A Single-center, Open-label, Randomized, Single Dose, Two-way Crossover Design to Evaluate the Relative Bioavailability of Pimicotinib Capsules Containing Free Base in Different Proportions Under Fasting Conditions in Healthy Participants

This is an open-label, randomized, two-treatment, single-dose, two-way crossover study to evaluate the relative bioavailability and tolerability of Pimicotinib capsules containing free base in different proportions in healthy participants. 20 healthy participants are planned to be enrolled and will be evenly randomized to either Study Sequence A or Study Sequence B.Subjects in Sequence A/Sequence B will receive a single 50 mg oral dose of test/reference pimicotinib in period 1 and cross over in period 2. Blood samples will be collected for PK analysis in totally 32 time-points.

开始日期2025-09-12

申办/合作机构

上海和誉生物医药科技有限公司

NCT07126249

/ Completed临床1期

A Single-Center, Open-label, Randomized, Single Dose, Two-way Crossover Design to Evaluate theBioequivalence of Two Different Pimicotinib Capsules Under Fasting Conditions in Healthy Subjects

This is a study to evaluate bioequivalence and tolerability of two different pimicotinib capsules in healthy subjects under fasting condition. 38 healthy subjects are planned to be enrolled and will be evenly randomized to either Study Sequence A or Study Sequence B . Subjects in Sequence A/Sequence B will receive a single 50 mg oral dose of test/reference pimicotinib in period 1 and cross over in period 2. Blood samples will be collected for PK analysis in totally 32 time-points.

开始日期2025-05-13

申办/合作机构

上海和誉生物医药科技有限公司

NCT06884072

/ Active, not recruiting临床1期

A Phase 1, Open-label, Randomized, Single Dose, 2-Treatment, 2-Sequence, 2-Period Crossover Study to Evaluate the Effect of a High-fat Meal on the Exposures of Pimicotinib Capsule in Healthy Subjects

This is a study to evaluate the impact of a high - fat meal on the exposure of Pimicotinib capsules in healthy subjects. It is planned to recruit 16 healthy subjects and randomly and equally assign them to either Study Sequence A or Study Sequence B. Subjects in Sequence A will take a single 50 - milligram oral dose of Pimicotinib capsules in a post - high - fat - meal state during Phase 1. Subjects in Sequence B will take a single 50 - milligram oral dose of Pimicotinib capsules in a fasting state during Phase 1 and then receive cross - over administration in Phase 2. In total, blood samples will be collected at 34 time points for pharmacokinetic (PK) analysis.

开始日期2025-04-08

申办/合作机构

上海和誉生物医药科技有限公司

100 项与匹米替尼相关的临床结果

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100 项与匹米替尼相关的转化医学

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100 项与匹米替尼相关的专利（医药）

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项与匹米替尼相关的文献（医药）

Future Oncology

MANEUVER: A Phase III study of pimicotinib to assess efficacy and safety in tenosynovial giant cell tumor patients

Article

作者: Shan, Boyao ; Gelderblom, Hans ; Shi, Haosong ; Niu, Xiaohui ; Ravi, Vinod ; Zou, Qingping ; Guo, Qiuxiang

Tenosynovial giant cell tumor (TGCT) is a rare, locally invasive soft tissue tumor arising from the synovium of joints, bursa and tendon sheaths and is associated with the overexpression of the colony-stimulating factor 1 (CSF-1) gene. Pimicotinib is an orally available, highly selective and potent small molecule CSF-1 receptor (CSF-1R) inhibitor with robust efficacy and safety profile in patients with TGCT and is under development in multiple diseases. In an open-label Phase I study in patients with TGCT not amenable to surgery, pimicotinib showed superior efficacy and safety. In this article, we elucidate the rationale and study design of the multi-region Phase III MANEUVER trial (NCT05804045), which is designed to assess the efficacy and safety of pimicotinib in patients with TGCT not amenable to surgical resection in Asia, North America and Europe.

