Astellas China Secures GBA Approval for First‑in‑Class Fezolinetant (VEOZA)

Astellas China Secures GBA Approval for First‑in‑Class Fezolinetant (VEOZA)

Astellas (TYO: 4503) China announced that its global first‑in‑class, non‑hormonal, selective neurokinin‑3 (NK3) receptor antagonist VEOZA (Fezolinetant) has received official approval for launch in the Guangdong‑Hong Kong‑Macao Greater Bay Area (GBA) under the “Hong Kong‑Macao Medicine and Equipment Connect” (HK‑Macao Connect) policy.

Why VEOZA Matters

  • First‑of‑its‑kind: The world’s first approved non‑hormonal NK3 antagonist for moderate‑to‑severe vasomotor symptoms (VMS) of menopause.
  • Targeted therapy: Selectively blocks NK3 receptors—key drivers of hot flashes and night sweats.
  • Improved quality of life: Reduces sleep disturbance, fatigue, cognitive “brain fog,” and mood irritability in menopausal women.

Key Details

FeatureInformation
DrugVEOZA (Fezolinetant)
IndicationModerate‑to‑severe vasomotor symptoms (hot flashes/night sweats) in post‑menopausal women
ApprovalGBA launch via HK‑Macao Connect policy
Regulatory PathwayApproved under the Hong Kong‑Macao Medicine and Equipment Connect framework
Market ImpactAddresses a high‑volume unmet need; expected to capture significant share of the GBA menopause‑symptom market

GBA Market Opportunity

  • Population: Over 70 million residents in the Guangdong‑Hong Kong‑Macao Greater Bay Area.
  • Unmet Need: ~40 % of menopausal women report moderate‑to‑severe VMS; current hormonal therapies pose safety concerns.
  • Competitive Advantage: Non‑hormonal profile reduces risk of breast cancer and cardiovascular events, differentiating VEOZA from existing options.

Astellas’ Strategic Vision

  • First‑Mover Advantage: By leveraging HK‑Macao Connect, Astellas positions VEOZA as the first NK3 antagonist available in the GBA, capturing early market share.
  • Global Expansion: Success in the GBA will inform rollout plans in other Asian markets and beyond.
  • Patient‑Centric Approach: Ongoing patient support programs and real‑world evidence collection to demonstrate long‑term benefit.

Forward‑Looking Statements

This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech