Category: 3. Business

Well-functioning electricity markets can be an efficient tool for balancing supply and demand, coordinating operational decisions and signalling investment needs. As electricity systems transform to accommodate a broader range of technologies and growing power demand, effective market designs for secure operations and timely investment are essential, according to a new IEA report released today.

The report – Electricity Market Design: Building on strengths, addressing gaps – looks at how wholesale market designs and the policies that complement them are performing across Europe, the United States, Japan and Australia, and provides insights on how they can adapt to changing system needs. It finds that while short-term markets have performed well in supporting efficient and secure electricity dispatch, long-term markets have been less effective in meeting investment and risk-management needs.

Complementary mechanisms, such as capacity remuneration schemes and renewable support programmes, have played a significant role in advancing investment and policy objectives, but in some cases their design has contributed to system inefficiencies and higher costs, the report says.

Across the markets analysed, electricity has been securely supplied more than 99.9% of the time over the past five years. Short-term markets have been broadly effective in maintaining reliable and efficient operations even as systems become more complex. They have enabled efficient scheduling, transparent price formation and broad participation across a diverse set of resources and actors. In Europe, for instance, the day-ahead market processes more than 400 000 bids every hour across thousands of registered actors.

Long-term markets, however, suffer from low liquidity across most of the regions analysed. This limits how easily market participants can find opportunities to protect themselves against short-term price risks. In forward and futures markets, most trading happens no more than 2 years ahead of electricity delivery, far short of the horizons of 10 to 30 years typically required to finance new capital-intensive projects. Overall, long-term market gaps make it harder for market participants to manage price risks over the time frames needed for investing in new generation, storage and electrification projects.  

For needs that markets alone cannot meet, complementary mechanisms provide targeted support to bring forward new investment and maintain essential existing capacity. Across many regions, they have helped advance policy objectives such as resource adequacy and emissions reductions targets. These mechanisms have become a structural feature of electricity markets, helping to deliver large-scale, low-emissions generation and retain dispatchable and flexible resources which may operate less frequently with rising shares of variable renewables, while remaining essential for system security. 

Overall, the report finds that short-term markets have managed to remain effective, and their strengths should be preserved while refining their designs to reflect the needs of more dynamic and distributed systems. Long-term markets have shown several gaps, undermining investment conditions and risk management. Many market participants would benefit from reforms that increase the liquidity, duration and accessibility of long-term markets.

The report underscores the importance of taking a holistic view of wholesale electricity market design. The analysis highlights the benefits of evolving market designs and emphasises the need for transparent and predictable reform processes to maintain stakeholder confidence and support effective implementation.

 

 

[Bangkok, Thailand, November 26, 2025] At the 10th 5G Core Network Summit hosted by Informa Tech, George Gao, President of Huawei Cloud Core Network Product Line, delivered a keynote address calling on telco operators to capitalize on AI opportunities. Mr. Gao advocated for building an agent communication network featuring terminal service collaboration through network agentization. Huawei also released the Striding Towards the Intelligent World White Paper 2025 on cloud core networks at the summit, which illustrates seven core network development trends around intelligent terminals, service scenarios, and AI core networks, facilitating industry collaboration and innovation.

Mr. Gao emphasized that as terminals and service applications increasingly incorporate intelligent agent capabilities, networks must evolve to bridge ecosystem gaps.

First, we can use intent entry, network service agents, network capability agents, and network O&M agents to make the network agent-based. The agentized network supports the agent-to-agent (A2A) protocol and the model context protocol (MCP), allowing agents to communicate with each other. This brings more efficient and intelligent terminal and service collaboration. The intent entry interacts with the terminal-side agents, letting them invoke network agents exactly when needed.

Second, we can build an agent communication network across ecosystems. We can introduce A2A session management capabilities based on IP sessions, and expand the authentication mode from SIM card-based authentication to digital identity authentication and authorization.

Mr. Gao also proposed four strategic actions to speed the evolution of operator networks into AI core networks:

Intelligent Network Services

Leveraging AI agents, we can roll out various intelligent services on the core network. AI Calling is a prime example. By introducing AI capabilities to calling services, we can build an AI call assistant that can understand user intent, emotions, and contextual information, creating more intelligent and efficient call experiences. Based on the data channel (DC), we can support interactive calling, which facilitates closed-loop service handling during calls. In this new model, the familiar dial pad serves as an entry point for AI services.