Scientific Reports

Role of CSF1R 550th-tryptophan in kusunokinin and CSF1R inhibitor binding and ligand-induced structural effect

Article

作者: Tipmanee, Varomyalin ; Graidist, Potchanapond ; Chompunud Na Ayudhya, Chompunud

Abstract:

Binding affinity is an important factor in drug design to improve drug-target selectivity and specificity. In this study, in silico techniques based on molecular docking followed by molecular dynamics (MD) simulations were utilized to identify the key residue(s) for CSF1R binding affinity among 14 pan-tyrosine kinase inhibitors and 15 CSF1R-specific inhibitors. We found tryptophan at position 550 (W550) on the CSF1R binding site interacted with the inhibitors' aromatic ring in a π–π way that made the ligands better at binding. Upon W550-Alanine substitution (W550A), the binding affinity of trans-(−)-kusunokinin and imatinib to CSF1R was significantly decreased. However, in terms of structural features, W550 did not significantly affect overall CSF1R structure, but provided destabilizing effect upon mutation. The W550A also did not either cause ligand to change its binding site or conformational changes due to ligand binding. As a result of our findings, the π–π interaction with W550's aromatic ring could be still the choice for increasing binding affinity to CSF1R. Nevertheless, our study showed that the increasing binding to W550 of the design ligand may not ensure CSF1R specificity and inhibition since W550-ligand bound state did not induce significantly conformational change into inactive state.

Journal of Translational Medicine

Pharmacologic inhibition of CSF-1R suppresses intrinsic tumor cell growth in osteosarcoma with CSF-1R overexpression

Article

作者: Chen, Zhui ; Li, Cong ; Liu, Manqi ; Shen, Bin ; Dai, Cheng ; Wang, Jie ; Shi, Wan ; Liu, Shenyan ; Yang, Shuqun ; Zhang, Nannan ; Zhu, Zhixuan ; Zhang, Qi ; Zhang, Jie

BACKGROUND:

Osteosarcoma is the most common primary malignant bone tumor affecting children and young adults. Metastatic osteosarcoma has poor prognosis and represents a significant unmet medical need in clinical settings. The CSF-1/CSF-1R signaling pathway is essential for the physiological functions of myeloid lineage cells, including osteoclasts and monocytes/macrophages. The purpose of this study is to investigate the role of CSF-1R in osteosarcoma pathogenesis and the therapeutical potentiality of CSF-1R inhibitor for osteosarcoma patients.

METHODS:

CSF-1, CSF-1R, and IL-34 expression across cancer types were evaluated using public database. Immunohistochemistry (IHC) was utilized to analyze human tissue microarray samples of osteosarcoma. We then investigated the anti-tumor effect and the mechanisms of action of pharmacologic inhibition of CSF-1R activity by pimicotinib (ABSK021), a highly potent and selective small molecule inhibitor of CSF-1R, in osteosarcoma models both in vitro and in vivo.

RESULTS:

IHC analysis of human tissue microarray samples revealed a high prevalence of CSF-1R overexpression in osteosarcoma patient samples. ABSK021 effectively inhibited CSF-1R signaling and the proliferation of osteosarcoma cells with high expression of CSF-1R, by inducing cell cycle arrest and apoptosis. In contrast, it had a marginal effect on osteosarcoma cell lines with low CSF-1R expression. In animal studies, ABSK021 demonstrated strong anti-tumor activity in both a syngeneic mouse osteosarcoma model and osteosarcoma patient sample-derived xenograft (PDX) models with CSF-1R overexpression. The analysis of endpoint tumor samples revealed downregulation of CSF-1R signaling and proliferative marker Ki67, along with the increase of apoptotic marker cleaved caspase-3, confirming the on-target effects of ABSK021 in vivo. Furthermore, combining ABSK021 with standard-of-care chemotherapy showed enhanced anti-tumor activity both in vitro and in vivo.

CONCLUSIONS:

These findings conclusively demonstrated that pharmacological inhibition of CSF-1R activity by ABSK021 resulted in significant anti-tumor effects in preclinical osteosarcoma models with CSF-1R overexpression. The high prevalence of CSF-1R expression observed in osteosarcoma patient samples highlights the potential clinical use of ABSK021, either as a monotherapy or in combination with chemotherapy, as a promising therapeutic strategy for osteosarcoma patients with CSF-1R as a potential predictive biomarker.

