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更新于：2025-05-07

GDF15

更新于：2025-05-07

基本信息

别名

GDF-15、GDF15、growth differentiation factor 15

+ [17]

简介

Hormone produced in response to various stresses to confer information about those stresses to the brain, and trigger an aversive response, characterized by nausea, vomiting, and/or loss of appetite (PubMed:23468844, PubMed:24971956, PubMed:28846097, PubMed:28846098, PubMed:28846099, PubMed:28953886, PubMed:29046435, PubMed:30639358, PubMed:31875646, PubMed:33589633, PubMed:38092039). The aversive response is both required to reduce continuing exposure to those stresses at the time of exposure and to promote avoidance behavior in the future (PubMed:30639358, PubMed:33589633, PubMed:38092039). Acts by binding to its receptor, GFRAL, activating GFRAL-expressing neurons localized in the area postrema and nucleus tractus solitarius of the brainstem (PubMed:28846097, PubMed:28846098, PubMed:28846099, PubMed:28953886, PubMed:31535977). It then triggers the activation of neurons localized within the parabrachial nucleus and central amygdala, which constitutes part of the 'emergency circuit' that shapes responses to stressful conditions (PubMed:28953886). The GDF15-GFRAL signal induces expression of genes involved in metabolism, such as lipid metabolism in adipose tissues (PubMed:31402172). Required for avoidance behavior in response to food allergens: induced downstream of mast cell activation to promote aversion and minimize harmful effects of exposure to noxious substances (By similarity). In addition to suppress appetite, also promotes weight loss by enhancing energy expenditure in muscle: acts by increasing calcium futile cycling in muscle (By similarity). Contributes to the effect of metformin, an anti-diabetic drug, on appetite reduction and weight loss: produced in the kidney in response to metformin treatment, thereby activating the GDF15-GFRAL response, leading to reduced appetite and weight (PubMed:31875646, PubMed:37060902). The contribution of GDF15 to weight loss following metformin treatment is however limited and subject to discussion (PubMed:36001956). Produced in response to anticancer drugs, such as camptothecin or cisplatin, promoting nausea, vomiting and contributing to malnutrition (By similarity). Overproduced in many cancers, promoting anorexia in cancer (cachexia) (PubMed:32661391). Responsible for the risk of nausea and vomiting during pregnancy: high levels of GDF15 during pregnancy, mostly originating from the fetus, are associated with increased nausea and vomiting (PubMed:38092039). Maternal sensitivity to nausea is probably determined by pre-pregnancy exposure to GDF15, women with naturally high level of GDF15 being less susceptible to nausea than women with low levels of GDF15 before pregnancy (PubMed:38092039). Promotes metabolic adaptation in response to systemic inflammation caused by bacterial and viral infections in order to promote tissue tolerance and prevent tissue damage (PubMed:31402172). Required for tissue tolerance in response to myocardial infarction by acting as an inhibitor of leukocyte integring activation, thereby protecting against cardiac rupture (By similarity). Inhibits growth hormone signaling on hepatocytes (By similarity).

关联

项与 GDF15 相关的药物

Ponsegromab

靶点

GDF15

作用机制

GDF15抑制剂

在研机构

原研机构

在研适应症

非在研适应症

最高研发阶段临床2期

首次获批国家/地区-

首次获批日期1800-01-20

Visugromab

维苏格罗单抗

靶点

GDF15

作用机制

GDF15抑制剂 [+2]

在研机构

CatalYm GmbH

原研机构

CatalYm GmbH

在研适应症

肌层浸润性膀胱癌 [+7]

非在研适应症-

最高研发阶段临床2期

首次获批国家/地区-

首次获批日期1800-01-20

GFS202A

靶点

GDF15 x IL-6

作用机制

GDF15抑制剂 [+1]