Network Capability Productization

By productizing network capabilities, we can help operators shift from just selling traffic to selling premium service experiences. Huawei has defined five essential elements for effective experience monetization: definable experiences, guaranteed quality, marketable products, perceptible exclusive identity, and reliable service provisioning. With technologies such as media relay, we can greatly improve HD video penetration rates and third-party service experiences, and reshape operator’s business model.

Network O&M Autonomy

We can also introduce digital employees to advance network O&M autonomy, achieving high O&M efficiency and secure, high-stability networks. The AI core network uses key technologies such as agents, digital twins, and the industry’s first mixture-of-models (MoM) architecture facilitating intelligent scheduling and collaborative inference between fast inference models and deep reasoning models. With the fusion of these technologies, we can enable the AI core network to achieve single-domain autonomy and accelerate the evolution to level-4 autonomous networks.

Diversified Telco Cloud Computing Power

We can integrate AI computing resources into the telecom infrastructure. Through resource pooling and unified orchestration and scheduling, we can build one cloud for general computing and intelligent computing, accommodating hundreds of billions of agents and vast service traffic in the mobile AI era.

Mr. Gao concluded by stating that the introduction of AI Core is not only a technological advancement, but also a reconstruction of the entire industry ecosystem. Huawei is committed to continuous innovation, to help operators unlock new revenue opportunities and secure a stronger position in the market.

Prior to today’s global debut, Tencent’s open-sourced Hunyuan 3D Models have earned worldwide acclaim and popularity among developers and creators

Tencent’s Hunyuan 3D capabilities launches globally, enabling creators to generate commercial-grade 3D assets with multimodal inputs.

Tencent today announced the official global launch of its Hunyuan 3D creation engine, bringing next-generation AI-powered 3D modeling tools to worldwide creators. With this release, users can instantly generate high-quality 3D assets from multimodal inputs such as text descriptions, images, or sketches (Refer to Appendix). This cuts production time from days or weeks to just minutes, eliminating the complexity of traditional workflows.

In addition, Tencent Cloud, the cloud business of global technology company Tencent, has made the Hunyuan 3D Model API available to global enterprises. This enables enterprises to seamlessly integrate advanced 3D generation capabilities into their workflows – for use cases such as game development, e-commerce promotion, special effects for filming, advertising, social media content creation, 3D printing, and more.

Users of Tencent Hunyuan 3D Global will receive 20 free generations daily, while enterprise users plugged into the Hunyuan 3D Model API via Tencent Cloud are set to receive 200 free credits which can be used for generating 3D assets.

Hunyuan 3D Large Model leads global industry for text-to-image, video, and 3D generation

Tencent’s Hunyuan 3D, an in-house developed generative AI large model, has become one of the most advanced in the Hunyuan series. Since the release of several open-sourced 3D models in November 2024, it has surpassed 3 million community downloads on Hugging Face, earning recognition as one of the world’s most popular 3D open-source models among developers, creators and the open-sourced community globally.

 

The Hunyuan 3D series has since evolved through multiple iterations, each improving generation quality and modeling accuracy. Today, models such as Hunyuan 3D 3.0 focuses on high-quality asset production for objects, while specialized Hunyuan3D World models are designed to help construct large scale interactive environments that users can roam in, opening new creative possibilities in in gaming, virtual reality and digital content creation.

More than 150 enterprises in Mainland China have integrated Tencent Hunyuan 3D Model through Tencent Cloud, including globally renowned real-time 3D engine company Unity China, leading consumer-grade 3D printing company Bambu Lab, and China’s largest AI content creation platform Liblib, among others.

The Hunyuan 3D international platform offers professional-grade model editing and adjustment capabilities, supports output in mainstream 3D formats such as OBJ and GLB, and can be seamlessly integrated into professional software like Unity, Unreal Engine, and Blender. It adapts to various workflows, enabling generated 3D assets to be immediately used in real projects.

Multi-modal inputs supported by Hunyuan 3D:

A) Text-to-3D: Instantly generate 3D models from natural language descriptions with precise fidelity to style, shape, and material details.

B) Image-to-3D: Upload up to four multi-view images to create accurate 3D models that capture geometry and texture with high precision.

C) Sketch-to-3D: Transform simple sketches into fully detailed 3D models by adding text-based attributes such as color, category, and material.

D) Smart Topology: Automatically optimize mesh topology for efficient rendering and compliance with professional standards, supporting both triangular and quadrilateral faces.

