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SSSTC Launches World’s First Industrial M.2 SSD Featuring KIOXIA’s 8th generation BiCS FLASH™ Technology and PCIe® 5.0 Interface


TAIPEI, TAIWAN – Media OutReach Newswire – 19 August 2025 – Solid State Storage Technology Corporation (SSSTC) proudly announces the launch of the SSSTC CA8 Series, the world’s first industrial M.2 SSD built with BiCS FLASH™ generation 8 3D flash memory technology and a PCIe® Gen5 x4 interface. Offered in the industry-standard M.2 2280 form factor, the SSSTC CA8 Series is available in 512 GB, 1 TB, 2 TB, and 4 TB capacities.

The SSSTC CA8 Series is the world’s first industrial M.2 SSD to combine KIOXIA’s 8th-generation BiCS FLASH™ 3D NAND technology with PCIe Gen5 x4 interface, image credit SSSTC.
The SSSTC CA8 Series is the world’s first industrial M.2 SSD to combine KIOXIA’s 8th-generation BiCS FLASH™ 3D NAND technology with PCIe Gen5 x4 interface, image credit SSSTC.

The SSSTC CA8 Series complies with PCIe® 5.0 and NVMe™ 2.0, supporting ultra-high-speed data access with transfer rates up to 32 GT/s per-lane—doubling the throughput of PCIe® 4.0 interface. With SLC caching, the SSSTC CA8 Series achieves sequential read speeds of up to 14,000 MB/s and write speeds up to 12,000 MB/s, along with random performance of up to 2,000K IOPS (read) and 1,600K IOPS (write) — making it one of the fastest industrial SSDs on the market.

At its core is KIOXIA’s 8th generation BiCS FLASH™ 218-layer 3D TLC NAND Flash Memory with CMOS directly Bonded to Array (CBA) wafer bonding technology , enabling a 20% improvement in write performance, over 10% reduction in read latency, and up to 30% better power consumption. These enhancements make the SSSTC CA8 Series a critical enabler for data-intensive edge computing and high-performance industrial workloads.

Designed for long-term reliability and broad system compatibility, the SSSTC CA8 Series features:
• MTBF exceeding 3 million hours
• Wide operating temperature range (0 °C to 85 °C)
• Supply longevity of 5 to 10 years

Its robust durability and consistent performance make it ideal for demanding applications such as AIoT, factory automation, networking, in-vehicle systems, and edge servers—especially those involving Edge AI workloads.

To ensure data integrity and system resilience, the CA8 Series includes:
• High-performance ECC
• Power Loss Notification (PLN) to prevent data corruption during unexpected shutdowns
• AES-256 encryption and TCG Opal support for advanced data protection

As a subsidiary of KIOXIA, SSSTC is committed to delivering highly stable, high-performance SSD solutions to global enterprise and industrial customers. The SSSTC CA8 Series is scheduled to enter mass production in Q4 2025. For more information, please visit the SSSTC website

Hashtag: #SSSTC

The issuer is solely responsible for the content of this announcement.

About Solid State Storage Technology Corporation (SSSTC)

SSSTC, a subsidiary of KIOXIA—one of the world’s leading memory solution providers—is dedicated to the development, manufacturing, and sales of solid-state drives (SSDs). By combining its in-house R&D capabilities with KIOXIA’s cutting-edge NAND flash technology, SSSTC consistently delivers high-quality, high-reliability industrial-grade and enterprise-grade SSD solutions to customers worldwide.

Trademark Notice:
-NVMe is a registered or unregistered trademarks of NVM Express, Inc. in the United States and other countries.
-PCIe is a registered trademark of PCI-SIG.
-Other company names, product names and service names may be trademarks of third-party companies.

Pinnacle Mastery Institute Launches “The Pinnacle” Leadership and Transformation Programme

Three-day intensive with follow-up practice sessions designed to help participants explore systemic dynamics and leadership challenges.

SINGAPORE – Media OutReach Newswire – 19 August 2025 – Pinnacle Mastery Institute, a Singapore-based training and development organisation, today announced the launch of The Pinnacle, a new programme created by founder Hun Ming Kwang. The programme is designed to help individuals strengthen their leadership capacity, tackle systemic challenges, and navigate personal and professional transitions with greater clarity.

The Pinnacle begins with a three-day in-person intensive and continues with five weeks of evening practice sessions. Participants undertake a 28-day project to apply the insights and methods learned, ensuring that the programme’s outcomes are grounded in practical action.

Drawing on process-oriented psychology and systemic constellations, the programme explores how unseen dynamics – such as unspoken group roles, family patterns, and internal conflicts – shape behaviour and decision-making. The structure is designed to help participants work through recurring challenges, access overlooked strengths, and realign with long-term goals.

