Nxera Pharma Receives a Manufacturing Approval Partial Amendment Regarding the Addition of a Manufacturing Site in Asia for QUVIVIQ® 25 and 50 mg

Second API manufacturing facility added to ensure supply for patients with insomnia in Japan and for future demand across the Asia-Pacific region
Expected to improve profitability through manufacturing cost reductions to advance toward the 2030 Vision
Cost reductions anticipated to begin contributing during 2027 through to the end of 2028

Tokyo, Japan and Cambridge and London, UK, 31 October 2025 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TSE 4565) announces that Nxera Pharma Japan Co., Ltd. (a wholly owned subsidiary of the Company) has received a manufacturing approval partial amendment with respect to QUVIVIQ® (daridorexant) 25 and 50 mg (“the Product”). Daridorexant was launched in Japan as QUVIVIQ® for the treatment of adults with chronic insomnia in December 2024, an application for approval has been submitted for regulatory review in Taiwan, and it is undergoing Phase 3 trials in South Korea.

To address the expected growth in demand for QUVIVIQ® in Japan and more broadly across the Asia-Pacific (APAC) region as it becomes available in new markets, Nxera submitted an application to Japan’s Ministry of Health, Labour and Welfare for an approval partial amendment regarding the addition of a manufacturing site in Asia. This approval will enable Nxera to establish a second API manufacturing site in Asia, in addition to its primary API manufacturing site in Europe. The Asian facility will commence operations in phases, with the aim of reducing manufacturing costs through economies of scale and optimized API procurement. Cost reductions for the Product are expected to improve profitability from 2027 onwards.

Nxera has planned three major projects as cost reduction measures to maximize profits for the Product, and one of the three projects has been completed with this approval. The cost reduction effect is expected to begin contributing gradually starting in 2027, and we plan to complete the remaining two projects by the end of 2028. The Company has established its 2030 Vision (sales exceeding JPY 50 billion with a profit margin exceeding 30%), and these cost reduction measures are expected to contribute to Nxera achieving this vision. Furthermore, the Company plans to continue implementing new cost reduction initiatives beyond 2029.

In September 2024, Nxera entered a new commercial partnership agreement with Shionogi & Co., Ltd. (“Shionogi”), regarding the distribution and sales for the Product in Japan. Under the terms of the agreement, Nxera is responsible for providing drug product for the Japanese market, and Shionogi is exclusively responsible for distribution and sales in Japan. Shionogi's full-year sales forecast for the Product for the fiscal year ending March 2026 is JPY 2.5 billion. Nxera’s full-year sales forecast for the Product for the fiscal year ending December 2025 is JPY 4.0 to JPY 5.0 billion.

In February 2025, Nxera Pharma announced that it had entered a license, supply and commercialization agreement with Holling Bio-Pharma Corp. for daridorexant in Taiwan.

Mr. Toshihiro Maeda, Chief Operating Officer of Nxera Pharma, said: “This approval enables Nxera to establish a second API manufacturing facility in Asia for QUVIVIQ®, in addition to our primary facility in Europe. This enhances our capacity to respond to the expected increased demand and strengthens supply resilience, while also enabling gradual reductions in manufacturing costs. We anticipate cost reduction effects to start materializing from 2027, thereby achieving both improved profitability and stable supply to patients with insomnia in Japan and across the APAC region as QUVIVIQ® becomes available. We will continue to implement all possible measures to accelerate our growth towards becoming a high-margin biopharmaceutical company.”

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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.

We have 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.

Behind that, and powered by our unique NxWave™ discovery platform, 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 of potentially first- and best-in-class candidates is focused on addressing major unmet needs in some of the fastest-growing areas of medicine across obesity and metabolic disorders, neurology/neuropsychiatry and immunology and inflammation.

Nxera employs approximately 400 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).

For more information, please visit www.nxera.life
LinkedIn: @NxeraPharma | X: @NxeraPharma | YouTube: @NxeraPharma

Enquiries:

Media and Investor Relations
Shinya Tsuzuki, VP, Head of Investor Relations
Shinichiro Nishishita, VP Investor Relations, Head of Regulatory Disclosures
Maya Bennison, Communications Manager
+81 (0)3 5962 5718 | +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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