Exclusive Summary

• - Fully off-patent and highly genericized since 2012 in the US, ensuring mature and stable global supply.
• - Targets adults/adolescents with asthma, allergic rhinitis, and EIB, reaching a multi-hundred-million patient pool (asthma ~260–340M; rhinitis ~500–700M).
• - Positioned as an alternative/add-on to ICS and for patients with comorbid rhinitis or poor inhaler adherence, with risk management per the 2020 FDA boxed warning.
• - US FDA GMP and US registration enable faster access and tender credibility in FDA/ICH/PIC/S-leaning markets.
• - >90% discount vs originator is achievable (typical tender prices <US$0.10/tablet), fitting self-pay and public procurement.