Core Viewpoint - The stock of Baiaosaitu-B (02315) has seen an increase of over 3%, currently trading at 31.86 HKD, following the announcement of FDA approval for a clinical trial by its partner IDEAYA Biosciences, Inc. for a novel dual-targeting antibody-drug conjugate project [1][2]. Group 1: Company Developments - IDEAYA Biosciences has received FDA approval for its Investigational New Drug (IND) application to advance the Phase I clinical trial of the B7H3/PTK7 dual-specific antibody-drug conjugate (ADC) [1]. - The patient enrollment for the trial is expected to begin in Q1 2026, focusing on solid tumors co-expressing B7H3 and PTK7, including lung cancer, colorectal cancer, head and neck cancer, and ovarian/gynecological tumors [1][2]. Group 2: Clinical Research Insights - Preclinical studies indicate that IDE034 monotherapy shows deep and durable tumor shrinkage in various B7H3/PTK7 positive tumor models, demonstrating strong anti-tumor activity [2]. - IDEAYA plans to explore a combination treatment strategy of IDE034 with its PARG inhibitor IDE161 to enhance the durability of efficacy, with data supporting the combination treatment mechanism to be shared at a major medical conference in H1 2026 [2]. - The co-expression rates of B7H3/PTK7 in solid tumors are approximately 30% for lung cancer, 46% for colorectal cancer, and 27% for head and neck cancer, indicating broad clinical applicability [2].

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 ...