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Menarini Silicon Biosystems announces PACE trial biomarker analysis results confirming clinical utility of CELLSEARCH® CTC enumeration to guide treatment decisions in a specific metastatic breast cancer subtype

The secondary analysis of the PACE trial highlights the value of counting Circulating Tumor Cells (CTCs) in the blood to help guide treatment escalation or de-escalation in patients with hormone receptor-positive (HR+), HER2-negative (HER2-) metastatic breast cancer whose disease progressed after treatment with aromatase inhibitors plus CDK4/6 inhibitors. CTC count is a standalone predictive biomarker, independent of clinical risk factors and circulating tumor DNA.

BOLOGNA, Italy and HUNTINGDON VALLEY, Pa., Dec. 22, 2025 /PRNewswire/ — Menarini Silicon Biosystems, a pioneer of cell-based liquid biopsy technology, announced today the publication in Clinical Cancer Research[1] of the CTC biomarker analysis from the PACE trial, a multicenter phase II clinical study initiated in 2017. The analysis examined whether CTC count could provide prognostic and predictive information in HR+/HER2- metastatic breast cancer patients progressing after first-line treatment. 

203 patients were randomized to receive either endocrine monotherapy or combination therapy consisting of a doublet (endocrine therapy plus a CDK4/6 inhibitor) or a triplet regimen (endocrine therapy plus a CDK4/6 inhibitor and an immune checkpoint inhibitor). Based on their CTC level, patients were classified into two prognostic groups: those with less than 5 CTCs per 7.5 mL of blood, defined as having indolent disease, and those with 5 or more CTCs, defined as having aggressive disease. While no significant difference in progression-free survival was observed between treatment groups in the overall population, patients with aggressive disease (5 or more CTCs) experienced a meaningful reduction in the risk of progression when treated with combination therapies. More specifically, the risk of progression was reduced by 57% in patients receiving doublet therapy and 74% in patients receiving triplet therapy, when compared with endocrine monotherapy.

Lorenzo Gerratana, MD, Associate Professor at the University of Udine and Physician Scientist at IRCCS CRO Aviano (Italy) and first author of the PACE biomarker analysis, said: “This analysis underscores the value of CTC enumeration to identify HR+/HER2- metastatic breast cancer patients more likely to benefit from intensified therapies after disease progression on first-line treatment. Patients with aggressive disease showed improved clinical outcomes with combination therapy, whereas patients with indolent disease did not show a meaningful benefit from treatment escalation compared to monotherapy”. As the biological mechanisms driving resistance to CDK4/6 inhibitors are still not fully understood, there is a clear unmet need for reliable biomarkers to guide treatment decisions following disease progression.

These recent findings are consistent with the results of the STIC trial[2], published in 2024, which showed that treatment decisions guided by CTC counts could differ from physician choice and, when discordant, either led to improved survival outcomes or allowed treatment de-escalation without negatively affecting survival.

“The STIC and PACE trials consistently demonstrate how our CELLSEARCH CTC enumeration can improve patient management in the heterogeneous metastatic breast cancer setting, where both resistance mechanisms and disease progression remain a challenge,” said Fabio Piazzalunga, President of Menarini Silicon Biosystems (MSB). “This test is available for In Vitro Diagnostic Use in Europe and China, and in the U.S. through our CAP/CLIA/ISO 15189 accredited laboratory in Huntingdon Valley, Pa., USA. We are committed to supporting physicians to make more informed decisions, whether to intensify treatment to control disease progression or reduce treatment intensity to preserve quality of life”.

About CELLSEARCH

CELLSEARCH is the only CE-marked, clinically validated, blood test cleared by the FDA for counting CTCs to aid physicians in managing patients with metastatic breast, prostate, and colorectal cancers.

CELLSEARCH CTC Kit is not cleared or approved for use to guide specific treatment decisions.  The clinical data described herein involve an investigational use of the CELLSEARCH system outside its cleared indications, and have not been submitted to or reviewed by any regulatory authority for approval.

For more information on the full intended use and limitations of the CELLSEARCH system, please refer to the Instructions for Use at http://documents.cellsearchctc.com/.

About MSB

Menarini Silicon Biosystems, based in Bologna, Italy, and Huntingdon Valley, Pa., U.S., is a wholly owned subsidiary of the Menarini Group, a multinational pharmaceutical, biotechnology, and diagnostics company headquartered in Florence, Italy, with more than 17,000 employees in 140 countries.

