Core Viewpoint - The company 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, indicating a significant advancement in its oncology pipeline [1][2] Group 1: HLX22 - HLX22 is a novel humanized monoclonal antibody targeting HER2, with potential indications including gastric cancer and breast cancer [1] - The drug has received orphan drug designation from the FDA and the European Commission for the treatment of gastric cancer, expected 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] - Preclinical studies show that HLX87 exhibits comparable anti-tumor activity to trastuzumab, with significant safety advantages [2] - Clinical data presented at the AACR 2024 indicates HLX87 demonstrates good tolerability and safety across a dosage range of 2.0 mg/kg to 8.4 mg/kg, showing excellent therapeutic effects in various solid tumors [2] - A phase 3 clinical trial for HLX87 in second-line treatment of HER2-positive breast cancer is currently underway in China [2] - The company has established a strategic partnership with external collaborators regarding HLX87, with formal licensing agreements to be finalized [2]
复宏汉霖(02696)：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