在研机构

劲方医药科技（上海）有限公司

原研机构

劲方医药科技（上海）有限公司

在研适应症

恶病质

非在研适应症-

最高研发阶段临床1期

首次获批国家/地区-

首次获批日期1800-01-20

项与 GDF15 相关的临床试验

NCT06898255

/ Not yet recruiting临床1期

An Open-label, Multi-center, Phase I Study to Evaluate the Safety/tolerability and Pharmacokinetics of GFS202A in Advanced Solid Tumor Patients with Pre-cachexia or Cachexia

An open-label, multi-center, phase I study to evaluate the safety/tolerability and pharmacokinetics of GFS202A in advanced solid tumor patients with pre-cachexia or cachexia. The primary objective is to assess the safety/tolerability of GFS202A, determine its maximum tolerated dose (MTD), and recommend a dose range for future studies.
Enroll participants with cancer cachexia or precachexia to receive GFS202A monotherapy. During the study period, participants will undergo assessments for safety and preliminary efficacy according to the visit schedule. Pharmacokinetic, anti-drug antibody (ADA), and pharmacodynamic (PD) /biomarker samples will be collected.

开始日期2025-04-14

申办/合作机构

劲方医药科技（上海）有限公司

NCT06059547

/ Active, not recruiting临床2期

A Multi-center Phase 2 Study of Neoadjuvant Immunotherapy in Combination With the Anti-GDF-15 Antibody Visugromab (CTL-002) for the Treatment of Muscle Invasive Bladder

This is a multi-center, stratified and single-blinded Phase 2 study of neoadjuvant immunotherapy in combination with the antiGDF15 antibody visugromab (CTL-002) for the treatment of subjects with MIBC set to undergo radical Cystectomy (RC)/Re-TURBT who cannot receive or refuse to receive cisplatin-based chemotherapy.

开始日期2023-09-06

申办/合作机构

CatalYm GmbH

NCT05865535

/ Recruiting临床1期

A Phase 1B Dose Escalation Study of AV-380 in Combination With Standard of Care Chemotherapy in Metastatic Cancer Patients With Cachexia and Elevated GDF-15 Levels

This open label ascending dose study is designed to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AV-380 in cancer patients with Cachexia. AV-380 is an immunoglobulin (Ig) G1 monoclonal antibody (mAb) intended to bind circulating human growth differentiation factor 15 (GDF-15), a cytokine involved in cancer-induced cachexia.

开始日期2023-06-13

申办/合作机构

AVEO Pharmaceuticals, Inc.

100 项与 GDF15 相关的临床结果

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100 项与 GDF15 相关的转化医学

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0 项与 GDF15 相关的专利（医药）

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3,548

项与 GDF15 相关的文献（医药）

2025-12-31·Pulmonology

Mendelian randomisation studies for causal inference in chronic obstructive pulmonary disease: A narrative review

Review

作者: Yang, Yuqiong ; Wang, Mingdie ; Wang, Fengyan ; Miao, Chengyu ; Chen, Zizheng ; Liang, Zhenyu ; Chen, Tingnan ; Li, Xueping ; Chen, Rongchang ; Peng, Chusheng ; Feng, Shengchuan ; Zhou, Zifei

BACKGROUND AND OBJECTIVEMost non-randomised controlled trials are unable to establish clear causal relationships in chronic obstructive pulmonary disease (COPD) due to the presence of confounding factors. This review summarises the evidence that the Mendelian randomisation method can be a powerful tool for performing causal inferences in COPD.METHODSA non-systematic search of English-language scientific literature was performed on PubMed using the following keywords: 'Mendelian randomisation', 'COPD', 'lung function', and 'GWAS'. No date restrictions were applied. The types of articles selected included randomised controlled trials, cohort studies, observational studies, and reviews.RESULTSMendelian randomisation is becoming an increasingly popular method for identifying the risk factors of COPD. Recent Mendelian randomisation studies have revealed some risk factors for COPD, such as club cell secretory protein-16, impaired kidney function, air pollutants, asthma, and depression. In addition, Mendelian randomisation results suggest that genetically predicted factors such as PM_2.5, inflammatory cytokines, growth differentiation factor 15, docosahexaenoic acid, and testosterone may have causal relationships with lung function.CONCLUSIONMendelian randomisation is a robust method for performing causal inferences in COPD research as it reduces the impact of confounding factors.

