[杭州,5月6日] 

杭州瑞奥生物医药有限公司(以下简称“瑞奥生物”或“Surio”),一家致力于开发全球首创(First-in-class)疗法以满足肿瘤领域未满足医疗需求的生物医药公司,今日宣布其子公司北京艾维速瑞新药技术有限公司(艾维速瑞)在研抗肿瘤药物SURIO-001的临床Ia期研究已顺利完成。研究结果显示,SURIO-001组合中的ST114分子在健康受试者中表现出良好的安全性和耐受性,在所有剂量组均未发生二级或以上不良反应,并达到了预设的药代动力学目标。这些数据为后续在肿瘤患者中的临床探索提供了坚实的基础。基于Ia期研究中取得的积极结果,公司即将启动该药物的临床Ib期研究。

关于SURIO-001

SURIO-001是瑞奥生物基于全球首创的ATTACK技术平台研发的首款抗肿瘤靶向药物,为肿瘤特异性标记药物ST114与细胞毒素偶联物ST205联用的组合疗法,并在艾维速瑞推进临床开发。ST114是基于ATTACK技术开发的非天然糖衍生物,可特异性识别并对肿瘤细胞标记可发生点击化学的人工受体,其针对的肿瘤特异性靶点在一系列实体瘤中均有超过30%的阳性表达率。ST205是ATTACK技术开发的小分子毒素偶联物,毒素荷载为微管蛋白抑制剂,可通过点击化学特异性识别ST114插入肿瘤细胞表面的人工受体,从而实现对于肿瘤的靶向毒素递送及靶向治疗。SURIO-001在胃癌、胆管癌、膀胱癌、肾癌、头颈癌、宫颈癌、卵巢癌、乳腺癌、前列腺癌、胰腺癌、肝癌、结直肠癌等多种实体瘤的治疗中具有广泛应用潜力。

关于SURIO001临床Ia研究

SURIO-001的临床Ia期研究是一项在健康受试者中开展的随机、双盲、安慰剂对照的单次/多次剂量递增研究,旨在评估SURIO-001组合中的ST114分子在健康人群中的安全性、耐受性及药代动力学特征。

关于SURIO001临床Ib研究

这项Ib期研究旨在进一步评估SURIO-001的ST114联用ST205药物在晚期肿瘤患者中的安全性、耐受性、药代动力学特征,并初步探索其抗肿瘤活性,适用人群为经病理组织学或细胞学确诊,且标准治疗失败,或无标准治疗方案,或现阶段不适合标准治疗的局部晚期或转移性实体瘤,包括但不限于胃癌、胆管癌、膀胱癌、肾癌、头颈癌、宫颈癌、卵巢癌、乳腺癌、前列腺癌、胰腺癌等。该研究是推动SURIO-001临床开发进程的关键一步,将为后续的临床验证性研究确定合适的剂量和治疗方案。

关于生物

杭州瑞奥生物医药有限公司成立于2019年,坐落于杭州云栖西湖大学科技园。瑞奥生物致力于全球首创的ATTACK(Active Tissue Targeting via Anchored ClicK chemistry)技术平台的开发及转化。ATTACK技术创新性地通过非天然糖代谢机制实现了选择性体内靶标组织人工受体标记,利用生物正交点击化学反应特异性识别人工受体标记,从而靶向递送药物用于现有技术不可靶向疾病的诊疗。公司致力于通过这一颠覆性技术平台,开发新一代精准靶向药物,解决未被满足的临床需求。

关于艾维速瑞

北京艾维速瑞新药技术有限公司由瑞奥生物和维梧资本于2025年底共同创立,是最早入驻维梧加速器的公司之一,用于推进瑞奥生物首发管线SURIO-001及相关产品的临床和商业化开发。”

关于资本加速器

维梧资本(Vivo Capital)成立于1996年,是一家全球领先的医疗健康投资机构,致力于通过生态策略实现战略赋能和资源整合。维梧资本在风险投资、成长型和控股型私募股权以及公开市场拥有多基金投资平台,累计管理16支美元基金和人民币基金,积极在管资产规模超过75亿美元,在全球范围内布局超过460家企业。旗下所有基金均广泛投资于医疗健康领域,包括生物技术、制药、医疗器械和医疗服务等,重点关注全球最大的医疗健康市场。维梧资本拥有一支由70余名专业人士组成的团队,总部位于美国加州帕洛阿尔托,在北京、上海、香港、台北和新加坡均设有办公室。

维梧加速器(Vivo Accelerator)是维梧资本打造的开放式国际化创新平台,于2025年8月正式启动。依托维梧资本30年来积累的独特全球医疗健康生态资源,加速器与合作伙伴共同筛选覆盖药物研发各阶段的优质项目和创新资产,充分发挥中国在临床前及临床阶段药物研发方面的资源与效率优势,助力全球生物医药企业高效推进研发与临床进程,旨在促进多方协同创新与合作共赢。

Surio Therapeutics Announces Successful Phase Ia Study for First-in-Class Oncology Drug SURIO-001; Advances to Phase Ib Patient Trial

[Hangzhou, May 6th, 2026] 

Hangzhou Surio Therapeutics Co., Ltd. (“Surio”), a biopharmaceutical company dedicated to developing first-in-class therapies to address unmet medical needs in oncology, today announced the successful completion of the Phase Ia clinical study for its investigational drug, SURIO-001. The trial, conducted by its subsidiary Avisure, evaluated the drug in healthy subjects.

