Core Insights - The company Fuhong Hanlin (02696) has received approval from the National Medical Products Administration for clinical trial applications of HLX22 and HLX87 for the treatment of HER2-positive breast cancer [1][2] Group 1: HLX22 - HLX22 is a novel humanized anti-HER2 monoclonal antibody that has potential indications for solid tumors including gastric and breast cancer [1] - The drug has received orphan drug designation from the FDA and the European Commission for the treatment of gastric cancer, with approvals granted in March and May 2025 respectively [1] Group 2: HLX87 - HLX87 is an innovative antibody-drug conjugate (ADC) targeting HER2, currently in phase 3 clinical trials for HER2-positive breast cancer treatment [2] - The drug utilizes a high-permeability topoisomerase inhibitor as an effective payload, demonstrating a balance between efficacy and safety by reducing systemic toxicity [2] - Preclinical studies indicate that HLX87 shows comparable anti-tumor activity to Trastuzumab with significant safety advantages [2] - Phase 1 clinical data presented at the AACR 2024 conference shows HLX87 has good tolerability and safety across a dosage range of 2.0 mg/kg to 8.4 mg/kg, with excellent therapeutic effects in various solid tumors including breast, gastric, and lung cancers [2] - A phase 3 clinical trial for HLX87 as a second-line treatment for HER2-positive breast cancer is currently underway in China [2] - The company has established a strategic partnership with external collaborators regarding HLX87, with specific arrangements to be formalized in a licensing agreement [2]
复宏汉霖：HLX22联合注射用HLX87分别用于BC一线治疗与BC neo的2/3期临床试验申请获国家药监局批准