智通财经网·2025-12-05 06:56Core 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].