Nxera Pharma Enters into Agreement with Holling Bio-Pharma for Daridorexant
Friday, February 28, 2025
Nxera Pharma has entered into a licence, supply, and commercialisation agreement with Holling Bio-Pharma for daridorexant in Taiwan.
Daridorexant is an oral dual orexin receptor antagonist (DORA) used to treat insomnia. It works by selectively binding to orexin receptors (OX1R and OX2R), reducing excessive wakefulness and promoting sleep.
According to Taiwan’s National Health Research Institutes, sleep disorders such as insomnia affected between 12-20% of the adult population in 2021, impacting approximately 4-5 million individuals.
Insomnia disorder is characterised by difficulty in initiating or maintaining sleep, leading to significant distress or impairment in daily activities. It is diagnosed when sleep disturbances occur at least three nights per week for three months or longer, despite adequate opportunity to sleep.
Under the agreement, Nxera will supply the drug product, while Holling will handle regulatory, commercial, and distribution activities, including obtaining regulatory approvals.
Holling plans to file a New Chemical Entity (NCE) application with the Taiwan Food and Drug Administration (FDA) in mid-2025. If approved, the product is expected to launch in mid-2026.
Nxera will receive an initial payment upon signing and is eligible for regulatory and sales milestone payments, as well as royalties on net sales. Revenue will also be generated through the supply of the drug product to Holling.
This agreement aligns with Nxera’s strategy to expand access to innovative medicines in Japan and across the Asia-Pacific region.
The company aims to collaborate with key regional partners for products targeting large patient populations while focusing internally on specialty and rare disease medicines.
Source: nxera.life
