BALI, INDONESIA – Media OutReach Newswire – 8 December 2025 – The ACES Awards 2025 unveiled one of the most compelling assemblies of international leaders in the event’s history.
This year’s winners — spanning Taiwan, India, Laos, Vietnam, Mongolia, Saudi Arabia, Hong Kong, Singapore, Myanmar and more — demonstrated not only operational excellence, but an emotional and moral depth that moved audiences and jury members alike.
A group of champions! Celebrating the exceptional talent, sustainability focus, and leadership of our Day 1 and Day 2 ACES Award winners.
Their achievements form a sweeping tapestry of courage, ingenuity, social commitment, and regional transformation.
From the mountains of Mongolia to the bustling innovation corridors of Singapore, from coastal Taiwan to the rapidly modernising landscapes of Laos and Myanmar — each winner brought a distinctly powerful story.
Yet, they all shared the same spirit: a refusal to settle for ordinary when the world needed extraordinary leadership.
MORS Group CEO Dr Shanggari Balakrishnan said that each international winner this year stood as proof that leadership was most powerful when it uplifted communities and shaped a future bigger than any one organisation.
“They remind us that impact knows no borders — and neither does responsibility,” said the ACES Awards organiser.
CPC Corporation Taiwan delivered one of the night’s most memorable narratives.
Its coral conservation programmes — supported by AI-driven monitoring, species rehabilitation, and reef regeneration — revealed how a major energy institution
can become a steward of fragile ocean ecosystems.
It was a breathtaking example of industry embracing accountability and healing.
In Vietnam, Highlands Coffee proved that a brand can be both commercially dominant and deeply human.
Through its roasting innovations, community outreach, and the Highlands Happiness Fund, the company reinforced that national identity and commercial ambition need not be at odds — they can build each other.
LCY Development brought forward a story of cross-border expansion guided by human values.
Their efforts in Brunei, Borneo and Australia, coupled with affordable housing and digital construction tools, showed how growth becomes meaningful when anchored in dignity and accessibility.
EDL-Generation Public Company stood as a pillar of stability for Laos, managing hydropower for national development while sustaining commitments to clean energy.
Mongolia’s Moncement shifted a nation’s industrial dependency through green cement and waste heat innovation.
Myanmar Agro Exchange modernised the agriculture sector with governance-first, farmer-first infrastructure — a beacon of consistency despite national challenges.
Singapore’s Lockton impressed with its independent ownership model and disciplined growth, proving that risk advisory can be principled, nimble and people-focused.
Ombra, led by Letright Industrial Corporation Founder Ren Li, stood tall as a pioneer of sustainable outdoor living, years ahead of industry standards.
He Eye Specialist Hospital Group delivered one of the evening’s most emotionally resonant submissions — its “blindness-free world” vision brought together AI, gene therapy, rural accessibility and medical excellence with heart.
Suzlon Energy reaffirmed wind power’s role in Asia’s decarbonised future, while Henderson Land and Manulife Asia showcased how blue-chip institutions can
lead with bold ESG ambition.
The Aseer Development Authority showcased transformative regional development underpinned by culture and community, while NagaWorld demonstrated evolving standards of responsibility in large-scale hospitality ecosystems.
Together, these stories remind Asia that leadership is not defined by geography, industry, or scale — it is defined by the courage to challenge norms and uplift
BALI, INDONESIA – Media OutReach Newswire – 8 Desember 2025 – The ACES Awards proudly announces Dato’ KL Bock as a distinguished winner of the Asia’s Most Inspiring Executives Award 2025, honouring his exceptional leadership, transformative vision, and outstanding contributions to Asia’s manufacturing and technology landscape.
Dato’ KL Bock: Asia’s Most Inspiring Executive honored.
With more than 30 years of experience in end-to-end operations, supply chain, and advanced manufacturing, Dato’ KL Bock has established a powerful reputation as one of Asia’s most progressive and influential leaders. As Senior Vice President of Global Flash Backend Operations at Sandisk, he has driven transformative change across the organisation’s manufacturing network, enabling advancements that have set new industry benchmarks.
