多	积极	2024-06-17