Since its first indication was approved by the FDA on March 28, 2017, Dupixent has rapidly become a blockbuster candidate. It achieved $220 million in sales in its debut year, broke through $2 billion in 2019, and has since maintained rapid growth, earning its title as the undisputed “king of autoimmune drugs.”

Dupilumab Sales History

Reviewing Dupixent’s rise to dominance, its success was no accident. It stemmed from three core strengths working in synergy:

• Precise target positioning
• Leading fully human technology platform
• Forward-looking indication expansion

It also stands as a classic example of turning industry insight into a solid first-mover moat.

First, precisely targeting the key IL‑4Rα pathway and addressing the core pathogenesis of type 2 inflammation forms the fundamental logic of dupilumab’s success.

IL‑4Rα antibodies are regarded as a “super gold mine” in immune inflammation, due to their dual mechanism:IL‑4Rα is a unique receptor subunit involved in signaling by both IL‑4 and IL‑13 – the two key cytokines driving type 2 inflammation.

Type 2 inflammation is recognized as the common pathological basis of multiple diseases, including atopic dermatitis, asthma, allergic rhinitis, and chronic rhinosinusitis with nasal polyps.In short, unlike therapies targeting a single cytokine, inhibiting IL‑4Rα blocks type 2 inflammation at its source.

Sanofi keenly identified the clinical value of this target, rapidly advanced development through forward-looking clinical trials, completed clinical validation and commercialization first, and established an unshakable first-mover advantage.

Second, the VelocImmune® fully human technology platform from Regeneron provided a strong technical barrier for safety and efficacy, supporting dupilumab’s market leadership.

Although fully human platforms involve higher R&D costs, they minimize immunogenicity risks and significantly improve safety.Using VelocImmune®, high-affinity 100% fully human antibodies can be efficiently generated from immunized mice, ensuring strong clinical efficacy while reducing adverse reactions – laying a solid foundation for multi-indication expansion.

Third, forward-looking clinical design and continuous indication expansion have been the key drivers behind dupilumab’s breaking through revenue ceilings and sustaining strong growth.

Unlike single-indication drugs limited by growth bottlenecks, Sanofi designed a broad clinical program across multiple diseases from an early stage. Leveraging clinical data from its first indication, it rapidly advanced and approved subsequent uses.

To date, dupilumab covers indications including:

• Atopic dermatitis
• Asthma
• Chronic rhinosinusitis with nasal polyps
• Eosinophilic esophagitis
• Prurigo nodularis
• Chronic spontaneous urticaria
• Chronic obstructive pulmonary disease (COPD)
• Allergic fungal rhinosinusitis
• Bullous pemphigoid

It has become a mega-blockbuster spanning dermatology, respiratory, and autoimmune diseases.

Sanofi continues to expand its indications and accelerate penetration in areas such as COPD and prurigo nodularis worldwide.

On February 24, dupilumab gained US approval for allergic fungal rhinosinusitis (AFRS) in patients aged 6 years and older with a history of nasal surgery – another world-first and currently only approval, further fueling Dupixent’s global expansion.

In the Chinese market, dupilumab was first approved in June 2020 for moderate-to-severe atopic dermatitis in adults.With the two latest approvals, it now has 9 approved indications (and populations) in China, covering all age groups from infants (6 months+) to adults, as well as asthma, COPD, prurigo nodularis, and bullous pemphigoid.

Dupilumab’s success has attracted a wave of Chinese pharma companies to the IL‑4Rα target, triggering intense red-ocean competition.

Chinese firms have formed a tiered layout targeting IL‑4Rα, from launched products to late-stage clinical candidates, building a complete competitive matrix.

Competition in the IL‑4Rα sector is now just as fierce as in the PD‑(L)1 field.

Kintor: First Domestic IL‑4Rα mAb Breaks Import Monopoly

Kintor took the lead: on September 12, 2024, NMPA approved sipicekimab for moderate-to-severe atopic dermatitis in adults, making it the world’s second and China’s first domestic IL‑4Rα antibody, breaking the import monopoly.

In December 2024 and January 2025, it gained approvals for:

• Chronic rhinosinusitis with nasal polyps
• Seasonal allergic rhinitis

Notably, it is the world’s only IL‑4Rα antibody and China’s only mAb approved for allergic rhinitis.

By focusing on rhinology as a differentiated entry point, sipicekimab avoided direct head-to-head competition with dupilumab.China’s allergic rhinitis population reached 245 million in 2024 and is projected to hit 261 million by 2030.This huge patient base made it a social-media hit, known as the “rhinitis shot.”