“This programme is about creating the conditions for deeper reflection and integration,” said Hun Ming Kwang, founder of Pinnacle Mastery Institute. “Our aim is not to provide quick solutions but to equip participants with tools and perspectives they can carry forward into their leadership and personal lives.”

Key areas of focus in The Pinnacle include:

  • Balancing independence with collaboration and support
  • Understanding systemic influences in families, organisations, and teams
  • Identifying “ghost roles” – hidden forces that shape dynamics and outcomes
  • Interpreting body signals as sources of insight and guidance

The Pinnacle is intended for professionals, entrepreneurs, and changemakers who want to expand their leadership practice and navigate complex environments with greater resilience and coherence.

To learn more or register for the upcoming cohort of The Pinnacle, visit: https://www.hunmingkwang.com/

Hashtag: #PinnacleMasteryInstitute





The issuer is solely responsible for the content of this announcement.

About Pinnacle Mastery Institute

Pinnacle Mastery Institute is a Singapore-based organisation dedicated to leadership, systemic awareness, and personal development. Through its programmes and workshops, the institute integrates psychological depth with practical application, supporting individuals and organisations in building clarity, resilience, and impact.

About Hun Ming Kwang

Hun Ming Kwang is the founder of Pinnacle Mastery Institute and a facilitator specialising in inner work and leadership development. He has led programmes and initiatives in Singapore and internationally, with participants from diverse professional and community backgrounds.

Introducing Miutine, the new irreverent, fragrance by Miu Miu

PARIS, Aug. 19, 2025 /PRNewswire/ — Miu Miu unveils Miutine, the new feminine fragrance, capturing the ultimate essence of the Miu Miu woman, irreverent, youthful in spirit, and unconventional. Miutine is worn entirely for oneself away from any gaze. Captured in a toffee-toned matelassé flacon, the scent within, a classic chypre signature, is twisted with a fruity gourmet cheekiness. 

To view the Multimedia News Release, please click:
https://www.multivu.com/miu-miu-beauty/9349051-en-introducing-miutine-new-irreverent-fragrance-by-miu-miu

The name: Miutine

Miutine. A mischievous, Miu Miu twist on the French ‘mutine’, a rebel’s spirit, bottled. The spirit of the Miu Miu girl: irreverent. She knows the rules and enjoys twisting them. Miutine is not a statement, but a knowing glance. A sweet rebellion, light-hearted and laced with wit, a gesture made for oneself. 

“The composition invites self-affirmation and confidence, creating a perfume for oneself away from any gaze. This colorful and modern composition captures the essence of the Miu Miu girl” Dominique Ropion, Master Perfumer.  

The juice: An irreverent, explosive gourmet

Imagined by master perfumer Dominique Ropion, Miutine is a twist of the codes, a gourmet cheekiness rendered in fragrance. Inspired by a timeless classic of women’s perfumery – the Chypre family – Miutine is characterized by a sophisticated blend of bright citrus, a floral heart, and a rich, earthy base of oakmoss and patchouli. This iconic chypre structure is subverted by a daring duo of wild strawberry and brown sugar accords, possessing a chypre signature, gourmand, intimate, and enveloping.  

The bottle: A tribute to the Miu Miu matelassé

The bottle echoes Miu Miu’s most iconic codes. The recognizable black and white label becomes a desirable collar, on a beautifully crafted Matelassé glass. A tribute to the iconic matelassé leather of the Miu Miu house.

The ambassador: An irreverent multi-awarded voice

Miu Miu’s ambassador, Golden Globe-winning actor Emma Corrin, perfectly embodies the Miutine spirit through constant transformation, effortless, wit, and boldness. They are a person perpetually recreating themselves for their own evolution, representing an irreverent multi-awarded voice.

“The scent represents all the aspects that I treasure and respect the most in myself and others; rebellion, expression, originality. It’s one for the free spirits” – Emma Corrin, Global Ambassador.

Directed by longtime friend of the House, Sundance Jury Prize winner, filmmaker Hailey Benton Gates, the Miutine campaign will debut on 20 August 2025. What – or who – is Miutine? The campaign is a definition of the Miutine spirit in motion.

 

Introducing Miutine, the new irreverent, fragrance by Miu Miu

 

Video – https://mma.prnasia.com/media2/2742991/Miu_Miu_Beauty.mp4

Digital Asset Anti-Money Laundering Council (DAAMC) Launched with Support from the Hong Kong Virtual Assets Industry Association (HKVAIA) to Strengthen Stablecoin Compliance and Financial Integrity

HONG KONG, Aug. 19, 2025 /PRNewswire/ — The Digital Asset Anti-Money Laundering Council (DAAMC), a groundbreaking, industry-led nonprofit organization supported by the Hong Kong Virtual Assets Industry Association (HKVAIA), proudly announces its launch. DAAMC is dedicated to promoting compliant stablecoin issuance and enhancing financial integrity in Hong Kong’s digital asset ecosystem through collaboration among regulated financial institutions to develop and promote best-in-class Anti-Money Laundering and Counter-Financing of Terrorism (AML/CFT) standards and practices.