Under his stewardship, the Sandisk Batu Kawan, Penang facility achieved global recognition as a Malaysia’s 1st World Economic Forum Advanced 4IR Lighthouse and Asia’s 1st World Economic Forum Sustainability Lighthouse in the World Economic Forum Global Lighthouse Network. This accomplishment reflects his relentless pursuit of operational excellence, sustainability, and integration of Fourth Industrial Revolution (4IR) technologies including automation, AI-driven optimisation, and lights-out manufacturing.
The ACES Awards recognises leaders who go beyond business results, and Dato’ Bock exemplifies this standard through his unwavering commitment to people development. His leadership philosophy emphasises empowerment, trust, and continuous learning. Through initiatives that prioritise upskilling, coaching, and exposure to emerging technologies, he has cultivated a future-ready workforce capable of thriving in a rapidly evolving industry. His strong focus on culture-building has fostered collaboration, innovation, and resilience—qualities that have strengthened organisational performance and employee engagement on a global scale.
Beyond corporate transformation, Dato’ Bock is a prominent figure in Asia’s semiconductor ecosystem. As Chairman of the SEMI Southeast Asia Regional Advisory Board and as an advisor to industry organisations, he actively champions ecosystem development, talent acceleration, and industry-academia collaboration. His ability to influence not only his organisation, but the broader semiconductor manufacturing community, demonstrates the depth of his impact.
The Asia’s Most Inspiring Executives Award 2025 recognises leaders who shape industries, uplift people, and drive sustainable progress. Dato’ KL Bock embodies these qualities through his vision, strategic foresight, and commitment to excellence making him a standout figure in the region’s leadership landscape.
The ACES Awards extends its heartfelt congratulations to Dato’ KL Bock for this prestigious achievement and celebrates his ongoing contributions to Asia’s transformation and technological advancement. Hashtag: #ACESAwards #MORSGroup #Sustainability #Leadership #ACES2025
The issuer is solely responsible for the content of this announcement.
SINGAPORE – Media OutReach Newswire – 8 December 2025 – In Singapore’s competitive education landscape, affordability often determines opportunity. Yet, for many aspiring learners, financial constraints can feel like an insurmountable barrier. SIM Global Education (SIM GE) is rewriting that narrative through sponsorships and community-driven initiatives that do more than ease tuition, they empower individuals and strengthen society.
Breaking Barriers with SAFRA-SIM Sponsorship
For National Servicemen transitioning to civilian life, the SAFRA-SIM Global Education Sponsorship offers a lifeline. Eligible SAFRA members can receive 50% coverage of course fees, making higher education attainable without the burden of loans or repayment obligations. This initiative reflects a commitment to reward service while fostering lifelong learning, a critical step in building a skilled, resilient workforce.
SIM Trust: A Catalyst for Social Impact
Launched in 2024, SIM Trust represents a bold vision, education as a force for equity and community transformation. With Institution of a Public Character (IPC) status, SIM Trust channels philanthropic contributions into programmes that uplift less privileged students and fund social impact projects. From bursaries of up to S$13,500 for Singaporeans to emergency crisis funds and overseas community engagement awards, these initiatives prioritise inclusivity and civic responsibility over repayment.
SIM Trust also invests in sector-strengthening, supporting research and training for social service professionals. This approach ensures that aid extends beyond individual beneficiaries creating ripple effects across communities.
Beyond Financial Aid: Building Changemakers
SIM’s sponsorship ecosystem is rooted in a philosophy of empowerment. Recipients are encouraged to engage in volunteerism and social projects, cultivating leadership and empathy alongside academic achievement. Programmes like the SIM Chairman’s Award for Resilience and RESSEC bursaries recognise not only scholastic merit but also resilience and community involvement, reinforcing SIM’s belief that education should inspire service.
In an era where education is often commodified, SIM’s initiatives stand out for their human-centric approach. By removing financial barriers and embedding social responsibility, SIM is shaping graduates who are not only career-ready but also community-minded. These programmes exemplify how partnerships between institutions, donors, and civic organizations can democratise education and at the same time drive sustainable social change.
The issuer is solely responsible for the content of this announcement.
