Investment Rating - The report maintains an investment rating of "Leading the Market-B" for the biopharmaceutical industry [1][10]. Core Insights - HLX43, a novel PD-L1 ADC candidate developed by Junshi Biosciences, shows significant anti-tumor efficacy in NSCLC based on preliminary results from Phase I clinical trials [3][5]. - The drug combines a fully human IgG1 anti-PD-L1 antibody with a novel linker-topoisomerase inhibitor payload, achieving a drug-to-antibody ratio (DAR) of approximately 8 [3]. - HLX43 demonstrates a dual mechanism of action, providing both targeted cytotoxicity and immune modulation, which may enhance its therapeutic potential [3][5]. Summary by Sections Clinical Trial Results - In the Phase I trial, HLX43 was administered to 21 patients with a median prior treatment line of 2 and 3 for Ia and Ib phases, respectively [4]. - The overall response rate (ORR) for the Ia phase was 36.8%, while the Ib phase at 2.0 mg/kg showed an ORR of 38.1% [5]. - The median progression-free survival (PFS) was 4.2 months for Ia and 5.4 months for Ib [5]. - Adverse events were primarily low-grade, with grade 3 or higher treatment-related adverse events (TRAE) occurring in 28.6% and 42.9% of patients in Ia and Ib phases, respectively [5]. Future Development - HLX43 is currently in over seven Phase II clinical trials exploring its synergistic anti-tumor effects in combination with immune checkpoint inhibitors [6]. - The drug has shown promising results across various NSCLC subtypes, including those with and without EGFR mutations and brain/liver metastases [6]. - HLX43 is positioned as a leading global PD-L1 ADC candidate, potentially addressing issues of non-response or resistance to PD-1/L1 therapies [6].
生物医药创新药动态更新：PD-L1ADCHLX43：I期临床研究初步显示NSCLC抗肿瘤疗效显著