BANGKOK — Asian shares and U.S. futures advanced on Wednesday after benchmarks on Wall Street surged on hopes the Federal Reserve will soon opt to cut interest rates.

Tokyo’s Nikkei 225 rose 1.7% to 49,502.38 in a broad rally that encompassed major exporters and technology shares. However, shares in Kioxia dropped 15% on reports that Bain Capital plans to sell $2.3 billion of the computer memory maker’s shares.

In South Korea, the Kospi gained 2.5%, to 3,960.84, helped by a 3.5% gain for Samsung Electronics, the market’s biggest heavyweight. Computer chip maker SK Hynix climbed 1%.

Taiwan’s Taiex surged 1.9%.

Chinese markets were mixed.

Hong Kong’s Hang Seng rose 0.4% to 25,992.25 and the Shanghai Composite index edged 0.1% lower, to 3,866.59.

Chinese e-commerce and technology giant Alibaba fell 1.3%. Its U.S.-traded shares fell 2.3% on Tuesday after its profit fell short of forecasts, though it reported stronger revenue than analysts had expected for the latest quarter.

Australia’s S&P/ASX 200 climbed 0.8% to 8,606.50. In New Zealand, the S&P/NZX 50 added 0.6% after the central bank cut its official cash rate to 2.25% from $2.5%.

U.S. markets will have a shortened trading week due to the Thanksgiving holiday, closing on Thursday and opening for shorter hours on Friday.

On Tuesday, the S&P 500 rose 0.9% and the Dow Jones Industrial Average rallied 1.4%. The Nasdaq composite gained 0.7%.

Easier interest rates can give particularly big boosts to smaller companies, because many of them need to borrow to grow. The Russell 2000 index of the smallest U.S. stocks jumped 2.1% to lead the market.

Mixed economic data left traders betting on a nearly 83% probability that the Fed will cut in December, according to data from CME Group.

Shoppers bought less at U.S. retailers in September than economists expected, while confidence among U.S. consumers worsened by more in November than expected, signals the economy could use help from lower interest rates.

Easier rates can boost the economy by encouraging households and companies to borrow more and investors to pay higher prices for investments than they would otherwise.

Another report said U.S. inflation at the wholesale level was a touch worse in September than expected, but a closely tracked underlying trend was slightly better. Lower interest rates can worsen inflation, and higher prices are the main reason the Fed has been holding back on rate cuts.

Later Wednesday, the U.S. was due to release more data that had been delayed by the six-week long government shutdown.

The Fed has already cut rates twice this year in hopes of shoring up the slowing job market.

Several retailers leaped after delivering stronger profits for the summer than analysts expected.

Abercrombie & Fitch soared 37.5% after the apparel seller reported a better profit than expected, while Kohl’s surged 42.5% after reporting a profit for the latest quarter, when analysts were expecting a loss. Best Buy rose 5.3% after boosting its profit forecast for the full year following a better-than-expected third quarter, citing strength across computing, gaming and mobile phones.

In other dealings early Wednesday, U.S. benchmark crude oil gained 24 cents to $58.19 per barrel. Brent crude, the international standard, picked up 26 cents to $62.06 per barrel.

The U.S. dollar rose to 156.13 Japanese yen from 156.06 yen. The euro rose to $1.1594 from $1.1569.

Geneva, 26 November 2025 – Today the World Business Council for Sustainable Development (WBCSD) releases the Nature Action Portal, a new digital resource to help companies turn ambition into measurable action and direct investment toward solutions that credibly contribute to halting and reversing nature loss by 2030.

As nature degradation and pressure to act accelerates, businesses face a complex landscape of frameworks, metrics, and disclosure requirements. The Nature Action Portal offers a practical, user-friendly resource to help sustainability practitioners navigate the landscape in which they operate. In a few clicks, users can identify the metrics that matter to drive action across their operations and supply chains.

Co-created with more than 100 leading companies, 6 service providers, and dozens of external partners, the Portal is a resource supporting sustainability practitioners to:

• Explore actions across operations and supply chains to halt and reverse nature loss
• Identify relevant metrics and targets linked to actions
• Align with key nature-related frameworks to measure and disclose progress transparently and consistently

The first version of the Portal features actionable insights for five sectors (agri-food, forest products, energy, built environment, and pharmaceuticals); along with two supply chains (bio-based materials flowing from the agri-food and forest sectors); and one cross-cutting topic (water), all rigorously tested with members and stakeholders throughout 2024–2025.

