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Kelun-Biotech’s SKB575/HBM7575 Wins NMPA Approval – Long-Acting TSLP Bispecific Targets Atopic Dermatitis with Q3+ Dosing Potential

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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) announced that SKB575/HBM7575, a long-acting bispecific antibody (bsAb) targeting TSLP and an undisclosed second target, has received NMPA IND approval for the treatment of atopic dermatitis (AD). Co-developed with Harbour BioMed (HBM Holdings), the candidate features extended half-life engineering supporting dosing intervals exceeding three months, positioning it as a potential best-in-class therapy that overcomes resistance limitations of single-target TSLP antibodies through synergistic dual-target blockade.

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Regulatory Milestone

ItemDetail
AgencyNational Medical Products Administration (NMPA)
Approval TypeInvestigational New Drug (IND) – Phase I-ready
ProductSKB575/HBM7575
Drug ClassLong-acting bispecific antibody (bsAb)
TargetsTSLP (thymic stromal lymphopoietin) + undisclosed second target
IndicationAtopic dermatitis
Co-DevelopersKelun-Biotech (6990.HK) + Harbour BioMed (HBM Holdings)
Lead PartnerKelun-Biotech (global development and commercialization)
Approval Date10 Mar 2026

Drug Profile & Mechanism

AttributeSKB575/HBM7575 Specification
Primary TargetTSLP (upstream cytokine in Th2 inflammation cascade)
Secondary TargetUndisclosed (synergistic immune modulation)
Mechanism• Blocks TSLP-receptor interaction → inhibits Th2 cell activation
• Dual-target blockade generates synergistic effect
• Overcomes resistance to TSLP monotherapy
Half-Life EngineeringExtended via Fc modifications or fusion technologies
Anticipated Human Half-LifeSupports dosing intervals >3 months
RouteSubcutaneous administration
DevelopabilityFavorable manufacturing and stability properties

Scientific Rationale:

  • TSLP Driver Role: Master switch for Th2 inflammation in AD; Tezepelumab (Amgen/AstraZeneca) validated target with $1.5B+ annual sales
  • Resistance Challenge: ~30-40% of AD patients inadequate responders to TSLP monotherapy; dual-target approach addresses heterogeneity
  • Convenience Advantage: Q3+ dosing vs. monthly/quarterly injections for existing biologics (dupilumab Q2W, lebrikizumab Q2W/Q4W)

Partnership Structure

ElementDetail
Lead DevelopmentKelun-Biotech (design, global development, commercialization)
Investment PartnerHarbour BioMed (HBM Holdings)
Benefit SharingPer collaboration agreement terms
Strategic ValueKelun-Biotech leverages Harbour BioMed’s antibody engineering platform; Harbour gains China market access via Kelun infrastructure

Market Context & Competitive Landscape

FactorMarket Implication
China AD Market70+ million patients; biologic penetration <5% vs. 15-20% in U.S./EU; rapid growth anticipated
TSLP Class ValidationTezepelumab (Amgen/AZ) approved 2021; annual sales approaching $2 billion globally
Competitive ThreatsDupilumab (IL-4Rα, Sanofi/Regeneron) dominates; lebrikizumab (IL-13, Lilly), nemolizumab (IL-31, Galderma) fragmenting market
DifferentiationDual-target mechanism + ultra-long half-life addresses unmet need in refractory AD and treatment burden
Pricing PowerQ3+ dosing supports premium positioning; cost-effectiveness vs. frequent injections

Competitive Dynamics

CompetitorProductMechanismDosingSKB575/HBM7575 Advantage
Amgen/AZTezspire (tezepelumab)TSLP mAbQ4W (monthly)Dual-target synergy; >3-month interval
Sanofi/RegeneronDupixent (dupilumab)IL-4Rα blockadeQ2WMechanistic differentiation for non-responders
Eli LillyEbglyss (lebrikizumab)IL-13 mAbQ2W/Q4WLonger dosing interval; dual-pathway inhibition
Kelun/HarbourSKB575/HBM7575TSLP + undisclosed bsAbQ3+ anticipatedBest-in-class convenience; resistance overcoming

Development Outlook

PhaseTimelineObjectives
Phase I2026-2027Safety, tolerability, PK/PD; dose-ranging; half-life confirmation
Phase II2027-2029Efficacy in moderate-severe AD; biomarker stratification; combination potential
Phase III2029-2031Non-inferiority/superiority vs. tezepelumab; China NDA; global expansion
Global Strategy2028+U.S./EU IND filing; Fast Track designation pursuit

Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical development timelines, half-life validation, and competitive positioning for SKB575/HBM7575. Actual results may differ due to target disclosure timing, manufacturing scale-up, and competitive dynamics in the atopic dermatitis biologics market.-Fineline Info & Tech

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