Guotai Haitong: Technological iteration leads the Self-exemption 3.0 era, intense catalysis in 2026 welcomes industrial change.

Guotai Haitong released a research report stating that the self-immunity industry is entering the 3.0 era brought about by technological change. With breakthrough therapeutic approaches such as oral small molecules, self-immunity TCE, dual/multi-target blockading antibodies, small nucleic acid drugs entering the data extraction period, the iteration path will gradually become clear, and companies strategically positioning for the next generation of self-immunity drugs are expected to achieve valuation reshaping. The "hold" rating is maintained. The self-immunity track is currently on the eve of the outbreak of the 3.0 era, as data on the next generation of self-immunity drugs are gradually revealed, the path and trends of drug iteration will become clearer. Guotai Haitong's main points are as follows: The self-immunity track has undergone multiple industry revolutions and is currently on the eve of the 3.0 era outbreak. Looking at the global history of self-immunity drugs, the industry has experienced multiple revolutionary changes across eras. From the TNF- inhibitors of the 1.0 era to the interleukin monoclonal antibodies of the 2.0 era, iterative changes in pathway mechanisms have led to broader indications and improved efficacy. The industry is currently on the eve of the outbreak of the self-immunity 3.0 era, focusing more on the expansion of new technological forms, potentially breaking the limitations of monoclonal antibodies in the 2.0 era, and bringing about new industry revolutions and investment opportunities. From self-immunity 1.0 to 2.0: From focusing on TNF- to a variety of pathways and mechanisms. From the self-immunity 1.0 era to the 2.0 era, the industry has focused more on the discovery of new pathways and targets. Considering only the core products of self-immunity disclosed by MNC, the global self-immunity market is expected to reach nearly 150 billion US dollars by 2025. Among them, T-cell pathway products have a large market share, with TH2 and TH17 pathways iterating the TH1 pathway of the 1.0 era, becoming new opportunities for self-immunity. From self-immunity 2.0 to 3.0: Breaking traditional monoclonal antibody forms, starting multi-dimensional technical iteration paths. From the self-immunity 2.0 era to the 3.0 era, the industry is focusing more on the expansion of new technological forms. As the patent cliff approaches, MNCs are accelerating their layout of next-generation self-immunity products. The industry is expected to release more early-stage data in 2026, forming the next industry opportunity for self-immunity. (1) Dual/multi-target blockading antibodies: Pfizer, UCB, Konoa, Jiangsu Hengrui Pharmaceuticals, and other products have shown excellent early clinical data, with the potential to differentiate advantages in clinical efficacy and dosing frequency. (2) Self-immunity TCE therapy: In the first quarter of 2026, the self-immunity TCE track saw several major BD transactions, with MNCs accelerating their layout in this track. It is expected that multiple TCE products will release early-stage self-immunity clinical data in the second half of 2026, creating industry resonance. (3) Oral drugs: Oral drugs, with excellent administration convenience and patient compliance, currently focus on the development of orally administered products such as TYK2 inhibitors, BTK inhibitors, targeted protein degraders, antibody-targeted peptides/small molecules, and PDE-4 inhibitors. (4) Small nucleic acid drugs: Targeting the complement pathway, small nucleic acid drugs are an ideal iterative choice for monoclonal antibodies. Special attention is given to Roche's CFBASO for phase III data on IgA nephropathy. Potential major varieties CM512 (IL-13/TSLP dual antibody, Konoa), SHR-1139 (IL-23p19/IL-36R dual antibody, Jiangsu Hengrui Pharmaceuticals), CM336 (CD3/BCMA dual antibody, Konoa), GR1803 (CD3/BCMA dual antibody, Zhixiang Jintai), Nomelcitinib (TYK2 inhibitor, Yifang Biotech), Apremilast (BTK inhibitor, InnoCare Pharma), HSK47388 (oral IL-23R inhibitor, Haisco Pharmaceutical Group), ATG-201 (CD3/CD19 dual antibody, Deqi Medicine), AK139 (IL-4R/ST2 dual antibody, AKESO), GB261 (CD3/CD20 dual antibody, EDDING GENOR), QX031N (TSLP/IL33 dual antibody, Quanxin Biotech), IBI3002 (IL-4R/TSLP dual antibody, INNOVENT BIO), etc. Risk warning R&D and commercialization risks may not meet expectations, and other unforeseen risks.