Core Viewpoint - The company, Sihuan Pharmaceutical (02096.HK), has received approval from the National Medical Products Administration of China for clinical trials of its self-developed bispecific antibody-drug conjugate candidate SIM0610, aimed at treating patients with locally advanced or metastatic solid tumors [1] Group 1 - The candidate drug SIM0610 is a bispecific antibody-drug conjugate (BsADC) [1] - The clinical trials will focus on patients with locally advanced or metastatic solid tumors [1]

Core Viewpoint - The company, Sihon Pharmaceutical, has received approval from the National Medical Products Administration of China for clinical trials of its dual-specific antibody-drug conjugate candidate SIM0610, aimed at treating patients with locally advanced or metastatic solid tumors [1] Group 1: Product Development - SIM0610 targets both Epidermal Growth Factor Receptor (EGFR) and c-MET, utilizing a dual-target approach to enhance anti-tumor activity and potentially overcome resistance associated with EGFR-Tyrosine Kinase Inhibitors (EGFR-TKIs) [1] - Preclinical studies have demonstrated significant anti-tumor activity of SIM0610 across various tumor models [1] Group 2: Company Profile - The company is an innovation and research-driven pharmaceutical firm, operating a national key laboratory for neuro and oncology drug development [1] - The company focuses on neuroscience, oncology, autoimmune diseases, and anti-infective fields, while strategically positioning itself in areas with significant clinical needs [1] - The company emphasizes a mission of "born for patients" and drives its initiatives through independent research and collaborative innovation, establishing strategic partnerships with various innovative enterprises and research institutions [1]

Core Viewpoint - The company announced that its self-developed bispecific antibody-drug conjugate (BsADC) candidate SIM0610 has received clinical trial approval from the National Medical Products Administration of China for trials targeting patients with locally advanced or metastatic solid tumors [1] Group 1: Product Development - SIM0610 targets both epidermal growth factor receptor (EGFR) and mesenchymal epithelial transition factor (cMET), releasing topoisomerase I inhibitors (TOP1i) to induce apoptosis in tumor cells [1] - The activation of EGFR and cMET is abnormally high in various solid tumors, including non-small cell lung cancer, with cMET activation being a significant mechanism for resistance to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) [1] - Preclinical studies have shown that SIM0610 exhibits significant anti-tumor activity across various tumor models [1] Group 2: Company Overview - The company is an innovation and research-driven pharmaceutical firm, operating a "National Key Laboratory for Neuroscience and Oncology Drug Development" [1] - The company focuses on neuroscience, anti-tumor, autoimmune, and anti-infection fields, while proactively positioning itself in areas with significant clinical needs [1] - The company emphasizes its mission of "born for patients" through self-innovation and collaborative innovation, establishing strategic partnerships with various innovative enterprises and research institutions [1]

Core Viewpoint - The announcement highlights that the bi-specific antibody-drug conjugate candidate SIM0610 developed by the company has received clinical trial approval from the National Medical Products Administration of China for trials targeting patients with locally advanced or metastatic solid tumors [1] Group 1: Drug Development - SIM0610 targets both epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition factor (cMET) as a bi-specific antibody-drug conjugate (BsADC) [1] - The drug induces apoptosis in tumor cells by releasing topoisomerase I inhibitors (TOP1i) through internalization [1] - Preclinical studies have shown significant anti-tumor activity of SIM0610 across various tumor models [1] Group 2: Mechanism of Action - EGFR and cMET are abnormally activated in several solid tumors, including non-small cell lung cancer [1] - Activation of cMET is a key mechanism for resistance to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) [1] - The dual-target approach of SIM0610 is expected to enhance anti-tumor activity and overcome drug resistance [1]