DAAMC responds to the Hong Kong Monetary Authority’s (HKMA) Guideline on Anti-Money Laundering and Counter-Financing of Terrorism (For Licensed Stablecoin Issuers) and explores emerging global industry compliance standards, such as on-chain identity verification, to ensure Hong Kong’s regulated stablecoins achieve mainstream adoption by balancing risk control with sustainable business development.

The Council, initiated by four leading organizations with diverse expertise, is committed to shaping the future of digital finance in Hong Kong, focusing on stablecoin innovation and compliance: 

  • HashKey Group: A leading digital asset financial services group in Asia with global operations. Its subsidiary, HashKey Exchange, is the licensed virtual asset exchange in Hong Kong, holding Type 1, Type 7, and AMLO licenses issued by the Hong Kong Securities and Futures Commission.
  • RD InnoTech Limited (a subsidiary of RD Technologies Group): A participant in the HKMA Stablecoin Issuer Sandbox, advancing compliant stablecoin issuance, ecosystem development, and use-case expansion. 
  • Beosin: A leading blockchain security and compliance solutions company specializing in smart contract security audit, AML/CFT tools, and blockchain forensics.
  • SlowMist: A leading blockchain threat intelligence firm, providing services such as security audits, red teaming, AML/CFT solutions, and more.

This diverse coalition reflects DAAMC’s commitment to uniting industry expertise to address the unique AML/CFT challenges of digital assets, including stablecoins, to achieve large-scale adoption and integration with traditional finance. By integrating expertise in digital asset trading, stablecoin innovation, blockchain analytics, and threat intelligence, DAAMC aims to establish a compliant ecosystem, setting a global benchmark for financial integrity in Hong Kong’s stablecoin issuance.

A Strategic Response to Hong Kong’s Stablecoin Ambitions

Hong Kong is solidifying its position as a global leader in digital finance through the government’s Digital Asset Policy Statement 2.0 (June 2025) and the recently effective Stablecoins Ordinance. DAAMC’s establishment aligns with this vision, directly supporting the HKMA’s Guideline on Anti-Money Laundering and Counter-Financing of Terrorism (For Licensed Stablecoin Issuers) to ensure regulated stablecoins comply with global financial standards while promoting innovation. DAAMC actively engages with industry discussions on regulatory strictness, committed to researching and exploring how to balance regulatory requirements with business development, enabling Hong Kong-issued compliant stablecoins to achieve mainstream adoption by regulated institutions and traditional enterprises.

Initiated by founding members HashKey Group, RD InnoTech Limited, Beosin, and SlowMist, DAAMC is dedicated to promoting digital asset industry development and collaboration, through activities such as offline seminars to engage relevant industry stakeholders in exploring innovative compliance solutions for stablecoins. DAAMC will soon release two AML technical reports on stablecoins to provide further industry guidance. At the end of this month, DAAMC will host a seminar, bringing together industry experts to discuss stablecoin compliance and innovation strategies. All industry stakeholders are cordially invited to participate.

DAAMC’s Mission and Impact

DAAMC serves as a central platform for regulated financial institutions—including banks, licensed Virtual Asset Service Providers (VASPs), and future licensed stablecoin issuers—to collaborate on critical initiatives. Led by its founding members, the Council will focus on: 

  • Developing Industry Best Practices: Creating practical guidelines for on-chain identity verification, Travel Rule implementation, risk-based digital asset management, and AML frameworks for Decentralized Finance (DeFi) to ensure compliance aligns with traditional financial standards. 
  • Fostering Regulatory Dialogue: Building trusted communication channels with regulators and law enforcement to shape effective policies that support stablecoin mainstreaming. 
  • Promoting Professional Education: Partnering with academic institutions to elevate AML/CFT expertise tailored to stablecoin issuance and digital asset compliance. 
  • Encouraging Responsible Innovation: Balancing risk control with sustainable business development, ensuring regulated stablecoins thrive in Hong Kong’s compliant ecosystem.

DAAMC welcomes participation from a wide range of stakeholders, including Institutional Members (banks, VASPs, stablecoin issuers), Associate Members (audit firms, legal firms, professional bodies such as ACAMS and HKIB), and Educational Partners. By joining DAAMC, organizations will shape policy, manage risks, and demonstrate a commitment to financial integrity while promoting the mainstream adoption of regulated stablecoins.

