Category: Asean

• DALY 2-EU results show zamtocabtagene autoleucel (zamto-cel) demonstrated clinically meaningful superiority over chemoimmunotherapy in patients with relapsed/refractory large B-cell lymphoma (r/r LBCL)¹
• Zamto-cel was well-tolerated in the majority of patients. DALY 2-EU included a high-risk study population, characterized by older age and clinically high-risk disease features
• A 12-day manufacturing time resulted in a vein-to-vein time of 14-16 days, reducing the likelihood for bridging therapy.

BERGISCH GLADBACH, Germany, Dec. 07, 2025 (GLOBE NEWSWIRE) — Miltenyi Biomedicine today announced results from the pivotal DALY 2-EU trial evaluating the efficacy and safety of zamtocabtagene autoleucel (zamto-cel) compared with standard chemoimmunotherapy (R-GemOx or Pola-BR) in patients with second-line, relapsed or refractory large B-cell lymphoma (r/r LBCL) who were transplant-ineligible due to age, comorbidities, or other medical reasons.

The primary analysis showed that zamto-cel demonstrated significant and clinically meaningful superiority over chemoimmunotherapy (R-GemOx) in transplant-ineligible patients who were at a high risk of rapid disease progression.¹ This study population was characterized by older age and clinically high-risk disease features: the median age was 74 years, 57% of patients had a high International Prognostic Index (IPI≥ 3) and 67% presented with stage III/IV disease. Zamto-cel was well tolerated in this predominantly older and high-risk population.¹

Dr. Peter Borchmann, Lead investigator of DALY 2-EU trial and Assistant Medical Director in the Department of Hematology and Oncology at the University Hospital of Cologne, Germany, said: “Zamto-cel demonstrated clinically meaningful and statistically significant superiority over R-GemOx in transplant-ineligible patients with high-risk disease, improving event-free survival while maintaining a favorable tolerability profile. These findings highlight the potential of zamto-cel as an important new treatment option for a clinically vulnerable patient population with limited therapeutic choices.”

Dr. Toon Overstijns, Chief Executive Officer of Miltenyi Biomedicine, said: “The DALY 2-EU results mark an important milestone in our commitment to advancing cell and gene therapies. Zamto-cel – the first tandem CD20-CD19 (directed), non-cryopreserved CAR-T cell therapy – demonstrated meaningful clinical benefit with promising efficacy and safety, bringing us closer to providing much needed treatment options for patients with high-risk lymphomas.”

• Zamto-cel is the first tandem CD20-CD19 (directed) non-cryopreserved chimeric antigen receptor T (CAR-T) cell therapy. The main mechanisms for relapse after treatments with CD19-directed CAR-T cell therapies are the limited persistence of CAR-T cells, inhibition of CAR-T cell function, and CD19 immunological antigen escape. To minimize the risk of relapse due to CD19 antigen escape, zamto-cel utilizes dual antigen targeting of CD20 and CD19. Zamto-cel has a 12-day manufacturing time, resulting in a vein-to-vein time of 14-16 days and reducing the likelihood for bridging therapy

DALY 2-EU Primary results¹

At the data cutoff, patients were randomly assigned to receive zamto-cel (n=82) or R-GemOx/ PolaBR (n=86). The trial allowed for crossover, 29 patients received zamto-cel following failure to achieve a response with either R-GemOx (n=28) or Pola-BR (n=1)

Efficacy Results (assessed by the blinded independent review committee (BIRC))

• The median event-free survival (EFS) for zamto-cel was 6.2 months (95% CI 3.8-13.8) compared to 2.5 months (95% CI 2.0-3.3) for R-GemOx (HR 0.39; 95% CI 0.27-0.58; p<0.0001).
• The median progression-free survival (PFS) was significantly longer with zamto-cel at 8.5 months (95% CI 3.8-16.8) versus 3.3 months (95% CI 2.0-3.8) for R-GemOx (HR 0.43 [95% CI 0.28-0.65]; p<0.0001).
• In the intent-to-treat (ITT) population, the overall response rate (ORR) was 72% with a 54% complete response rate (CRR) for zamto-cel compared to 45% ORR and 14% CRR for R-GemOx.

