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SKEMA presents UNVEIL, its 2025 – 2030 strategic plan

To unveil talents and transform societies

PARIS, Oct. 9, 2025 /PRNewswire/ — Autumn 2025 marks a pivotal moment for SKEMA Business School. With 10 sites across 7 countries, 11,000 students, and 63,000 alumni, the school is launching its new 2025–2030 strategic plan titled UNVEIL. Behind this name lies a clear ambition: to unveil talents and unleash the potential of new generations to shape more sustainable organisations, and build, through SKEMA, a global educational platform spanning all continents.

To view the Multimedia News Release, please click: 
https://www.multivu.com/skema/9359751-en-presents-unveil-2025-2030-strategic-plan-reveal-talents-transform-societies

Four structuring pillars to rethink the school

To design this fourth strategic plan, SKEMA consulted all its stakeholders: students, faculty, alumni, staff, and corporate partners. Four interconnected pillars form a dynamic loop within UNVEIL – SEEK, COMMIT, BUILD, and GROW – redefining SKEMA’s student experience, societal engagement, and global ambition.

With ‘SEEK’, SKEMA is undertaking a profound transformation of its pedagogies and reinventing learning in the age of AI.

The school is adopting a pioneering doctrine, “Learn, Teach, Search, Work in the age of AI“, which integrates AI into all the structuring dimensions of the institution. By 2030, every student will benefit from an AI-enhanced CV. Faculty and staff will be supported by KOMPASS, a tool designed to guide their professional trajectory. An interdisciplinary academic and scientific framework will also be established.

COMMIT expresses SKEMA’s determination to create sustainable futures. Through its Move for Good initiatives and AI for Accelerating Impact programme, the school is mobilising its community around social and environmental causes and aims to support 150 impact-driven start-ups by 2030. A Global Impact Observatory will assess the tangible outcomes of these initiatives. A business hub will also bring together companies and alumni.

Major investments and global expansion

With BUILD, SKEMA is investing €150 million in its campuses to make them “Great Places to Work and Study”. The school is evolving into a global higher education platform to deliver a unique and unified learning experience across all its campuses worldwide, developed with the support of its AI Innovation Centre in Montréal, Canada.

Finally, GROW embodies SKEMA’s global ambition: following the opening of a campus in Dubai in 2025, the school will open two new campuses, in India and Australia, by 2030, expanding SKEMA’s global network to 12 locations across 9 countries and 6 continents. The school will also create a School of Professional Studies (SPS) to train professionals and address the growing needs of regions and industries for degree, certification, and distance learning programmes.

2030 targets: 16,000 students and 250 faculty members

By 2030, SKEMA will welcome 16,000 students, 250 faculty members will make up the school’s permanent academic staff, and the school’s overall budget will reach €250 million.

With UNVEIL, SKEMA reaffirms its mission: to empower generations to reinvent organisations and societies.

Contact:

marcom@skema.edu

 

 

SKEMA Business School | UNVEIL – Strategic Plan 2025-2030

 

SKEMA presents "UNVEIL", its 2025-2030 strategic plan to reveal talents and transform societies
SKEMA presents “UNVEIL”, its 2025-2030 strategic plan to reveal talents and transform societies

 

 

Kimberly-Clark Launches Enhanced Global Partnerships to Advance Essential Care for 24 Million Women and Girls

DALLAS, Oct. 9, 2025 /PRNewswire/ — Kimberly-Clark Corporation (NASDAQ: KMB) is deepening its commitment to advancing essential care for women and girls through four enhanced strategic, charitable partnerships. Through new programs with Baby2Baby, Plan International, Project HOPE, and UNICEF, Kimberly-Clark aims to expand access to life-changing care in Brazil, Peru, China, India, Indonesia, Vietnam, and the United States. Taken together, these partnerships will work to improve the lives of an estimated 24 million women and girls over the next three years. 

Experience the full interactive Multichannel News Release here: https://www.multivu.com/kimberly-clark/9238951-en-kimberly-clark-global-partnerships-women-and-girls

This announcement is a direct result of the Kimberly-Clark Foundation‘s recent sharpening of its strategic focus: to advance essential care for women and girls on their journeys through puberty and motherhood. The foundation will fund this three-year, $28.7 million commitment, which focuses on menstrual care and maternal & infant care. 

