招银国际：维持康方生物“买入”评级 目标价182.12港元

Core Viewpoint - 招银国际 maintains a "Buy" rating for 康方生物 (09926), citing positive overall survival (OS) trends from the HARMONi trial, which enhances confidence in its first-line indication potential [1] Group 1: Clinical Trial Results - Summit released the latest data from the HARMONi global clinical trial, evaluating the efficacy of AK112 combined with chemotherapy versus chemotherapy alone in second-line EGFR-TKI resistant NSCLC patients [2] - Chinese patients demonstrated superior progression-free survival (PFS) results, with a median PFS of 6.8 months for AK112 combined with chemotherapy compared to 4.4 months for chemotherapy alone (HR=0.52, p<0.001) [3] - In long-term follow-up, the PFS HR slightly worsened to 0.57, potentially due to increased data maturity in Western populations, with North American and European patients showing PFS HRs of 0.67 and 0.55 respectively [3] Group 2: Overall Survival Analysis - In the final OS analysis, the median OS for the AK112 combined chemotherapy group was 16.8 months compared to 14.0 months for the chemotherapy alone group, with an HR of 0.79 (95% CI: 0.62–1.01, p=0.0570) [4] - Long-term follow-up showed an improvement in OS HR to 0.78 (95% CI: 0.62–0.98) with a nominal p-value of 0.0332, indicating a positive trend despite the FDA's reliance on pre-specified analysis results [4] - North American patients exhibited strong OS results with an HR of 0.70, although the confidence interval was wide (0.38–1.30) [5]