Nxera Wins Taiwan Approval for QUVIVIQ Insomnia Drug, Eyes 2026 Launch

Sosei Group ( (JP:4565) ) has issued an announcement.

Nxera Pharma has secured regulatory approval in Taiwan for its insomnia drug QUVIVIQ (daridorexant) in 25mg and 50mg doses, with commercialization to be led by local partner Holling Bio-Pharma and a launch targeted for 2026. Under their agreement, Nxera will supply the drug and receive an approval milestone, future sales milestones, royalties, and product supply revenue, while leveraging Taiwan’s Streamlined Review Designation to accelerate market entry.

The approval positions Nxera to tap into Taiwan’s sizable insomnia market, estimated at 4–5 million adults, and strengthens its strategy to build a regional insomnia franchise across APAC alongside existing commercialization in Japan and regulatory efforts in South Korea. By introducing a dual orexin receptor antagonist with a differentiated mechanism of action, the company aims to address a significant unmet medical need in sleep medicine and enhance its competitive standing in the central nervous system therapeutics space.

The most recent analyst rating on (JP:4565) stock is a Buy with a Yen1400.00 price target. To see the full list of analyst forecasts on Sosei Group stock, see the JP:4565 Stock Forecast page.

More about Sosei Group

Nxera Pharma is a Japan-based biopharmaceutical company focused on developing and commercializing innovative specialty medicines, particularly in neuroscience and sleep disorders, across Japan and the broader Asia-Pacific region. It partners with regional distributors such as Shionogi in Japan and Holling Bio-Pharma in Taiwan to expand market access for therapies like daridorexant, marketed as QUVIVIQ.

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