2025-12-01·Current Heart Failure Reports

Clinical Insights from Proteomics in Heart Failure

Review

作者: Pompian, Alexander ; Stitziel, Nathan O ; Imam, Adnan ; Lotfinaghsh, Aynaz ; Javaheri, Ali

PURPOSE OF REVIEWThe pathophysiology of heart failure (HF), a complex and heterogenous condition, remains to be fully understood. Troponin and b-type natriuretic peptide are the only biomarkers that are utilized in clinical practice for HF clinical management. Recent advances in proteomics present a powerful tool to identify risk markers and ultimately, potential molecular mechanisms underlying HF pathogenesis. Herein, we explore traditional and novel heart biomarkers, highlighting their potential role in the pathogenesis of HF.RECENT FINDINGSRecent proteomic analyses have identified numerous proteins including Galectin-3, sST2, GDF-15, FGF21, Endotrophin, THSB-2, ADAMSTL, SVEP1, and anthracycline that are associated with clinical outcomes in HF. These biomarkers are not presently utilized in HF management but may be useful in the future for prediction of death or HF hospitalization. While traditional biomarkers remain essential, proteomic strategies have revealed additional targets that require further mechanistic exploration. Future research should focus on validating these biomarkers and translating proteomic insights into clinical practice to enhance HF management.

2025-08-01·Journal of Critical Care

ICU-acquired weakness: Critical illness myopathy and polyneuropathy

Review

作者: Gozum, Nimrod ; Harrison, Taylor B ; Huang, Audrey ; Salazar, Marco ; Mayer, Stephan A ; Weber, Harli ; Yang, Jenny ; Badjatia, Neeraj ; Henson, Theresa

Critical illness myopathy (CIM) and critical illness polyneuropathy (CIP) are significant complications in intensive care unit (ICU) patients, first identified in the late 20th century. These conditions often present as flaccid paralysis and respiratory muscle weakness, making it challenging for patients to wean off ventilatory support. The incidence of ICU-acquired weakness, which includes CIM and CIP, ranges from 25 % to 84 % among long-term ventilated patients, with higher rates observed in those with sepsis or systemic inflammatory response syndrome. CIM is characterized by muscle wasting and can be confirmed using electromyography and muscle biopsy. The pathogenesis of CIM involves the loss of thick myosin filaments, while the proposed etiology of CIP centers around increased permeability of nerve axons, leading to axonal degeneration. Risk factors for developing these conditions include prolonged ICU length of stay, sepsis, multi-system organ dysfunction, hyperglycemia, as well as exposure to steroids and neuromuscular blocking agents. Emerging diagnostic tools including muscle ultrasound, magnetic resonance imaging (MRI), and biomarkers such as interleukin-6 (IL-6) and growth differentiation factor-15 (GDF-15) show promise in early detection and differentiation of CIM and CIP. Preventative and therapeutic treatment focuses on early mobilization, minimizing sedation, optimizing nutritional support, and use of intensive insulin therapy to prevent prolonged hyperglycemia. Despite these advancements, CIM and CIP continue to pose significant challenges, emphasizing the need for ongoing research to improve patient outcomes and develop effective treatments.