About SIM Global Education
SIM Global Education (SIM GE) is a leading private education institution in Singapore and the region. We offer more than 140 academic programmes ranging from diplomas and graduate diploma programmes to bachelor’s and master’s degree programmes with some of the world’s most reputable universities from Australia, Canada, Europe, United Kingdom, and the United States. SIM GE’s cohort is made up of 16,000 full- and part-time students and adult learners, of which approximately 36% are international students hailing from over 50 countries.
SIM GE’s holistic learning approach and culturally diverse learning environment aim to equip students with knowledge, industry skills and employability competencies, as well as a global perspective to succeed as future leaders in a fast-changing, technologically driven world.
For more information on SIM Global Education, visit sim.edu.sg
SHANGHAI, Dec. 8, 2025 /PRNewswire/ — AGIBOT, a leading robotics company specializing in embodied intelligence, today announces the official roll-out of its 5,000th mass-produced humanoid robot at its factory. This milestone represents a step forward in AGIBOT’s ongoing efforts to improve the mass production and practical use of embodied robotics.
“We are grateful to reach this milestone after years of steady effort in tackling core challenges in embodied robotics. Through ongoing improvements, we have enhanced the stability, reliability, and durability of our systems.” AGIBOT Co-Founder, President, and CTO Mr. Zhihui Peng said, “Building on this progress, AGIBOT will continue listening to the needs of its industry partners and work to contribute practical general-purpose humanoid robots to real-world operations.”
AGIBOT offers a diversified product portfolio tailored to a wide range of real-world applications. To date, the full-size embodied robot AGIBOT A-Series has achieved mass production with 1,742 units, the fully intelligent and agile half-size robot AGIBOT X-Series has reached 1,846 units, and the task-optimized AGIBOT G-Series, designed for complex operations in manufacturing, logistics, and services, has reached 1,412 units.
AGIBOT’s robots are currently deployed in eight key commercial applications, including guided reception and exhibition services, entertainment and commercial performances, intelligent manufacturing, logistics sorting, security inspection, commercial cleaning, data-collection training, and scientific research and education. Through widespread adoption across multiple industries, AGIBOT is demonstrating the potential of embodied AI to drive industrial upgrades, transform service and production processes, and support broader digital transformation efforts.
Moving forward, AGIBOT will continue strengthening its technologies and delivery capabilities to meet evolving market needs and provide practical, general-purpose humanoid robotic solutions for a wider range of industrial users.
About AGIBOT AGIBOT is dedicated to driving innovation through the integration of AI and robotics, creating world-leading general-purpose embodied robot products and an application ecosystem. Built on the foundation of robotic body and powered by the fusion of interaction, manipulation, and locomotion intelligence — “1 Robotic Body + 3 Intelligence” — AGIBOT is a leading robotics company in the industry to deliver a complete product portfolio and deploy across all major application scenarios.
Also featured in top media and industry reviews as one of the best ergonomic chair brands, including WIRED, Tom’s Guide, and international design award panels
SINGAPORE – Media OutReach Newswire – 8 December 2025– Hinomi, Singapore’s top-selling ergonomic chair brand, has been named in the prestigious Forbes Go-International 30&30 Series 2025, a recognition of companies demonstrating exceptional global growth and innovation.
This recognition, announced recently, solidifies the company’s position among the world’s best ergonomic brands by highlighting its commitment to rapid international expansion and to bringing superior solutions to users worldwide (including new showrooms in the USA, UK, and France).
Hinomi’s innovative product line has been validated by a host of critical industry and media endorsements, underscoring Hinomi’s status as a market leader:
International Design Excellence: Securing Gold Winner status at both the 2025 London Design Awards and the 2025 French Design Awards
Media and Consumer Choice: Hinomi was honoured with Tom’s Guide’s Editor’s Choice and featured in WIRED’s “The 15 Best Office Chairs” list
Specific Category Leadership: Recognized in IGN’s Best Gaming and Office Chairs and selected as Best for Adjustability in The Independent‘s “Best Ergonomic Office Chairs 2025”
H2 Pro: Award-winning comfort and design among the best ergonomic chairs
At the heart of Hinomi’s success lies the flagship H2 Pro ergonomic chair, a meticulously engineered seating solution that has captured the attention of professionals, gamers, and creators alike. The H2 Pro stands out in the competitive landscape of the best ergonomic chair options with its 19 points of adjustability, accommodating users of all body types and work styles.
