- Synmosa to lead regulatory approvals, market access, distribution and sales in Singapore, Thailand, Indonesia, Malaysia, the Philippines, Vietnam, Australia and New Zealand.
- Nxera to supply drug product and receive an upfront payment, regulatory approval milestones, royalties and product supply revenue.
- Agreement significantly expands potential access to QUVIVIQ® across Asia-Pacific, building on progress in Japan, Taiwan and South Korea.
Tokyo, Japan and Cambridge, UK, 14 October 2026 – Nxera Pharma Co., Ltd. (“Nxera” or the “Company”; TSE: 4565) today announces that its subsidiary, Nxera Pharma Japan Co., Ltd. (“Nxera Pharma Japan”), has entered into an exclusive license, supply and commercialization agreement (the “Agreement”) with Taiwan-headquartered Synmosa Biopharma Corporation (“Synmosa”) for QUVIVIQ® (daridorexant), a treatment for insomnia, in Singapore, Thailand, Indonesia, Malaysia, the Philippines, Vietnam, Australia and New Zealand (the “Territory”).
Under the Agreement, Nxera has granted Synmosa exclusive rights to submit regulatory applications for QUVIVIQ®, obtain and maintain the applicable regulatory approvals, and commercialize the product in the Territory. Synmosa will lead regulatory affairs, market access, marketing, distribution and sales in each country, while Nxera will be responsible for product supply and any necessary regulatory support. In consideration for the rights granted under the Agreement, Nxera will receive an upfront payment and will be eligible to receive regulatory approval milestone payments, royalties based on sales and revenue from the supply of drug product.
Discovered and developed by Idorsia Pharmaceuticals, QUVIVIQ® is a dual orexin receptor antagonist (“DORA”) that blocks the binding of orexin, a wake-promoting neuropeptide, to orexin receptors 1 and 2 (OX1R and OX2R). In Japan, it is marketed under the brand name QUVIVIQ® Tablets for the treatment of insomnia in adults. It has also been approved in Taiwan, and a marketing authorization application is currently under review in South Korea. This new partnership announced today will advance regulatory approvals and commercialization in Southeast Asia, Australia and New Zealand, further expanding Nxera’s specialty pharmaceutical business in Japan and across the broader Asia-Pacific (“APAC”) region.
Christopher Cargill, President and CEO of Nxera Pharma, commented: “We are delighted to partner with Synmosa and build the foundation for bringing QUVIVIQ® to patients across Southeast Asia, Australia and New Zealand. Insomnia is a serious yet under-recognized health burden that affects not only nighttime sleep but also daytime functioning. Synmosa brings extensive experience and a strong regional platform spanning regulatory affairs, market access, sales and distribution in the Asia-Pacific region, making it an important partner in maximizing the value of QUVIVIQ® in each of these markets. This agreement further advances our strategy to expand access to innovative specialty medicines across Japan and the wider APAC region.”
Peter C. H. Lin , President of Synmosa, commented: “We thank Nxera for its trust and partnership. This agreement recognizes Synmosa’s regional capabilities and marks an important step in expanding our portfolio with QUVIVIQ®, an innovative treatment for insomnia. Through our established partner network and experience in regulatory affairs, market access and commercialization, we look forward to working with Nxera to bring this additional treatment option to patients across the Territory, subject to local regulatory approvals.
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About Synmosa Biopharma Corporation
Headquartered in Taipei, Taiwan, Synmosa Biopharma Corporation (TWSE: 4114) is a specialty pharmaceutical company with activities spanning in-licensing, research and development, manufacturing and commercialization. The company has built commercial operations and partner networks across Asia and offers capabilities including product registration, market access, promotion, warehousing and logistics.
Synmosa develops and supplies products across multiple therapeutic areas and has established specialised pharmaceutical technology platforms. For more information, please visit www.synmosa.com.tw.
About Insomnia Disorder
Insomnia disorder is defined as difficulty initiating or maintaining sleep, causing clinically significant distress or impairment in important areas of daytime functioning. As defined this impact on sleep quantity or quality should be present for at least three nights per week, lasts for at least three months, and occurs despite an adequate opportunity to sleep.
Insomnia is a condition of overactive wake signaling and studies have shown that areas of the brain associated with wakefulness remain more active during sleep in patients with insomnia. The disorder is quite different from a brief period of poor sleep, and it can take its toll on both physical and mental health. It is a persistent condition with a negative impact on daytime functioning. Research has shown that poor quality sleep can affect many aspects of daily life, including the ability to concentrate, mood, and energy levels.
The goal of treatments for insomnia is to improve sleep quality and quantity, as well as daytime functioning, while avoiding adverse events and next-morning residual effects. Current recommended treatment of insomnia includes sleep hygiene therapy, cognitive behavioral therapy, and pharmacotherapy.
About the Orexin system
Wake and sleep signaling is regulated by intricate neural circuitry in the brain. One key component of this process is the orexin system, which helps promote wakefulness. There are two forms of orexin neuropeptides – small protein-like molecules used by nerve cells (neurons) to communicate with each other in the brain – orexin A and orexin B. Orexin promotes wakefulness through its receptors OX1R and OX2R. Together, these neuropeptides and receptors make up the orexin system. The orexin system stimulates targeted neurons in the wake system – leading to the release of several chemicals (serotonin, histamine, acetylcholine, norepinephrine) – to promote wakefulness. Orexin regulates wake signaling, which might be overactive at night, preventing people with insomnia from falling asleep or staying asleep. Daridorexant is a dual orexin receptor antagonist (DORA) that equipotently antagonizes orexin receptors 1 and 2, consequently decreasing overactive wake signals throughout the entire night.
About Nxera Pharma
Nxera Pharma is a technology powered biopharma company in pursuit of new specialty medicines to improve the lives of patients with unmet needs in Japan and globally. The Company has built an agile, new-generation commercial business in Japan to develop and commercialize innovative medicines, including several launched products, to address this high-value, large and growing market and those in the broader APAC region. In addition, the Company is advancing an extensive pipeline internally and in partnership with leading pharma and biotech companies, powered by its unique NxWave™ GPCR structure-based drug discovery platform. Nxera Pharma operates at key locations in Tokyo and Osaka (Japan), London and Cambridge (UK), Basel (Switzerland) and Seoul (South Korea) and is listed on the Tokyo Stock Exchange (ticker: 4565).
For more information, please visit www.nxera.life
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Enquiries:
Nxera – Media and Investor Relations
Shinya Tsuzuki, VP, Head of Investor Relations
+81 (0)3 5210 3399 | +44 (0)1223 949390 | IR@Nxera.life
MEDiSTRAVA (for International Media)
Mark Swallow, Frazer Hall, Erica Hollingsworth
+44 (0)203 928 6900 | Nxera@medistrava.com
Forward-looking statements
This press release contains forward-looking statements, including statements about the discovery, development, and commercialization of products. Various risks may cause Nxera Pharma Group’s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in clinical development programs; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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