The study results demonstrated that the ST114 molecule in the SURIO-001 combination exhibited a favorable safety and tolerability profile in healthy subjects with no grade 2 or higher adverse event. Predefined pharmacokinetic objectives were also achieved. These data provide a robust foundation for subsequent clinical investigation in cancer patients. Based on the positive safety and tolerability results from the Phase Ia study, the company will initiate the Phase Ib clinical trial of the drug very soon.

[About SURIO-001]

SURIO-001 is the lead product developed from Surio’s proprietary ATTACK (Active Tissue Targeting via Anchored ClicK chemistry) platform, a combination product comprising of tumor-specific labeling reagent ST114 and cytotoxin conjugate ST205 under development in Surio’s subsidiaryAvisure. Both ST114 and ST205 are developed from the ATTACK technology. ST114 is an unnatural sugar derivative, which could specifically label cancer cells with Clickable artificial receptors through selective recognition by a protein target that is overexpressed in a series of solid tumors with positivity rate more than 30%. ST205 is a tubulin inhibitor conjugate, which could specifically recognize the artificial receptors on cancer cell surface inserted by ST114 through Click Chemistry to achieve targeted payload delivery and treatment. SURIO-001’s potential oncology indications include gastric cancer, biliary tract cancer, bladder cancer, kidney cancer, head and neck cancer, cervical cancer, ovarian cancer, breast cancer, prostate cancer, pancreatic cancer, liver cancer, colorectal cancer, etc.

[About the SURIO-001 Phase Ia Study]

The Phase Ia study of SURIO-001 was a randomized, double-blind, placebo-controlled, single/multiple ascending dose study conducted in healthy volunteers. It was designed to evaluate the safety, tolerability, and pharmacokinetic profile of the ST114 molecule in the SURIO-001 combination in a healthy population.

[About the SURIO-001 Phase Ib Study]

The Phase Ib study aims to further evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of SURIO-001 in patients with advanced solid tumors. The trial recruits patients with locally advanced or metastatic solid tumors confirmed by histopathology or cytology who have failed standard of care, have no standard treatment options, or are not suitable for standard treatment at the current stage, including but not limited to gastric cancer, cholangiocarcinoma, bladder cancer, renal cancer, head and neck cancer, cervical cancer, ovarian cancer, breast cancer, prostate cancer, and pancreatic cancer. This study represents a pivotal step in advancing the clinical development of SURIO-001 and will help determine the appropriate dose and regimen for subsequent confirmatory clinical studies.

[About Surio]

Surio Therapeutics Co. Ltd. was established in early 2019 and is currently located in the Science and Technology Park of Westlake University in Yunxi town, Hangzhou. Surio Therapeutics is committed to developing the First-in-class Active Tissue Targeting via Anchored ClicK chemistry (ATTACK) technology. ATTACK innovatively achieves selective in vivo tissue artificial labeling by unnatural sugar metabolic glycoengineering and then targets the labeling to accomplish targeted drug delivery to otherwise untargetable disease for treatment and diagnostic applications. The company is committed to developing a new generation of precision-targeted drugs through this disruptive technology platform to address unmet clinical needs.

[About Avisure]

Avisure is a joint venture established by Surio Therapeutics and Vivo Capital in late 2025. As one of the inaugural members of the Vivo Accelerator, Avisure is focused on advancing the clinical and commercial development of SURIO-001 and related assets.

[About Vivo Capital And Vivo Accelerator]

Vivo Capital, founded in 1996, is a leading global healthcare investment firm with a comprehensive multi-fund platform spanning venture capital, growth equity, and public markets. With over $7.5 billion in active assets under management and a global portfolio of more than 460 companies, Vivo invests across the healthcare spectrum, including biotech, pharmaceuticals, and medical devices. The firm is headquartered in Palo Alto, California, with additional offices in Beijing, Shanghai, Hong Kong, Taipei, and Singapore.

Launched in August 2025, the Vivo Accelerator is an open, international innovation platform built by Vivo Capital. It leverages Vivo’s deep healthcare ecosystem and global resources to identify and accelerate high-potential projects across all stages of drug development. The accelerator aims to foster collaboration and efficiently advance the R&D and clinical processes of its portfolio companies.