EASTONBIOPHARMACEUTICALS(SH:688513) Shang Hai Zheng Quan Bao·2025-11-10 19:27Core Viewpoint - Chengdu Yuandong Biopharmaceutical Co., Ltd. has announced the initiation of I/II phase clinical trials for its novel antibody-drug conjugate YLSH003, aimed at treating advanced solid tumors, with the first subject successfully enrolled [1][3]. Group 1: Drug Overview - YLSH003 is a new type of antibody-drug conjugate targeting Tissue Factor (TF), which is implicated in the recurrence and metastasis of many solid tumors [1][2]. - The drug is developed using a high-affinity humanized IgG1 antibody and a small molecule topoisomerase I inhibitor, utilizing the Uni-linker ADC technology platform [2]. - Preclinical studies indicate that YLSH003 has high anti-tumor activity and potential superior safety, offering better treatment options for patients with advanced solid tumors [2]. Group 2: Clinical Trial Details - YLSH003 received acceptance from the National Medical Products Administration (NMPA) in July 2025 and was granted a clinical trial approval notice in September 2025 [3]. - The I/II phase clinical study aims to evaluate the safety, tolerability, pharmacokinetics, and efficacy of YLSH003 in patients with advanced solid tumors, with the I phase focusing on dose escalation and the II phase on efficacy at the recommended dose [3]. - The first subject in the I phase has been successfully enrolled, and recruitment for additional subjects is progressing rapidly [3].