Nxera Pharma Enters Agreement with Holling to Commercialize Daridorexant in Taiwan

• Daridorexant is a potential best-in-class treatment in the high-growth, dual orexin antagonist class of medicines treating sleep disorders, such as insomnia
• Filing of daridorexant in Taiwan planned for 2025, and launch, if approved, is expected during 2026
• Daridorexant is launched in Japan as QUVIVIQ™ and is in Phase 3 trials in South Korea

Tokyo, Japan and Cambridge, UK, 28 February 2025 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TSE 4565) announces that it has entered a license, supply and commercialization agreement with Holling Bio-Pharma Corp. (“Holling”) for daridorexant in Taiwan.

Daridorexant is an oral dual orexin receptor antagonist (DORA) for the treatment of insomnia that selectively binds to receptors of the wake-promoting neuropeptide orexin (OX1R and OX2R), inhibiting excessive wakefulness and facilitating the transition to sleep. According to Taiwan’s National Health Research Institutes, sleep disorders such as insomnia affected 12-20% of the adult population in 2021, approximately 4-5 million people.

Under the terms of the agreement, Nxera will be responsible for the supply of drug product and Holling will be responsible for regulatory, commercial and distribution activities and will hold all regulatory approvals. Holling expects to file a New Chemical Entity (NCE) to the Taiwan Food and Drug Administration (FDA) in mid-2025, which if approved would lead to an expected launch in mid-2026.

Nxera will receive an upfront payment on signing and is eligible for near-term regulatory and sales milestones plus royalties on net sales from Holling, as well as revenue on the supply of drug product to Holling.

Dr. Makoto Sugita, CMO and President of Nxera Pharma Japan, commented: “This new partnership with Holling will enable us to bring daridorexant, a potential best-in-class treatment, to the growing population of patients suffering with insomnia in Taiwan. Holling’s wealth of experience as a leading commercial distributor in Taiwan makes it the ideal partner and we look forward to working together to prepare daridorexant for filing and launch, if approved, in 2026. This latest agreement is part of our strategy to expand access to innovative medicines in Japan and throughout the APAC region, working with leading regional commercialization partners for products targeting larger patient populations while leveraging our internal capabilities in specialty medicine and rare diseases.”

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About Daridorexant  

Daridorexant is a dual orexin receptor antagonist that blocks the binding and activity of the wake-promoting neuropeptides known as orexins. Daridorexant 25mg and 50mg was approved in Japan in September 2024 and launched under the brand name of QUVIVIQ™ by Nxera Pharma Japan (“NPJ”) and Shionogi in December 2024. Nxera is also conducting a Phase 3 trial with daridorexant in adults with insomnia in South Korea. QUVIVIQ™ is approved in the US, Europe and certain other countries and marketed in these territories by Idorsia Pharmaceuticals Ltd.

* QUVIVIQ™ is a trademark of Idorsia Ltd.

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. According to Taiwan’s National Health Research Institutes, sleep disorders such as insomnia affected 12-20% of the adult population in 2021, approximately 4-5 million people.

Insomnia as a 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 Holling Bio-Pharma Corp.

Headquartered in Taipei, Taiwan, Holling Bio-Pharma has been established for nearly five decades and is now the largest pharmaceutical distributor in Taiwan. Over the years, Holling Bio-Pharma primarily work with companies with innovate products and has continuously introduced the latest therapeutic drugs ranging from small molecule drugs and biologics to vaccines to help patients in Taiwan combat various diseases. With a fully equipped and professional team, Holling Bio-Pharma offers comprehensive services including drug registration, market access, product promotion, warehousing, and logistics. Holling Bio-Pharma also has extensive experience and expertise in the CNS field, with successful launch of innovative CNS products from both EU and US. The company is committed to delivering high-quality services that meet international standards, ensuring the latest medical innovations reach patients efficiently and effectively.

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.

In addition to several products being commercialized in Japan, we are advancing an extensive pipeline of over 30 active programs from discovery through to late clinical stage internally and in partnership with leading pharma and biotech companies. This pipeline is focused on addressing major unmet needs in some of the fastest-growing areas of medicine across neurology, GI and immunology, metabolic disorders and rare diseases, and leverages the power of our unique and industry leading GPCR-targeted structure-based drug discovery NxWave™ platform to provide a sustainable source of best- or first-in-class candidates.

Nxera employs over 350 talented people 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).

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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.