The initiative seeks to support the harmonization of existing nature-related corporate action and disclosure frameworks, and to enhance their practical application through a user-friendly portal that helps sustainability practitioners to navigate through extensive guidance.

Meaningful and comparable data is vital for companies to signal risks to financial markets and stakeholders, and to justify the investments needed to address them. Yet with an overwhelming number of metrics, consistency remains out of reach. The Nature Action Portal seeks to simplify and harmonize the use of nature-related metrics by providing companies with a practical pathway to identify, measure and disclose the actions to address their most material dependencies and impacts.

– Peter Bakker, President & CEO, WBCSD

To address the need for a globally accepted approach to measuring and disclosing nature-related impacts and dependencies, WBCSD and the Nature Positive Initiative have recently announced their intention to convene the development of a Nature Measurement Protocol, in collaboration with leading organizations at the forefront of sustainable development. As this work progresses in the coming years, the Nature Action Portal will provide a valuable transitional solution, enabling corporate action to continue without delay.

In recent years, WBCSD and the Nature Positive Initiative have worked to simplify and harmonize nature-related metrics so businesses can accelerate meaningful action for nature. As we now move toward developing a Nature Measurement Protocol – aimed at delivering decision-ready data and robust measurement methodologies – the Nature Action Portal provides an essential bridge. It gives companies a practical way to act now, driving momentum for nature-positive transformation while the Protocol is being developed.

– Marco Lambertini, Convener, Nature Positive Initiative

I am pleased to see WBCSD and the Nature Positive Initiative carrying forward the Nature Measurement Protocol initiative recommended by the TNFD in its recent nature data recommendations. We look forward to supporting their shared leadership on this effort which will be critical to provide market participants with specific guidance on measurement methodologies for key nature-related metrics already recommended by the TNFD, SBTN and others. While that work progresses, the Nature Action Portal offers a practical tool to help sustainability practitioners navigate and implement regulatory and voluntary frameworks such as the TNFD.

– Tony Goldner, CEO, Taskforce on Nature-related Financial Disclosures

The Nature Action Portal was developed with support from Arcadis, The Biodiversity Consultancy, Environmental Resource Management (ERM), EY, PwC and Quantis, a BCG company.

For any requests related to the Nature Action Portal, please contact nature@wbcsd.org.

WBCSD partners and members across sectors who supported this work highlight:

Business leaders are asking for clear, actionable guidance. They need priority actions, aligned metrics, and simple disclosures. This will help them move faster, show credible progress and halt and reverse nature loss. The Nature Action Portal delivers targeted sectoral actions identified by Business for Nature, WBCSD and World Economic Forum. Businesses can explore their impacts, plan priority actions, and choose the most sector-relevant metrics to measure progress, helping us demonstrate credible business contributions towards the Global Biodiversity Framework.

– Eva Zabey, CEO, Business for Nature

Science-based action is essential for companies to make credible contributions to a nature-positive future. We welcome WBCSD’s efforts to help companies turn ambition into impact through science-based targets for nature.

– Erin Billman, Executive Director of the Science Based Targets Network (SBTN)

As a financial service provider in the food and agri sector, we aim to understand the key dependencies, risks, impacts, and opportunities related to nature in the sectors where we operate. Our objective is to help customers transition to more sustainable practices and strengthen their resilience. By linking sector initiatives to practical metrics and disclosures, the Portal lays the foundation for a system where nature-related data is applied consistently by all actors, supporting purposes from prioritization to performance monitoring.

– Aafke Keizer, Chief Sustainability Officer, Rabobank

To achieve the needed transformation, every business must recognize the complex interdependence between its activities and nature. Holcim is proud to have contributed to the collaborative process behind the Nature Action Portal which has delivered clarity and consistency across the built environment system – building alignment on priority actions, metrics and accelerating the shift to a more resilient, nature-positive future.

– Antonio Carrillo, Vice President Sustainability, Holcim

The resilience of our agri-food system is highly dependent on nature and the services it provides. A unified approach to measuring the benefits of these services across farmers, suppliers, consumers, and financial partners is essential to measure and track progress of landscape-based actions and initiatives. The Portal and the underlying work to align metrics is an important first step in harmonizing corporate impact monitoring and reporting. It builds trust and a common language, which can unlock finance and de-risk investments – accelerating credible nature-positive action and accountability.

