Nxera Pharma Co.,Ltd. [4565.T]
TOKYO, Apr 14 (Pulse News Wire) – Nxera Pharma CO.,LTD. (4565.T) announced today that its insomnia treatment drug QUVIVIQ® (dralorexant) received marketing approval from the Taiwan Food and Drug Administration (TFDA).
Holling Bio-Pharma Corp., Taiwan's largest pharmaceutical distributor, plans to launch the product in Taiwan in 2026. The Taiwanese market is estimated to have around four to five million adult patients suffering from sleep disorders. Under the agreement, Nxera Pharma will supply theto Holling, which will handle application, distribution, and sales.
Nxera Pharma will receive milestone payments upon approval and royalties based on net sales. The approval was expedited through TFDA’s Streamlined Review Designation program, leveraging data from overseas regulatory approvals. "We are thrilled to bring QUVIVIQ®, a differentiated dual orexin receptor antagonist, to Taiwanese patients," said Christopher Kargil, CEO of Nxera Pharma.
"This milestone aligns with our strategy to expand access to innovative specialty medicines in Japan and APAC." For the fiscal year ending December 2026, the impact of this approval is already reflected in the company's forecast released on Feb 13, 2026.
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