Women’s Health Remains an Urgent Issue around the World
Every seven seconds, a woman or infant dies during or shortly after childbirth, according to the World Health Organization. Furthermore, approximately 500 million women and girls lack access to resources to manage menstruation, as reported by the World Bank. Despite the difficult landscape, opportunities to uplift women and in turn—entire communities—abound: according to the World Economic Forum, “Investment in women’s [health] is unrivaled in its return on the investment for the health of all of society.”

“We envision a world where women and girls everywhere can receive equal access to the fundamental care they need to thrive,” said Mike Hsu, Chairman and Chief Executive Officer of Kimberly-Clark and President of the Kimberly-Clark Foundation. “Kimberly-Clark invented the feminine care category in 1921, and we’ve remained committed to advancing care for women and girls ever since. From developing innovations that meet our consumers’ unmet needs to deploying strategic social impact programming, we take great pride in our responsibility to work to improve the lives of the communities we serve.  Now, we’re aiming to accelerate our impact because we know Better Can’t Wait.”

The programs funded will focus on supporting underserved communities. Key initiatives will include menstrual hygiene and stigma-breaking educational programs for adolescents; programs to expand access to safe sanitation solutions; comprehensive perinatal and newborn care services; maternal mental health supports; and programs aimed at strengthening health systems to improve outcomes for the most vulnerable.

Transformational Partnerships to Deliver Better Care for a Better World
Kimberly-Clark’s alliance with Baby2Baby to provide essential baby items for families living in poverty began in 2011 as the nonprofit organization’s first corporate partner. In 2024, the company’s Huggies® brand deepened this commitment by supporting Baby2Baby’s initiative to address rising maternal mortality rates in the U.S., in partnership with the U.S. Department of Health & Human Services. Through the distribution of Maternal Health & Newborn Supply Kits, the program addresses the critical intersection of diaper need, newborn health and maternal mental health.

“We are deeply thankful to our longtime partners at Kimberly-Clark and their Huggies brand for their unwavering support. Thanks to their extraordinary donation and three-year commitment, we will make a greater impact in the fight against maternal mortality,” said Baby2Baby Co-CEOs Norah Weinstein and Kelly Sawyer Patricof. “With their help, we are expanding our efforts to deliver supplies to new mothers across 15 states, ensuring they have the basic essentials they need for themselves and their babies, especially during the often overwhelming postpartum period.”

Since 2020, Plan International and Kimberly-Clark, alongside its Kotex® brand, have reached an estimated 11 million people through programs that support girls’ menstrual health. This evolved partnership serving the U.S., Brazil, China and Peru will create period-friendly community and school environments by ensuring access to supplies, bathroom facilities, and education that empowers girls to manage their periods with confidence and dignity.

“With over 80 years of experience championing opportunity for girls, Plan International knows that menstrual health is key to unlocking girls’ potential,” said Kate Ezzes, Vice President of Program Development at Plan International USA. “We also know lasting change happens when boys are engaged as allies. Our partnership with Kimberly-Clark helps dismantle harmful taboos and ensures every child can learn, lead, decide and thrive.”

Kimberly-Clark’s partnership with Project HOPE will expand access to menstrual and maternal health for women and girls in China and Indonesia. The initiative focuses on menstrual hygiene education, respectful maternity care, and mental health support. Through a life-cycle approach, the program empowers individuals from adolescence through pregnancy and early motherhood with education, digital tools, and compassionate care.

“Kimberly-Clark and Project HOPE share a deep commitment to a world where women and girls have access to the care, dignity, and opportunities they deserve,” said Dr. Uche Ralph-Opara, Chief Health Officer at Project HOPE. “Kimberly-Clark has long been part of our journey, supporting our work through product donations and core mission support that have helped expand access to essential health services for women and girls across the globe. This next phase of our partnership takes that impact even further through a holistic approach that supports women and girls at every stage—from a girl’s first period, to pregnancy, childbirth, and beyond. Together, we’re investing in education, mental health, capacity-building, and advocacy to drive sustainable, systemic change.”