A Call to Action

With Hong Kong’s Stablecoins Ordinance taking effect in August 2025, DAAMC’s launch underscores its commitment to driving digital asset industry compliance and integrity through collaborative leadership. DAAMC invites leading industry companies, compliance institutions, and innovative enterprises to join this transformative initiative. 

The Asian Century: Myanmar workers in China

BEIJING, Aug. 19, 2025 /PRNewswire/ — Masanda is an ordinary young woman from Myanmar working at Youngor (Ruili) Co., Ltd. She has a gentle and simple personality and is quite shy. During her shifts, she works diligently, and in her leisure time, like her fellow Myanmar coworkers, she listens to music, sings, and dreams of finding a boyfriend she likes, hoping to create a life of her own.


The third episode of the micro-documentary series The Asian Century, titled Myanmar Workers in China

The year 2025 marks the 75th anniversary of the establishment of diplomatic relations between China and Myanmar. The two countries are connected by shared mountains and rivers, and their peoples have maintained a friendship across generations, bound by the profound “pauk-phaw” bond. As Zhang Bo, the workshop director of this company, explained, she understands “pauk-phaw” as “sincerity for sincerity” in human interactions. Masanda and this group of young people from neighboring Myanmar, in the prime of their youth, have experienced firsthand in China what “pauk-phaw” truly means.

We captured the most vibrant details of their daily lives through our lens. Please watch the third episode of the micro-documentary series The Asian Century, titled Myanmar Workers in China.

The Asian Century is a social and cultural documentary series centered on the theme of building an Asian community with a shared future. Through authentic, multidimensional, and comprehensive storytelling, it showcases the shared historical roots, cultural bonds, and developmental aspirations of Asian nations.

https://www.youtube.com/watch?v=QdQkgGr_iyY

123 Food Pte Ltd Expands into Southeast Asia with Singapore’s Only Halal-Certified Cuttlefish Snacks

SINGAPORE, Aug. 19, 2025 /PRNewswire/ — 123 Food Pte Ltd, Singapore’s only MUIS halal-certified cuttlefish snack manufacturer, is accelerating its regional expansion across Southeast Asia. Building on its recent export success in Brunei and past exports to East Malaysia, the company is now actively seeking distribution partners in Indonesia, Thailand, and Mainland Malaysia to meet growing demand for halal-certified heritage snacks made in Singapore.

With increasing regional interest in quality snacks that combine tradition, authenticity, and food safety, 123 Food is uniquely positioned to scale. Backed by a strong track record in OEM and private label production, the brand is now offering exclusive distribution opportunities and custom production partnerships across Asia.

“We’re excited to connect with partners who value quality, halal certification, and the rich food heritage of Singapore,” said Shannon Lee, Director of 123 Food Pte Ltd. “Our goal is to bring Singapore’s beloved cuttlefish snacks to a new generation of snack lovers across the region.”

From Heritage Recipes to Modern Production: A Legacy Carried Forward

Founded in 2017, 123 Food Pte Ltd took over the recipes and traditional snack preparation methods passed down from the older generation of local snack makers. These time-honoured techniques, such as manually rolling cuttlefish through sugar cane presses and grilling over charcoal, are part of Singapore’s broader snack heritage, inspiring the brand’s commitment to preserving authentic flavours.

In the 1950s to 1970s, cuttlefish sheets were cut into squares and pasted onto tikam tikam boards, a nostalgic nod to childhood street-side games that left many fond memories for generations of Singaporeans. These playful yet humble beginnings laid the foundation for the brand’s enduring identity, reminding today’s consumers of the deep cultural roots behind each snack.

While 123 Food has modernised its operations, the artisanal craft remains at the heart of production. Today, high-efficiency baking and conveyor ovens ensure consistency and scalability, while decades of seasoning know-how from previous generations continue to deliver bold, umami-packed flavours that honour its heritage.

The Only MUIS Halal-Certified Cuttlefish Snack in Singapore

All products are proudly made in Singapore, manufactured under strict adherence to the country’s renowned food safety and hygiene regulations. With ISO22000:2018 certification and MUIS halal certification, 123 Food upholds the highest quality standards trusted by both distributors and consumers. This reputation as a Singapore-made product gives the brand a competitive edge in regional markets, where “Made in Singapore” is synonymous with reliability, cleanliness, and premium quality.

Made without preservatives or MSG, and seasoned with only natural ingredients, 123 Food’s products come in a variety of flavours and textures, crispy or chewy, spicy or sweet, ensuring appeal to a wide market base.

Flexible B2B Solutions, OEM and Private Label Services

123 Food Pte Ltd partners with a growing list of supermarkets, minimarts, distributors, and wholesalers. The company offers OEM and private-label solutions to help partners introduce halal-certified heritage snacks under their own branding. With the recent closure of several local cuttlefish snack producers, 123 Food is uniquely positioned to fill the gap and meet increasing regional demand.

