Core Viewpoint - The clinical data for HLX43, a PD-L1 ADC developed by the company, shows significant efficacy and safety in treating recurrent/metastatic cervical cancer, indicating strong commercial potential in the oncology market [1][2]. Efficacy and Safety - The Phase II clinical study included 30 patients with recurrent/advanced cervical cancer, all of whom had previously failed or were intolerant to standard first-line treatments [1]. - The overall objective response rate (ORR) was 41.4%, with a disease control rate (DCR) of 82.8%. The 3 mg/kg dosage group showed an ORR of 70.0% and a DCR of 100% [2]. - Safety data revealed that 60.0% of patients reported grade 3 or higher treatment-related adverse events (TRAEs), but there were no TRAEs leading to treatment discontinuation or death [2]. - Immune-related adverse events (irAEs) were reported in 23.3% of patients, primarily including thyroid dysfunction and skin rashes, with no grade 3 or higher irAEs, indicating manageable safety profiles [2]. Commercial Outlook - HLX43's efficacy data in cervical cancer is superior to other drugs in the same indication, with safety profiles comparable to competitors, suggesting a favorable commercial outlook [2]. - The company is conducting over 10 ongoing Phase Ib/II clinical trials for HLX43, with promising data already reported for non-small cell lung cancer and thymic cancer, and plans to expand indications to colorectal cancer, nasopharyngeal cancer, gastric cancer, and esophageal cancer [2]. Financial Forecast - The company projects total revenue of 5.873 billion, 5.912 billion, and 7.504 billion yuan for 2025-2027, reflecting year-on-year growth of 2.60%, 0.66%, and 26.92% respectively [3]. - Net profit attributable to shareholders is expected to be 827 million, 778 million, and 1.243 billion yuan for the same period [3].
复宏汉霖(02696.HK)：HLX43首个Ⅱ期数据表现优异 确定性进一步提升