268

项与匹米替尼相关的新闻（医药）

2025-11-27

·新华网

发现企业的价值｜和誉医药董事长徐耀昌：抓住中国医药人才黄金时代追求创新药企卓越之路

新华网北京11月27日电（黄海荣）在全球创新药研发的竞技场上，中国力量正以前所未有的速度崛起。作为这股浪潮中的代表性企业，和誉医药（股票代码：2256.HK）在2025年中期业绩报告中交出了一份亮眼的成绩单：上半年实现净利润3.28亿元，同比增长59%，现金储备高达23.22亿元。在这份成绩单背后，是一家中国创新药企对“卓越”二字的执着追求，以及对中国医药研发人才的深度信赖。新华网上市公司频道近日专访了和誉医药董事长兼首席执行官徐耀昌，从创新药研发企业的发展路径中，探寻中国医药创新崛起的底层逻辑。卓越，是唯一的选择 “我们追求的，永远是First-in-Class（同类首创）和Best-in-Class（同类最佳）。”在近两小时的访谈中，这句话被董事长多次强调。在他看来，这是和誉医药从成立之初就坚定的战略核心，也是中国药企在全球竞争中能够脱颖而出的关键。以公司核心产品匹米替尼（Pimicotinib，CSF-1R抑制剂）为例，该药在2025年ASCO（美国临床肿瘤学会）大会上公布的全球III期临床数据显示，其客观缓解率（ORR，评估肿瘤治疗效果的核心指标）达54%，显著优于同类已上市药物，且安全性表现优异。在临床上，匹米替尼有望为需系统治疗的腱鞘巨细胞瘤（TGCT）患者提供一种高效、安全且便捷的每日一次口服治疗方案。正是凭借这一“同类最佳”的数据和应用前景，德国默克公司与和誉医药签署商业化授权协议并于去年支付7500万美元首付款。今年4月，默克公司行使其全球权益，并于5月支付全球商业化选择权行权费8500万美元。据介绍，和誉医药有资格收取合共最高6.055亿美元的付款，包括首付款、选择权行权费、开发及商业化里程碑付款，以及年净销售额的两位数比例销售提成。对此，徐耀昌表示：“我们不希望选择一个有几十家公司在做的靶点，哪怕是一个小适应症，如果能做到唯一或最佳，其商业潜力也会非常巨大。” 同样，在肝癌治疗领域，和誉医药的依帕戈替尼（Irpagratinib，FGFR4抑制剂）作为全球首个在该机制上进入注册性临床的药物，单药应答率超过40%，与阿替丽珠联合治疗后更提升至50%以上，远超现有标准疗法20%多的应答水平。徐耀昌介绍称，“这意味着我们对标的不再是中国市场，而是全球临床需求。” 自创立至今，和誉医药已搭建起由20余种候选药物构成的研发管线，其中12款药物已进入临床阶段。徐耀昌表示，和誉医药致力于在肿瘤及其他疾病领域开发具有差异化的创新疗法，以满足中国及全球患者尚未满足的关键临床需求。高效的人才团队与充裕的资金储备，正是实现这一目标的两大核心支柱。人才，是创新的根基 “中国的人才，是我们在创新药领域最大的底气。”徐耀昌分享了他从国际药企到中国创业的经历。他曾在美国礼来、诺华等公司任职多年，与众多中外科学家共事的经历，让他对中国科学家的特质有着深刻洞察：“中国的科学家不仅能提出创新思路，更能亲手将想法付诸实验验证，这种‘既能想又能做’的能力非常突出。” 这种洞察也与宏观趋势相互印证。麦肯锡公司发布的《中国生物医药创新崛起：迈向全球舞台》报告指出，中国生物医药研发人才总数已跃居全球第二，在2017至2022年间，核心研发人才规模实现翻番，呈现出显著的“井喷”之势。徐耀昌指出，这一趋势在过去十年中推动了中国医药人才从“仿制”向“创新”的深刻转变。“如今在上海、苏州、北京等地，从事创新药研发的人才无论从数量还是质量上，都已形成一股不可忽视的力量。”正是基于对本土人才的深度信任，和誉医药逐步建立起一支约两百人的研发与临床团队，构建了从靶点发现到临床推进的高效闭环，为持续创新提供了核心引擎。现金流，为长期主义护航截至2025年6月，和誉医药现金储备达23亿元，足以支持多年运营需求。在徐耀昌看来，充足的现金流是创新药企能够坚持长期主义的生命线。“一款创新药从立项到上市，往往需要十年。如果没有稳定的资金支持，很多项目可能中途夭折。” 公司通过BD合作（如匹米替尼授权默克）获取首付款和里程碑收入，同时为自主商业化做准备。 “BD收入是‘输血’，自主商业化才是‘造血’。中国药企最终一定要走通这条路。”徐耀昌说。中国创新药企的下一站：全球价值在徐耀昌看来，中国创新药企的发展已进入新阶段：“我们不再只是为中国患者做药，而是为全球患者做药。只有立足全球市场，才能实现真正的价值回报。” 他以口服PD-L1抑制剂ABSK043为例，该药目前是全球进展最快的口服PD-L1项目，因其用药便利性和安全性，有望在联合用药领域开辟新市场。ABSK043联合其他药物用于晚期非小细胞肺癌（NSCLC）和胃癌一线治疗的二期临床研究正在进行中。 “当我们可以把药送到患者床边，而不必让他们频繁去医院注射，这就是在解决真实的临床痛点。”在徐耀昌看来，中国创新药企的价值实现，必然要经过全球市场的检验。“真正的创新，必须能解决全球患者的未满足需求。”口服PD-L1抑制剂ABSK043为例指出，其价值不仅在于疗效，更在于“口服”带来的用药革命。“当患者无需频繁入院注射，能在家庭场景中接受治疗，我们解决的就是一个全球性的临床痛点，这本身就创造了巨大的全球市场价值。”徐耀昌说。从靶点创新到临床突破，从授权出海到自主商业化探索，和誉医药的发展路径，正是中国创新药企坚定迈向全球市场的一个缩影。从和誉医药的发展路径中，我们看到以人才为基，以卓越为尺，以全球为场。在政策、资本、人才的三重共振下，中国医药创新正迎来黄金时代。而如董事长所言：“当我们真正把目光放在患者需求上，创新才会持续，企业才会走远。”