Businesses looking to expand their product portfolio, explore exclusive distribution agreements, or request custom samples are welcome to connect.

Preserving Singapore’s Snack Culture, One Pack at a Time

Every pack from 123 Food is a celebration of Singapore’s rich culinary history. The brand bridges the past with the present and brings beloved seafood jerky into the hands and mouths of new generations. Proudly made in Singapore and grounded in decades of authenticity, the company continues its mission to share local flavours with the world.

For business enquiries, OEM/private label production, or to explore distribution opportunities with 123 Food Pte Ltd, contact:

Email: sales@123food.sg

About 123 Food Pte Ltd

123 Food Pte Ltd is Singapore’s only local halal-certified cuttlefish snack manufacturer, dedicated to honouring local snack heritage and delivering high-quality products made with natural ingredients. Proudly “Made in Singapore,” the company leverages the nation’s strict food safety and hygiene standards to provide products trusted by both domestic and regional markets. 123 Food partners with distributors across Singapore, Brunei, and East Malaysia, while continuing to expand its reach throughout Southeast Asia with OEM and private-label production.

123 Food Official Website

Tigermed Receives MSCI ESG AAA Rating

HANGZHOU, China, Aug. 19, 2025 /PRNewswire/ — Tigermed is proud to announce that it has been awarded an MSCI Environmental, Social, and Governance (ESG) Rating of AAA, the highest rating in the industry. This recognition underscores our commitment to excellence in ESG practices, positioning us as a leader in sustainable business performance.

MSCI’s AAA rating is reserved for companies that demonstrate superior ESG performance and strong resilience to long-term risks. It reflects Tigermed’s consistent efforts to integrate ESG principles into our core operations and strategic decision-making.


Environmental:
Tigermed has set science-based targets for reducing greenhouse gas emissions, which have been validated by the Science Based Targets initiative (SBTi). The company has implemented a comprehensive environmental management system, improved monitoring of emissions and resource utilization, and adopted digital platforms and green office initiatives to promote environmental sustainability.

Social:
W has advanced its digital transformation and leveraged AI technologies to enhance clinical trial efficiency. In 2024, Tigermed invested 39.997 million yuan in employee training, with an average of 99.48 hours per employee. The company ensures gender equality, promotes workforce diversity, and supports the well-being of its employees. Through the Hangzhou Tigermed Foundation, it engages in various public welfare activities, including medical assistance, education support, and poverty alleviation, while also contributing to rural revitalization through consumption-based poverty reduction efforts.

Corporate Governance:
Tigermed has strengthened its ESG governance and compliance framework. The board of directors oversees all ESG-related matters, and the Compliance and ESG Committee is directly led by the General Manager and managed by the Chief Compliance Officer. ESG performance is incorporated into the General Manager’s compensation structure. All employees receive 100% coverage of business ethics training, and new suppliers are required to sign the Supplier Code of Conduct upon onboarding, followed by regular assessments.

Since receiving its first MSCI ESG rating in 2020, Tigermed has consistently improved its performance, moving from a baseline rating to AA in 2023 and now achieving AAA. This progress reflects our ongoing investment in talent development, safety and quality management, carbon reduction, and ethical business practices.

This AAA rating marks a new milestone in our ESG journey. We will continue to strengthen our ESG governance framework, refine our management systems, and drive sustainable growth. As a company committed to “Serving Innovation, Building Health Together,” we aim to deliver long-term value to our stakeholders while contributing to global health and well-being.


About Tigermed

Tigermed (Stock code: 300347.SZ/3347.HK) is a leading global provider of integrated research and development solutions for biopharmaceutical and medical device industry. With a broad portfolio of services and a promise of quality, from preclinical development to clinical trial to commercialization, we are collaborating with over 3,600 customers and committed to moving their development journey efficiently and cost-effectively. Tigermed currently represents a worldwide network of more than 180 locations with over 10,000 employees across Asia Pacific, Europe, North America, Latin America and Africa. We are devoted to building an integrated platform that enables the boundless possibilities for the healthcare industry, embracing challenges to fulfill our commitment to serving unmet patients’ needs, and ultimately saving lives.

Learn more at www.tigermedgrp.com

Beyfortus® (nirsevimab) approved in Singapore to protect all infants against RSV disease

  • Beyfortus (nirsevimab) is the only option that can offer RSV protection designed for all infants with proven high, sustained efficacy, favourable safety and public health impact demonstrated in the real world.[1]
  • In the recent HARMONIE trial findings, Beyfortus reduced RSV hospitalisations in infants by 82.7% (95% CI: 67.8 to 91.5; p<0,0001) through six months (180 days). [2], [3]
  • Administration can be timed during the first year of life to provide protection from birth, or as early as possible.