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项与 GDF15 相关的新闻（医药）

2025-04-22

·微信

石药集团JMT203（抗GFRAL单克隆抗体）获美国临床试验批准

4月22日，石药集团（1093.HK）宣布，本集团附属公司上海津曼特生物科技有限公司自主研发的抗体药物JMT203（下称：该产品）已获美国食品药品监督管理局(FDA)批准，可以在美国开展临床研究。此前，该产品已经于2023年6月获得中华人民共和国国家药品监督管理局批准，并正在中国开展临床试验。该产品为本集团自主研发的抗GDNF家族受体蛋白(GFRAL)重组人源化单克隆抗体，能有效拮抗GDF15-GFRAL/RET信号，具有食欲和代谢调节作用，可潜在逆转或者减轻由肿瘤以及化疗药物引起的体重降低、厌食和肌肉萎缩等恶病质症状，从而有效提高肿瘤病人的生活质量。本次获批的临床适应症为肿瘤恶病质，临床前研究显示该产品具有良好的安全性，可显著抑制恶病质小鼠的体重下降、增加其非空腹血糖和前爪握力，从而改善恶病质症状，进而提高恶病质小鼠的带瘤存活率，与抗肿瘤治疗联用显著增加治疗耐受性、延长生存期。目前，全球范围内尚未有GDF15或GFRAL靶点药物上市，该产品有望成为治疗肿瘤恶病质的有效药物，具有较高的临床开发价值。【声明】1、本新闻旨在分享公告信息，非广告用途；2、本资料仅供医药专业人士参考，非产品推荐依据，也不应被视为诊疗建议。

