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.

267

项与匹米替尼相关的新闻（医药）

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

2025-11-16

·香港证券交易所

自願性公告 - 和譽醫藥於CTOS 2025年會展示匹米替尼臨床III期MANEUVER研究長期療效和安全性數據

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部分內容所產生或因依賴該等內容而引致的任何損失承擔任何責任。 Abbisko Cayman Limited 和譽開曼有限責任公司（於開曼群島註冊成立的有限公司）（股份代號：2256）自願性公告和譽醫藥於CTOS 2025年會展示匹米替尼臨床III期 MANEUVER研究長期療效和安全性數據和譽開曼有限責任公司（「本公司」，連同其附屬公司統稱「本集團」）謹此隨附新聞稿，以告知本公司股東及潛在投資者，本公司之附屬公司上海和譽生物醫藥科技有限公司（「和譽醫藥」）宣佈，其在結締組織腫瘤學會（「CTOS」）2025年會上以壁報形式展示了匹米替尼(pimicotinib/ABSK021)治療腱鞘巨細胞瘤（「TGCT」）患者的全球III期MANEUVER研究的長期療效、安全性及患者報告結果數據。該長期分析顯示，持續接受匹米替尼治療可為TGCT患者在腫瘤緩解方面帶來療效持續提升與患者報告結果（包括疼痛與功能）的進一步改善，同時維持可接受的安全性，強化了匹米替尼在適合患者中的長期應用潛力。此為本公司刊發的自願性公告。本集團無法保證ABSK021最終將成功獲批上市。本公司股東及潛在投資者於買賣本公司股份時務請審慎行事。上海，2025年11月17日於本公告日期，本公司董事會包括執行董事徐耀昌博士、喻紅平博士及嵇靖博士；以及獨立非執行董事孫飄揚博士、孫洪斌先生及徐海音女士。和譽醫藥於CTOS 2025年會展示匹米替尼臨床III期MANEUVER研究長期療效和安全性數據 2025年11月17日，上海和譽生物醫藥科技有限公司（「和譽醫藥」）宣佈，其在結締組織腫瘤學會（「CTOS」）2025年會上以壁報形式展示了匹米替尼(pimicotinib/ ABSK021)治療腱鞘巨細胞瘤（「TGCT」）患者的全球III期MANEUVER研究的長期療效、安全性及患者報告結果數據。該長期分析顯示，持續接受匹米替尼治療可為TGCT患者在腫瘤緩解方面帶來療效持續提升與患者報告結果（包括疼痛與功能）的進一步改善，同時維持可接受的安全性，強化了匹米替尼在適合患者中的長期應用潛力。 TGCT是一種罕見的局部侵襲性間葉性腫瘤，主要累及關節、腱鞘及滑囊，可導致嚴重的局部病變和功能障礙。其發生機制為腫瘤性滑膜細胞中過度表達集落刺激因子1（「CSF-1」），從而導致表達集落刺激因子1受體（「CSF-1R」）的炎症細胞在腫瘤中大量聚集。 MANEUVER研究是一項由三部分組成的全球多中心、隨機、雙盲、安慰劑對照 III期臨床試驗，旨在系統評估匹米替尼在TGCT患者中的療效與安全性。研究第一部分在第25周時達到了主要終點及所有關鍵次要終點，並已在2025年美國臨床腫瘤學會（「ASCO」）年會上公佈相關結果。主要終點為第一部分結束時，由盲態獨立評審委員會（「BIRC」）依據RECIST v1.1標準評估的客觀緩解率（「ORR」）。