Category: 3. Business

• Exdensur is the first and only ultra-long-acting biologic in Japan for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP)  
• Approval based on data from the SWIFT and ANCHOR phase III trials showing sustained efficacy in two doses a year versus placebo
• Patients with severe asthma face frequent exacerbations, hospitalisations and disease progression, requiring an urgent need for novel solutions

GSK plc (LSE/NYSE: GSK) today announced the approval of Exdensur (depemokimab) by Japan’s Ministry of Health, Labour and Welfare (MHLW) as a treatment for bronchial asthma (limited to severe or refractory patients whose asthma symptoms cannot be controlled with existing treatments) and CRSwNP (limited to patients inadequately controlled with standard treatment).

The MHLW approval was based on data from the SWIFT and ANCHOR phase III trials, which demonstrated the sustained efficacy of a twice-yearly dose of depemokimab versus placebo, both plus standard of care. In SWIFT-1 and SWIFT-2, treatment with depemokimab resulted in significant reductions in asthma exacerbations. Additionally, ANCHOR-1 and ANCHOR-2 showed significant improvements in nasal polyp size and nasal obstruction, two key measures of disease severity.^1,2

Kaivan Khavandi, SVP and Global Head, Respiratory, Immunology & Inflammation R&D, GSK said: “Building on other recent regulatory milestones, the approval of Exdensur in Japan could set a new standard of care for patients with severe asthma or CRSwNP. By delivering sustained suppression of type 2 inflammation in just two doses a year, physicians can now provide an ultra-long-acting option to help protect against asthma exacerbations and the debilitating symptoms of CRSwNP.”

Patients in Japan living with severe asthma can experience frequent exacerbations and progression of their disease, leading to hospitalisations and increased overall healthcare costs.^3-6 In addition, patients with CRSwNP face debilitating daily symptoms and almost half remain uncontrolled.^3,7 Depemokimab is a novel therapy that has been developed with an extended half-life, enabling the sustained suppression of disease-driving type 2 inflammation with twice-yearly dosing.¹ These distinct properties could potentially improve patient outcomes while reducing health system burden. 

Results from the SWIFT trials showed treatment with depemokimab resulted in a significant 58% and 48% reduction in the rate of annualised asthma exacerbations (asthma attacks) over 52 weeks from SWIFT-1 and SWIFT-2, respectively [rate ratio (95% confidence interval) p-value: SWIFT-1 0.42 (0.30, 0.59) p<0.001 and SWIFT-2 0.52 (0.36, 0.73) p<0.001] (AER depemokimab versus placebo: SWIFT-1 0.46 vs. 1.11 and SWIFT-2 0.56 vs. 1.08 exacerbations per year).¹

In addition, results from the ANCHOR trials showed an improvement (reduction) from baseline in nasal polyp score (scale: 0-8) at 52 weeks [treatment difference (95% confidence interval) p-value: ANCHOR-1 -0.7 (-1.1, -0.3) p<0.001 and ANCHOR-2 -0.6 (-1.0, -0.2) p=0.004] and in nasal obstruction verbal response scale (scale: 0-3) over weeks 49-52 [treatment difference (95% confidence interval) p-value: ANCHOR-1 -0.23 (-0.46, <0.00) p=0.047 and ANCHOR-2 -0.25 (-0.46, -0.03) p=0.025].²

Across these trials, depemokimab was well-tolerated, with patients experiencing a similar rate and severity of side effects as those receiving placebo.^1,2

Approval in Japan marks the third regulatory approval for depemokimab, following marketing authorisation from the US Food and Drug Administration (FDA) and UK’s Medicines and Healthcare products Regulatory Agency (MHRA).^8,9 Depemokimab recently received a positive CHMP opinion in the EU and it is currently under regulatory review in other countries, including in China.¹⁰

About asthma

Asthma affects more than 260 million people globally, many of whom continue to experience symptoms and exacerbations despite treatment.^11,12 Severe asthma is defined as asthma that requires treatment with medium- to high-dose inhaled corticosteroids plus a second therapy (i.e., systemic corticosteroid or biologic) to prevent it from becoming uncontrolled, or which remains uncontrolled despite therapy.¹³ Type 2 inflammation is the underlying cause of pathology in more than 80% of patients with severe asthma, in which patients exhibit elevated levels of eosinophils (a type of white blood cell).¹³

