Core Viewpoint - The clinical update of PD-L1 ADC HLX43 presented at the World Conference on Lung Cancer demonstrates its superior efficacy in advanced non-small cell lung cancer (NSCLC) compared to standard treatments, indicating strong potential for broader application in various cancer types [1][2]. Investment Highlights - Expanded sample size continues to show excellent efficacy: The updated data from NSCLC patients in the Ia and Ib phase with doses of 2.0 mg/kg and 2.5 mg/kg show an overall response rate (ORR) of 28.6% and a disease control rate (DCR) of 82.1% in fourth-line and later squamous NSCLC patients (n=28), significantly outperforming docetaxel (ORR=12.8%) [1]. In third-line and later non-squamous NSCLC patients (n=26), the ORR reached 46.2% and DCR was 96.2% [1]. - Significant benefits across multiple subgroups highlight broad potential: In previously treated third-line and later NSCLC patients (n=10), the ORR was 30.0% and DCR was 80% [1]. In EGFR wild-type non-squamous NSCLC patients (n=15), confirmed objective response rate (cORR) was 46.7% and DCR was 93.3% [2]. Patients receiving 2.5 mg/kg HLX43 (n=5) had a cORR of 60.0% and DCR of 80% [2]. In advanced brain metastasis NSCLC patients (n=11), cORR was 36.4% and DCR was 100.0% [2]. In PD-L1 negative patients (TPS<1%, n=21), ORR and DCR were 38.1% and 85.7%, respectively, indicating efficacy independent of PD-L1 expression [2]. - Safety profile remains favorable, supporting expansion into first-line therapy and combination treatments: The most common grade ≥3 treatment-related adverse events (TRAEs) included anemia (19.6%), leukopenia (19.6%), neutropenia (16.1%), and lymphopenia (12.5%), with thrombocytopenia at only 3.6%. This aligns with previously reported safety data, indicating low hematological toxicity and supporting future expansion into first-line and combination therapy [2]. Investment Recommendation - The company's biosimilar business is driven by both domestic and overseas markets, providing robust cash flow for innovative R&D. The innovative pipeline, including HLX43, shows potential for competitive advantage and opportunities for global market expansion. The projected net profit for 2025-2027 is estimated at 840 million, 790 million, and 1.06 billion yuan, with year-on-year growth rates of 2%, -6%, and 34%, respectively, corresponding to P/E ratios of 44, 47, and 35 [2]. - Initiating coverage with a "Buy" rating [3].
复宏汉霖(2696.HK)：样本扩大夯实广谱抗癌疗效 看好HLX43大品种潜力