結果顯示，治療25周時，匹米替尼治療組ORR顯著優於安慰劑組（54.0% vs 3.2%，P<0.0001）。本屆CTOS 2025年會上展示的為MANEUVER研究第二部分完成後的長期療效及安全性數據。中位隨訪14.3個月時，自研究開始即接受匹米替尼治療的患者顯示出強勁而持久的腫瘤緩解。根據BIRC採用RECIST v1.1標準的評估，ORR從第25 周的54%顯著提升至76.2%（95% CI: 63.8, 86.0），其中4例實現完全緩解。與此同時，研究還顯示，在關節活動度、僵硬、疼痛及軀體功能等多項影響 TGCT患者生活質量的臨床結果評估（「COAs」）中，均出現了具有臨床意義的改善。此外，壁報還展示了基於EQ-5D-5L健康量表視覺模擬量表（「VAS」）評估的生活質量（「QoL」）獲益。接受匹米替尼治療的患者在第25周時，QoL較基線平均提高7.4%，並在第73周時進一步提升至13.1%。此外，第一部分初始隨機分配至安慰劑組的患者在第二部分改用匹米替尼後，同樣獲得臨床效益，中位隨訪時間8.5個月時，ORR達到64.5%，且COAs也有顯著改善。安全性方面，治療期間患者的中位劑量強度保持在88.2%的較高水平。大多數治療相關不良事件（「TEAEs」）為1-2級，未觀察到新的安全性信號，亦無膽汁淤積性肝毒性、藥物性肝損傷或毛髮╱皮膚色素減退等相關證據。值得一提的是，在今年10月舉辦的2025年歐洲腫瘤內科學會（「ESMO」）大會上， MANEUVER研究的牽頭主要研究者（「PI」）—— 北京積水潭醫院牛曉輝教授已通過口頭報告形式介紹了上述研究成果。關於匹米替尼匹米替尼是由和譽醫藥獨立研發的一款新型、口服、高選擇性且高活性的小分子CSF-1R抑制劑，其在全球III期MANEUVER研究中針對TGCT治療的積極頂線結果已於2024年11月發佈。目前，匹米替尼已被中國國家藥品監督管理局（「NMPA」）藥品審評中心（「CDE」）納入優先審評程序，用於需要系統性治療的 TGCT成人患者。匹米替尼還被NMPA授予了突破性療法認定（「BTD」）。2023年 12月，和譽醫藥與德國默克公司就匹米替尼的商業化權利達成協議，據此，德國默克公司會負責匹米替尼在全球的商業化。在中國以外，匹米替尼也獲得了美國食品藥品監督管理局（「FDA」）授予BTD，和獲得歐洲藥品管理局（「EMA」）授予優先藥品（「PRIME」）認定。關於和譽醫藥上海和譽生物醫藥科技有限公司成立於2016年4月，是一家專注於腫瘤領域的生物製藥公司，總部位於上海，其致力於發現和開發創新藥物，以滿足中國和全球未滿足的醫療需求。公司的創始人和管理團隊均為資深藥物研發專家，擁有來自頂尖跨國藥企的豐富研發和管理經驗。自成立以來，和譽醫藥已經建立了豐富的創新產品管線，專注腫瘤精準治療領域以及腫瘤免疫治療領域。更多信息，歡迎訪問 www.abbisko.com 。前瞻性陳述本文所作出的前瞻性陳述僅與本文作出該陳述當日的事件或資料有關。除法律規定外，於作出前瞻性陳述當日之後，無論是否出現新資料、未來事件或其他情況，我們並無責任更新或公開修改任何前瞻性陳述及預料之外的事件。請閣下細閱本文，並理解我們的實際未來業績或表現可能與預期有重大差異。本文內有關任何董事或本公司意向的陳述或提述乃於本文刊發日期作出。任何該等意向均可能因未來發展而出現變動。