Over the course of an almost 25-year relationship, Kimberly-Clark and UNICEF have worked together to improve the health and well-being of babies, girls, and women in 26 countries. Now, that legacy continues through a new multi-region initiative focused on menstrual hygiene education and access for girls and maternal health for young mothers across Brazil, India, Indonesia, Peru, and Vietnam. 

“Since 2001, our partnership with Kimberly-Clark has empowered close to 14 million children and adults through the provision of neonatal healthcare, early childhood development, clean water, sanitation and hygiene, and lifesaving services during emergencies,” said Kitty van der Heijden, UNICEF Deputy Executive Director, Partnerships. “We are grateful that this transformative partnership for girls and women is now deepening to save even more lives, deliver services that promote dignity and create lasting impact for future generations.”

While some of these charitable partners are long-standing collaborators with Kimberly-Clark, this marks a new chapter in how these organizations work with the foundation. By aligning around two critical impact areas—menstrual care and maternal & infant care—as part of the foundation’s new strategic focus, these partnerships address interconnected challenges that are often treated in isolation.

This integrated approach reflects the full continuum of care, recognizing the deep links between menstrual health, maternal wellbeing, and infant development. As a company whose brands already serve these populations with essential products like diapers and feminine hygiene solutions in each of these regions, Kimberly-Clark is strategically positioned to make a meaningful impact, at scale, through these partnerships.

“We seek to lead with care in everything we do,” said Russ Torres, President and Chief Operating Officer of Kimberly-Clark. “‘We Care’ is, in fact, one of our three core values. Whether it’s caring for our people, our customers, our consumers, or the communities in which we live and operate, care is at the heart of Kimberly-Clark. These strategic partnerships enable us to extend this value even further as we work to ensure women and girls around the world receive the essential support they deserve.”

The Kimberly-Clark Foundation’s enhanced focus on caring for women and girls is one of the many ways the company works to live its purpose of Better Care for a Better World. It is also aligned to the company’s Powering Care business strategy and will directly contribute to delivering on Kimberly-Clark’s global ambition to positively impact 1 billion lives by 2030.

To learn more about Kimberly-Clark’s 2030 ambition and the work of the Kimberly-Clark Foundation, visit https://www.kimberly-clark.com/en-us/sustainability/2030-ambition.

[KMB-C] [KMB-S]  

About Kimberly-Clark 
Kimberly-Clark (NASDAQ: KMB) and its trusted brands are an indispensable part of life for people in more than 175 countries and territories. Our portfolio of brands, including Huggies, Kleenex, Scott, Kotex, Cottonelle, Poise, Depend, Andrex, Pull-Ups, Goodnites, Intimus, Plenitud, Sweety, Softex, Viva and WypAll, hold No. 1 or No. 2 share positions in approximately 70 countries. Our company’s purpose is to deliver Better Care for a Better World. We are committed to using sustainable practices designed to support a healthy planet, build strong communities, and enable our business to thrive for decades to come. To keep up with the latest news and learn more about the company’s more than 150-year history of innovation, visit the Kimberly-Clark website

About the Kimberly-Clark Foundation
Established in 1952, the Kimberly-Clark Foundation is the charitable arm of Kimberly-Clark Corporation and is dedicated to supporting global causes that create lasting social change. Funded by the corporation, the foundation’s primary focus is on social impact investments that help advance essential care for women and girls on their journeys through puberty and motherhood. 

 

NYSE Content Advisory: Pre-Market Update + Alliance Laundry raises $826 million in IPO

NEW YORK, Oct. 9, 2025 /PRNewswire/ — The New York Stock Exchange (NYSE) provides a daily pre-market update directly from the NYSE Trading Floor. Access today’s NYSE Pre-market update for market insights before trading begins. 