上市批准临床研究

2025-04-18

·米内网

【瞩目】这家药企爆发了！海外收入大涨62%，1类新药抢攻2200亿市场

精彩内容近日，科兴制药（688136.SH）发布2024年业绩报告，报告期内实现营收约14.07亿元，同比增长约12%；扣非归母净利润约3525万元，同比增长约118%。科兴制药坚持“创新+海外商业化”双轮驱动，2024年海外销售收入同比增长约62%，并实现了由新兴市场向成熟市场扩张的新突破，白蛋白紫杉醇、英夫利西单抗、贝伐珠单抗等引进产品海外注册火速推进；多项创新药研发进度全球领先，聚焦抗肿瘤、自免等热门领域。出海“加速度”！海外收入大涨62%2000年左右，科兴制药就开始探索海外市场，目前公司的国际化业务已覆盖南美、东南亚、中亚、西非、东非等新兴市场，同时还实现了向欧盟成熟市场的延伸步入。2024年，科兴制药积极推进“国际化”战略，持续完善海外营销组织架构，聚焦重点疾病领域不断引进产品，在国内医药行业的出海示范作用日益凸显，报告期内海外销售收入约2.24亿元，同比增长约61.96%。2024年以来，科兴制药先后与西岭源药业、亚宝生物、正大天晴药业、青峰医药、博安生物签署合作协议，获得甲磺酸艾立布林注射液、甲苯磺酸索拉非尼片、哌柏西利胶囊、奥拉帕利片、地舒单抗注射液等品种的海外商业化权益。此外，公司与海创药业、百诚医药、百奥泰、科伦药业等企业签署出海战略合作协议，围绕高品质药的海外商业化等达成深度协作。目前科兴制药已累计引进16款重磅产品，涵盖抗肿瘤、自身免疫、代谢、肾病等治疗领域。在2024年全球销售额TOP100药品中，抗肿瘤药以约29%的比重占据主导地位，相关产品总收入超过1400亿美元；自身免疫疾病用药以约20%的占比紧接其后，相关产品总收入超过900亿美元；代谢性疾病用药表现同样亮眼，相关产品总收入超过800亿美元，增长势头强劲。科兴制药引进产品情况来源：公司微信公众号2024年科兴制药实现了由新兴市场向成熟市场扩张的新突破——白蛋白紫杉醇在欧盟、英国获批上市，并已在欧洲开始销售，陆续收到一定体量的订单。米内网数据显示，2024年前三季度白蛋白紫杉醇全球销售额超过11亿美元，科兴制药的产品在欧盟多个国家的市场份额不断提升。此外，根据不完全统计，其他引进产品的注册工作也在新兴市场多国稳步推进：英夫利西单抗在秘鲁、孟加拉国、巴基斯坦、印尼获批上市，同时取得巴西、埃及等国家的GMP认证；贝伐珠单抗取得巴西、印尼、埃及、哥伦比亚等国家的GMP认证，完成巴基斯坦远程GMP审计等；阿达木单抗取得沙特药监局的GMP证书，完成菲律宾和埃及监管机构GMP现场审计；人促红素通过秘鲁药监局GMP审计；利拉鲁肽取得哥伦比亚GMP证书，完成埃及卫生部GMP现场审计等。截至目前，科兴制药引进产品已在60余个国家提交了120多项注册申请。未来，公司将加快推进上述产品的注册进程，巩固海外商业化平台价值，大力引进高技术壁垒产品，预计未来5-10年内，公司将不断拓展国际市场版图，覆盖更多区域与客户群体。值得一提的是，根据科兴制药2024年公告的股权激励计划，2025年外销收入增速目标设定为相比2023年增长200%-400%。可见，公司对国际化战略的实施信心十足。研发管线看点多多！1类新药抢攻2200亿市场在新药研发上，科兴制药由最初的“Fast-follow”单抗药物到布局“成熟靶点+创新靶点”的双抗或三抗药物，到如今布局全球首创(First-in-Class)三抗药物，可见公司在不同阶段有着明确的战略和差异化思路。2024年公司与百图生科达成战略合作，利用AI技术参与多靶点药物的早期分子设计与开发。随着AI技术的深入应用，公司将逐步拓展到双靶及三靶点药物的研发领域，进一步提升研发效率。3月19日，CDE官网显示，科兴制药申报的1类新药GB18注射液临床申请获得受理，为公司2025年首款提交IND的1类新药。