Available in five sophisticated colorways – Coal Black, Cream White, Mint Green, Mist Pink, and Moon Gray – the H2 Pro seamlessly blends into any workspace aesthetic while delivering uncompromising comfort and support.
“We are truly honored to be recognized by the Forbes Go-International 30&30 Series. This award reflects the dedication and hard work of our entire team, and it reinforces our commitment to delivering the highest quality ergonomic solutions. At Hinomi, we strive every day to provide our customers with products that combine exceptional comfort, thoughtful design, and innovative functionality.” – Jerry Zhang, CEO & Founder of Hinomi
Beyond Comfort: Ergonomics Designed for Real Life
What sets Hinomi apart in the ergonomic chair category is its human-centered approach to design, one that adapts to people rather than asking people to adapt to the chair. With the new H2 Pro offering an industry-leading 19 adjustment points, Hinomi ensures that every individual, regardless of body type, size, or lifestyle, can achieve a perfectly tailored fit. This reflects the brand’s core philosophy: let the chair adjust to you.
“True comfort is more than just measurements on a chart,” the team shares. “It’s about creating solutions that adapt intuitively to your needs, helping you stay focused, feel supported, and bring your best self to work, play, or creativity.” This balance of emotional support and highly customizable adjustability has resonated with users across diverse industries, from corporate professionals seeking all-day productivity to content creators crafting their dream workspaces at home.
A Growing Global Ergonomic Chair Brand
From its Singapore headquarters, Hinomi has expanded to serve customers in over 25 countries, establishing itself as a truly global ergonomic chair brand. To provide customers with hands-on experiences, the company has opened premium showrooms in key international markets. They allow customers to experience Hinomi’s ergonomic chairs first-hand, test key adjustments and understand why many consider Hinomi among the best ergonomic chair brands for everyday use.
Hinomi showrooms are currently accessible in four key international markets: Singapore, the USA, France, and the UK. Hashtag: #Hinomi
The issuer is solely responsible for the content of this announcement.
About Hinomi
Founded in Singapore, Hinomi is a global ergonomic brand dedicated to designing chairs and workspace solutions that adapt to every body and every moment. As Singapore’s No.1 selling ergonomic chair brand, Hinomi serves professionals, gamers, and creators across 25+ countries through its online platforms and premium showrooms in Singapore, New York, London, and Paris.
The company’s flagship H2 Pro has earned recognition as one of the best ergonomic chair options available, receiving multiple international design awards and editorial acclaim from leading technology and lifestyle publications. Hinomi continues to build long-term trust with customers worldwide through its commitment to superior design, exceptional comfort, and innovative ergonomic solutions.
HEFEI, China, Dec. 8, 2025 /PRNewswire/ — Sungrow, the global leading PV inverter and energy storage system provider, successfully launched its global website on December 5th, demonstrating strong digital marketing capabilities and establishing a unified brand image across all global regions. More than 1000 pages of original content have been published, which is 36% higher than the energy industry average. The website has already attracted over 10 million active users across more than 100 countries and regions, with 33 country-specific sites set to launch gradually in the near future.
Sungrow Global Website
Pristine Visual Renovation: While showcasing our technological expertise, this platform also offers a glimpse into our commitment to achieving harmony with nature, clean and simplify design. Through rich videos, captivating images, and seamless contextual integration, Sungrow delivers an immersive experience. This interactive website is designed to engage and captivate, using innovative animations and immersive graphics to decode complex technologies and make them accessible to you.
Client-Centric Journey Design: The information architecture has been optimized to serve better core client segments, including residential, C&I, utility-scale clients as well as installers, and distributors. Sungrow enhances clients’ decision-making journey with multimedia product details, quick-decision tools, and a distributor finder. We offer comprehensive resources — such as training programs, tool-book, and whitepapers — to deliver our value proposition and foster partners’ growth. Additionally, our friendly search engine and AI engine optimization ensures a seamless and intuitive global digital experience for users, starting right from the search.