 

NYSE Content Advisory: Pre-Market Update + Alliance Laundry raises $826 million in IPO

Kristen Scholer delivers the pre-market update on October 9th

  • Equities are little changed early Thursday after the S&P 500 rose to a new record on Wednesday. No economic data is due today with government agencies on pause during shutdown.
  • Yesterday’s Federal Reserve minutes unveiled voting members divided on the path forward on interest rates. Inflation remains a concern as it is still above the 2% target.
  • Alliance Laundry (NYSE: ALH) will make its trading debut today. The company raised $826 million after pricing its shares at $22 each.
  • Zeta Global (NYSE: ZETA) hosts its fifth annual Zeta Live Conference today. The premiere AI-powered marketing event will be headlined by Tom Brady.

Opening Bell
Alliance Laundry (NYSE: ALH) celebrates its IPO

Closing Bell
Ameriprise Financial (NYSE: AMP) celebrates its 20th anniversary of listing

Click here to download the NYSE TV App

 

 

Video – https://mma.prnasia.com/media2/2792563/NYSE_Market_Update_Oct_9.mp4

 

LEIFRAS Co., Ltd. Announces Listing on the Nasdaq Capital Market in the U.S.

TOKYO, Oct. 9, 2025 /PRNewswire/ — LEIFRAS Co., Ltd. (Nasdaq: LFS) (the “Company” or “Leifras”), a sports and social business company dedicated to youth sports and community engagement, today announced that its American Depository Shares (“ADSs”) will commence trading on the Nasdaq Capital Market under the ticker symbol “LFS” on October 9, 2025.

A registration statement on Form F-1 (File Number: 333-283712), as amended, relating to this offering was filed with the U.S. Securities and Exchange Commission (the “SEC”) and was declared effective by the SEC on September 29, 2025. This offering is being made only by means of a prospectus, forming a part of the effective registration statement. Kingswood Capital Partners, LLC (“Kingswood”) is acting as the representative of the underwriters for the Offering. Electronic copies of the final prospectus relating to the offering may be obtained from Kingswood by email at ttian@kingswoodus.com, by standard mail to 126 E 56th Street, Suite 22S, New York, NY 10022, or by telephone at +1-732-208-4091. In addition, copies of the final prospectus, when available, relating to this offering may be obtained via the SEC’s website at www.sec.gov.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy any of the Company’s securities, nor shall such securities be offered or sold in the United States absent registration or an applicable exemption from registration, nor shall there be any offer, solicitation, or sale of any of the Company’s securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

About LEIFRAS Co., Ltd.

Headquartered in Tokyo, Leifras is a sports and social business company dedicated to youth sports and community engagement. The Company primarily provides services related to the organization and operations of sports schools and sports events for children. As of December 31, 2024, Leifras was recognized as one of Japan’s largest operators of children’s sports schools in terms of both membership and facilities by Tokyo Shoko Research. The Company’s approach to sports education emphasizes the development of non-cognitive skills, following the teaching principle “acknowledge, praise, encourage, and motivate.” The holistic approach that integrates physical and mental development sets Leifras apart in the industry. Building upon deep experience and know-how in sports education, Leifras also operates a robust social business sector, dispatching sports coaches to meet various community needs with the aim to promote physical health, social inclusion, and community well-being across different demographics. For more information, please visit the Company’s website: https://ir.leifras.co.jp/.

Forward-Looking Statements

Certain statements in this announcement are forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties and are based on the Company’s current expectations and projections about future events that the Company believes may affect its financial condition, results of operations, business strategy, and financial needs, including the expectation that the Company’s initial public offering will be successfully completed. Investors can find many (but not all) of these statements by the use of words such as “approximates,” “believes,” “hopes,” “expects,” “anticipates,” “estimates,” “projects,” “intends,” “plans,” “will,” “would,” “should,” “could,” “may,” or other similar expressions in this press release. The Company undertakes no obligation to update or revise publicly any forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law. These statements are subject to uncertainties and risks, including, but not limited to, the uncertainties related to market conditions, and other factors discussed in the “Risk Factors” section of the registration statement filed with the SEC. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results in the registration statement and other filings with the SEC. Additional factors are discussed in the Company’s filings with the SEC, which are available for review at www.sec.gov.