2025-11-18

·核心周期投研报告精选

高盛重磅报告：中国小盘创新药企迎来历史性拐点，如何把握“生存到繁荣”的投资逻辑？

点击👇小卡片关注我，更多优质资讯分享中国小盘创新药企业已度过至暗时刻，正凭借高效研发、差异化管线与坚定的全球合作，步入新一轮成长周期。报告核心内容概述高盛于2025年10月26日发布的中国生物科技行业深度报告，系统性地剖析了中国小盘创新药企业从“艰难求存”到“蓬勃发展”的转型路径。报告通过对美国小盘生物科技公司20年发展史的复盘，以及对中国行业近4年下行周期的总结，提炼出成功企业的关键特质。基于此框架，高盛首次覆盖和誉医药（2256.HK），并给予“买入”评级，其设定的12个月目标价为27.10港元，较当前股价隐含约91%的上行空间。本报告旨在为读者提炼该研究的核心观点与关键数据。（一）行业拐点已现：从“生存”到“繁荣”的三大核心驱动力 1高效研发是生存之本：报告借鉴美国市场经验指出，过去20年间，成功实现市值增长33倍的“繁荣者”与市值萎缩66%的“未繁荣者”分化显著。关键在于，前者多聚焦于罕见病等领域，其药物开发路径具备“成本更低（试验规模小）、速度更快（监管快通道）、成功率更高（未满足需求大）”的高效特征。 2差异化管线是价值核心：在资源受限的下行周期中，企业必须做出精准的“继续/终止”决策。成功的公司始终专注于开发具备差异化治疗特性、有利竞争地位的候选药物，并果断终止回报前景不佳或运营障碍巨大的非核心管线投入。 3全球合作是增长关键：对于小盘生物科技而言，坚定的全球合作伙伴是将其创新成果推向国际舞台、实现商业价值最大化的关键。报告以传奇生物/强生、科伦博泰/默沙东的合作案例，印证了强大合作伙伴在推动后期临床试验、全球注册申报和商业化方面的战略价值。（二）标杆案例深度剖析：和誉医药的“精准医疗”全球化之路高盛选择和誉医药作为首次覆盖的正面范例，认为其集中体现了上述成功要素。 1核心资产Pimicotinib：同类最佳的潜力与巨大市场空间药物定位：作为CSF-1R抑制剂，其在腱鞘巨细胞瘤和慢性移植物抗宿主病领域展现出同类最佳的潜力。关键数据：高盛预测，该药风险调整后的全球销售峰值可达16亿美元。其在关键III期临床试验中展现出54%的客观缓解率、优异的疼痛缓解能力和低于2%的停药率，在安全性和便利性上（每日一次口服）显著优于同类已上市药物。市场预期：预计将于2026年在美国获批腱鞘巨细胞瘤适应症。 2默克集团的强力背书：全球化进程的“加速器” 和誉医药与德国默克集团就Pimicotinib达成的全球独家许可协议，总金额高达6.055亿美元。这不仅是对公司研发能力的强有力认可，更将借助默克覆盖65个国家、拥有超过6.3万名员工的全球网络，极大提升该药的国际商业化能见度。 3深厚的小分子研发底蕴与清晰的扩张路线图和誉医药拥有22个在研药物管线，其中12个已进入临床阶段。公司凭借其在小分子药物研发领域的深厚积累，制定了清晰的“三步走”战略：从小分子肿瘤药物，拓展至下一代抗体偶联药物，并进一步进军自身免疫及代谢疾病领域，为长期发展奠定基础。（三）财务与估值透视：基于风险调整的未来现金流 1财务预测：高盛预计，和誉医药将于2026年开始确认Pimicotinib的全球销售分成，并逐步改善其财务状况。 2估值方法：报告采用风险调整的贴现现金流法进行估值，关键假设包括11%的贴现率和3%的永续增长率，以反映其管线资产的未来盈利潜力和内在风险。（四）潜在风险提示报告亦明确指出投资者需关注的风险，主要包括：核心管线药物的全球价值未能完全实现的风险、早期管线临床开发失败的风险、人才招募与保留的挑战，以及公司目前尚缺乏自主商业化和大规模生产经验等。总结高盛此份报告描绘了一幅中国创新药产业，特别是具备核心竞争力的中小型公司，正穿越周期、迈向全球的清晰图景。对于关注这一领域的市场参与者而言，理解“高效研发、差异化、全球化”这一成功范式，并密切关注如和誉医药这样具备标杆潜质的企业动态，将有助于把握行业发展的结构性机遇。完整报告分享在星球，扫码加入，有更多精选资讯供您参考。星球刚刚成立，价格实惠，旨在为大家分享优质资讯，有兴趣的小伙伴可以扫码加入。