值得一提的是，该新药已在推进中美双报，为进入海外成熟市场储备更高品质的药物梯队。据悉，GB18是一种针对生长分化因子15(GDF-15)靶点的创新型药物，用于治疗肿瘤恶病质。肿瘤恶病质在癌症患者中有较高的发病率，目前尚无有效的逆转方法，而GDF-15是治疗恶病质的潜力新星。米内网数据显示，目前全球暂无靶向GDF-15的药物获批上市。同靶点同适应症的在研新药中，辉瑞的ponsegromab(PF-06946860)处于II期临床，AVEO的AV-380处于I期临床。针对GDF-15靶点治疗肿瘤恶病质的国产新药中，GB18注射液进展最快。该药采用独特的Fc融合纳米抗体结构设计，并完成了国际专利布局。临床前数据显示，GB18能显著改善体重下降，提高肌肉和脂肪重量，改善运动功能。预计可实现每3-4周一次的注射频率，提高患者依从性。科兴制药在研新药来源：公司公告目前，科兴制药布局开发了14款新药，涵盖抗肿瘤、自身免疫、眼底疾病等热门领域。米内网数据显示，近年来中国三大终端六大市场（统计范围详见本文末）抗肿瘤和免疫调节剂（化学药+生物药）销售额逐年上涨，2023年超过2200亿元，2024上半年以约8%的增速继续增长。近年来中国三大终端六大市场抗肿瘤和免疫调节剂（化学药+生物药）销售情况（单位：万元）来源：米内网格局数据库从科兴制药披露的研发管线可以看到，公司1类创新药的占比在逐渐提升，且多个新药展现出“同类最优”或“进展最快”的潜力。GB10通过结合血管内皮生长因子(VEGF)和血管生成素-2(ANG-2)两个关键靶点，实现对病理机制的双重干预，具有给药周期间隔长、安全性高、机制明确等潜在优势。目前全球已获批的VEGF/ANG-2双抗药物仅有1款，为罗氏的法瑞西单抗(Faricimab)，该药2024年全球销售额达38.64亿瑞士法郎。GB12为靶向白介素-4受体(IL-4R)和白介素-31受体(IL-31)的双特异性抗体，可同时作用于炎症和止痒两条通路，达到双管齐下的效果。目前全球尚无同类产品获批，已步入临床阶段的在研新药有强生的NM26（NM26-2198）等。根据弗若斯特沙利文预测，2030年中国特应性皮炎市场规模有望超过40亿美元。GB20（TL1A单抗）、GB24（TL1A双抗）是针对炎症性肠炎(IBD)的2款药物。TL1A为IBD领域的热门靶点，目前全球暂无同靶点药物获批上市。GB24除了靶向TL1A之外，还靶向另一个在功能、机制上和TL1A有较强协同效应的新兴靶点，可以覆盖IBD的全病程治疗。从研发进度看，改良型新药人干扰素α1b吸入溶液处于III期临床，上市可期。该药是治疗儿童呼吸道合胞病毒(RSV)感染（肺炎、毛细支气管炎等）的对症药物。据贝哲斯咨询发布的呼吸道合胞病毒（RSV）治疗市场调研报告，全球呼吸道合胞病毒（RSV）治疗市场规模2023年达到33.75亿元（人民币）。同样处于III期临床的聚乙二醇化人粒细胞刺激因子注射液是一款长效的升白药，具有高度的位点选择性、高修饰率、副产物少等优点。米内网数据显示，近年来中国三大终端六大市场升白药销售规模均超过90亿元。近年来中国三大终端六大市场升白药销售情况（单位：万元）来源：米内网格局数据库结语综上，科兴制药具有清晰的研发布局和发展策略：一方面，聚焦肿瘤、自免等热门领域，按照中美双报的标准开展研发立项工作，全面向创新药研发转型；另一方面，依托成熟的海外商业化平台，持续引入高潜力产品并推动其注册销售，实现业务的长期增长。随着多款引进产品的海外放量和多个创新药的研发推进，科兴制药未来值得期待！资料来源：米内网数据库、公司公告注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至4月11日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