For more information, please contact:

LEIFRAS Co., Ltd.
Investor Relations Department
Email: IR@leifras.co.jp 

Ascent Investor Relations LLC
Tina Xiao
Phone: +1-646-932-7242
Email: investors@ascent-ir.com

NAVEE Introduces K100 Series Kids Electric Scooter: Where Safety Meets Play

SHENZHEN, China, Oct. 9, 2025 /PRNewswire/ — What if kids could explore the neighborhood with a scooter built just for them, while parents felt completely at ease? NAVEE, a fast-growing brand in smart mobility, has answered that question with the launch of its K100 Series Kids Electric Scooter, the company’s first line designed specifically for riders aged 6 to 14.

The K100 Series is now available through NAVEE’s official online store and Amazon, with prices starting at $249.99.

Available in three models: K100, K100 Pro, and K100 Max, the series blends child-friendly design with parental peace of mind. Each scooter offers three riding modes and adjustable handlebars, allowing it to grow with kids through different stages. Beyond adaptability, the scooters also provide dependable performance: in tests with a 132 lbs rider, the K100 Max delivers up to 11.2 miles (18 km) of range at 9.3 mph (15 km/h) and 8.7 miles (14 km) at 12.4 mph (20 km/h), ensuring everyday play remains both fun and reliable.

NAVEE K100 Series Kids Electric Scooter
NAVEE K100 Series Kids Electric Scooter

But this isn’t just another kids’ scooter. NAVEE has layered in thoughtful details to make riding safe, smart, and engaging. Puncture-proof tires and a child-sized brake lever build confidence with every ride, while lightweight foldable frames make it easy for families to take along on adventures. Parents can use the NAVEE App to set speed limits, control lighting, and receive system alerts, while the flagship K100 Max adds Apple Find My integration for real-time GPS tracking and safe zone notifications.

For kids, the K100 Series is just as exciting. A colorful 4-inch LED display shows speed and battery with playful icons, RGB lights glow as they move, and the Max model even features a Bluetooth speaker and voice assistant to make rides more interactive.

“The K100 Series is built to give children the joy of exploration, while giving parents confidence through safety and smart controls,” said Freya, the Product Director of the K100 Series. “It’s about creating freedom and fun that families can trust.”

With this launch, NAVEE continues its mission of making micromobility enjoyable and reliable for every generation.

About NAVEE

NAVEE is a leading brand in electric mobility, recognized for its industry-leading suspension technology and climbing efficiency, and as the fastest-growing new brand in sales, delivering products with cutting-edge design and sustainability. For more information, please visit https://naveetech.us/

 

LuX-Valve Plus Approved for Hong Kong-Macao Medicine and Equipment Connect

BEIJING, Oct. 9, 2025 /PRNewswire/ — Jenscare Scientific Co., Ltd. (“Jenscare” or the “Company”) (HKEX: 9877), an innovative medical device company with comprehensive structural heart disease interventional solutions, recently announced that LuX-Valve Plus transjugular tricuspid valve replacement system, the product of its subsidiary Jenscare Scientific (Netherlands) B.V., has been officially approved to be included in the Medical Device Catalog of Hong Kong-Macao Medicine and Equipment Connect, enabling commercial clinical application in designated medical institutions in mainland of the Greater Bay Area (GBA).

“Hong Kong-Macao Medicine and Equipment Connect” is a medical innovation policy implemented in the Guangdong-Hong Kong-Macao Greater Bay Area of China, which allows medicines or medical devices that have been purchased and used by public hospitals in Hong Kong and Macao and are urgently needed clinically in mainland to be used in designated medical institutions in mainland of GBA after approval.

LuX-Valve Plus has successfully obtained this approval for commercial clinical application in mainland of GBA by leveraging its extensive successful clinical application experience, outstanding clinical performance, and unique and advanced product design in major countries/regions worldwide, including Asia-Pacific, North America, Europe, South America, and Middle East. Through this access pathway, LuX-Valve Plus is expected to initially meet the urgent and substantial treatment needs of patients suffering from tricuspid regurgitation (TR) in the region.