临床3期申请上市

2025-11-17

·上海和誉生物医药科技有限公司

和誉医药匹米替尼临床III期MANEUVER研究长期疗效和安全性数据亮相CTOS 2025年会

2025年11月17日，和誉医药（港交所代码：02256）宣布，公司在2025年国际结缔组织肿瘤学会（CTOS）年会上以壁报形式展示了自主研发的小分子CSF-1R抑制剂匹米替尼（pimicotinib/ABSK021）治疗腱鞘巨细胞瘤（TGCT）患者的全球III期MANEUVER研究的长期疗效、安全性及患者报告结局数据。结果显示，持续接受匹米替尼治疗可为TGCT患者带来疗效持续提升与患者报告结局的进一步改善，同时具有良好的安全性，验证了匹米替尼在该人群中的长期应用潜力。腱鞘巨细胞瘤是一种罕见的局部侵袭性间叶性肿瘤，主要累及关节、腱鞘及滑囊，可导致严重的局部病变和功能障碍。其发生机制为肿瘤性滑膜细胞中过度表达集落刺激因子1（CSF-1），从而导致表达集落刺激因子1受体（CSF-1R）的炎症细胞在肿瘤中大量聚集。 MANEUVER研究是一项由三部分组成的全球多中心、随机、双盲、安慰剂对照III期临床试验，旨在系统评估匹米替尼在TGCT患者中的疗效与安全性。研究第一部分的主要及次要终点均已成功达到，并已在2025年美国临床肿瘤学会（ASCO）年会上公布相关结果。主要终点为第一部分结束时，由盲态独立审查委员会（BIRC）依据RECIST v1.1标准评估的客观缓解率（ORR）。结果显示，治疗25周时，匹米替尼治疗组ORR显著优于安慰剂组（54.0% vs 3.2%，P＜0.0001）。本届CTOS年会上展示的为MANEUVER研究第二部分完成后的长期疗效及安全性数据。中位随访14.3个月时，自研究开始即接受匹米替尼治疗的患者显示出强劲而持久的肿瘤缓解疗效。根据盲态独立审查委员会（BICR）采用RECIST v1.1标准的评估，该类患者的ORR从第25周的54%显著提升至76.2%（95% CI：63.8，86.0），其中4例实现完全缓解。与此同时，在关节活动度、僵硬、疼痛及躯体功能等多项影响TGCT患者生活质量的临床结局评估（COAs）中，也观察到具有临床意义的显著改善。壁报还展示了基于EQ-5D-5L健康量表视觉模拟量表（VAS）评估的生活质量（QoL）获益。接受匹米替尼治疗的患者在第25周时，QoL较基线平均提高7.4%，并在第73周时进一步提升至13.1%。此外，研究第一部分随机分配至安慰剂组的患者在研究第二部分改用匹米替尼后，同样获得临床获益，中位随访时间8.5个月时，ORR达到64.5%，且COAs也有显著改善。安全性方面，治疗期间患者的中位剂量强度保持在88.2%的较高水平。大多数治疗相关不良事件（TEAEs）为1–2级，未观察到新的安全性信号，亦无胆汁淤积性肝毒性、药物性肝损伤或毛发/皮肤色素减退等相关证据。值得一提的是，在今年10月举办的2025年欧洲肿瘤内科学会（ESMO Congress 2025）上，MANEUVER研究的牵头研究者——北京积水潭医院牛晓辉教授已通过口头报告形式介绍了上述研究成果。 Abbisko Therapeutics Presents Longer-Term Efficacy and Safety Outcomes from Phase III MANEUVER Study of Pimicotinib at CTOS 2025 Annual Meeting 17 November 2025, Shanghai – Abbisko Therapeutics Co. Ltd. (Abbisko Therapeutics 00256.HK) announced the poster presentation of longer-term efficacy, safety and patient-reported outcomes from the global Phase III MANEUVER study of pimicotinib (ABSK021) in patients with tenosynovial giant cell tumour (TGCT) at the Connective Tissue Oncology Society (CTOS) 2025 Annual Meeting. This longer-term analysis showed that sustained treatment with pimicotinib in patients with TGCT led to continued improvements in tumor response, patient-reported outcomes including pain and function, and maintained an acceptable safety profile, reinforcing its potential for long-term use in eligible patients. TGCT is a rare and locally aggressive tumor primarily affecting joints, tendon sheaths, and bursae with potentially devastating morbidity. TGCT is driven by overexpression of colony-stimulating factor-1 (CSF-1) in neoplastic synovial cells that leads to accumulation of colony-stimulating factor-1 receptor (CSF-1R)–expressing inflammatory cells in the tumor. The MANEUVER study is a global, multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial consisting of three parts, designed to evaluate the efficacy and safety of pimicotinib in patients with TGCT. The primary endpoint and all key secondary endpoints were met in Part 1 at week 25, and the corresponding results were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The primary endpoint is the objective response rate (ORR) at the end of Part 1, as assessed by blind independent review