About CRSwNP

CRSwNP is caused by inflammation of the nasal lining that can lead to soft tissue growths, known as nasal polyps.^14,15 People with CRSwNP experience symptoms such as nasal obstruction, loss of smell, facial pain, sleep disturbance, infections and nasal discharge that can significantly affect their emotional and physical well-being.^14,15  Similar to asthma, the majority of cases of CRSwNP (85%) are driven by chronic type 2 inflammation, which is strongly associated with comorbidities, more severe disease, recurring symptoms and tissue remodelling.^14-19

About Exdensur (depemokimab)

Exdensur is the first ultra-long-acting biologic being evaluated for certain respiratory diseases with underlying type 2 inflammation, such as severe asthma. It combines high interleukin-5 (IL-5) binding affinity and high potency with an extended half-life to enable twice-yearly dosing.^1,2 IL-5 is a key cytokine in type 2 inflammation.

Please refer to the updated Product Information (PI) for precautions concerning indications, dosage and administration, and safety information in Japan which will shortly be updated at this link: Japan Pharmaceuticals and Medical Devices Agency.

About the SWIFT phase III trials

Results from the SWIFT trials were presented at the 2024 European Respiratory Society International Conference and published in the New England Journal of Medicine.^1,20

The SWIFT-1 and SWIFT-2 clinical trials assessed the efficacy and safety of depemokimab adjunctive therapy in 382 and 380 participants with severe asthma who were randomised to receive depemokimab or a placebo respectively, in addition to their standard of care (SOC) treatment with medium to high-dose inhaled corticosteroids plus at least one additional controller. The full analysis set in SWIFT-1 included 250 patients in the depemokimab plus SOC arm and 132 in the placebo plus SOC arm; in SWIFT-2, 252 patients were included in the depemokimab plus SOC arm and 128 in the placebo plus SOC arm.¹

About the ANCHOR phase III trials

Results from the ANCHOR trials were presented at the 2025 American Academy of Allergy, Asthma and Immunology (AAAAI) and World Allergy Organization (WAO) Joint Congress and published in The Lancet.^2,21

ANCHOR-1 included 143 patients in the depemokimab plus SOC arm and 128 in the placebo plus SOC arm; in ANCHOR-2, 129 patients were included in the depemokimab plus SOC arm and 128 in the placebo plus SOC arm. All 528 patients had inadequately controlled CRSwNP, including nasal polyps in both nasal cavities (an endoscopic bilateral NPS ≥5), and had either undergone previous surgery for CRSwNP, had received previous treatment with SCS or were intolerant to SCS. Patients received depemokimab or placebo at six-monthly intervals (26 weeks) in addition to SOC (maintenance intranasal corticosteroids).²

About the depemokimab development programme

Depemokimab is currently being evaluated in phase III trials for the treatment of other diseases with underlying type 2 inflammation, including OCEAN for eosinophilic granulomatosis with polyangiitis (EGPA) and DESTINY for hyper eosinophilic syndrome (HES).^22,23 GSK has also initiated the ENDURA-1, ENDURA-2 and VIGILANT phase III trials assessing the efficacy and safety of depemokimab as an add-on therapy in patients with uncontrolled moderate to severe COPD with type 2 inflammation.^24-26

About GSK in respiratory

GSK continues to build on decades of pioneering work to deliver more ambitious treatment goals, develop the next generation standard of care and redefine the future of respiratory medicine for hundreds of millions of people with respiratory diseases. With an industry-leading respiratory portfolio and pipeline of vaccines, targeted biologics and inhaled medicines, GSK is focused on improving outcomes and the lives of people living with all types of asthma and COPD, along with less understood refractory chronic cough or rarer conditions like systemic sclerosis with interstitial lung disease. GSK is harnessing the latest science and technology with the aim of modifying the underlying disease dysfunction and preventing progression. 

About GSK

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. Find out more at gsk.com.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2024, and GSK’s Q3 Results for 2025.

CLCH is the largest community healthcare trust in England, providing a wide range of services across London and Hertfordshire, including child health visiting and adult services, walk-in centres, sexual health clinics, and diabetes care.

To support the Trust’s journey towards operational and reporting standardisation, Capita will deploy its Element data solution, delivering operational and clinical metrics, robust data quality management, and self-service reporting. This will enable CLCH to streamline processes, unlock deeper insights, and continue providing exceptional care to patients.

Capita’s Business Intelligence and Performance Analytics (BIPA) team will work closely with CLCH, providing end-to-end analytics services from data ingestion to report development and process optimisation. The partnership will also explore opportunities to scale innovative performance management and data quality solutions across the wider healthcare sector.