[1] https://pubmed.ncbi.nlm.nih.gov/40853871/
[2] https://pubmed.ncbi.nlm.nih.gov/37931185/ 

Contact: PAVY Consulting, Linda PAVY, lipavy@pavyconsulting.com 

 

Beko Secures €100 Million Sustainability-Linked Loan from IFC to Drive Global Innovation and Net-Zero Transformation

Beko has secured its first sustainability-linked loan to expand renewable energy capacity, strengthen earthquake resilience, and promote next-generation eco-efficient appliances and diversity, with sustainability targets tied to emission reduction and increased women’s representation.

ISTANBUL, Dec. 22, 2025 /PRNewswire/ — Beko, the leading global home appliance company, has signed a €100 million sustainability-linked loan with IFC, a member of the World Bank Group. Marking Beko’s first sustainability-linked loan, the agreement reinforces the company’s commitment to integrating sustainability across its value chain and driving innovation in energy-efficient technologies.

Barış Alparslan, Beko CFO
Barış Alparslan, Beko CFO

IFC is the world’s largest development institution focused on the private sector in emerging markets. The newly secured financing will facilitate the ongoing operation of Beko’s two solar power plants dedicated to renewable energy use and strengthen six production facilities which will improve resilience against potential earthquake damage. The loan will also accelerate Beko’s global research and development (R&D) into digitalization and the creation of smart, resource-efficient, and health-focused appliances, supporting sustainable living worldwide.

This five-year financing, structured in accordance with the company’s Sustainability-Linked Financing Framework, includes the company’s 2030 targets to reduce greenhouse gas emissions and strengthen gender diversity within the workforce; reflecting IFC’s focus on inclusive and climate-resilient growth.

“The sustainability-linked loan with IFC marks yet another important milestone in our journey toward building a net-zero future,” said Barış Alparslan, Chief Financial Officer of Beko. “By investing in renewable energy, earthquake resilience, and R&D for smarter, more efficient products, we’re strengthening our ability to meet global sustainability expectations while continuing to deliver value to our customers and communities worldwide. Beko is proud to deepen its collaboration with IFC as we scale innovation that respects the world and is respected worldwide.”

“Our investment in Beko underscores the importance of building resilient infrastructure and advancing R&D to ensure the long-term competitiveness and sustainability of the region’s manufacturing sector,” said Ashruf Megahed, IFC Regional Industry Head for Manufacturing, Agribusiness and Services in the Middle East and Central Asia. “By working with leading companies like Beko, we want to drive economic resilience and create jobs, generating positive effects for the wider economy.”

ABOUT BEKO  

Beko is an international home appliance company with a strong global presence, operating through subsidiaries in more than 55 countries with a workforce of over 50,000 employees and production facilities spanning multiple regions—including Europe, Asia, Africa, and the Middle East. Beko has 22 brands owned or used with a limited license (Arçelik, Beko, Whirlpool*, Grundig, Hotpoint, Arctic, Ariston*, Leisure, Indesit, Blomberg, Defy, Dawlance, Hitachi*, Voltas Beko, Singer*, ElektraBregenz, Flavel, Bauknecht, Privileg, Altus, Ignis, Polar). Beko became the largest white goods company in Europe with its market share (based on volumes) and reached a consolidated turnover of 10.6 billion Euros in 2024. Beko’s 28 R&D and Design Centers & Offices across the globe are home to over 2,300 researchers and hold more than 4,500 international registered patent applications to date. The company has achieved the highest score in the S&P Global Corporate Sustainability Assessment (CSA) in the DHP Household Durables industry for the seventh consecutive year (based on the results dated 16 October 2025) and has been included in the Dow Jones Sustainability Indices for the eighth consecutive year.** The company has been recognized as the 17th most sustainable company on TIME Magazine and Statista’s 2025 list of the World’s Most Sustainable Companies. Beko’s vision is ‘Respecting the World, Respected Worldwide.’  

www.bekocorporate.com  

*Licensee limited to certain jurisdictions.  
**The data presented belongs to Arçelik A.Ş., a parent company of Beko.  

lAbout IFC

IFC — a member of the World Bank Group — is the largest global development institution focused on the private sector in emerging markets. We work in more than 100 countries, using our capital, expertise, and influence to create markets and opportunities in developing economies. In fiscal year 2025, IFC committed a record $71.7 billion to private companies and financial institutions, leveraging private sector innovation and investment to help create a world free of poverty on a livable planet.
www.ifc.org

 

 

 

Guardant Health Japan receives regulatory approval of Guardant360® CDx liquid biopsy as companion diagnostic for imlunestrant in metastatic or recurrent breast cancer previously treated with endocrine therapy