committee (BIRC) per RECIST v1.1. At Week 25, pimicotinib demonstrated a statistically significant improvement in ORR compared with placebo at Week 25 (54.0% vs 3.2%, P＜0.0001). The outcomes presented at the CTOS 2025 Annual Meeting were the longer-term efficacy and safety data from the completion of Part 2 of the MANEUVER study. With a median follow-up of 14.3 months, patients who had received pimicotinib from the beginning of the study demonstrated robust and durable tumor responses. The ORR by blinded independent review committee (BIRC) per RECIST v1.1 increased from 54% at week 25 to 76.2% (95% CI: 63.8, 86.0), with four patients achieving complete response. Meanwhile, the study also showed continued clinically meaningful improvements in clinical outcome assessments (COAs) related to TGCT patients’ quality of life, including range of motion, stiffness, pain, and physical function. The poster also presented quality of life (QoL) benefits assessed by the EQ-5D-5L visual analog scale (VAS). Patients receiving pimicotinib treatment showed a mean QoL improvement of 7.4% from baseline at Week 25, which further increased to 13.1% at Week 73. In addition, patients who were initially randomized to the placebo arm in Part 1 and subsequently switched to pimicotinib in Part 2 also derived clinical benefit, achieving an ORR of 64.5% at a median follow-up of 8.5 months, along with notable improvements in COAs. In terms of safety, the median dose intensity remained high at 88.2% during treatment. Most treatment-emergent adverse events (TEAEs) were Grade 1–2. No new safety signals were observed, and there was no evidence of cholestatic hepatotoxicity, drug-induced liver injury, or hair/skin hypopigmentation. It is noteworthy that at the European Society for Medical Oncology (ESMO) Congress 2025 held in October this year, Professor Xiaohui Niu from Beijing Jishuitan Hospital, the leading principal investigator (PI) of MANEUVER study, presented these significant research findings in an oral presentation. About Abbisko Therapeutics Founded in April 2016, Abbisko Therapeutics Co., Ltd. (HKEX: 02256.HK), is an oncology-focused biopharmaceutical company based in Shanghai that is dedicated to the discovery and development of innovative medicines to treat unmet medical needs in China and globally. The Company was established by a group of seasoned drug hunters with rich research & development and managerial expertise from top multinational pharmaceutical companies. Since its founding, Abbisko Therapeutics has built an extensive pipeline of innovative programs focused on precision oncology and immuno-oncology. Please visit www.abbisko.com for more information. 关于和誉和誉医药（香港联交所代码：02256）成立于2016年，是一家立足中国，着眼全球的创新药研发公司。公司的创始人和管理团队拥有多年顶尖跨国药企的研发和管理经验，并参与了多个临床及上市新药的研发。和誉医药专注于肿瘤新药研发，以小分子肿瘤精准治疗和小分子肿瘤免疫治疗药物为核心，着眼病患及医药市场的需求，秉承国际新药开发的理念和标准，致力于开发新颖及高潜力药物靶点的潜在first-in-class或best-in-class创新药物，用于改善中国及全球病人的生活质量。自成立以来，和誉医药已经建立了丰富的创新产品管线，涵盖肿瘤精准治疗领域以及肿瘤免疫治疗领域。更多信息，欢迎访问 www.abbisko.com。