Fran Zimber, Client Partner at Capita, said: “By helping the Trust unlock deeper insights, streamline processes, and strengthen data quality, we’re enabling teams to make faster, smarter decisions that improve patient experiences and outcomes. It’s a privilege to contribute to such vital work in community healthcare.”

Andrew Chronias, Chief Information Officer at CLCH, added: “CLCH is pleased to continue our data and Business Intelligence (BI) relationship with Capita and take advantage of the expertise within the team. We look forward to exploring the opportunities that lie ahead.”

This new agreement builds on a successful partnership that began in 2015, when Capita started delivering core support services to CLCH, including ICT, HR, estates and facilities management, and financial services.

Today, Capita’s BIPA team continues to provide essential reporting for commissioners, regulatory bodies, and operational teams, helping CLCH deliver high-quality care to communities.

The Everest Group PEAK Matrix® assesses the market impact, vision and capability of service providers. This year, the report highlights Capita’s AI solutions and its, technology ecosystem, as well as the company’s ability to deliver high-quality service and respond with agility to client demands, as its key strength areas.

David Rickard, Partner, Everest Group, said: “Capita’s strong expertise in regulated sectors such as government, BFSI, telecom, and energy and utilities is being reshaped by its bold investments in AI-powered CX capabilities. Through its AI Catalyst Lab and AgentSuite, its gen AI- powered proprietary solutions suite driving agent productivity, quality assurance, and customer insights, Capita is evolving its service portfolio to meet the rising demand for AI-powered customer engagement. These advancements, combined with its strong presence in the UK&I and Germany, underpin Capita’s recognition as a Major Contender in Everest Group’s Customer Experience Management (CXM) Services PEAK Matrix® Assessment 2025 – EMEA.”

Corinne Ripoche, CEO of Capita Experience, said: “We’re proud to be recognised by Everest Group. It’s a brilliant reflection of the energy, creativity and commitment our teams bring every day.

“We’re not just imagining the future of customer experience, we’re building it, together with our clients, for their customers.”

Sparking success in the utilities sector

A leading energy retailer has extended its partnership with Capita until the end of 2027 in a multimillion-euro deal. Since 2018, Capita has helped reduce debt by 10% annually through specialist collection services, with teams in Ireland and Poland combining local expertise with operational scale to deliver advanced technology, greater efficiencies and outstanding service.

Driving engagement behind the news

One of the UK and Ireland’s largest commercial news groups, has confirmed a two-year extension with Capita from 2026. This marks the next phase of a partnership spanning two decades, with Capita managing customer service, order processing, supply chain operations and outbound sales for thousands of newspaper agents across the Republic of Ireland. This renewal reflects confidence in Capita’s ability to run seamless operations and effectively engage audiences.

Fast-tracking fair outcomes

A key public sector organisation responsible for resolving claims has signed a one-year extension from the second quarter of 2026. For more than 20 years, Capita has delivered fair and efficient outcomes, introducing digital enhancements such as automated Voice of Customer surveys, SMS reminders powered by Amazon Web Services, and improved role-based access controls. These innovations help claimants and insurers achieve faster resolutions.

Connecting confidence in telecoms

A major telecoms brand has renewed its partnership with Capita until 2027, with teams in Ireland and Poland providing diligent debt collection and accounts receivables management to ensure accurate reconciliation and strong financial performance. This renewal reinforces Capita’s role as a trusted partner in safeguarding operational integrity.

Capita Ireland delivers customer experience solutions supporting utilities, telecoms, retail, and public sector clients with AI-enabled, people-powered solutions. It employs a substantial workforce of over 840 colleagues in its sites in Clonakilty and Little Island, both in Co Cork, and continues to grow through strategic partnerships and technology innovation.

Corinne Ripoche, CEO of Capita’s Experience Division, said: “These renewals are more than contracts; they represent trust, progress and shared ambition. We are further reinforcing our capability in Ireland and underlining our strategy to be a better business. Each renewal reflects our values: putting customers first, embracing fearless innovation and achieving together.

“Crucially, these wins span complex customer support across claims, collections, account receivables, and supply chain management. In a world where AI handles the simple tasks, we are able to focus on our people delivering expertise where it matters most.”

Capita has worked with Samsung UK, a world-renowned technology leader, since 2011, providing customer experience services including technical voice support for mobile customers, customer solutions and online social media community management.

