CGS has released a research report highlighting that autoimmune diseases affect over 10% of the global population, with the market size ranking second only to oncology and continuing to expand. The industry's R&D focus is shifting from "broad-spectrum anti-inflammatory" approaches to "precision regulation," with novel targets and mechanism-based drugs emerging in areas such as psoriasis and atopic dermatitis. Facing substantial unmet clinical needs, domestic companies are actively expanding through innovative R&D, creating related investment opportunities. Key insights from CGS are as follows:
**Autoimmune Disease Market Offers Blue Ocean Potential as Novel Targets Accelerate Industry Development** A 2023 Lancet report indicates autoimmune diseases may impact over 10% of the global population, with patient numbers growing rapidly. The autoimmune drug market, second only to oncology, is in a phase of rapid expansion. Frost & Sullivan data shows the global autoimmune market reached $132.3 billion in 2022, projected to grow to $176.7 billion by 2030 (CAGR 3.68%). Drug development is transitioning from broad anti-inflammatory therapies to precision-targeted mechanisms, with significant room for improvement in efficacy and safety. Recent breakthroughs in disease-specific mechanisms, multi-omics technologies, and novel delivery systems have spurred new drug development, offering safer, longer-lasting, and personalized treatments.
**Complex Disease Mechanisms Present Breakthrough Opportunities in Psoriasis, Atopic Dermatitis, and Beyond** Psoriasis affects approximately 125 million patients globally, with current treatments dominated by biologic antibodies. Emerging oral small-molecule TYK2 inhibitors show promise as potential replacements. Atopic dermatitis impacts over 204 million people worldwide; IL-4Rα antibody dupilumab achieved $12.9 billion in sales in the first three quarters of 2025, becoming the top-selling autoimmune drug. Novel STAT6 PROTAC oral therapies demonstrate superior efficacy, advancing type II autoimmune disease treatment. Rheumatoid arthritis (global prevalence 0.5%-1%) sees JAK inhibitors outperforming biologics, though JAK1 selectivity remains a challenge. COPD, the fourth-leading cause of death globally, has limited treatment options, but new targets like IL-33/ST2, TSLP, and PDE3/4 show improved FEV1 outcomes. SLE, often termed "undying cancer," affects multiple systems; telitacicept leads current therapies, while future CAR-T and targeted therapies may redefine treatment paradigms. Overall, novel targets and formulations promise enhanced efficacy.
**Substantial Unmet Clinical Needs Highlight Investment Potential in Domestic Innovators** Chinese companies are aggressively developing innovative autoimmune drugs through target discovery and expanded indications. Based on clinical pipelines, R&D efficiency, and operational performance, CGS recommends monitoring: 1) **Simcere Pharmaceutical**: Focused on differentiated targets like SIM0278 (IL-2mu-Fc), SIM0709 (TL1A/IL23p19), and SIM0711 (IRAK4 PROTAC), with ongoing BD potential. 2) **Keymed Biosciences**: CM310 (anti-IL-4Rα) is in rapid commercialization, targeting peak sales of ¥5 billion; CM512 (TSLPxIL-13 bispecific) exhibits best-in-class potential with a 70-day half-life. 3) **Qyuns Therapeutics**: QX013N (anti-c-kit mAb) targets CSU, with four bispecific programs slated for IND submissions by 2025-2026. 4) **InventisBio**: D-2570 (TYK2 inhibitor) initiated Phase II for UC, with psoriasis Phase III trials underway following strong Phase II data. 5) **3SBio**: 610 (anti-IL-5, fastest domestic pipeline) significantly improves lung function in asthma, targeting 2027 NDA; 613 (anti-IL-1β) is in NDA for gouty arthritis.
**Risks**: R&D delays; policy uncertainties; commercialization setbacks; intensified competition.
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