Guotai Haitong has released a research report stating that the autoimmune disease industry is entering a 3.0 era driven by generational technological shifts. As breakthrough therapies, including oral small molecules, autoimmune T-cell engagers (TCEs), dual/multi-cytokine blocking antibodies, and small nucleic acid drugs, enter a phase of data readouts, the pathways for iteration will become clearer. Companies that strategically position themselves in next-generation autoimmune therapies are poised for a revaluation. The firm maintains an "Overweight" rating. The autoimmune sector is currently on the cusp of the 3.0 era explosion. As data for next-generation autoimmune drugs are progressively released globally, the drug iteration pathways and trends will become increasingly distinct.
Reviewing the history of global autoimmune drug development, the industry has undergone multiple transformative shifts. From TNF-α inhibitors in the 1.0 era to interleukin-class monoclonal antibodies in the 2.0 era, iterations in pathway mechanisms have enabled broader indication expansion and improved efficacy. The industry now stands at the brink of the autoimmune 3.0 era, increasingly focused on expanding new technological formats. This shift is expected to overcome the limitations of 2.0-era monoclonal antibodies, ushering in new industry transformations and investment opportunities.
The transition from the autoimmune 1.0 to 2.0 era primarily involved the discovery of new pathways and targets. Considering only core autoimmune products with disclosed sales by multinational corporations (MNCs), the global autoimmune market is projected to approach $150 billion by 2025. Within this market, products targeting T-cell pathways hold a significant share. TH2 and TH17 pathways are now iterating upon the TH1 pathways of the 1.0 era, emerging as new focal points in the autoimmune space.
The shift from the autoimmune 2.0 to 3.0 era is characterized by a focus on expanding new technological formats, moving beyond traditional monoclonal antibody structures. With the approach of patent cliffs, MNCs are accelerating their deployment in next-generation autoimmune products. Significant early-stage data readouts are anticipated in 2026, potentially creating the next major industry trend in the autoimmune field.
Key areas of focus include: (1) Dual/Multi-cytokine Blocking Antibodies: Related assets from Pfizer, UCB, CMAB (Connhuaya), and Hengrui Pharmaceuticals have demonstrated promising early clinical data, potentially offering differentiated advantages in clinical efficacy and dosing frequency. (2) Autoimmune TCE Therapies: The first quarter of 2026 saw several significant business development deals in the autoimmune TCE space, with MNCs rapidly expanding their presence. Multiple TCE products are expected to report early autoimmune clinical data in the second half of 2026, which could create industry-wide resonance. (3) Oral Medications: These offer superior dosing convenience and patient compliance. Key oral products under development include TYK2 inhibitors, BTK inhibitors, targeted protein degraders, cyclic peptide/small molecules targeting antibody targets, and PDE-4 inhibitors. (4) Small Nucleic Acid Drugs: Targeting complement pathways, these represent an ideal iterative alternative to monoclonal antibodies. The Phase III data for Roche's Iptacopan (CFBASO) in IgA nephropathy is a key focus.
Notable pipeline assets with significant potential include CM512 (IL-13/TSLP bispecific, CMAB), SHR-1139 (IL-23p19/IL-36R bispecific, Hengrui), CM336 (CD3/BCMA bispecific, CMAB), GR1803 (CD3/BCMA bispecific, Zxlxb), Nomelcitinib (TYK2 inhibitor, Yifang Bio), Orelabrutinib (BTK inhibitor, InnoCare), HSK47388 (oral IL-23R inhibitor, Haisco), ATG-201 (CD3/CD19 bispecific, Antengene), AK139 (IL-4Rα/ST2 bispecific, Akeso), GB261 (CD3/CD20 bispecific, EOC), QX031N (TSLP/IL33 bispecific, Quanxin Bio), and IBI3002 (IL-4Rα/TSLP bispecific, Innovent).
The report highlights risks including potential setbacks in R&D and challenges in commercialization.
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