Sales responded immediately:Even before reimbursement, sipicekimab achieved approximately ¥170 million in sales in H1 2025.Following its inclusion in the national reimbursement drug list in December 2025, 2026 is set to be its first full year of volume growth under insurance, with strong commercial certainty.

Long-Acting Candidates: Lower Dosing Frequency

A wave of late-stage domestic players is positioning around long-acting, broad coverage, and differentiation.

• 3S Bio SSGJ‑611 (recently filed for approval)Supports dosing every 2 weeks (Q2W) or every 4 weeks (Q4W).High maintenance efficacy (EASI‑75 ~97%, IGA 0/1 ~89%) supports low-frequency long-term control.

• Ledekizumab by Kintor Pharma & ConcureDeveloped by Concure, licensed to Kintor for Greater China in a ¥1.025 billion deal.Q4W dosing directly addresses patient adherence pain points.

• Kemeqizumab by Camber Pharma & Maiji BioPromoted as the world’s first long-acting IL‑4Rα mAb, with Q4W dosing –only 13 injections per year, half the frequency of dupilumab.

Differentiated Indications

• Zhixiang Biotech Telikizumab (filed in September 2025)Broad pipeline covering AD, asthma, allergic rhinitis, CRSwNP, and chronic spontaneous urticaria (CSU).Currently only Novartis omalizumab is approved for CSU in China; telikizumab could become the first IL‑4Rα‑targeting option.

• Hengrui SHR‑1819Focuses on prurigo nodularis – a niche currently dominated only by dupilumab.

Akeso Biotech: Rapid Itch Relief + Bispecific Future

Akeso’s mandokizumab stands out for rapid itch relief in early-stage improvement, a critical benefit for atopic dermatitis patients suffering from severe pruritus, sleep disturbance, and mood disorders.

It is filing for adult indications while advancing a pivotal Phase III in adolescent AD (12–18 years), reflecting a full-lifecycle strategy.

Beyond mAbs, Akeso’s next-generation IL‑4R/ST2 bispecific antibody AK139 is in Phase II, targeting COPD, severe asthma, CSU, allergic rhinitis, CRSwNP, AD, and prurigo nodularis.

Its “mAbs as foundation, bsAbs for the future” strategy aims for broader and deeper control of type 2 inflammatory diseases.

Overall, domestic players are pursuing diverse technical and commercial routes.The future competition in China will be a comprehensive battle of efficacy, convenience, indication coverage, and commercial intelligence.

China’s fierce competition is just a microcosm of the global hunt.As a pinnacle of the autoimmune sector, dupilumab is facing challengers from all directions.

Since the start of the year, multiple overseas biotechs have released positive data targeting Dupixent:

• Corvus: oral ITK inhibitor soquelitinib
• Nekta: IL‑2 inhibitor REZPEG (NKTR‑358)
• Evommune: IL‑18 therapy EVO301

Despite differing mechanisms, all show potential to challenge dupilumab, driving sharp stock rallies.

Sanofi’s 2025 full-year revenue reached €43.626 billion, with dupilumab alone contributing €15.714 billion – ~36% of total revenue, up 25.2% year-on-year.

This heavy reliance on one product brings growing anxiety:Dupilumab’s core patents are expected to expire around 2031, bringing a looming patent cliff.

To mitigate risk, Sanofi is aggressively building a next-generation autoimmune portfolio via internal R&D + external acquisitions:

• Rilzabrutinib (BTK inhibitor)Approved by FDA in August 2025 for immune thrombocytopenia –the world’s first BTK inhibitor specifically developed for autoimmune diseases.

• Amlitelimab (OX40L mAb)Restores immune balance without T‑cell depletion.Ultra-long dosing: only 4 injections per year.Phase III for atopic dermatitis met primary and key secondary endpoints in September 2025.

• Lunsekimig (TSLP/IL‑13 tetravalent nanobody bispecific)In clinical development for asthma, AD, COPD, and CRSwNP.

On the external front:

• June 2025: acquired Blueprint Medicines for $9.5 billion, entering rare autoimmune diseases.
• March 2025: acquired DrenBio for $1.9 billion, strengthening B‑cell targeting and lupus.

Autoimmune diseases are now the world’s second-largest therapeutic market after oncology.Frost & Sullivan projects the global market will exceed $176 billion by 2030.

In this battle for a hundred-billion-dollar market,the anxiety and counterattack of the reigning “drug king,”and the hunting and breakthrough of domestic innovators,together paint the most realistic competitive landscape of the autoimmune sector.

The fight is in full swing – and the final winner is yet to be decided.