Southwest Securities has released a research report indicating that the current first-line treatment for advanced driver gene-negative non-small cell lung cancer (NSCLC) primarily relies on PD-(L)1 inhibitors with or without chemotherapy. The firm estimates that by 2030, the market size for immunotherapy drugs used in first-line treatment of advanced driver gene-negative NSCLC will reach approximately RMB 7.5 billion in China and USD 18 billion in the United States. The next generation of immunotherapy regimens for NSCLC is advancing simultaneously, focusing on dual/multi-specific antibodies and IO+ADC combinations. Key catalysts for dual/multi-specific antibodies to watch include the release of critical clinical data for ivonescimab in 2026, the initiation of multiple Phase III clinical studies for SSGJ-707, and clinical exploration and data readouts for dual-specific antibody plus ADC combinations. For IO+ADC therapies, important catalysts are the key data readouts from the AVANZAR trial in the first half of 2026 and the SKB264-Ⅲ-14 trial in the second half of 2026. The main viewpoints of Southwest Securities are as follows:
What is the market potential for driver gene-negative NSCLC? Driver gene-negative refers to tumor samples where no clearly targetable driver gene mutations are detected, accounting for 31% of newly diagnosed NSCLC patients in both China and the United States. Based on current guidelines in China and the U.S., first-line treatment for advanced driver gene-negative NSCLC patients mainly depends on PD-(L)1 inhibitors ± chemotherapy. It is estimated that by 2030, the market size for immunotherapy drugs used in first-line treatment of advanced driver gene-negative NSCLC will be approximately RMB 7.5 billion in China and USD 18 billion in the United States.
The next generation of immunotherapy regimens for NSCLC is advancing together—dual/multi-specific antibodies and IO+ADC combinations. From a clinical guideline perspective, PD-(L)1 drugs, represented by pembrolizumab and atezolizumab, used with or without chemotherapy, have comprehensively covered first-line and subsequent treatments for driver gene-negative NSCLC, maintaining a stable clinical position. However, limitations persist in the long term: 1) Immuno-oncology (IO) resistance, where long-term efficacy reaches a plateau (dual-specific antibodies): Compared to traditional chemotherapy, immunotherapy with or without chemotherapy significantly improves long-term survival rates, but the 5-year survival rate drops to 10%–30%, and long-term treatment efficacy for patients with low to medium PD-L1 expression gradually plateaus. 2) Limited options for chemotherapy-intolerant patients and a scarcity of highly effective regimens. Current evidence only supports the use of immunotherapy monotherapy (such as atezolizumab or pembrolizumab) for patients with high PD-L1 expression (TPS ≥50%), while patients with low to medium expression and those intolerant to chemotherapy lack clinically effective options (IO+ADC).
Dual/multi-specific antibody treatment: Bispecific antibodies are artificial antibodies that can simultaneously and specifically bind two antigens or epitopes, achieving a balance between safety and efficacy. The approval and launch of ivonescimab in 2024 has sparked enthusiasm for PD-(L)1/VEGF targeting, with over ten companies subsequently entering the field, frequent large-scale business development activities, and record-high transaction values. PD-(L)1/CTLA-4 combinations feature synergistic mechanisms, optimized safety, and broader tumor coverage. As clinical data and technological pathways for bispecific antibodies are validated, trispecific antibodies are expected to become a new frontier in IO therapy. Future catalysts to watch include the critical clinical data readout for ivonescimab in 2026, the initiation of multiple Phase III clinical studies for SSGJ-707, and clinical exploration and data readouts for dual-specific antibody plus ADC combinations. Related companies: Akeso Biopharma, 3SBio/3S Bio International,普米斯,荣昌生物,华海药业.
IO+ADC therapy: Antibody-drug conjugates (ADCs) are complexes formed by linking cytotoxic drugs to tumor-targeting monoclonal antibodies, combining the characteristics of targeted drugs and chemotherapeutic agents to enable precise drug delivery with low toxicity and high efficacy. Clinical results for TROP2 ADC combined with Keytruda show non-inferior objective response rate and progression-free survival data compared to Keytruda plus chemotherapy, with superior performance in squamous cell carcinoma, offering a new solution for chemotherapy-intolerant patients. Key future catalysts include the data readout from the AVANZAR trial in the first half of 2026 and the SKB264-Ⅲ-14 trial in the second half of 2026. Related companies: Kelun-Biotech, Hengrui Pharmaceuticals.
Risk warnings include potential delays in research and development progress, worsening competitive landscape, slower-than-expected market promotion, and policy risks.
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