– Natasha Santos, VP Sustainability, Bayer

The Portal creates a well thought-through overview of nature related indicators and metrics across supply chains. Aligned metrics and definitions will help harmonize reporting and enable efficient monitoring – all the way to the forests and agricultural landscapes helping companies understand dependencies, impacts, risks, and opportunities – both for their business and for nature.

– Sofia Gape, Head of Biodiversity and Land use, Inter IKEA Group

Sustainably managed forests are core business assets, securing raw-material supply, storing carbon, and providing biodiversity habitat and water. The Nature Action Portal helps the forest sector to further implement sustainable forest management and align on relevant metrics across operations and value chain.  It also assists us to make better investment decisions and report consistently to customers and financiers.

– Yuuko Iizuka, Executive Officer, Sustainability Department, Sumitomo Forestry

• Findings from the post-hoc analysis of LIBERTY-CD study indicates efficacy of ZYMFENTRA^® (subcutaneous infliximab) regardless of disease location, consistent across ileum-dominant and colon-dominant Crohn’s disease (CD)
• Findings support the therapeutic potential of ZYMFENTRA in addressing persistent treatment gaps especially in ileum-dominant CD

INCHEON, South Korea, Nov. 26, 2025 /PRNewswire/ — Celltrion, Inc. today announced that a post-hoc analysis of the LIBERTY-CD study, which showed that the efficacy of ZYMFENTRA® (infliximab-dyyb) is consistent regardless of disease location, has been published in a peer reviewed journal, Clinical Gastroenterology and Hepatology.^[1]

“The consistency of treatment effect across disease locations is important, as ileal Crohn’s disease (CD) is highly correlated with negative long-term outcomes and the fact that the terminal ileum being the most challenging segment to treat,” said Prof. Jean-Frédéric Colombel, MD, Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai. “The consistent clinical and endoscopic outcomes observed with subcutaneous formulation of infliximab, regardless of disease location, suggest its potential as an effective therapy across different ileocolonic segments.”

The post hoc analysis utilized the endoscopic data from the phase 3 LIBERTY-CD trial of subcutaneous formulation of infliximab (infliximab SC), ZYMFENTRA, to investigate the clinical outcomes and related predictive factors by disease location in patients with moderately-to-severely active CD who received infliximab SC maintenance treatment.

Among 329 patients, 52.6% had colon-dominant CD (n=173) and 47.4% had ileum-dominant CD (n=105). At Week 54, patients receiving infliximab SC achieved significantly greater efficacy outcomes across all endpoints compared with placebo, regardless of disease location. Rates of clinical remission were 60.95% in the ileum-dominant group and 66.95% in the colon-dominant group, versus 37.25% and 29.09%, respectively, in the placebo group. Clinical response and endoscopic response rates similarly favored infliximab SC over placebo in both location groups (clinical response: 62.86% vs 41.18% in ileum-dominant and 67.80% vs 38.18% in colon-dominant; endoscopic response: 53.33% vs 19.61% in ileum-dominant and 52.54% vs 18.18% in colon dominant). When assessed at the segment level, endoscopic responses at Week 54 were greater with infliximab SC versus placebo across all ileocolonic segments, including the terminal ileum, with consistent treatment effect sizes observed throughout each segment.

“As 70-80% of patients with Crohn’s disease have ileal involvement at diagnosis, effective treatment of the ileum has the potential to benefit a large proportion of patients with Crohn’s disease,” said Nam Lee, Vice President of Global Medical Affairs at Celltrion. “It is encouraging to have this additional analysis that supports consistent efficacy of subcutaneous infliximab regardless of different disease location and segments.”

The full manuscript “Endoscopic response to subcutaneous infliximab by disease location: A post hoc analysis of the LIBERTY-CD study” is available online at Clinical Gastroenterology and Hepatology today.

Notes to Editors:

About ZYMFENTRA^® (infliximab-dyyb; subcutaneous infliximab)

ZYMFENTRA^® (infliximab-dyyb) is a prescription medicine used as an injection under the skin (subcutaneous injection) by adults for the maintenance treatment of moderately-to-severely active ulcerative colitis following treatment with an infliximab product given by intravenous infusion (IV), Moderately-to-severely active Crohn’s disease following treatment with an infliximab product given by intravenous infusion (IV). ZYMFENTRA blocks the action of tumor necrosis factor-alpha (TNF-alpha), a protein that can be overproduced in response to certain diseases and cause the immune system to attack normal, healthy parts of the body.

