Nxera Partner Wins Taiwan Approval For QUVIVIQ Insomnia Treatment, Expanding Nxera’s Presence in Asian Markets

Nxera Pharma has announced that its partner, Holling Bio-Pharma, has received approval from the Taiwan Food and Drug Administration to market and sell QUVIVIQ (daridorexant) in Taiwan. The therapy, approved in 25 mg and 50 mg doses, is indicated for the treatment of adults with insomnia, with a commercial launch planned for 2026.

The approval was granted under the TFDA’s Streamlined Review Designation (SRD), which accelerates the evaluation of new medicines that have already been approved by major global regulators. This pathway leverages existing regulatory data to shorten review timelines, enabling faster patient access to innovative therapies in Taiwan.

Christopher Cargill, President and CEO of Nxera Pharma, commented: “The approval of QUVIVIQ® in Taiwan marks an important milestone in our strategy to expand access to innovative specialty medicines in Japan and across the APAC region. Insomnia remains a significant and under-recognised health burden, impacting both nighttime sleep and daytime functioning for millions of patients. With QUVIVIQ®, a dual orexin receptor antagonist with a differentiated mechanism of action, we are pleased to bring a new 2 of 3 treatment option to patients in Taiwan. We look forward to working closely with our partner Holling to ensure a successful launch and broad access following this approval.” 

Under the partnership agreement, Nxera will supply the drug product, while Holling will manage regulatory, commercialization, and distribution activities. Nxera is eligible to receive milestone payments, sales-based incentives, and royalties, along with revenue from product supply, supporting its broader commercialisation strategy in Asia.

Insomnia remains a significant public health concern in Taiwan, affecting an estimated 12–20% of the adult population. QUVIVIQ, originally discovered by Idorsia Pharmaceuticals, is already marketed in regions including the U.S., Canada, and Europe, and in Japan through a partnership with Shionogi. Nxera is also advancing regulatory efforts in South Korea, further expanding the drug’s presence in key Asian markets.