LuX-Valve Plus is an independently developed transcatheter tricuspid valve replacement system designed for patients with severe TR and high surgical risk. TR presents significant unmet clinical needs, particularly in cases involving severely dilated tricuspid annular and complex anatomical structures, where safe and effective treatment options have long been scarce. LuX-Valve Plus features a globally innovative valve design with ventricular-septum anchoring and a self-adaptive anti-leak ring. Delivered via transjugular approach and available in seven sizes (40mm-70mm), it is suitable for patients with TR presenting various anatomical challenges and barely has other treatment options. The product has been successfully implanted worldwide, with follow-up results showing good safety and efficacy profiles. Its technological advancement and clinical value have gained widespread recognition in the international market.

The Company will fully take advantage of this policy opportunity to actively promote commercial implantation of LuX-Valve Plus, accelerate market penetration, and proactively address the substantial unmet clinical needs. It will further accumulate essential experience for the subsequent comprehensive expansion of LuX-Valve Plus in global markets, driving the Company to achieve long-term sustainable revenue growth.

MOGOX Wins Contract for Singapore’s Milestone L4 Driverless Bus Service

SINGAPORE, Oct. 9, 2025 /PRNewswire/ — Singapore’s Land Transport Authority (LTA) recently announced that a consortium comprising MKX Technologies, MOGOX (trading as Zhidao Network Technology Co. Ltd., Beijing) and BYD (Singapore), has been awarded the contract for Singapore’s autonomous bus service pilot project. This landmark initiative establishes Singapore’s first L4 autonomous public bus pilot, marking a strategic advancement in the company’s global expansion.

In the second half of 2026, LTA plans to deploy autonomous public buses for pilot operations on Service 191 in one-north and Service 400 along Marina Bay and Shenton Way. Connecting major hubs such as Marina Bay Cruise Centre, Gardens by the Bay and MRT stations, the initiative marks the first time autonomous buses have been incorporated into a public transport system overseas for real-world daily use.

In January this year, LTA launched a Request for Proposal (RFP) to seek industry’s proposals to pilot autonomous public bus services. These autonomous buses will be deployed from mid-2026 for an initial period of three years. MOGOX distinguished itself from several competitors through its advanced L4 full-stack autonomous driving technology, proven deployment experience, and reliable delivery capabilities.

As a core technical service provider for the project, MOGOX is tasked with L4 full-stack autonomous driving technology R&D and providing integrated hardware and software suites for autonomous vehicles, including components such as lidar, millimeter-wave radar, and cameras, along with fleet management and remote operation systems.

“We commend the strong collaboration with our consortium partners MKX and BYD,” said Bin Lv, Vice President of MOGOX. “In the next phase, we will maintain our joint efforts to implement and advance the autonomous driving project in Singapore.”

As a technology company focused on building AI Network and developing applications for L4 autonomous driving technology, MOGOX is one of the few companies in China that has established joint ventures with multiple commercial vehicle manufacturers and engaged in deep collaboration on autonomous vehicle R&D and real-world deployment.

In recent years, MOGOX has consistently deepened the integration of AI capabilities with autonomous driving technologies. By employing end-to-end perception models and hybrid architectures, the company has significantly enhanced vehicle adaptability and generalization capabilities in urban scenarios. Coupled with its self-developed MogoMind physical AI large model, the vehicles are endowed with deep cognitive and autonomous decision-making abilities, ensuring high safety and reliability of the autonomous driving system in real-road conditions.

Currently, MOGOBUS autonomous buses have been deployed in regular operations across open roads, scenic areas, and campuses in more than 10 provinces in China, having accumulated over 2 million kilometers of safe driving distance and served more than 200,000 passenger rides. These vehicles have repeatedly provided autonomous shuttle services for international events and competitions, including the United Nations Global Environmental Scientists Conference, the 31st FISU World University Games, and the Formula 1 Chinese Grand Prix.

Moving forward, MOGOX will deepen collaboration with Singapore’s transport authority and local partners, contributing to the development of safe, smart, and sustainable public transportation systems in Singapore and more cities worldwide. Through these efforts, autonomous driving is poised to become another exemplary showcase of Chinese technological innovation on the global stage.

