Nxera Pharma Co., Ltd. (TSE 4565) announced that its partner Holling Bio-Pharma Corp. has received approval from the Taiwan Food and Drug Administration (TFDA) to market and sell QUVIVIQ 25 mg and 50 mg for the treatment of adult patients with insomnia.
The approval marks another step in Nxera's strategy to expand access to specialty medicines across the Asia-Pacific region.
Insomnia is a common sleep disorder characterized by difficulty falling asleep, staying asleep, or achieving restorative sleep. Chronic insomnia can significantly impair daytime functioning, mood, and overall quality of life. According to Taiwan's National Health Research Institutes, sleep disorders affected 12-20% of adults in 2021, representing roughly 4-5 million people.
QUVIVIQ (daridorexant), a dual orexin receptor antagonist is designed to reduce overactive wake signals by blocking orexin receptors, which play a key role in wakefulness. The medicine is already approved and marketed in Japan under a commercialization agreement with Shionogi, and is also marketed by Idorsia in the U.S., Canada, and several European countries.
The TFDA granted approval for QUVIVIQ under its Streamlined Review Designation (SRD), using the Japanese marketing authorization application dossier. The SRD pathway allows Taiwan to expedite reviews of new chemical entities by relying on prior regulatory assessments from major overseas authorities.
Under the agreement between Nxera and Holling, Nxera will supply the drug product, while Holling will oversee regulatory, commercial, and distribution activities in Taiwan. Nxera will receive an approval milestone payment, along with eligibility for near-term sales milestones, royalties on net sales, and revenue from supplying the product.
"We are pleased to bring QUVIVIQ to patients in Taiwan who are struggling with insomnia," said Christopher Cargill, President and CEO of Nxera Pharma. "This approval marks an important milestone as we work with Holling to ensure a successful launch and broad access."
The launch of QUVIVIQ in Taiwan is planned for 2026.
In addition to QUVIVIQ, Nxera is advancing an extensive pipeline internally and through partnerships with leading pharmaceutical and biotechnology companies, powered by its NxWave GPCR structure-based drug discovery platform.
TSE 4565 has traded between JPY 723 and JPY 1,074 over the past year. The stock closed Monday's trading at JPY 1,011, down 0.39%.
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