临床结果ASCO会议临床3期临床2期申请上市

100 项与匹米替尼相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
腱鞘巨细胞瘤	申请上市	中国	默克雪兰诺（北京）医药有限公司	2025-06-10
腱鞘巨细胞瘤	申请上市	中国	凯莱英生命科学技术（天津）有限公司	2025-06-10
转移性胰腺癌	临床2期	中国	上海和誉生物医药科技有限公司	2023-10-17
慢性移植物抗宿主病	临床2期	中国	上海和誉生物医药科技有限公司	2023-05-30
肉瘤	临床1期	中国	上海和誉生物医药科技有限公司	2022-07-20
色素沉着的绒毛结节性滑膜炎	临床1期	美国	上海和誉生物医药科技有限公司	2020-01-20
色素沉着的绒毛结节性滑膜炎	临床1期	中国	上海和誉生物医药科技有限公司	2020-01-20
晚期恶性实体瘤	临床1期	美国	上海和誉生物医药科技有限公司	2020-01-02
非小细胞肺癌	临床1期	美国	上海和誉生物医药科技有限公司	2020-01-02
胰腺癌	临床1期	美国	上海和誉生物医药科技有限公司	2020-01-02

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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


NCT05804045 (MANEUVER, ESMO2025 \| Company_Website) 人工标引	临床3期	腱鞘巨细胞瘤	135	Pimicotinib	顧構壓衊鑰鬱願鬱遞餘(鬱網窪觸蓋糧齋廠艱艱) = 餘遞齋網築夢襯艱鬱製網範鑰觸繭窪積製糧醖 (鹹鏇窪觸鑰壓鏇蓋簾餘 ) 达到更多	积极	2025-10-17
				Placebo	顧構壓衊鑰鬱願鬱遞餘(鬱網窪觸蓋糧齋廠艱艱) = 範憲餘簾網衊積簾襯範網範鑰觸繭窪積製糧醖 (鹹鏇窪觸鑰壓鏇蓋簾餘 ) 达到
NCT05804045 (MANEUVER, ASCO2025 \| PipelineReview) 人工标引	临床3期	腱鞘巨细胞瘤	94	Pimicotinib 50 mg QD	網願醖積膚獵餘獵構窪(繭鏇襯鹹蓋願齋網觸糧) = 繭齋窪醖淵憲糧鏇簾齋窪襯艱鬱顧網蓋範衊製 (夢鏇築網築鏇築醖鏇壓 ) 更多	积极	2025-05-30
				Placebo	網願醖積膚獵餘獵構窪(繭鏇襯鹹蓋願齋網觸糧) = 鹽鑰窪簾糧選餘衊顧糧窪襯艱鬱顧網蓋範衊製 (夢鏇築網築鏇築醖鏇壓 ) 更多
NEWS 人工标引	临床2期	慢性移植物抗宿主病	-	匹米替尼 20 毫克 QD	簾齋襯範壓壓築糧窪鹽(願醖窪範憲廠選範鏇餘) = 製淵製簾壓鏇遞範鬱壓窪齋鹽鹹築鹽願膚鬱遞 (襯範遞糧選鬱憲遞憲願 ) 更多	积极	2024-12-09
NCT06186804 (ASH2024) 人工标引	临床2期	慢性移植物抗宿主病	28	Total	選遞壓願製醖艱淵齋獵(網糧鬱淵壓襯衊齋蓋襯) = 鹽蓋衊築鑰顧願顧鑰積積簾構夢淵遞鬱鬱繭鬱 (窪壓鏇觸壓築餘選鬱鑰 ) 更多	积极	2024-12-07
				Pimicotinib 5 mg	選遞壓願製醖艱淵齋獵(網糧鬱淵壓襯衊齋蓋襯) = 鹽鑰膚鏇範繭窪壓製廠積簾構夢淵遞鬱鬱繭鬱 (窪壓鏇觸壓築餘選鬱鑰 )
