Announcement of Approval for Manufacturing and Marketing Authorization of Insomnia Treatment Drug Daridorexant in Taiwan

Product Approval and Sales Framework

Nexelpha Pharma, Inc. announces that its partner in Taiwan, Holling Bio-Pharma Corp., has obtained manufacturing and marketing authorization for the insomnia treatment drug Daridorexant (QUVIVIQ®) from the Taiwan Food and Drug Administration (TFDA). Holling is responsible for application, approval, distribution, and sales, while Nexelpha Pharma will supply the formulation and receive royalty revenues under the contract. Utilizing Taiwan's priority review system, the product is scheduled for launch within 2026.

Business Strategy and Impact on Performance

The approval in Taiwan marks a significant milestone in the strategy to expand access to innovative specialty pharmaceuticals in the APAC region. Entering a market with an estimated patient population of approximately 4 to 5 million, milestone payments and royalty revenues are anticipated. This is already reflected in the consolidated earnings guidance for the fiscal year ending December 2026. Going forward, we will continue close collaboration with our partner to ensure smooth commercialization and market expansion.