Scenario-based Solution: Real-world application scenarios are used to present products and solutions. The website starts from the real pain points of our clients, evolving from a simple product seller to a comprehensive solution provider. By demonstrating clear value through real-world applications, the website can address the distinct needs of residential, commercial, industrial and utility-scale users.
Magazine-style Demonstration: Our project cases and products are presented in magazine format. Sungrow’s website moves beyond traditional, rigid display methods, showcasing its products’ core value clearly and intuitively. Through dynamic demonstrations and real-world case studies, we highlight key technologies and their practical applications, allowing every user to easily grasp Sungrow’s strengths. We are committed to enhancing user satisfaction through the integration of fresh layout styles and engaging content. All content is fully integrated with major social media platforms, enabling effortless sharing and ensuring digital interconnectivity.
“By gathering hundreds of survey responses and conducting over 1000 hours of in-depth face-to-face interviews with internal and external users, we confirm the final layout of our website.” Said by Simon Liu, general manager of Global Marketing Center at Sungrow, “We prioritize client’s satisfaction by focusing on three key aspects: Experience, Innovation and Service. And make sure those standards are well-adopted in every detail so our clients can consistently rely on our solutions and services at any time, from any place.”
BANGKOK, THAILAND – Media OutReach Newswire – 8 December 2025 – PTT Oil and Retail Business Public Company Limited (OR),Thailand’s largest fuel retailer and the operator of the rapidly expanding Café Amazon chain, delivered a solid financial performance in the third quarter of 2025, reflecting strengthening fuel margins, disciplined cost management, and continued momentum across its retail and consumer-facing businesses.
M.L. Peekthong Thongyai, Chief Executive Officer of PTT Oil and Retail Business Public Company Limited (OR).
The company reported EBITDA of 4.88 billion baht, an increase of 7.2% from the previous quarter, while net profit rose 17.1% to 2.61 billion baht. Over the first nine months of the year, OR’s net profit nearly doubled from the same period in 2024, reaching 9.23 billion baht, supported by a 24.5% rise in EBITDA to 15.9 billion baht. The earnings growth was achieved despite lower global oil prices, underscoring OR’s ability to strengthen profitability through operational efficiency and a more balanced business portfolio.
A key highlight of the third quarter was the continued improvement in fuel margins. Average gross profit per liter rose across both gasoline and diesel, signaling what OR views as a return to a more stable and healthy cycle in Thailand’s fuel retail market. This momentum was complemented by growing aviation fuel demand and the steady expansion of OR’s nationwide networks of PTT Stations and EV Station PluZ chargers, which now operate at more than 1,300 locations. Together, these developments reinforce the company’s long-term strategy to advance both mobility and clean-energy infrastructure.
The Lifestyle segment also delivered another strong quarter, led by Café Amazon’s continued growth in Thailand and abroad. Total beverage sales reached 109 million cups, an 11% increase year-on-year. OR now operates 4,729 food and beverage outlets, including Café Amazon, Pearly Tea, Pacamara Coffee Roasters and the company’s broader retail ecosystem—at the center of its diversification strategy. Café Amazon has become a significant contributor to OR’s earnings profile, helping reduce exposure to energy price cycles while strengthening consumer engagement through everyday retail touchpoints.
OR’s push into digital platforms also advanced meaningfully with the launch of the upgraded blueplus+ app, designed to unify loyalty rewards, fuel services, payments, and Café Amazon privileges in a single ecosystem. The refreshed digital experience reflects OR’s emphasis on consumer-centric innovation and its ambition to build deeper, more personalized relationships across its customer base.
Sustainability remains a strategic pillar for the company. OR was recently recognized with the Climate Action Excellence Award, a milestone that highlights its commitment to responsible growth and community impact, from clean-energy expansion to sustainable sourcing initiatives across its retail operations.
M.L. Peekthong Thongyai, Chief Executive Officer of OR, described the company’s performance as a reflection of both market recovery and the strength of its evolving business model. “This quarter’s performance reflects more than a financial recovery—it shows the strength of the ecosystem we have been building over many years,” said M.L. Peekthong Thongyai, Chief Executive Officer of OR. “As fuel margins return to a healthier balance, we are encouraged by the continued rise of Café Amazon and the strong engagement across our retail and digital platforms. These are not just growth engines; they are touchpoints that connect us to people and communities every day.”