In 2016, Capita established a Business Service Centre (BSC) to serve the needs of Samsung’s business partners, offering services including technical support, customer service, and managed services.

Under the new contract, Capita will continue to provide voice, email, and social media community management support to Samsung customers who purchase electronic products, ranging from TVs to mobile phones.

The new contract will deliver impactful transformation driven by technology, including the migration of the telephony system to AWS Connect-powered Capita Contact and running a proof-of-concept in the BSC with Agent Suite, Capita’s flagship GenAI-powered platform.

These solutions will provide a more personalised and proactive service, improving the customer and colleague experience. This approach aligns with and supports Samsung’s mission to inspire consumers to adopt the company’s innovative technology, and to get more out of their technology and relationship with Samsung.

Corinne Ripoche, CEO of Capita Experience, said: “These new contracts further strengthen our 14-year partnership with Samsung, and we will be prioritising innovation and quality to ensure seamless, efficient, and valuable experiences for Samsung and their customers. I am especially excited that we will be driving these experiences via the increased application of technology and AI.”

“Our focus on transformation for clients by bringing technology, people and processes together is at the heart of Capita’s strategy, and I am looking forward to seeing this in action with Samsung.” 

Toulouse, France, 6 January 2026 – STARLUX Airlines of Taiwan has taken delivery of its first of 18 A350-1000s, becoming the 11th global operator of the largest version of the A350. The new A350-1000 will join a fleet of 10 A350-900s already in service with the airline, deployed on premier long-haul services from Taipei to Europe and North America, as well as selected destinations within the Asia-Pacific region. 

To mark the arrival of its newest fleet member, STARLUX has unveiled a striking livery that reflects both innovation and identity. The design integrates the airline’s signature visual elements with a carbon-fibre motif, representing the advanced composite materials integral to the aircraft’s construction. The prominent ‘1000’ emblazoned on the fuselage highlights the aircraft’s designation as the largest in-production Airbus model, now serving as the airline’s new flagship.

STARLUX currently operates an all-Airbus fleet comprising the A321neo, the A330-900, and the A350-900 aircraft. The new A350-1000 will seamlessly complement the airline’s existing fleet. Furthermore, the airline has ordered 10 A350F freighters to develop its future cargo network.

The A350 is the world’s most modern widebody aircraft and has set new standards for intercontinental travel. The A350’s all-new design includes state-of-the-art technologies and aerodynamics delivering unmatched standards of operational efficiency and passenger comfort. Its new generation engines and use of lightweight materials bring a 25 per cent advantage in fuel burn, operating costs and carbon dioxide (CO₂) emissions, compared to previous generation competitor aircraft. The A350 is equipped with a comfortable and spacious Airspace cabin, wide seats, high ceilings and alluring ambient lighting. 

As with all Airbus aircraft, the A350 aircraft is already able to operate with up to 50% Sustainable Aviation Fuel (SAF). Airbus is targeting to have its aircraft up to 100% SAF capable by 2030.

At the end of November 2025, the A350 had won nearly 1,500 orders from 66 customers worldwide.

@Starluxairlines @Airbus #A350 #LongRangeLeader 

Network Rail said the junction was used by up to 500 trains a day, and the project – which cost £26m – took nearly a year of planning.

Workers replaced 130 track panels and renewed the foundation stone beneath the tracks.

There were also improvements made to points, switches and crossings.

Follow-up work is scheduled for Hanslope Junction on 11 and 25 January, with trains between Milton Keynes and Northampton suspended while it takes place.

While the line was closed, other projects took place nearby.

Uneven surfaces on platform 4 at Milton Keynes Central Station were replaced. Elsewhere in Buckinghamshire, there was resurfacing work on platforms 3 and 4 at Wolverton Station to improve stepping distances between trains and the platforms.

At Roade, Northamptonshire, about 1,500m of new rail was installed.

Amsterdam, 6 January 2026 – Arcadis N.V. (Arcadis), the world’s leading company delivering data-driven sustainable design, engineering, and consultancy solutions for natural and built assets, repurchased 246,237 of its own shares in the period 29 December 2025 – 2 January 2026 at an average price of €35.73. The total consideration of this repurchase was €8,798,027.

The total number of shares repurchased under this program to date is 3,680,327 shares for a total consideration of €141,923,695 at an average price of €38.56.

The repurchase is in accordance with the share buyback program to reduce the capital of Arcadis, as announced on 1 October 2025.

Overviews of all transactions under this program are published in weekly press releases and on the website of Arcadis.