Safety Results¹
Zamto-cel was well-tolerated in this elderly patient population with high risk

• Grade ≥ 3 cytokine release syndrome (CRS) was reported in 4 patients (5.3).
• Grade 3 Immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 1 patient (1.3%).

About DALY 2-EU²
DALY 2-EU (NCT04844866) is a pivotal, randomized, multi-center, open-label Phase II trial conducted in 12 countries within the EU, evaluating the safety and efficacy of genetically engineered autologous T-cells expressing anti-CD20 and anti-CD19 specific chimeric antigen receptor, zamtocabtagene autoleucel (zamto-cel), compared to chemoimmunotherapy (CIT), (rituximab, gemcitabine, and oxaliplatin (R.GemOx)) or polatuzumab vedotin plus bendamustine/rituximab (Pola-BR)), as a second-line therapy for primary relapsed/refractory large B-cell lymphoma (r/r LBCL). To our knowledge, is the only CAR-T randomized study in this patient population to date.

Eligible patients were adults with r/r LBCL who were refractory or relapsed within 24 months from the start of their first-line treatment, had received at least an anthracycline and a rituximab-containing regimen and were ineligible for a stem-cell transplant.

Participants were randomized 1:1 to receive either zamto-cel or CIT (R-GemOx/Pola-BR). Zamto-cel was administered as a single non-cryopreserved infusion at a dose of 2.5 x 10^6 CAR-transduced T cells per kg body weight after lymphodepletion with fludarabine and cyclophosphamide. Patients randomized to the comparator arm received either R-GemOx or Pola-BR.

The primary endpoint of the trial is event-free survival (EFS) assessed by a blinded independent review committee (BIRC), defined as the time from randomization to objective disease progression, failure to achieve a partial response (PR) or complete response (CR) at or beyond Week 8, leading to a new anti-lymphoma therapy or death from any cause. Secondary endpoints include progression-free survival (PFS), best complete response rate (CRR), duration of complete response (DOR), and overall survival (OS).

These data will be reported as part of a pre-planned EFS interim analysis after a median follow-up of 17 months. Additional analyses are planned with longer follow-up periods and will be presented at future meetings.

DALY 2-EU results join previous zamto-cel publications in other indications and populations, including:

• DALY II USA (NCT04792489), a multicenter, open label, single-arm Phase II trial of zamto-cel in patients with r/r DLBCL after at least two prior lines of treatment, including anti-CD20 monoclonal antibody and anthracycline-containing regimen and measurable disease per Lugano 2014 classification. The ORR in the evaluable patient population (n=59) as assessed by an Independent Radiology Committee was 72.9% (95% CI, 59.7-83.6) with a CRR of 49.2% (95% CI, 35.9-62.5).
• In the DALY II USA clinical trial, a dedicated cohort for r/r central nervous system lymphoma was opened. In this cohort of 16 patients, the data showed an overall response rate of 80% and 100% and a complete response rate of 50% and 100% in the PCNSL (primary CNS lymphoma) and SCNSL (secondary CNS lymphoma) respectively.
• Zamto-cel is being explored in r/r Mantle cell lymphoma (MCL) and r/r Richter’s transformation (RT)

About zamtocabtagene autoleucel (zamto-cel)
Zamto-cel is an investigational autologous chimeric antigen receptor (CAR) T-cell therapy designed to target both CD20 and CD19. It is being studied in clinical trials for the treatment of relapsed or refractory B-cell malignancies, including large B-cell lymphoma (LBCL), diffuse large B-cell lymphoma (DLBCL), primary and secondary central nervous system (CNS) lymphoma, mantle cell lymphoma (MCL), Richter’s transformation (RT), and other B-cell neoplasms.