“Looking ahead, our focus is on creating long-term, sustainable value by integrating energy, retail, and digital innovation in a way that supports everyday life while contributing positively to the environment and society. We believe this holistic approach—rooted in responsibility, partnership, and shared progress—will guide OR through its next chapter of growth.”
With improvements across all major business lines, OR enters the final quarter of 2025 with strong momentum and a deeper integration of energy, retail, and digital services—positioning the company as one of Thailand’s most resilient and broad-based growth stories.Hashtag: #OR
The issuer is solely responsible for the content of this announcement.
About OR
PTT Oil and Retail Business Public Company Limited (OR) is a leading Thai energy and retail company with operations across 10 countries. OR operates through four core business groups: Mobility, delivering energy solutions via PTT Station, PTT Lubricants, PTT LPG, EV Station PluZ, and Energy Solution Provider; Lifestyle, anchored by Café Amazon—one of Asia’s largest coffee chains—alongside convenience stores and space management; Global Business, driving international expansion with over 2,700 PTT Stations and 5,000 Café Amazon outlets worldwide; and OR Innovation Business, incubating new ventures and sustainable solutions through technology. Complementing these businesses is blueplus+, OR’s digital app that integrates online and offline benefits across its ecosystem of retail and service platforms.
Seizure reduction: phase 3 study achieved primary endpoint as fenfluramine demonstrated a statistically significant reduction in countable motor seizure frequency (CMSF) compared with placebo1
Holistic benefit: secondary endpoints showed significant and clinically meaningful improvements in Clinical Global Impression–Improvement (CGI-I) in patients treated with fenfluramine compared with placebo1
Fenfluramine was generally well tolerated, with no new safety signals identified1
UCB plans to submit for regulatory approval of fenfluramine for the treatment of seizures associated with CDKL5 Deficiency Disorder (CDD) as soon as possible, marking fenfluramine’s third developmental and epileptic encephalopathy (DEE) to be submitted for regulatory approval
BRUSSELS, Dec. 8, 2025 /PRNewswire/ — UCB, a global biopharmaceutical company, today presented positive efficacy and safety results from the GEMZ phase 3 study investigating adjunctive fenfluramine in children and adults with CDKL5 Deficiency Disorder (CDD) at the American Epilepsy Society (AES) meeting, Atlanta, USA, December 5-9, 2025.1 The trial met its primary endpoint and key secondary endpoints, demonstrating a statistically significant reduction in countable motor seizure frequency (CMSF) and a clinically meaningful improvement on the Clinical Global Impression–Improvement (CGI-I) scale, compared with placebo.1
“UCB is proud to share these important results with the medical community at AES, especially given the significant unmet need in CDD. Families affected by this ultra-rare condition face immense daily challenges with frequent, treatment-resistant seizures that are profoundly disruptive to daily life. These trial results emphasize the impact that seizure control can have on the lives of patients and their families, and we look forward to working with health authorities to make this treatment available as soon as possible”, said Fiona du Monceau, Executive Vice President, Patient Evidence, UCB.