上市批准财报医药出海

2025-04-09

·劲方医药GenFleet

AACR预告：劲方医药三款大、小分子产品临床前研究将登陆2025 AACR年会壁报

劲方医药宣布其管线中三款新药的临床前研究入选2025年美国癌症研究协会（AACR）壁报环节。今年AACR年会将于4月25日至30日在美国芝加哥举行，劲方管线中的三款大、小分子产品GFH276、GFS202A、GFH375/VS-7375临床前研究数据将在会议中公布。入选壁报产品的分子形态多元、靶向多个市场广阔的大适应症，展现了公司“全球新”产品开发的创新度、确定性和丰富性。基于公司管线中已上市产品氟泽雷塞（KRAS G12C抑制剂）的开发经验，劲方RAS疗法矩阵不断拓展并将在此次会议公布其Pan RAS (ON) 抑制剂GFH276临床前研究数据。此外，两款临床阶段产品的临床前更新数据也将登陆壁报：GFS202A（GDF15/IL-6双抗）为全球首个恶病质双抗疗法，GFH375则位于国内口服KRAS G12D抑制剂开发第一梯队，显示了公司深耕RAS疗法、同时放眼不同疾病领域的管线厚度与可持续创新能力。GFH276：Pan RAS (ON) 抑制剂，临床前研究展现广谱抗肿瘤活性摘要编号：389展览时间：4月27日下午2:00-5:00分会场标题：Degraders and glues 1 摘要简介：GFH276为具有优越口服生物利用度的分子胶类泛RAS抑制剂，可抑制多数活化状态的野生/突变型RAS蛋白亚型，包括肿瘤中常见的KRAS突变型（G12C、G12D、G12V等）以及NRAS、HRAS亚型蛋白。GFH276在激酶选择性和安全相关靶点测试中展现了良好的安全性及靶向特异性；并在多种机理的KRAS G12C抑制剂耐药细胞系中，均保持强效活性并显示多重抗耐药潜力。GFS202A：全球首个GDF15/IL-6双抗产品及恶病质双抗靶向疗法摘要编号：6078展览时间：4月29日下午2:00-5:00分会场标题：Antibodies 3: Multi-target checkpoint inhibitors and immune activators摘要简介：GFS202A双抗疗法已在国内获批针对肿瘤恶病质患者开展I期临床试验。恶病质为机制复杂的代谢性综合征，常见于肿瘤、艾滋病、心衰、慢阻肺等多种慢性疾病患者。临床前实验显示GFS202A与人体GDF15、IL-6蛋白的高亲和力、高特异性结合；体内实验显示低剂量注射GFS202A即可有效逆转恶病质动物模型的体重减轻，使之呈现剂量依赖式的体重、脂肪和肌肉组织增加，并有效降低实验动物的C反应蛋白水平。同时，GFS202A在动物毒理实验中呈现良好的安全性、耐受性。GFH375/VS-7375：口服KRAS G12D（ON/OFF）抑制剂，单药及联合疗法临床前实验均显示强效抗肿瘤活性摘要编号：4394展览时间：4月29日上午9:00-晚间12:00 分会场标题：RAS inhibitors, experimental and molecular therapeutics摘要简介：GFH375为临床阶段的口服小分子KRAS G12D（ON/OFF）抑制剂，在临床前研究中表现了对G12D突变细胞系的高选择性及强效抑制，并在多个结直肠癌、胰腺癌动物模型中实现显著的肿瘤消退。GFH375还在与西妥昔单抗（EGFR单抗）、avutometinib（RAF/MEK抑制剂）分别联用的两项临床前动物实验中，显示了超越GFH375单药的抑瘤活性；GFH375、西妥昔单抗联用的结直肠癌模型中，所有实验小鼠全部达到完全缓解。关于参会项目GFH276为机制独特的口服小分子泛RAS（ON）抑制剂，采用三复合物作用机制(CypA-GFH276-RAS)，可高效抑制多数活化状态的野生/突变型RAS蛋白亚型，包括常见的KRAS突变型（G12C、G12D、G12V等）以及NRAS、HRAS亚型蛋白。GFS202A为GDF15/IL-6双抗产品，已获批进入国内I期肿瘤恶病质临床试验；肿瘤为恶病质最常见的诱因之一，恶病质在多个瘤种发病率超过50%、死亡率可达30%，GDF15、IL-6水平在恶病质患者体内异常升高，均与肿瘤患者病情、生存率恶化相关。GFH375/VS-7375为口服高活性、高选择性小分子KRAS G12D（ON/OFF）抑制剂，目前国内II期研究已经完成首例患者入组；2023年8月，劲方医药与纳斯达克上市公司Verastem Oncology（纳斯达克股票代码：VSTM）对劲方开发的三款产品达成授权及早期合作开发协议；2025年1月，Verastem宣布对GFH375/VS-7375行使选择权，获得GFH375在大中华区之外的开发和商业化权利。关于劲方医药劲方医药是一家全球布局的创新药物开发企业，聚焦肿瘤、免疫类疾病领域高度未满足的临床需求，以疾病生物学机理和临床转化医学为核心，构建并发挥自主化、一体化研发体系优势，主攻尚无临床验证的创新靶点与适应症，并拥有全球自主知识产权。自2017年成立以来，劲方医药已建立包含多个自主研发的“全球新”大、小分子项目，多个产品在中国、欧洲、美国进入全球多中心临床试验，包括多项后期或关键性临床研究。达伯特®（氟泽雷塞）为劲方管线中首个国内上市获批产品，也是国内首个、全球第三个上市的KRAS G12C抑制剂，曾获得国家药品监督管理局优先审评及两项突破性疗法资格认定；氟泽雷塞、西妥昔单抗的一线联合疗法也在欧洲进入II期研究，为全球首个KRAS、EGFR抑制剂一线非小细胞肺癌联用治疗方案。目前，公司已形成RAS靶向疗法的一体化深耕矩阵，并积极拓展其他“全球新”靶向药及新类型疗法管线开发。同时，公司近年来不断深化商业合作网络，已与多个境内外上市公司达成战略授权协议、或开展“全球新”临床合作并已取得积极进展。联系我们电话：021-68821388邮箱：pr@genfleet.com; bd@genfleet.com官网：www.genfleet.com 地址：上海市浦东新区张江路1206号A座邮编：201203

AACR会议临床1期临床结果