Phase 3 Clinical Trial of HANSIZHUANG Plus Chemotherapy Meets Primary Endpoint in Neoadjuvant/Adjuvant Gastric Cancer, Greenlighting Early NDA Submission

  • The phase 3 clinical trial of HANSIZHUANG for perioperative gastric cancer treatment met its EFS primary endpoint, supporting an early New Drug Application (NDA) submission
  • World-first regimen in gastric cancer that replaces adjuvant chemotherapy with mono-immunotherapy in the perioperative setting
  • The ASTRUM-006 study demonstrated a significant improvement in event-free survival (EFS) and achieved a more than threefold higher pathological complete response (pCR) rate compared with the control arm, unlocking the potential for a cure

SHANGHAI, Oct. 9, 2025 /PRNewswire/ — Shanghai Henlius Biotech, Inc. (2696.HK) announced that its self-developed innovative anti-PD-1 monoclonal antibody, HANSIZHUANG (serplulimab, Hetronifly® in Europe), in combination with chemotherapy for the neoadjuvant/adjuvant monotherapy treatment of gastric cancer, has met the primary endpoint of Event-Free Survival (EFS) in an interim analysis of its phase 3 clinical study (ASTRUM-006). This outcome represents a breakthrough, making it the world-first regimen to replace adjuvant chemotherapy with mono-immunotherapy in the perioperative treatment of gastric cancer.

ASTRUM-006 is a randomized, double-blind, multi-centre phase 3 clinical study among patients with early-stage gastric cancer, aiming to compare the efficacy and safety of HANSIZHUANG or placebo in combination with chemotherapy as a neoadjuvant/adjuvant monotherapy treatment for patients with early-stage gastric cancer. According to the interim analysis conducted by the Independent Data Monitoring Committee (IDMC), the trial met its predefined efficacy criteria. Compared with placebo plus chemotherapy, HANSIZHUANG plus chemotherapy significantly prolonged EFS and achieved a more than threefold higher pathological complete response (pCR) rate compared with the control arm, with a significant reduction in the risk of recurrence. Furthermore, the combination regimen demonstrated a favorable safety profile, with no new safety signals identified. Based on this positive outcome, the IDMC has recommended an early NDA submission.

Professor Jiafu Ji from Beijing Cancer Hospital, a leading principal investigator of the ASTRUM-006 study, commented: “Surgery is the cornerstone of gastric cancer treatment, and perioperative therapy is critical to long-term survival. This study is the first to confirm the feasibility of replacing adjuvant chemotherapy with mono-immunotherapy in the postoperative setting. It not only opens a new path to consolidate surgical outcomes and reduce recurrence risk, but also paves the way for innovation in clinical practice.”

Professor Lin Shen from Beijing Cancer Hospital, a leading principal investigator of the ASTRUM-006 study, stated: “The positive results from this study confirm the significant potential of serplulimab in the perioperative setting for gastric cancer. The innovative exploration of a ‘chemotherapy-free, mono-immunotherapy’ regimen during the adjuvant phase tangibly improves patients’ quality of life, offering a new approach for optimizing clinical strategies.”

Dr. Jason Zhu, Executive Director, and Chief Executive Officer of Henlius, said: “Gastrointestinal (GI) cancer is a core therapeutic area of dedicated focus for Henlius. The successful achievement of the primary endpoint in the phase 3 perioperative study of HANSIZHUANG in gastric cancer marks a pivotal breakthrough for the company. We are committed to actively advancing the translation of these findings into clinical practice, with the goal of bringing benefits to patients at the earliest opportunity. Concurrently, we will continue to accelerate the in-depth exploration and broad application of more innovative therapies.”