The GEMZ phase 3 study is a randomized, double-blind, placebo-controlled, fixed-dose, multi-center study examining the efficacy, safety, and pharmacokinetics of adjunctive fenfluramine treatment in 86 children and adults aged 1 – 35 years, with a CDD diagnosis and uncontrolled seizures.1
Phase 3 study results
Patients treated with fenfluramine (n=42) (0.7 mg/kg/day, maximum 26 mg/day) experienced a median reduction of 47.6% in CMSF from baseline, compared with 2.8% for placebo (n=44) (p<0.001).1 This translated into an estimated median reduction of 52.7% (95% CI: −70.0 to −36.7) between treatment groups during a 14-week titration and maintenance period1
After 14 weeks, 45.2% (n=19) of fenfluramine-treated patients achieved at least 50% reduction in CMSF, compared with only 4.5% (n=2) of patients who received placebo (p<0.001)1
Most fenfluramine-treated patients experienced an increase in countable motor seizure-free days, with a median of >6 additional seizure-free days a month from baseline compared with placebo1
Investigators rated 38.1% (n=16) of patients on fenfluramine as ‘much improved’ or ‘very much improved’ on the CGI-I scale, compared with 6.8% (n=3) of those on placebo (p<0.001)1
According to caregiver’s report of improvement, a CGI-I rating of ‘much improved’ or ‘very much improved’ was provided by 53.7% (n=22) vs just 2.3% (n=1) in the placebo group (p<0.001)1
Fenfluramine was generally well tolerated in the trial, with no new safety signals identified and no cases of valvular heart disease (VHD) or pulmonary arterial hypertension (PAH) occurring.1 Treatment-emergent adverse events (TEAEs) were consistent with the known safety profile of fenfluramine in Dravet syndrome and Lennox-Gastaut syndrome, with 14.3% (n=6) of patients who received fenfluramine experiencing serious TEAEs* compared to 6.7% (n=3) of patients who received placebo.1 UCB is currently conducting an open-label, flexible-dose, long-term 54-week extension (52-week OLE treatment period + 2-week taper) phase of the study to characterize the long-term safety profile and tolerability of fenfluramine in children and adult individuals with CDD.2
CDD is an ultra-rare, DEE characterized by multiple types of drug-resistant seizures, plus severe global neurodevelopmental delays resulting in intellectual, motor, cortical visual, gastrointestinal and sleep impairments as major features. It is caused by pathogenic variants in the Cyclin Dependent Kinase-like 5 (CDKL5) gene located on the X chromosome and affects four times more females than males. It is estimated that CDD affects approximately 1 in 40,000 to 60,000 live births, with a median age of onset of six weeks.3,4,5,6,7
In the European Union (EU), fenfluramine is approved for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older.8 In the United States, fenfluramine oral solution is indicated for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients 2 years of age and older.9 In Japan, fenfluramine is approved for treating seizures associated with Dravet syndrome and Lennox-Gastaut syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years and older.10 It is not approved for use in CDD by any regulatory authority worldwide.
*Serious TEAEs included urinary tract infection (n=2), metapneumovirus infection (n=1), RSV pneumonia (n=1), decreased appetite (n=1), and dyskinesia (n=1) in patients on FFA, and gastroenteritis and pneumoperitoneum in the 2 patients on PBO.
[1] Specchio N, Marsh E, Devinsky O, et al. Fenfluramine in CDKL5 deficiency disorder: primary efficacy and safety results from a phase 3, randomized, double-blind, placebo-controlled study. AES. 2025. Abstract number: 2.429. [2] ClinicalTrials.gov. NCT05064878. Available at: https://clinicaltrials.gov/study/NCT05064878. Accessed: September 2025. [3] Zuberi SM, et al. ILAE classification and definition of epilepsy syndromes with onset in neonates and infants: Position statement by the ILAE Task Force on Nosology and Definitions. Epilepsia. 2022;63(6):1349-97. [4] Epilepsy Foundation. CDKL5 Deficiency Disorder. Available at: https://www.epilepsy.com/sites/default/files/2023-03/CDKL5_Deficiency_Disorder_March2023.pdf. Accessed: October 2025. [5] Rodak M, et al. CDKL5 Deficiency Disorder (CDD)—Rare Presentation in Male. Children (Basel). 2022;9(12):1806. [6] Jakimiec M, et al. CDKL5 Deficiency Disorder—A Complex Epileptic Encephalopathy. Brain Sci. 2020;10(2):107. [7] Hong W, et al. CDKL5 Deficiency Disorder-Related Epilepsy: A Review of Current and Emerging Treatment. CNS Drugs. 2022;36(6):591–604. [8] Fintepla® EU SmPC. https://www.ema.europa.eu/en/documents/product-information/fintepla-epar-product-information_en.pdf. Accessed: September 2025. [9] Fintepla® US PI. https://www.ucb-usa.com/fintepla-prescribing-information.pdf. Accessed: September 2025. [10] Fintepla® Japan PI. Available at: フィンテプラ内用液2.2mg/mL (pmda.go.jp). Last accessed: September 2025.