ZYMFENTRA was approved by the FDA through the Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act (a “stand-alone” BLA). ZYMFENTRA is considered a new biologic with a first-approved subcutaneous administration form and thus will be under patent protection for its dosage form by 2037 and for its route of administration by 2040.

Indication and Important Safety Information

ZYMFENTRA^® is a prescription medicine indicated in adults for maintenance treatment of:

• Moderately-to-severely active Crohn’s disease following treatment with an infliximab product administered intravenously.
• Moderately-to-severely active ulcerative colitis following treatment with an infliximab product administered intravenously.

It is not known if ZYMFENTRA is safe and effective in children under 18 years of age.

What is the most important information I should know about ZYMFENTRA?

SERIOUS INFECTIONS

Patients treated with ZYMFENTRA are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Discontinue ZYMFENTRA if a patient develops a serious infection or sepsis.

Reported infections include:

• Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before and during treatment with ZYMFENTRA. Treatment for latent infection should be initiated prior to treatment with ZYMFENTRA.
• Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients may present with disseminated, rather than localized, disease. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
• Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

The risks and benefits of treatment with ZYMFENTRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with ZYMFENTRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

Risk of infection may be higher in patients greater than 65 years of age, patients with comorbid conditions and/or patients taking concomitant immunosuppressant therapy. In clinical trials, other serious infections observed in patients treated with infliximab included arthritis bacterial, pneumonia, and urinary tract infection.

MALIGNANCIES

Malignancies, some fatal, have been reported in children, adolescents, and young adults treated with TNF blockers, including infliximab products.

Approximately half of these cases were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants.

Post-marketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including infliximab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported cases have occurred in patients with Crohn’s disease or ulcerative colitis, and most were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treatment with ZYMFENTRA, especially in these patient types.

In clinical trials of all TNF blockers, more cases of malignancies were observed compared with controls and the expected rate in the general population. In clinical trials of some TNF blockers, including infliximab products, more cases of other malignancies were observed compared with controls. As the potential role of TNF blocker therapy in the development of malignancies is not known, caution should be exercised when considering treatment of patients with a current or a past history of malignancy.

Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy, including infliximab products. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.

CONTRAINDICATIONS

ZYMFENTRA is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab-dyyb, other infliximab products, any of the inactive ingredients of ZYMFENTRA or any murine proteins (severe hypersensitivity reactions have included anaphylaxis, hypotension and serum sickness).

HEPATITIS B VIRUS REACTIVATION

TNF blockers, including infliximab products, have been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases were fatal. Patients should be tested for HBV infection before initiating ZYMFENTRA. For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. Exercise caution when prescribing ZYMFENTRA for patients identified as carriers of HBV and monitor closely for active HBV infection during and following termination of therapy with ZYMFENTRA. Discontinue ZYMFENTRA in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of ZYMFENTRA and monitor patients closely.

HEPATOTOXICITY

Hepatobiliary disorders, including acute liver failure, jaundice abnormal hepatic function, hepatic steatosis, hepatitis, hepatotoxicity, hyperbilirubinemia and non-alcoholic fatty liver, have been reported in patients receiving infliximab products post-marketing. Some cases were fatal or required liver transplant. Aminotransferase elevations were not noted prior to discovery of liver injury in many cases. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. If jaundice and/or marked liver enzyme elevations (eg, ≥5 times the upper limit of normal) develop, ZYMFENTRA should be discontinued and a thorough investigation of the abnormality should be undertaken.

CONGESTIVE HEART FAILURE

Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers. Some cases had a fatal outcome. In several exploratory trials of other TNF blockers in the treatment of CHF, there were greater proportions of TNF-blocker-treated patients who had CHF exacerbations requiring hospitalization or increased mortality. ZYMFENTRA has not been studied in patients with a history of CHF and ZYMFENTRA should be used with caution in patients with CHF.

HEMATOLOGIC REACTION

Cases of leukopenia, neutropenia, thrombocytopenia and pancytopenia (some fatal) have been reported. The causal relationship to infliximab-product therapy remains unclear. Exercise caution in patients who have ongoing or a history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs and symptoms of blood dyscrasias or infection. Consider discontinuation of ZYMFENTRA in patients who develop significant hematologic abnormalities.