Guardant360® CDx is the first companion diagnostic to be approved in Japan to identify ESR1 mutations in patients with hormone receptor-positive, HER2-negative breast cancer for treatment with imlunestrant

TOKYO, Dec. 22, 2025 /PRNewswire/ — Guardant Health Japan Corp. today announced that the Ministry of Health, Labour and Welfare (MHLW) has approved Guardant360® CDx on 23 October 2025 as a companion diagnostic to identify ESR1 mutations in patients with hormone receptor–positive, HER2-negative breast cancer with disease progression following endocrine therapy, for consideration of treatment with imlunestrant. This approval makes Guardant360® CDx comprehensive genomic profiling panel the first blood-based companion diagnostic to be approved in Japan for the detection of ESR1 mutations.

The ESR1 gene encodes the estrogen receptor alpha proteins, one of the key hormone receptors involved in breast cancer. ESR1 mutations are recognized drivers of resistance to aromatase inhibitors, a class of endocrine therapies widely used as first-line treatment in breast cancer. In a randomized multicenter trial, ESR1 mutations were detected approximately 20 to 40% of patients with locally advanced or metastatic breast cancer previously treated with an aromatase inhibitor¹, and it has been reported ESR1 mutation prevalence increased with additional lines of therapy².

This regulatory approval of the Guardant360® CDx test, which identifies ESR1 mutations using a blood sample, is expected to increase targeted treatment options for patients with hormone receptor–positive, HER2-negative breast cancer who have developed resistance to aromatase inhibitors.

Guardant360® CDx was approved by MHLW in March 2022 for comprehensive genomic profiling in patients with advanced solid tumors. The test is approved as a companion diagnostic for multiple cancer drugs approved in Japan. Testing under the national health insurance system is available at cancer genome core hospitals, cancer genome hub hospitals, and affiliated cancer genome medical institutions designated by MHLW. Please refer to Annex A for the list of approved companion diagnostics.

References:

  1. Jhaveri KL, et al. N Engl J Med. 2025; 392(12): 1189-1202. 
  2. Bhave MA, et al. Breast Cancer Res Treat. 2024; 207: 599-609. 

About Guardant360® CDx 

Guardant360® CDx is a liquid biopsy test that uses next generation sequencing to analyse circulating tumour DNA (ctDNA), which is produced when tumours shed small pieces of their genetic material into the bloodstream. The test provides comprehensive genomic profiling results from a simple blood draw, helping oncologists move beyond the limitations of tissue biopsies to obtain clinically relevant information in time to match patients to the optimal personalized treatment.

About Guardant Health

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer*. For more information, please visit https://guardanthealthjapan.com and follow the company on LinkedIn.

The complete portfolio of Guardant Health products may not be available in all regions. 

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2024 and in its other reports filed with or furnished to the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.

Annex A

List of Approved Companion Diagnostics in Japan

Biomarker

Cancer

Companion Diagnostic

KRAS G12C

Non-small cell
lung cancer
(NSCLC)

sotorasib

ERBB2 (HER2) mutation

trastuzumab deruxtecan 

EGFR exon 20 insertion
mutation

amivantamab-vmjw

ESR1 mutation

Breast cancer

imlunestrant

BRAF  V600E

Colorectal
cancer

encorafenib, binimetinib, and cetuximab

encorafenib and cetuximab

KRAS/NRAS wild-type 

cetuximab 

panitumumab

ERBB2 copy number
alteration (HER2 gene
amplification positive)

trastuzumab and pertuzumab 

Solid tumor

trastuzumab deruxtecan

MSI-High 

Colorectal
cancer

nivolumab

Solid tumor

pembrolizumab

Note: Underlined item has been added with this approval.

Fijian and Chinese Scholars Gather to Discuss Bilateral Friendship and the Outlook for APEC 2026

SHENZHEN, China, Dec. 22, 2025 /PRNewswire/ — Shenzhen Media Group’s “Telling China’s Story: The ‘Circle of Friends’ of the Global Development Initiative” program has brought the “Gather in Shenzhen” Salon Series to Suva, Fiji, at the China Cultural Centre in Fiji, on Dec 8 and 9, bringing scholars and Gen Z together to discuss cooperation, opportunities, and APEC 2026 in Shenzhen.

