Nxera Pharma Receives a Manufacturing Approval Partial Amendment Regarding the Addition of a Manufacturing Site in Asia for QUVIVIQ® 25 and 50 mg

Core Insights - Nxera Pharma has received a manufacturing approval partial amendment for QUVIVIQ® (daridorexant) 25 and 50 mg, which was launched in Japan in December 2024 for chronic insomnia treatment [1][2] - The company aims to establish a second API manufacturing site in Asia to meet the growing demand for QUVIVIQ® across the Asia-Pacific region, which is expected to reduce manufacturing costs and improve profitability starting in 2027 [2][6] - Nxera has set a 2030 Vision with sales exceeding JPY 50 billion and a profit margin exceeding 30%, supported by ongoing cost reduction initiatives [3] Manufacturing and Cost Reduction - Nxera submitted an application to Japan's Ministry of Health, Labour and Welfare for a partial amendment to add a manufacturing site in Asia, which will enhance supply resilience and reduce costs [2][6] - The company has planned three major projects for cost reduction, with one project completed and the remaining two expected to be finished by the end of 2028 [3] Commercial Partnerships and Sales Forecast - Nxera entered a commercial partnership with Shionogi & Co., Ltd. for the distribution and sales of QUVIVIQ® in Japan, with Shionogi forecasting JPY 2.5 billion in sales for the fiscal year ending March 2026 [4] - Nxera's sales forecast for QUVIVIQ® for the fiscal year ending December 2025 is between JPY 4.0 billion and JPY 5.0 billion [4] Future Developments - Nxera has entered a license, supply, and commercialization agreement with Holling Bio-Pharma Corp. for daridorexant in Taiwan, indicating expansion into new markets [5] - The company is focused on enhancing its capacity to respond to increased demand and aims to implement further cost reduction measures beyond 2029 [6]