NCT05804045 (MANEUVER, Company_Website \| PRNewswire \| NEWS) 人工标引	临床3期	腱鞘巨细胞瘤	94	匹米替尼	鹹鹽顧鹽築鬱憲構憲獵(遞淵餘醖繭繭鏇繭願淵) = 積憲選選衊膚簾醖鏇餘醖遞蓋遞淵鏇壓觸遞鏇 (製膚鑰淵願鏇蓋夢蓋鹹 ) 达到更多	积极	2024-11-12
				安慰剂	鹹鹽顧鹽築鬱憲構憲獵(遞淵餘醖繭繭鏇繭願淵) = 簾築鬱廠範選範膚淵糧醖遞蓋遞淵鏇壓觸遞鏇 (製膚鑰淵願鏇蓋夢蓋鹹 ) 达到更多
NCT04192344 (Corporate Publications) 人工标引	临床1期	腱鞘巨细胞瘤	56	Pimicotinib 50mgQD	範構鑰廠艱鬱淵餘鏇網(獵廠膚積窪遞艱襯觸製) = 鏇製憲艱壓製積顧蓋網繭鬱蓋餘醖鹹網壓築鬱 (簾鬱觸糧壓壓齋廠遞餘 ) 更多	积极	2023-11-03
				Pimicotinib 25mgQD	範構鑰廠艱鬱淵餘鏇網(獵廠膚積窪遞艱襯觸製) = 願鏇顧蓋壓遞壓蓋廠膚繭鬱蓋餘醖鹹網壓築鬱 (簾鬱觸糧壓壓齋廠遞餘 ) 更多
NCT04192344 (ASCO 12023 \| ASCO 22023) 人工标引	临床1期	HR阳性/HER2低表达实体瘤	74	pimicotinib	壓憲鏇製廠鑰鏇簾膚窪(構積憲憲鑰網鹽鏇襯鏇) = 3 pts (4.1%) reported serious TRAEs of ascites, blood bilirubin increase, and vaginal hemorrhage 糧鑰網餘製窪顧憲憲構 (觸鏇蓋製蓋醖築齋網襯 ) 更多	积极	2023-05-31
NCT04192344 (ASCO 12023 \| ASCO 22023) 人工标引	临床1期	腱鞘巨细胞瘤	49	Pimicotinib 50 mg	醖觸選夢鬱築艱鑰鑰襯(鹹艱淵願膚衊選築網壓) = include LDH increase (75.5%), CPK increase (67.3%), α-HBDH increase (63.3%), AST increase (42.9%), amylase increase (26.5%), ALT increase (24.5%), pruritus (20.4%) and rash (20.4%) 餘構遞艱醖蓋鹹築遞鑰 (範醖鏇艱築醖齋窪窪衊 ) 更多	积极	2023-05-26
				Pimicotinib 25 mg
NCT04192344 (NEWS) 人工标引	临床1期	腱鞘巨细胞瘤	27	ABSK021	廠艱衊選簾壓鏇觸廠夢(鬱顧網鑰積蓋簾範鏇鏇) = The majority of treatment-period adverse events (treatment-period adverse events) were grade 1 or grade 2 events. No cases of color change or severe liver injury were reported. 遞蓋壓襯構選憲顧衊顧 (醖齋積窪積膚繭鏇窪鑰 )	积极	2022-11-15