Workflow
RenLite®平台
icon
Search documents
百奥赛图-B(02315)业务合作伙伴IDEAYA取得美国食品药品监督管理局对IDE034的IND批准
智通财经网· 2025-12-05 00:14
智通财经APP讯,百奥赛图-B(02315)发布公告,其合作伙伴IDEAYA Biosciences, Inc. (Nasdaq: IDYA) (IDEAYA),一家专注于肿瘤精准治疗药物研发的公司,已获得美国食品药品监督管理局的临床试验用 新药(IND)批准,推进同类首创B7H3/PTK7双特异性抗体偶联物(ADC)项目IDE034的I期临床试验。 IDEAYA预计将在2026年第一季度开始患者入组,初步评估B7H3和PTK7共表达的实体瘤类型,包括肺 癌、结直肠癌、头颈癌及卵巢╱ 妇科肿瘤。 IDE034获批IND,是IDEAYA将首创TOP1 ADC管线拓展至双特异性、精准靶向策略的重要一步,同时 也是公司对外授权项目取得的重要研发进展。这充分验证了公司的RenLite®平台及专有linker-payload技 术在双抗ADC发现与优化中的领先能力。公司期待IDE034能在多种B7H3/PTK7共表达实体瘤中展现临 床潜力,为患者提供新的治疗选择。 临床前研究显示,IDE034单药在多种B7H3/PTK7阳性肿瘤模型中表现出深度且持久的肿瘤回缩,显示 出强效抗肿瘤活性。此外,IDEAYA计划探索IDE0 ...
百奥赛图(02315)技术平台频结硕果 连签默克、Tubulis等推进国际化合作
智通财经网· 2025-09-18 03:43
Core Insights - Baiaosaitu (02315) has recently announced multiple collaborations and R&D advancements with Merck, Tubulis, and IDEAYA, highlighting its platform strength in antibody drug development and innovative delivery technologies [1][2] Group 1: Collaborations and Partnerships - Baiaosaitu's partner IDEAYA Biosciences unveiled the bispecific antibody-drug conjugate (bsADC) IDE034 (BCG034) during its tenth anniversary R&D day, which targets B7-H3 and PTK7, demonstrating significant efficacy in specific tumor models [1] - The collaboration with Tubulis involves the introduction of Baiaosaitu's fully human antibodies to advance ADC product development and commercialization, with Baiaosaitu set to receive an upfront payment and potential milestone payments [2] - The partnership with Merck focuses on developing antibody-conjugated lipid delivery solutions for nucleic acid drugs, such as antibody-conjugated lipid nanoparticles (LNP) [2] Group 2: Product Development and Clinical Trials - The IDE034 drug, developed on Baiaosaitu's RenLite® platform, is expected to cover multiple indications, including lung cancer and colorectal cancer, with a clinical trial application planned for submission in Q4 of this year [1]