SINGAPORE, Aug. 19, 2025 /PRNewswire/ — The Health Sciences Authority (HSA) has approved Sanofi and AstraZeneca’s BEYFORTUS (nirsevimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

Globally, around 2 in 3 babies will catch RSV before their first birthday[4] and it remains the most common cause of lower respiratory tract disease, including bronchiolitis and pneumonia, in infants[5]. RSV is also a leading cause of hospitalisation among infants in Singapore, with most cases occurring in otherwise healthy, full-term babies. Each year, approximately 1,804 children under 29 months are hospitalised due to RSV-related illness[6-10].

A panel of leading paediatricians in Singapore recently published an expert consensus, underscoring the urgent need for RSV protection in all infants. They concur that nirsevimab is key to alleviating the RSV burden on the healthcare system and recommend that immunisation be considered for all infants under the National Immunisation Programme in Singapore.[11]

Zainab Sadat, Head of Vaccines, Sanofi Southeast Asia & India

“Today, Singapore joins other countries worldwide where an innovative immunisation solution is now available to protect all infants against RSV. The approval of BEYFORTUS marks a critical step towards giving parents the ability to protect their babies during their first year of life, when they are most vulnerable to severe RSV disease. We are committed to working with stakeholders across the RSV care continuum to ensure seamless implementation and broad availability of this innovative preventive solution — because every baby needs protection. Our goal is simple: to help parents protect their babies, and give them peace of mind.” 

The approval was based on results from the extensive BEYFORTUS clinical development programme spanning three pivotal late-stage clinical trials. Across all clinical endpoints, a single dose of BEYFORTUS demonstrated high and consistent efficacy against RSV disease sustained for at least five months. BEYFORTUS was well tolerated with a favourable safety profile that was consistent across all clinical trials. The overall rates of adverse events were comparable between BEYFORTUS and placebo and the majority of adverse events were mild or moderate in severity.

In temperate countries, the single administration of BEYFORTUS was developed to correspond with the beginning of the RSV season for babies born prior to the season or at birth for those born during the RSV season. In clinical trials, BEYFORTUS helped prevent RSV disease requiring medical care in all infant populations studied, including those born healthy, at term or preterm, or with specific health conditions that make them vulnerable to severe RSV disease. RSV disease requiring medical care included physician office, urgent care, emergency room visits and hospitalisations.

About RSV

RSV is a highly contagious virus that can lead to serious respiratory illness for infants.[5] It is a leading cause of hospitalisation in all infants, with most hospitalisations for RSV occurring in otherwise healthy infants born at term[6-10]. Two out of three infants are infected with RSV during their first year of life and almost all children are infected by their second birthday[4]. Globally, in 2019, there were approximately 33 million cases of acute lower respiratory infections leading to more than three million hospitalisations, and it was estimated that there were 26,300 in-hospital deaths of children younger than five years[12]. RSV-related direct medical costs, globally — including hospital, outpatient and follow-up care — were estimated at €4.82 billion in 2017[13]. 

About BEYFORTUS

BEYFORTUS (nirsevimab) is the first immunisation designed for all newborns and infants for protection against RSV disease through their first RSV season, including for those born healthy at term or preterm, or with specific health conditions. It is also indicated for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. 

As a long-acting antibody provided directly to newborns and infants as a single dose, BEYFORTUS offers rapid protection to help prevent lower respiratory tract disease caused by RSV without requiring activation of the immune system. BEYFORTUS administration can be timed to coincide with the RSV season.

BEYFORTUS has been approved for use in the European Union, the US, China, Japan, and many other countries around the world. Special designations to facilitate expedited development of BEYFORTUS were granted by several regulatory agencies, including Breakthrough Therapy Designation and Priority Review designation by The China Center for Drug Evaluation under the National Medical Products Administration; Breakthrough Therapy Designation and Fast Track Designation from the US Food and Drug Administration; access granted to the European Medicines Agency (EMA) PRIority MEdicines (PRIME) scheme and EMA accelerated assessment; Promising Innovative Medicine designation by the UK Medicines and Healthcare products Regulatory Agency; and BEYFORTUS has been named “a medicine for prioritized development” under the Project for Drug Selection to Promote New Drug Development in Pediatrics by the Japan Agency for Medical Research and Development.

About the clinical trials

The Phase 2b trial[14] was a randomised, placebo-controlled trial designed to measure the efficacy of BEYFORTUS against medically attended lower respiratory tract disease (LRTD) caused by RSV through 150 days post-dose in healthy preterm infants of 29 to less than 35 weeks’ gestation (n=1,453). Infants were randomised (2:1) to receive a single 50 mg intramuscular injection of BEYFORTUS (n=969) or placebo (n=484) regardless of weight at the RSV season start. The primary endpoint was met, significantly reducing the incidence of medically attended RSV LRTD by 70.1% (95% CI: 52.3, 81.2; P<0.001) compared to placebo. In a prespecified secondary endpoint, BEYFORTUS reduced medically attended RSV LRTD with hospitalisation by 78.4% (95% CI 51.9, 90.3) versus placebo.

