The Pacific Securities: Clinical data determines the value of BD PD~(L)1 dual antibody reshaping immunotherapy

The Pacific Securities released a research report stating that the efficacy (ORR50% is the benchmark) and safety of VEGF dual-antigen monotherapy 1LPD-L1 positive lung cancer is critical. One of the important criteria for MNC product selection is the efficacy (ORR50% is the benchmark) and safety of first-line treatment of PD-L1+(TPS1%) NSCLC; IL2/TIGIT/4-1BB dual antigens, and triple antigens are advancing in clinical trials to obtain more POC data. The company's BD probability will also be further improved, focusing on the company catalyzed by the 25H2-26H1 data. The long-term value of dual antigens needs to consider the global clinical advancement speed of major indications, the synergistic benefits of combination therapy with chemotherapy/ADC/TCE, focus on overseas clinical leaders, and actively explore companies that explore combination therapy. The key points of Pacific Securities are as follows: Why does the firm focus on PD-(L)1 dual antigens? PD-(L)1 has a wide market space, with a steep patent cliff. Global PD-(L)1 sales revenue is expected to exceed $50 billion in 2024, and is expected to reach $90 billion by 2028. The core drug patents will expire in 2028. Dual antigens can serve as iterative solutions to partially offset some MNC patent cliffs, or serve as potential newcomers in the IO field. PD-(L)1 has efficacy bottlenecks, and dual antigens achieve better clinical benefits. PD-(L)1 monotherapy ORR is only 10-20%, cold tumors have almost no response, the population with low PD-L1 expression has limited benefits, and the population resistant to IO lacks effective treatment options. In response to these unmet clinical needs, PD-(L)1 dual antigens have shown excellent efficacy. MNCs have a strong need for BD collaboration. Pipeline filling (MNCs are lagging behind in the layout of PD-(L)1 dual antigens, both IO leaders and potential newcomers need to take advantage through BD); technical synergy (combining dual antigens with chemotherapy, ADC, TCE to improve efficacy); market positioning (seizing the market of major indications such as lung cancer). What are the conclusions of this study? VEGF dual antigens have completed POC, BD transactions are intense, the first echelon has been established, and the second echelon is worth noting. AKESOAK112 has outperformed PD-1 in multiple first-line lung cancer Phase III trials, with 13 Phase III trials progressing simultaneously. BioNtech/BMS/Pumis, Pfizer/3SBIO have entered the registration clinical stage through BD cooperation; the second echelon of PD-(L)1/VEGF dual antigens is in Phase II clinical trials, and 25H2 is expected to read early data in first-line lung cancer. The advantage of IL2 dual antigens lies in patients resistant to IO and cold tumors. INNOVENT BIO's globally pioneering PD-1/IL2 dual antigen IBI363 has shown good clinical efficacy in late-stage colorectal cancer, IO-resistant lung cancer, and melanoma, with mPFS of 9.3 months in IO-resistant lung squamous cell carcinoma (SOC <4 months). TIGIT dual antigens have shown efficacy advantages in cholangiocarcinoma, cervical cancer, etc. AstraZeneca is advancing Rilve in first-line treatment and combination with ADC in five major cancers, and Zejing Pharmaceuticals' ZG005 has differentiated layouts in cervical cancer, small lung cancer, etc. Two 4-1BB dual antigen products have entered registration clinical trials, Virelin's LBL-024 layout includes neuroendocrine tumors, and Genmab's GEN1046 layout includes IO-resistant lung cancer. Triple antigens are expected to synergistically enhance efficacy through multiple target points and are in the early exploration stage. Risk warning: Innovative drug research and development progress is not as expected; risks of changes in the pharmaceutical industry policies; macroeconomic risks.