Zamto-cel is manufactured using Miltenyi’s proprietary platform, a closed, automated system. The manufacturing time of 12 days results in a vein-to-vein time of 14-16 days, reducing the need for bridging therapy and increasing the ability to receive cellular therapy for high risk patients with urgent therapeutic needs. Its non-cryopreserved formulation eliminates cryopreservation-related logistical steps and costs.

About Miltenyi Biomedicine
Miltenyi Biomedicine is committed to making innovative cancer treatments and regenerative therapies accessible to patients with serious diseases. Leveraging cutting-edge technology, the company innovates independently to address hard-to-treat blood cancers and harness the potential of CAR technology to transform patient care. Miltenyi Biomedicine is currently investigating its first cell therapy asset.

About Miltenyi Biotec
Miltenyi Biotec is a global leader in innovating technologies and services for patient-specific cell and gene therapies, transforming scientific discoveries into practical treatments for personalized medicine. With over 35 years of expertise, it supports biomedical discoveries and translates them into clinical applications, enhancing patient access to new therapies. Miltenyi Biotec, with its integrated solutions, including GMP-certified cell factories, provides expert guidance to therapy developers efficiently from process development to commercialization through its Miltenyi Bioindustry global CDMO division.

Contact
Miltenyi Biomedicine
Jasmine Oberwalleney
Friedrich-Ebert-Strasse 68
51429 Bergisch Gladbach, Germany
[email protected]

References

1. Borchmann P, et al. Zamtocabtagene-autoleucel, a tandem CD20-CD19 directed CAR-T cell therapy as second-line treatment for Relapsed/Refractory large B-cell lymphoma: primary analysis of the randomized pivotal DALY 2-EU study. Presented at American Society of Hematology (ASH) Annual Meeting. Abstract #abs25-738.
2. ClinicalTrials.Gov. Efficacy and Safety of MB-CART2019.1 vs. SoC in Lymphoma Patients (DALY 2-EU). Available at: https://clinicaltrials.gov/study/NCT04844866. Accessed September 2025.

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Date of Preparation: December 2025

GlobeNewswire Distribution ID 1001143400

Moonup Technology CEO Aaron Hsu

This year’s showcase echoes Shelly Group’s 2025 global vision:

“To develop the most valuable smart solutions that simplify life and help people use energy more efficiently.”

CEO Aaron Hsu stated:

“Shelly’s mission is to bring new intelligence to existing equipment, and Moonup’s role is to make this truly achievable in Taiwan.”

Shelly: A Global Standard in Smart Building Technology

Shelly Group is globally recognized for its innovative, open, and highly precise smart home architecture. Through the Shelly Cloud ecosystem, which integrates hardware modules, cloud services, energy monitoring, and open API connectivity, Shelly has become one of the most influential technology standards for building intelligence.

According to official data (as of Q3 2025):

• Deployed in over 100 countries worldwide
• More than 2.5 million Shelly Cloud users
• Over 28.8 million devices installed globally
• Publicly listed in Germany and Bulgaria
• Trusted by both professional engineering teams and consumers for its non-intrusive installation, cross-brand compatibility, and high-precision energy management

Shelly’s rapid growth and ecosystem innovation have propelled it into the ranks of unicorn-class technology companies, with a valuation exceeding USD 1 billion.

Moonup Technology Advancing Toward Capital Markets and Global Expansion

Moonup Technology has initiated the counseling process for the Taipei Exchange (TPEx) Go Incubation Board for Startup and Acceleration Firms (GISA / Pre-IPO), marking a significant milestone on its path toward the capital markets. The company is committed to integrating European smart-home technologies with Taiwan’s local R&D strengths and on-site system integration capabilities—creating intelligent building solutions that combine international-grade standards with localized application advantages.