The BEYFORTUS dosing regimen was determined based on further exploration of the Phase 2b data and was used in subsequent trials as a single 50 mg dose for infants who weigh less than 5 kg, or a single 100 mg dose for those who weigh 5 kg or greater. A post-hoc analysis of the Phase 2b study that applied the recommended 50 mg dose in a subgroup of infants weighing less than 5 kg showed the efficacy of BEYFORTUS against medically attended RSV LRTD and medically attended RSV LRTD with hospitalisation was 86.2% (95% CI 68.0, 94.0) and 86.5% (95% CI 53.5, 96.1), respectively.

The Phase 3 MELODY trial[15] was a randomised, double-blind, placebo-controlled trial conducted across 21 countries designed to determine the safety and efficacy of BEYFORTUS against medically attended LRTD caused by RSV in healthy term and late preterm infants (35 weeks gestational age or greater) entering their first RSV season, including efficacy against severe disease such as hospitalisation, through 150 days after dosing. The primary endpoint was met, reducing the incidence of medically attended RSV LRTD by 74.5% (95% CI 49.6, 87.1; P<0.001) compared to placebo. The efficacy of BEYFORTUS against the secondary endpoint of hospitalisation was 62.1% (-8.6, 86.8). A pre-specified pooled analysis of the Phase 3 MELODY trial showed the efficacy of BEYFORTUS against medically attended RSV LRTD and medically attended RSV LRTD with hospitalisation was 79.5% (95% CI 65.9, 87.7; P<0.0001) and 77.3% (95% CI 50.3, 89.7; P<0.001), respectively.

MEDLEY was a Phase 2/3[16], randomised, double-blind, palivizumab-controlled trial with the primary objective of assessing safety and tolerability for BEYFORTUS in preterm infants of less than 35 weeks’ gestational age and infants with congenital heart disease (CHD) and/or chronic lung disease (CLD) of prematurity eligible to receive palivizumab. Between July 2019 and May 2021, a total of 925 infants at higher risk for severe RSV disease entering their first RSV season were randomised to receive BEYFORTUS or palivizumab. Safety was assessed by monitoring the occurrence of treatment emergent adverse events (TEAEs) and treatment emergent severe adverse events (TESAEs) through 360 days post-dose. Serum levels of BEYFORTUS following dosing (on day 151) in this trial were comparable with those observed in the Phase 3 MELODY trial, indicating similar protection in this population to that in healthy term and late preterm infants is likely.

BEYFORTUS was well tolerated with a favourable safety profile that was similar to palivizumab in the MEDLEY Phase 2/3 trial and consistent with the safety profile in healthy term and preterm infants compared to placebo across the MELODY and Phase 2b trials. The overall rates of adverse events were comparable between BEYFORTUS and placebo and the majority of adverse events were mild or moderate in severity.

The results of MELODY, Phase 2/3 MEDLEY and the Phase 2b trials illustrate that BEYFORTUS helped prevent RSV disease requiring medical care in all infant populations studied, including those born healthy at term or preterm, or with specific health conditions that make them vulnerable to severe RSV disease. RSV disease requiring medical care included physician office, urgent care, emergency room visits and hospitalisations.[11]

These trials form the basis of regulatory submissions that began in 2022.

Another study, the Hospitalized RSV Monoclonal Antibody Prevention (HARMONIE) trial[2], [3], was a large European interventional clinical trial in 250 sites and including over 8,000 infants aiming to determine the efficacy and safety of a single intramuscular (IM) dose of BEYFORTUS (<5 kg 50 mg; ≥5 kg 100 mg), compared to no intervention (standard of care), for the prevention of hospitalisations due to RSV-related LRTD in infants under 12 months of age who are not eligible to receive palivizumab.

The data from HARMONIE show that BEYFORTUS reduced the incidence of hospitalisations due to RSV-related LRTD by 82.7% (95% CI: 67.8-91.5; p<0.0001) through 180 days after administration compared to no intervention, exceeding the typical length of the five-month RSV season. The high efficacy of 83.2% previously reported in the primary analysis was sustained over the longer follow-up period with no evidence of waning protection in infants born before or during the RSV season. BEYFORTUS maintained a favorable safety profile, consistent with clinical study results. [2], [3]

About Sanofi

Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.

For more information, visit www.sanofi.com.