“Gather in Shenzhen” Salon Series by Shenzhen Media Group
“Gather in Shenzhen” Salon Series by Shenzhen Media Group

https://youtube.com/shorts/GAj4_bAUY6g?si=3dkKfwmMG1KUpE2T

Video: “When Shenzhen Meets Fiji” by Shenzhen Media Group

The event invited prominent local scholars, including Joseph Veramu, Deputy Vice-Chancellor of the Fiji National University (FNU), and Professor Pal Ahluwalia, Former Vice-Chancellor and President at University of the South Pacific (USP). They were joined by Chinese scholars Niu Li, Chen Hong, and Ni Peng for in-depth discussions on topics such as the APEC 2026, the Global Development Initiative, the marine economy, and agricultural modernization.

Tevita Boseiwaqa, the Acting CEO of Suva City Council, also attended the event. He gave an exclusive interview to “Telling China’s Story,” interacted with the Shenzhen technology products and engaged in dialogue with the audience, speaking warmly about the new prospects for FijiChina relations and cooperation.

This year marks the 50th anniversary of diplomatic relations between China and Fiji. Chen Hong, Professor and Director of the Australian Studies Centre at East China Normal University, stated in an interview that the relationship between the two nations has transcended standard bilateral diplomacy. He noted that the comprehensive strategic partnership has laid a solid foundation for future cooperation. Professor Chen highlighted that the blue economy, green energy, and sustainable development are becoming key pillars of bilateral cooperation. Professor Pal Ahluwalia of USP remarked that China’s efforts in promoting clean energy and green development are of great significance to the global response to climate change. This is particularly crucial for Pacific Island nations like Fiji, which face the most direct impacts of rising temperatures.

Earlier this year, it was officially announced that the 2026 APEC Economic Leaders’ Meeting will be held in Shenzhen, China. Regarding this, Joseph Veramu told reporters that Shenzhen has transformed itself from a small fishing village into a global economic powerhouse, making it a symbolic venue for the APEC 2026. In his view, Shenzhen serves not only as a vivid example of Chinese-style modernization but also offers a practical reference for Pacific Island nations with large youth populations regarding the green economy and digital development.

 

Laos Considers National Mental Health Association, Hotline Proposal

Laos Considers National Mental Health Association, Hotline Proposal

On 5 December, the University of Health Sciences (UHS), in collaboration with Gamlangchai, a Community-Based Mental Health Organization in Laos, conducted a National Mental Health Stakeholders Consultation.

International Forum “Problem-Solving City: Hong Kong as a Disputes Resolver”

HONG KONG, Dec. 22, 2025 /PRNewswire/ — On December 19, 2025, Hong Kong hosted the forum “Problem-Solving City: Hong Kong as a Disputes Resolver”, co-organized by Friday Culture Limited, Hong Kong Coalition, and the AALCO Hong Kong Regional Arbitration Centre. The event brought together senior government officials, legal experts, and industry leaders to position Hong Kong as a global hub for dispute resolution in both traditional and emerging sectors.

Friday Culture Limited - International Forum "Problem-Solving City: Hong Kong as a Disputes Resolver
Friday Culture Limited – International Forum “Problem-Solving City: Hong Kong as a Disputes Resolver

The forum told that Hong Kong’s government is positioning the city as a global disputes’ resolver and digital finance hub through its LEAP framework and comprehensive regulatory measures.

The AALCO Hong Kong Regional Arbitration Centre offers trained mediators, arbitrators, and adjudicators with specialist expertise in sports and digital finance. Director Nick Chan noted the Centre’s development of LawTech capabilities and interdisciplinary specialists to lead global dispute resolution efforts.

Chairman Herman Hu of Friday Culture Limited highlighted Hong Kong’s selection as home to the International Organization for Mediation, reinforcing the city’s commitment to peaceful dispute resolution under the “One Country, Two Systems” framework.

The sports mediation panel emphasized Hong Kong’s common law system, bilingual legal status, and strategic position between China and international markets. Experts discussed how Hong Kong’s access to 1.3 billion consumers and collaborative initiatives between the central government, Hong Kong, and Macau create unique advantages for establishing the city as a premier sports dispute resolution center.

The technology panel featured discussions on Hong Kong’s comprehensive regulatory framework for digital finance, moderated by Witman Hung. Expert emphasized interoperability, security, and user protection across decentralized platforms. Industry leaders highlighted Hong Kong’s pioneering work in digital bonds using updated ISO protocols and its role in resolving disputes in the $15 billion digital finance industry.

Dr. Johnny Ng stressed the importance of a gradual approach to digital finance to build public confidence, while Dr. Au King Lun discussed Hong Kong’s role in building cross-border connections across regulatory, technical infrastructure, and market capital layers.

Hong Kong Coalition’s representative concluded that Hong Kong is transitioning from regulator to rule-setter, leveraging 30 member-organizations advancing international standards. The forum demonstrated how Hong Kong’s legal infrastructure, strategic positioning, and government collaboration establish it as the world’s most influential disputes resolver.

