Nxera’s accomplice Holling Bio-Pharma Corp. will commercialize QUVIVIQ® in Taiwan, a market with roughly 4–5 million sufferers, with launch deliberate throughout 2026QUVIVIQ® is accredited via Taiwan’s Streamlined Assessment Designation pathway
Tokyo, Japan and Cambridge, UK, 14 April 2026 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TSE 4565) pronounces that its accomplice Holling Bio-Pharma Corp. (“Holling”), a number one pharmaceutical distribution and commercialization firm primarily based in Taipei, Taiwan, has obtained approval from the Taiwan Meals and Drug Administration (“TFDA”) to market and promote QUVIVIQ® (daridorexant, marketed in Taiwan underneath the product identify 科唯可® film-coated tablets) 25 and 50 mg for the remedy of adults with insomnia. Plans are underway to launch QUVIVIQ® in Taiwan throughout 2026.
Underneath the phrases of the settlement with Holling, Nxera is chargeable for the provision of drug product and Holling is chargeable for regulatory, industrial and distribution actions. Underneath this settlement, Nxera will obtain a milestone fee upon this approval, the quantity of which is undisclosed. Nxera can also be eligible for near-term gross sales milestones plus royalties on web gross sales from Holling, in addition to income on the provision of drug product to Holling.
QUVIVIQ® is accredited by the TFDA underneath its Streamlined Assessment Designation (SRD), utilizing the Japanese advertising authorization utility file. The designation mechanism is designed to expedite the TFDA’s evaluation of recent chemical entities accredited by main abroad regulatory authorities by making use of present evaluation outcomes and, topic to sure situations, permitting for a shortened evaluation interval in Taiwan.
Insomnia, characterised by difficulties in sleep onset and/or sleep upkeep, impacts each bodily and psychological well being. In line with Taiwan’s Nationwide Well being Analysis Institutes, sleep issues resembling insomnia affected 12-20% of the grownup inhabitants in 2021, roughly 4-5 million folks.
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Daridorexant is accredited and marketed in Japan as QUVIVIQ® underneath a commercialization settlement between Nxera and Shionogi. In South Korea, Nxera submitted a advertising authorization utility for daridorexant to the Ministry of Meals and Drug Security (MFDS) in March 2026. QUVIVIQ®, found by Idorsia Prescription drugs, is marketed by Idorsia within the US, Canada, and a number of European international locations.
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.”
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Notes to Editors
About Holling Bio-Pharma Corp.Headquartered in Taipei, Taiwan, Holling Bio-Pharma has been established for practically 5 a long time and is now the biggest pharmaceutical distributor in Taiwan. Through the years, Holling Bio-Pharma primarily work with corporations with innovate merchandise and has constantly launched the newest therapeutic medication starting from small molecule medication and biologics to vaccines to assist sufferers in Taiwan fight varied illnesses. With a totally outfitted {and professional} group, Holling Bio-Pharma provides complete companies together with drug registration, market entry, product promotion, warehousing, and logistics. Holling BioPharma additionally has intensive expertise and experience within the CNS subject, with profitable launch of revolutionary CNS merchandise from each EU and US. The corporate is dedicated to delivering high-quality companies that meet worldwide requirements, guaranteeing the newest medical improvements attain sufferers effectively and successfully.
About Insomnia DisorderInsomnia dysfunction is outlined as issue initiating or sustaining sleep, inflicting clinically important misery or impairment in essential areas of daytime functioning. As outlined this impression on sleep amount or high quality needs to be current for at the least three nights per week, lasts for at the least three months, and happens regardless of an satisfactory alternative to sleep.
Insomnia is a situation of overactive wake signaling and research have proven that areas of the mind related to wakefulness stay extra lively throughout sleep in sufferers with insomnia. In line with Taiwan’s Nationwide Well being Analysis Institutes, sleep issues resembling insomnia affected 12-20% of the grownup inhabitants in 2021, roughly 4-5 million folks.
The dysfunction is kind of totally different from a short interval of poor sleep, and it may well take its toll on each bodily and psychological well being. It’s a persistent situation with a adverse impression on daytime functioning. Analysis has proven that poor high quality sleep can have an effect on many elements of every day life, together with the power to pay attention, temper, and power ranges.
The purpose of therapies for insomnia is to enhance sleep high quality and amount, in addition to daytime functioning, whereas avoiding hostile occasions and next-morning residual results. Present beneficial remedy of insomnia consists of sleep hygiene remedy, cognitive behavioral remedy, and pharmacotherapy.
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In regards to the Orexin systemWake and sleep signaling is regulated by intricate neural circuitry within the mind. One key element of this course of is the orexin system, which helps promote wakefulness. There are two types of orexin neuropeptides – small protein-like molecules utilized by nerve cells (neurons) to speak with one another within the mind – orexin A and orexin B. Orexin promotes wakefulness via its receptors OX1R and OX2R. Collectively, these neuropeptides and receptors make up the orexin system. The orexin system stimulates focused neurons within the wake system – resulting in the discharge of a number of chemical substances (serotonin, histamine, acetylcholine, norepinephrine) – to advertise wakefulness. Orexin regulates wake signaling, which could be overactive at night time, stopping folks with insomnia from falling asleep or staying asleep. Daridorexant is a twin orexin receptor antagonist (DORA) that equipotently antagonizes orexin receptors 1 and a couple of, consequently lowering overactive wake indicators all through the whole night time.
About Nxera PharmaNxera Pharma is a know-how powered biopharma firm in pursuit of recent specialty medicines to enhance the lives of sufferers with unmet wants in Japan and globally. The Firm has constructed an agile, new-generation industrial enterprise in Japan to develop and commercialize revolutionary medicines, together with a number of launched merchandise, to deal with this high-value, giant and rising market and people within the broader APAC area. As well as, the Firm is advancing an intensive pipeline internally and in partnership with main pharma and biotech corporations, powered by its distinctive NxWave™ GPCR structure-based drug discovery platform. Nxera Pharma operates at key areas in Tokyo and Osaka (Japan), London and Cambridge (UK), Basel (Switzerland) and Seoul (South Korea) and is listed on the Tokyo Inventory Trade (ticker: 4565).
QUVIVIQ® is trademark of Idorsia Ltd.
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Ahead-looking statementsThis press launch comprises forward-looking statements, together with statements concerning the discovery, improvement, and commercialization of merchandise. Varied dangers might trigger Nxera Pharma Group’s precise outcomes to vary materially from these expressed or implied by the ahead trying statements, together with: hostile ends in scientific improvement applications; failure to acquire patent safety for innovations; industrial limitations imposed by patents owned or managed by third events; dependence upon strategic alliance companions to develop and commercialize services and products; difficulties or delays in acquiring regulatory approvals to market services and products ensuing from improvement efforts; the requirement for substantial funding to conduct analysis and improvement and to increase commercialization actions; and product initiatives by opponents. On account of these components, potential traders are cautioned to not depend on any forward-looking statements. We disclaim any intention or obligation to replace or revise any forward-looking statements, whether or not on account of new info, future occasions or in any other case.
