Nxera Pharma Enters Agreement with Holling to Commercialize Daridorexant in Taiwan

• Daridorexant is a potential best-in-class treatment in the high-growth, dual orexin antagonist class of medicines treating sleep disorders, such as insomnia
• Filing of daridorexant in Taiwan planned for 2025, and launch, if approved, is expected during 2026
• Daridorexant is launched in Japan as QUVIVIQ™ and is in Phase 3 trials in South Korea

Tokyo, Japan and Cambridge, UK, 28 February 2025 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TSE 4565) announces that it has entered a license, supply and commercialization agreement with Holling Bio-Pharma Corp. (“Holling”) for daridorexant in Taiwan.

Daridorexant is an oral dual orexin receptor antagonist (DORA) for the treatment of insomnia that selectively binds to receptors of the wake-promoting neuropeptide orexin (OX1R and OX2R), inhibiting excessive wakefulness and facilitating the transition to sleep. According to Taiwan’s National Health Research Institutes, sleep disorders such as insomnia affected 12-20% of the adult population in 2021, approximately 4-5 million people.

Under the terms of the agreement, Nxera will be responsible for the supply of drug product and Holling will be responsible for regulatory, commercial and distribution activities and will hold all regulatory approvals. Holling expects to file a New Chemical Entity (NCE) to the Taiwan Food and Drug Administration (FDA) in mid-2025, which if approved would lead to an expected launch in mid-2026.

Nxera will receive an upfront payment on signing and is eligible for near-term regulatory and sales milestones plus royalties on net sales from Holling, as well as revenue on the supply of drug product to Holling.

Dr. Makoto Sugita, CMO and President of Nxera Pharma Japan, commented: “This new partnership with Holling will enable us to bring daridorexant, a potential best-in-class treatment, to the growing population of patients suffering with insomnia in Taiwan. Holling’s wealth of experience as a leading commercial distributor in Taiwan makes it the ideal partner and we look forward to working together to prepare daridorexant for filing and launch, if approved, in 2026. This latest agreement is part of our strategy to expand access to innovative medicines in Japan and throughout the APAC region, working with leading regional commercialization partners for products targeting larger patient populations while leveraging our internal capabilities in specialty medicine and rare diseases.”