CEO Aaron Hsu stated:

“Taiwan has a mature intelligent-building market and exceptional engineering capabilities. Moonup Technology’s mission is to bring together Taiwan’s efficiency in implementation and system integration with Shelly’s global technical standards, and build a truly international smart-building brand.”

Photo: https://www.globenewswire.com/NewsRoom/AttachmentNg/3979978c-5e44-42ea-bd40-7d9e95dd50d1

Contact person: [email protected]

GlobeNewswire Distribution ID 9597514

CGTN: China-Europe Ties: Shaping the Next 50 Years

BEIJING, Dec. 04, 2025 (GLOBE NEWSWIRE) — This year marks the 50th anniversary of the establishment of diplomatic relations between China and the European Union – a pivotal moment not only for reflecting on the past, but for exploring the pathway for the next half-century. As the year draws to a close, prominent European leaders and thinkers have visited China, engaging in open dialogue about where China and Europe will go from here.

Looking back, former Italian Prime Minister Romano Prodi offered an arresting reflection. “China and Europe have never been enemies, but we have never been brothers,” he said. “And this is the moment in which history obliges us to change.” Prodi made the sharp observation that Europe must fully recognize the scale of China’s rise and understand that China’s role in global affairs is now indispensable.

While Prodi pointed out this historical urgency, former Austrian Chancellor Wolfgang Schüssel shed light on the challenges facing global governance. For him, one of Europe’s significant responsibilities to the world, together with China, is to safeguard stability. He noted that the world is confronting US-initiated tariff wars, which have triggered global trade upheaval. Schüssel believes that a Europe-China partnership would safeguard the architecture of peace and address disruptions.

Peter Jungen, Chairman of Germany’s Peter Jungen Holding, issued a call to entrepreneurs to focus on the dynamic Chinese market. He is convinced that China’s transformation into an innovation-driven, entrepreneurial economy has created opportunities the world cannot afford to ignore. His message to global business leaders is direct: China is not just a market, but a place where ideas, technology, and industry continuously regenerate and empower each other.

“Europe’s competitiveness will depend on cooperation with fast-growing Asian economies,” says Iván Kovácsics, Director for International Strategy and Cooperation at Magyar Nemzeti Bank. He believes Europe must accelerate innovation and broaden its partnerships, and that China – with its strong industrial capacity and advanced technologies – is essential in this process.

The next 50 years are now beginning for China and Europe, two major players in a multipolar world. A shared test lies ahead: how they will connect the two major markets and civilizations to build a comprehensive strategic partnership of global influence.

https://news.cgtn.com/news/2025-12-04/China-Europe-Ties-Shaping-the-Next-50-Years-1IPjpmty9FK/p.html

A photo accompanying this announcement is available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/0e2ecd3b-265b-4877-a7fc-acb23493ed73

Contact: Jiang Simin [email protected]

GlobeNewswire Distribution ID 9596792

SAN FRANCISCO, Dec. 03, 2025 (GLOBE NEWSWIRE) — Meltwater, a global leader in media, social, and influencer intelligence, has been recognized as a Leader in the new IDC MarketScape: Worldwide Influencer Management for SMB Companies 2025–2026 Vendor Assessment (doc #US52967425, November 2025). The recognition follows Meltwater’s recent recognition as a Leader in the IDC MarketScape: Worldwide Influencer Marketing Platforms for Large Enterprises 2025–2026 Vendor Assessment (doc #US53601825, November 2025). Meltwater is the only vendor named a Leader across both reports.

We believe being recognized in these reports solidifies Meltwater as the industry’s most comprehensive influencer management solution, built to support organizations of every size with precision discovery, intelligent workflows, measurable ROI, and global scale.