Revisit Online: https://www.youtube.com/watch?v=7ZIgriESgkU

OK Biotech Recognized at International Innovation Awards (IIA) 2025 for OTC Hearing Aid Innovation

SHANGHAI, Dec. 22, 2025 /PRNewswire/ — OK Biotech Co., Ltd. has been honoured at the International Innovation Awards (IIA) 2025, organized by Enterprise Asia, for its development of the OKB OTC Hearing Aid, a device designed to improve comfort and sound clarity for adults with hearing loss.

The OKB OTC Hearing Aid was created from personal experience, with the company’s Chairman—who has lived with hearing impairment—personally leading its development. The device addresses common challenges with traditional hearing aids, focusing on ease of use, comfort, and effective sound capture for daily activities.

A defining feature of the hearing aid is its split-unit design, which separates the main controller from the earpiece. This allows the receiver to be placed closer to the sound source, improving direct sound pickup and reducing distance-related loss. Built-in noise reduction and refined digital signal processing help users hear conversations and media clearly, even in busy environments such as restaurants or social gatherings.

The device also features large, easy-to-press buttons and comes with a companion receiver, enabling users to watch television or listen to conversations without needing additional accessories. Its lightweight, comfortable earpiece supports full-day wear, and the rechargeable system ensures practical, affordable accessibility.

Developed by OK Biotech, a medical device company with over 20 years of experience, the OKB OTC Hearing Aid demonstrates the company’s commitment to user-centered innovation, combining technology and design to enhance the daily lives of older adults.

The grand milestone was announced globally through PR Newswire, the Official News Release Distribution Partner of the IIA 2025.

About Enterprise Asia
Enterprise Asia is a non-governmental organization in pursuit of creating an Asia that is rich in entrepreneurship as an engine toward sustainable and progressive economic and social development within a world of economic equality. Its two pillars of existence are investment in people and responsible entrepreneurship. Enterprise Asia works with governments, NGOs, and other organizations to promote competitiveness and entrepreneurial development, uplifting the economic status of people across Asia and ensuring a legacy of hope, innovation, and courage for future generations. Please visit https://www.enterpriseasia.org/ for more information.

About the International Innovation Awards
The International Innovation Awards (IIA) is an annual recognition program that recognizes outstanding innovations, and in the process, encourages organizations to continue investing in innovations. For more information, visit www.innovationaward.org.

Nan Yang Textile Group Honoured for Advanced Elitech 360° Fabric Technology

SHANGHAI, Dec. 22, 2025 /PRNewswire/ — Nan Yang Textile Group has been honoured at the International Innovation Awards (IIA) 2025, organized by Enterprise Asia, for the development of Elitech 360°, an advanced fabric technology designed to deliver optimal performance across a wide range of applications.

Elitech 360° is a lightweight, high-performance fabric engineered with true 360-degree stretch to enhance mobility in every movement. It combines a specially developed elastic synthetic yarn with a unique knitting technique to achieve a woven-like appearance and stretch without the use of spandex, enabling diverse garment applications. The fabric is quick-drying, wrinkle-resistant, and highly durable, maintaining its color and appearance even after more than 150 washes, while selected constructions provide permanent UV protection. Designed for easy care and long-lasting performance, Elitech 360° is well suited for active lifestyle, outdoor activities, and workwear, supporting comfort, functionality, and performance in any situation.

Innovation knows no bounds, and with Elitech 360°, fabric itself becomes a functional tool that enhances everyday movement, comfort, and sustainability. This recognition at IIA 2025 highlights Nan Yang Textile Group’s leadership in developing advanced materials that meet the evolving demands of modern lifestyles and professional use—a milestone shared globally through PR Newswire, the awards’ Official News Release Distribution Partner.

About Enterprise Asia

Enterprise Asia is a non-governmental organization in pursuit of creating an Asia that is rich in entrepreneurship as an engine toward sustainable and progressive economic and social development within a world of economic equality. Its two pillars of existence are investment in people and responsible entrepreneurship. Enterprise Asia works with governments, NGOs, and other organizations to promote competitiveness and entrepreneurial development, uplifting the economic status of people across Asia and ensuring a legacy of hope, innovation, and courage for future generations. Please visit https://www.enterpriseasia.org/ for more information.

About the International Innovation Awards

The International Innovation Awards (IIA) is an annual recognition program that recognizes outstanding innovations, and in the process, encourages organizations to continue investing in innovations. For more information, visit www.innovationaward.org.