HYPERSENSITIVITY AND OTHER ADMINISTRATION REACTIONS

In post-marketing experience, serious systemic hypersensitivity reactions (including anaphylaxis, hypotension and serum sickness) have been reported following administration of infliximab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue ZYMFENTRA.

INJECTION SITE REACTIONS

In clinical studies, localized injection-site reactions were reported following administration of ZYMFENTRA. If a clinically significant injection-site reaction occurs, institute appropriate therapy and discontinue ZYMFENTRA.

NEUROLOGIC REACTIONS

Agents that inhibit TNF have been associated with central nervous system (CNS) manifestation of systemic vasculitis, seizure and new onset or exacerbation of CNS demyelinating disorders, including multiple sclerosis and optic neuritis and peripheral demyelinating disorders, including Guillain-Barré syndrome. Exercise caution when considering ZYMFENTRA in patients with these disorders and consider discontinuation if these disorders develop.

RISK OF INFECTION WITH CONCURRENT ADMINISTRATION OF OTHER BIOLOGICS PRODUCTS

Serious infections and neutropenia have been reported with concurrent use of ZYMFENTRA with other immunosuppressive biological products. The concurrent use of ZYMFENTRA with other immunosuppressive biological products used to treat UC and CD may increase the risk of infection and is not recommended.

RISK OF ADDITIVE IMMUNOSUPPRESSIVE EFFECTS FROM PRIOR BIOLOGICAL PRODUCTS

Consider the half-life and mode of action of prior biological products to avoid unintended additive immunosuppressive effects when initiating ZYMFENTRA.

AUTOIMMUNITY

Treatment with TNF blockers may result in the formation of autoantibodies and in the development of a lupus-like syndrome. Discontinue ZYMFENTRA treatment if symptoms of a lupus-like syndrome develop.

VACCINATIONS AND USE OF LIVE VACCINES/THERAPEUTIC INFECTIOUS AGENTS

Prior to initiating ZYMFENTRA, update vaccinations in accordance with current vaccination guidelines. Live vaccines or therapeutic infectious agents should not be given with ZYMFENTRA due to the possibility of clinical infections, including disseminated infections. At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to ZYMFENTRA.

ADVERSE REACTIONS

In clinical trials with ZYMFENTRA, the most common adverse reactions occurring in ≥3% of ZYMFENTRA-treated patients included site reactions, COVID-19, anemia, arthralgia, infection site reaction, increased alanine aminotransferase and abdominal pain for UC, and COVID-19, headache, upper respiratory tract infection, injection site reaction, diarrhea, increased blood creatine phosphokinase, arthralgia, increased alanine aminotransferase, hypertension, urinary tract infection, neutropenia, dizziness and leukopenia for CD.

Please click for Full U.S. Prescribing Information.

Globally, prescribing information varies; refer to the individual country product label for complete information.

About Celltrion, Inc.

Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people’s lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world’s first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website https://www.celltrion.com/en-us. and stay updated with our latest news and events on our social media: LinkedIn, Instagram, X, and Facebook.

About Celltrion USA

Celltrion USA is Celltrion’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion’s FDA-approved biosimilar products in immunology, oncology, hematology, and endocrinology include: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (ustekinumab-stba), STOBOCLO® (denosumab-bmwo), OSENVELT® (denosumab-bmwo), OMLYCLO® (omalizumab-igec), and EYDENZELT® (aflibercept-boav) as well as the novel biologic ZYMFENTRA® (infliximab-dyyb).

Celltrion USA will continue to leverage Celltrion’s unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit www.celltrionusa.com and stay updated with our latest news and events on our social media: LinkedIn.

FORWARD-LOOKING STATEMENT

Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion, Inc. and its subsidiaries that may constitute forward-looking statements under pertinent securities laws. This press release contains forward looking statements. These statements may be also identified by words such as “prepares”, “hopes to”, “upcoming”, “plans to”, “aims to”, “to be launched”, “is preparing”, “once gained”, “could”, “with the aim of”, “may”, “once identified”, “will”, “working towards”, “is due”, “become available”, “has potential to”, “anticipate” the negative of these words or such other variations thereon or comparable terminology.

In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion, Inc. and its subsidiaries’ management, of which many are beyond its control.

Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.

Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company’s business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements.

Celltrion, Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws.

For further information please contact:
Katie Gallagher
[email protected]   
+1 617-657-1324

SOURCE Celltrion