Pioneering New Pathways in Gastric Cancer Perioperative Care

Gastric cancer represents a major global public health challenge. According to the latest GLOBOCAN statistics, there were approximately 969,000 new cases and 660,000 deaths worldwide in 2022, ranking it fifth in both incidence and mortality among all cancers. [1] While radical surgery remains the primary treatment modality, optimizing perioperative (neoadjuvant/adjuvant) strategies has become pivotal to improving long-term patient survival. [2]

In recent years, immunotherapy is fundamentally reshaping the treatment landscape for gastric cancer. While the combination of immunotherapy and chemotherapy has become the first-line standard for advanced disease, its potential in the perioperative setting is now a major focus of clinical investigation, with multiple trials underway to evaluate its efficacy and safety in this context. However, the field faces a dual challenge. On one hand, no immunotherapy has yet been formally approved for this specific indication, and only a limited number of phase 3 studies have successfully met their primary endpoints. On the other hand, in clinical practice, factors such as slow postoperative recovery and poor chemotherapy tolerance often prevent patients from completing adjuvant chemotherapy, thereby compromising their long-term survival outcomes. This significant unmet medical need underscores the urgent demand for novel treatment strategies that deliver both superior efficacy and improved tolerability.

As a core oncology asset for Henlius, HANSIZHUANG demonstrates unique advantages in treating various solid tumors via its differentiated mechanism. The drug not only induces stronger PD-1 internalization—reducing PD-1 receptor presence on T cells for rapid and potent immune activation [3]—but also minimizes PD-1-mediated recruitment of the co-stimulatory molecule CD28, thereby preserving CD28 signaling [4-6], enhancing downstream AKT activity [7], and promoting sustained T-cell activation. The ASTRUM-006 study innovatively employed a “chemotherapy-free” serplulimab monotherapy strategy in the adjuvant setting. This approach maintained therapeutic efficacy while effectively circumventing toxicity related to conventional chemotherapy, significantly improved patients’ quality of life, and provided a new clinical option. The success of this trial marks a pivotal shift in perioperative gastric cancer care—from a conventional intensity-driven paradigm toward a more refined “high-efficacy, low-toxicity” treatment model.

Delving into the Frontiers of GI Oncology

GI cancer is a strategically core therapeutic area for Henlius, with dedicated focus and extensive development. The company has built a diversified product portfolio spanning from immunotherapy to targeted agents, and from established targets to novel molecular modalities, addressing high-incidence GI cancers such as esophageal, gastric, and colorectal cancers. This portfolio forms a differentiated treatment system covering various molecular subtypes and disease stages.

In esophageal cancer, HANSIZHUANG received approval in China in September 2023 for the first-line treatment of esophageal squamous cell carcinoma (ESCC). Its efficacy and safety profile have earned it broad clinical recognition, rapidly establishing it as a key therapeutic option in this field. In the gastric cancer segment, Henlius demonstrates strong R&D depth and synergistic advantages. Beyond the positive outcomes achieved with HANSIZHUANG in the neoadjuvant/adjuvant setting, the company’s internally developed, differentiated novel epitope HER2 mAb, HLX22, is challenging the current first-line standard of care for HER2-positive advanced gastric cancer through an international multi-centre, head-to-head phase 3 trial. In colorectal cancer, Henlius is actively advancing an international multi-centre phase 3 clinical study evaluating HANSIZHUANG-based combinations in the first-line treatment of metastatic CRC (mCRC). Concurrently, the company continues to push the boundaries of GI cancer treatment by developing next-generation therapies, such as the PD-L1-targeting ADC HLX43, now in clinical studies for advanced gastric/gastroesophageal junction adenocarcinoma and other tumors.

Looking ahead, Henlius will leverage its robust pipeline of innovative therapies and extensive global multi-centre clinical trial data to solidify its leadership in GI oncology. The company is dedicated to bringing a growing portfolio of high-quality therapeutic options to patients worldwide, addressing significant unmet needs across the globe.

References

[1] Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2022: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2024;74(3):229-263.

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About Henlius

Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. To date, 9 products have been approved for marketing across multiple countries and regions, and 4 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.

Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company’s launched products include HANSIZHUANG (serplulimab, trade name: Hetronifly in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, HANQUYOU (trastuzumab, trade name: HERCESSI in the U.S., Zercepac in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANLIKANG (rituximab), the first China-developed biosimilar, and denosumab BILDYOS and BILPREVDA. What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.