Investment Rating - The report maintains an investment rating of "Leading the Market-B" for the biopharmaceutical industry [1][9]. Core Insights - PD-(L)1 monoclonal antibodies combined with ADCs are expected to become first-line standard therapies for various tumors, with PD-(L)1 monoclonal antibodies being foundational in tumor immunotherapy [3][4]. - The combination of PD-(L)1 monoclonal antibodies and ADCs shows promise in overcoming resistance and improving overall response rates (ORR) in clinical settings [3][4]. - Keytruda combined with Nectin-4 ADC Padcev has already received FDA approval for first-line treatment of la/mUC, indicating the potential for similar combinations in other cancers [3][4]. Summary by Sections Market Performance - The biopharmaceutical industry has shown significant market performance over the past year, with innovative drug developments leading the way [1]. Drug Evaluation - PD-(L)1 monoclonal antibodies are crucial in activating T cells for anti-tumor effects, and their combination with ADCs is expected to enhance ORR and provide new options for immune-resistant cases [3][4]. - Clinical trials indicate that PD-1/L1 monoclonal antibodies combined with TROP2 ADCs show superior progression-free survival (PFS) compared to traditional chemotherapy in non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC) [4][5]. Clinical Trial Results - In a clinical trial for first-line treatment of non-squamous, driver-gene-negative NSCLC, the combination of TROP2 ADC and PD-L1 monoclonal antibody showed an ORR of 59.3% and a median PFS of 15.0 months, outperforming chemotherapy [4]. - For TNBC, the combination of Keytruda and Trodelvy achieved a median PFS of 11.2 months, indicating a significant improvement over standard chemotherapy [4]. Future Outlook - The report highlights the potential of PD-1/L1 monoclonal antibodies combined with HER2 ADCs in treating HER2-positive gastric cancer, showing promising results in clinical trials [5]. - The PD-L1 ADC HLX43 demonstrated significant anti-tumor efficacy in late-stage NSCLC, with an ORR of 38.5% and a median PFS of 5.4 months [5].
生物医药创新药动态更新:PD-(L)1+ADC:PD-(L)1 单抗+国产 TROP2、HER2 ADC 有望迭代肿瘤一线疗法,PD-L1 ADC 提供免疫耐药新选择
Shanxi Securities·2025-07-28 05:11