临床3期上市批准

100 项与匹米替尼相关的药物交易

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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
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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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


NCT05804045 (MANEUVER, ESMO2025)	临床3期	腱鞘巨细胞瘤 CSF-1 receptor	135	Pimicotinib 50 mg	蓋衊鹽選鏇餘觸積鹹觸(願積齋選網憲構壓夢範) = 鬱廠襯鹽襯齋鬱窪網願鹹鹹鬱壓鏇製夢齋鹹蓋 (願積簾願簾膚願網餘膚, 63.8 ~ 86.0) 更多	积极	2025-10-17
NCT05804045 (MANEUVER, ASCO2025 \| PipelineReview) 人工标引	临床3期	腱鞘巨细胞瘤	94	Pimicotinib 50 mg QD	糧醖簾醖窪簾齋願願艱(廠繭糧蓋鬱製簾衊選膚) = 構鬱觸願餘蓋憲鹽繭蓋構遞積選願憲蓋艱鬱簾 (簾夢顧構鑰範觸鏇蓋觸 ) 更多	积极	2025-05-30
				Placebo	糧醖簾醖窪簾齋願願艱(廠繭糧蓋鬱製簾衊選膚) = 鬱遞顧壓鹽鑰襯艱繭鏇構遞積選願憲蓋艱鬱簾 (簾夢顧構鑰範觸鏇蓋觸 ) 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	廠壓糧範鬱繭鹹齋糧鬱(鬱鹹顧衊衊憲艱鬱餘繭) = 築顧獵窪衊鏇餘積壓餘餘糧糧襯齋夢膚糧鑰鹹 (願鹽窪夢鏇憲選遞範網 ) 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	鹽選壓簾鏇齋艱範構艱(鬱鑰簾餘夢鹽糧獵壓鹹) = 廠範製襯築憲積鹹餘壓觸範鹽衊簾鏇衊蓋糧壓 (醖鬱鏇鬱淵憲鬱齋鬱蓋 ) 更多	积极	2024-12-07
				Pimicotinib 5 mg	鹽選壓簾鏇齋艱範構艱(鬱鑰簾餘夢鹽糧獵壓鹹) = 齋糧艱獵鑰簾鬱衊願築觸範鹽衊簾鏇衊蓋糧壓 (醖鬱鏇鬱淵憲鬱齋鬱蓋 )
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	築遞鏇網遞簾範繭鬱鏇(齋壓築鏇夢醖衊糧簾鏇) = 顧築壓淵衊鏇願憲憲選鑰範鑰蓋顧齋壓糧齋製 (鏇蓋齋鹽鏇壓簾獵艱遞 ) 达到更多	积极	2024-11-12
				安慰剂	築遞鏇網遞簾範繭鬱鏇(齋壓築鏇夢醖衊糧簾鏇) = 膚範蓋觸鏇構鹹夢構齋鑰範鑰蓋顧齋壓糧齋製 (鏇蓋齋鹽鏇壓簾獵艱遞 ) 达到更多
NCT04192344 (Corporate Publications) 人工标引	临床1期	腱鞘巨细胞瘤	56	Pimicotinib 50mgQD	願齋築顧鑰襯範襯壓築(夢製製鬱鏇艱鹹鏇憲壓) = 夢齋糧壓憲鏇襯淵願憲願獵築壓憲糧艱範鹹蓋 (壓構衊壓窪艱艱衊艱衊 ) 更多	积极	2023-11-03
				Pimicotinib 25mgQD	願齋築顧鑰襯範襯壓築(夢製製鬱鏇艱鹹鏇憲壓) = 醖網齋鏇鏇簾積廠鑰廠願獵築壓憲糧艱範鹹蓋 (壓構衊壓窪艱艱衊艱衊 ) 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	憲醖餘廠壓觸糧蓋願淵(遞蓋範衊憲獵觸淵簾繭) = 3 pts (4.1%) reported serious TRAEs of ascites, blood bilirubin increase, and vaginal hemorrhage 醖廠蓋襯衊網夢齋壓築 (製齋夢鹹獵壓鏇鹽憲願 ) 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	鬱鬱鬱窪衊蓋鬱糧築鏇(願顧構網獵網齋鬱觸壓) = 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%) 範鑰憲網遞糧簾觸網壓 (廠鹽廠範醖獵願獵餘襯 ) 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	鹹襯選範獵醖膚糧獵鬱(壓醖願襯夢積繭醖壓範) = 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. 獵醖構鹹衊觸淵窪鑰鏇 (願簾遞製壓願網鹽積觸 )	积极	2022-11-15