Company Drug

Hengrui’s Ivarmacitinib NDA Accepted for Non‑Radiographic Axial Spondyloarthritis

By Fineline Cube #Hengrui Pharmaceuticals #HKG: 1276 #Market approval filings #SHA: 600276
Hengrui's Ivarmacitinib NDA Accepted for Non‑Radiographic Axial Spondyloarthritis

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the China National Medical Products Administration (NMPA) has accepted its new drug application (NDA) for ivarmacitinib (Aisuda) to treat active non‑radiographic axial spondyloarthritis (nr‑axSpA) in adults with inadequate response to NSAIDs, based on positive Phase 3 SHR0302‑305 data showing statistically significant ASAS40 improvement at Week 12.

Regulatory Milestone

ItemDetail
ProductIvarmacitinib (Aisuda)
CompanyJiangsu Hengrui Pharmaceuticals
AgencyNMPA (China)
Application TypeNew indication NDA
IndicationActive nr‑axSpA with elevated CRP and/or abnormal MRI
Study BasisPhase 3 SHR0302‑305 (multi‑center, randomized, double‑blind, placebo‑controlled)
Primary EndpointASAS40 at Week 12
Key ResultStatistically significant and clinically meaningful improvement vs. placebo

Drug Profile

  • Mechanism: Highly selective JAK1 inhibitor blocking inflammatory cytokine signaling
  • Current Indications: Approved March 2025 for ankylosing spondylitis, rheumatoid arthritis, atopic dermatitis, severe alopecia areata (4 total)
  • Innovation: Fifth potential indication would make ivarmacitinib the most versatile JAK1 inhibitor in China
  • Patient Population: Targets ~180,000 nr‑axSpA patients in China who are NSAID‑refractory

Clinical Evidence – SHR0302-305 Trial

ParameterResult (Ivarmacitinib vs. Placebo)
Primary (ASAS40 at Week 12)Statistically significant improvement (p < 0.001)
Secondary (ASAS20, BASDAI, CRP)Clinically meaningful improvements across all measures
Safety ProfileConsistent with prior JAK1 inhibitor data; no new safety signals
Patient Population304 adults with active nr‑axSpA and objective inflammation

Market Context & Outlook

MetricValue
China nr‑axSpA Patients~180,000 eligible for advanced therapy
Progression Risk~10% convert to ankylosing spondylitis within 2 years
Current StandardNSAIDs (first‑line); TNF/IL‑17 inhibitors (second‑line)
JAK Inhibitor MarketAbbVie’s upadacitinib (Rinvoq) approved for nr‑axSpA in China in 2024
Peak Sales Forecast¥2.8‑3.5 billion (~US$380‑480 million) by 2032
Market Share Target25‑30% of nr‑axSpA patients (competing with upadacitinib)
  • Reimbursement Path: NMPA acceptance triggers Priority Review; NRDL inclusion likely within 12 months of approval
  • Competitive Moat: Strong Phase 3 data, established safety profile, and Hengrui’s commercial scale provide first‑mover advantage vs. newer entrants

Forward‑Looking Statements
This brief contains forward‑looking statements regarding ivarmacitinib’s regulatory review, market penetration, and commercial performance. Actual results may differ materially due to risks including NMPA approval timelines, competitive dynamics, and market adoption rates.-Fineline Info & Tech

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