“We believe being named a Leader in both the enterprise and SMB IDC MarketScape categories underscores a simple truth: Meltwater is setting the standard for influencer marketing globally,” said Chris Hackney, Chief Product Officer at Meltwater. “In a discovery landscape increasingly shaped by AI answer engines, creators, and social signals, brands deserve solutions that are accurate, predictive, and trustworthy. Meltwater’s integrated suite empowers marketing teams everywhere, from fast-growing SMBs to the world’s largest brands, to build creator programs that are measurable, authentic, and scalable.”

Meltwater’s Strengths Highlighted in the IDC MarketScape for Influencer Marketing for SMB Companies

Meltwater was recognized for the following strengths in the IDC MarketScape for Influencer Marketing for SMB Companies:

• “High-precision creator discovery”
• “End-to-end campaign management and reporting”
• “Proprietary True Reach scoring system to measure creators’ authentic audience size and influence levels”
• “Built in CRM functionality to manage influencers”

The IDC MarketScape for Influencer Marketing for SMB Companies notes that “Meltwater emphasizes systematic, AI-driven influencer strategies backed by comprehensive social listening capabilities that enable brands to monitor influencer content sentiment, track brand mentions, and integrate creator campaigns with broader media intelligence and reputation management initiatives,” and that the company is a partner-of-choice for “needs that span from global to local in nature.”

The IDC MarketScape for Influencer Marketing for Large Enterprises highlights the shifts and key trends in the Influencer Marketing Landscape today, noting that AI “underpins creator identification, campaign optimization, and performance modeling” and “enables faster, more informed decision-making.”

The Meltwater platform is purpose-built to address these shifts — offering advanced analytics, sentiment tracking, attribution modeling, and AI-driven insights that help brands adapt quickly and confidently.

“As discovery shifts toward AI-generated answers and creator-led influence, brands need a unified, intelligent system that connects influencer activity with real business outcomes,” said Aditya Jami, Chief Technology Officer at Meltwater. “Our investment in AI, data quality, and global infrastructure ensures our customers can scale with precision and act with intention.”

For more information about Meltwater’s influencer marketing solution, visit meltwater.com.

For more information, please contact:
Kelly Costello
[email protected]

About Meltwater
Meltwater empowers companies with a suite of solutions that spans media, social and consumer intelligence. By analyzing ~1 billion pieces of content each day and transforming them into vital insights, Meltwater unlocks the competitive edge needed to drive results. With 27,000 global customers, 50 offices across six continents, and 2,200 employees, Meltwater is the industry partner of choice for global brands making an impact. Learn more at meltwater.com.

About IDC MarketScape

IDC MarketScape vendor assessment model is designed to provide an overview of the competitive fitness of technology and service suppliers in a given market. The research utilizes a rigorous scoring methodology based on both qualitative and quantitative criteria that results in a single graphical illustration of each supplier’s position within a given market. IDC MarketScape provides a clear framework in which the product and service offerings, capabilities and strategies, and current and future market success factors of technology suppliers can be meaningfully compared. The framework also provides technology buyers with a 360-degree assessment of the strengths and weaknesses of current and prospective suppliers.

GlobeNewswire Distribution ID 9595805

JAKARTA, Indonesia, Dec. 03, 2025 (GLOBE NEWSWIRE) — EZVIZ celebrates a major milestone with its first-ever win at the International Innovation Awards, honored for its breakthrough AI-powered Wild Animal Detection. Debuting on the brand’s signature outdoor lineup, the EB8 Pro Series, the innovation ushers in a new era of smart outdoor monitoring. By introducing this new capability that significantly broadens the use of outdoor cameras, while reinforcing fundamentals like connectivity, power endurance, imaging performance, and environmental resilience, EZVIZ redefines the potential of battery-powered cameras and prepares them for an even wider range of real-world challenges.

The International Innovation Awards, renowned for celebrating the world’s most impactful and forward-looking innovations, sets rigorous standards for evaluating solutions that redefine industry benchmarks. For EZVIZ, earning its place on this stage for the first time, and emerging as a winner, is an extraordinary distinction that speaks to the originality and real-world value of its innovation.