Sanofi Forward-Looking Statements  

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

References  

  1. Beyfortus® Product Prescribing Information for Singapore.
  2. Drysdale SB, Cathie K, Flamein F, Knuf M, Collins AM, Hill HC, Kaiser F, Cohen R, Pinquier D, Felter CT, Vassilouthis NC, Jin J, Bangert M, Mari K, Nteene R, Wague S, Roberts M, Tissières P, Royal S, Faust SN; HARMONIE Study Group. Nirsevimab for Prevention of Hospitalizations Due to RSV in Infants. N Engl J Med. 2023 Dec 28;389(26):2425-2435. doi: 10.1056/NEJMoa2309189.
  3. Munro APS, Drysdale SB, Cathie K, Flamein F, Knuf M, Collins AM, Hill HC, Kaiser F, Cohen R, Pinquier D, Vassilouthis NC, Carreno M, Moreau C, Bourron P, Marcelon L, Mari K, Roberts M, Tissières P, Royal S, Faust SN; HARMONIE Study Group. 180-day efficacy of nirsevimab against hospitalisation for respiratory syncytial virus lower respiratory tract infections in infants (HARMONIE): a randomised, controlled, phase 3b trial. Lancet Child Adolesc Health. 2025 Jun;9(6):404-412. doi: 10.1016/S2352-4642(25)00102-6.
  4. Walsh, EE. Respiratory Syncytial Virus Infection: An Illness for All Ages. Clinics in Chest Medicine. 2017;38(1):29-36.
  5. Karron A. Respiratory Syncytial Virus Vaccines and Monoclonal antibodies. Orenstein W, Offit P, Edwards KM, Plotkin S. Plotkin’s Vaccines, eighth edition: 998-1004. Elsevier 2023.
  6. Leader S, Kohlhase K. Recent trends in severe respiratory syncytial virus (RSV) among US infants, 1997 to 2000. J Pediatr. 2003;143(5 Suppl):S127-S132. doi:10.1067/s00223476(03)00510-9.
  7. Zhou H, et al. Hospitalizations associated with influenza and respiratory syncytial virus in the United States, 1993-2008. Clin Infect Dis. 2012;54:1427–1436.
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  10. Tam CC, et al. Burden and Cost of Hospitalization for Respiratory Syncytial Virus in Young Children, Singapore. Emerg Infect Dis. 2020 Jul;26(7):1489-1496
  11. Goh, D.Y.T., Goh, A., Chen, C.K. et al. Expert consensus on the burden of respiratory syncytial virus disease and the utility of nirsevimab for disease prevention and protection of infants. World J Pediatr 21, 552–565 (2025). https://doi.org/10.1007/s12519-025-00926-2
  12. Li Y, et al. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in children younger than 5 years in 2019: a systematic analysis. Lancet 2022;399:92047–64.
  13. Zhang S, et al. Cost of Respiratory Syncytial Virus-Associated Acute Lower Respiratory Infection Management in Young Children at the Regional and Global Level: A Systematic Review and Meta-Analysis. J Infect Dis. 2020;222(Suppl 7):S680-687.
  14. Simões EAF, Madhi SA, Muller WJ, Atanasova V, Bosheva M, Cabañas F, Baca Cots M, Domachowske JB, Garcia-Garcia ML, Grantina I, Nguyen KA, Zar HJ, Berglind A, Cummings C, Griffin MP, Takas T, Yuan Y, Wählby Hamrén U, Leach A, Villafana T. Efficacy of nirsevimab against respiratory syncytial virus lower respiratory tract infections in preterm and term infants, and pharmacokinetic extrapolation to infants with congenital heart disease and chronic lung disease: a pooled analysis of randomised controlled trials. Lancet Child Adolesc Health. 2023 Mar;7(3):180-189. doi: 10.1016/S2352-4642(22)00321-2. Epub 2023 Jan 9. 
  15. Hammitt LL, Dagan R, Yuan Y, Baca Cots M, Bosheva M, Madhi SA, Muller WJ, Zar HJ, Brooks D, Grenham A, Wählby Hamrén U, Mankad VS, Ren P, Takas T, Abram ME, Leach A, Griffin MP, Villafana T; MELODY Study Group. Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants. N Engl J Med. 2022 Mar 3;386(9):837-846. doi: 10.1056/NEJMoa2110275.
  16. Domachowske J, Madhi SA, Simões EAF, Atanasova V, Cabañas F, Furuno K, Garcia-Garcia ML, Grantina I, Nguyen KA, Brooks D, Chang Y, Leach A, Takas T, Yuan Y, Griffin MP, Mankad VS, Villafana T; MEDLEY Study Group. Safety of Nirsevimab for RSV in Infants with Heart or Lung Disease or Prematurity. N Engl J Med. 2022 Mar 3;386(9):892-894. doi: 10.1056/NEJMc2112186.

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