“What inspires us is the possibility of technology becoming a bridge between people and the natural world,” said Po Wang who’s in charge of EZVIZ International Business Center, “We envision a future where smart products interpret the rhythms of nature and help people live more safely and harmoniously within it.”

To address the increasing unpredictability of wildlife activity around human living spaces, EZVIZ introduces dedicated AI-powered detection that enables its Pro series to identify animal presence in real time, ensuring every alert sent through the EZVIZ App is timely, relevant, and actionable. This added intelligence meaningfully expands the situations where battery-powered cameras can offer protection, extending protection from typical household monitoring to locations closer to nature or exposed to incidental wildlife movement. It offers reassurance to a broader community of users, from those living near open landscapes to those overseeing shared outdoor spaces, by providing earlier cues, clearer context, and the confidence of understanding what is happening around them before potential risks emerge.

What truly elevates EZVIZ’s wild-animal detection is the stronger outdoor backbone built into the series. Reliable connectivity comes first: with Wi-Fi 6 and 4G switching automatically, the cameras stay online and responsive even when users are far from stable networks. Endurance follows through AOV 2.0 and solar-powered flexibility, keeping the system alert for extended periods with minimal upkeep. And with high-clarity imaging paired with smooth, far-reaching rotation, the cameras capture a broader, more detailed view of their surroundings.

These strengthened fundamentals, connection, endurance, and visibility, reform the essential backbone of every EZVIZ outdoor camera. They not only empower the new wild-animal detection to perform with consistent accuracy, but also define the reliable experience users can expect across the lineup. From the reliable Lite Series to the high-end 90× 4G Series, EZVIZ offers a range of outdoor options built on the same core principles—so users can choose the model that best fits their needs while enjoying the trusted performance that EZVIZ is known for.

Charlene Li [email protected]

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GlobeNewswire Distribution ID 9595945

WATERFORD, Ireland, Dec. 03, 2025 (GLOBE NEWSWIRE) — Minimum Deposit Casinos (MDC), a division of the OneTwenty Group, has released new analysis on how upcoming federal oversight of non-bank digital wallets may significantly reshape the cost structure of online casino payments.

The Consumer Financial Protection Bureau (CFPB) recently finalized a rule to supervise large fintech wallet providers—those processing over 50 million transactions annually. The regulation brings major players under direct federal scrutiny for data security, fraud protections, and error resolution, placing them on par with traditional banks.

“The CFPB’s push for non-bank payment transparency is necessary, but it has a clear downstream effect on digital commerce,” said an MDC spokesperson. “For the casino industry, this signals the end of easy, low-cost third-party payment rails. Operators who don’t invest in transparent, bank-grade Account-to-Account (A2A) solutions now will soon face rising compliance costs. The player will feel this through either slower withdrawals or stricter verification processes.”

While the rule was subject to a Congressional Review Act (CRA) resolution in May, MDC notes that the debate permanently altered industry expectations. The CFPB’s stated intent to pursue further protections has already prompted wallet providers to tighten internal risk protocols—raising operational costs across the chain.

“Most players won’t see a new fee in bold text,” the MDC spokesperson added. “But there is a hidden cost curve forming. Payment processors must upgrade infrastructure, and those expenses will trickle down. Low-deposit platforms especially need to prepare for this.”

MDC’s report highlights the shift toward open-banking-powered A2A solutions as one of the most effective responses. By reducing intermediaries and increasing transaction auditability, these tools help platforms meet growing compliance demands without compromising user experience.

About MDC
Minimum Deposit Casinos (MDC), a division of the OneTwenty Group, is a trusted global portal that advocates for transparent, licensed, and regulatorily compliant online casino experiences. MDC focuses on reviewing and recommending platforms that adhere to the highest standards of KYC, responsible gaming, and secure payment processing, guiding players toward safe and regulated low-deposit options.

Contact Email: [email protected]

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