GenSci and RTW Investments Announce Strategic Partnership on Anti-TSHR Antibody GS-098 (YB-101) for Graves’ Disease and Thyroid Eye Disease, With Global Ex-China Development Being Led by Yarrow Bioscience




GenSci and RTW Investments Announce Strategic Partnership on Anti-TSHR Antibody GS-098 (YB-101) for Graves’ Disease and Thyroid Eye Disease, With Global Ex-China Development Being Led by Yarrow Bioscience

• Collaboration to focus on building a leading, US-based biotech dedicated to addressing underserved patients impacted by autoimmune and endocrinology disorders
• GenSci to receive $70 million non-refundable upfront payment, a $50M near-term development milestone and further development, regulatory and commercial milestone payments in a total deal value up to $1.365 billion with tiered double-digit royalties on future net sales in licensed territories; GenSci retains the rights for development and commercialization of GS-098 in China
• Agreement grants Yarrow Bioscience, Inc. exclusive global ex-China rights to develop and commercialize GS-098 (YB-101) for Graves’ disease (GD) and thyroid eye disease (TED)

SHANGHAI & NEW YORK–(BUSINESS WIRE)–Shanghai Scizeng Medical Technology Co., LTD, a subsidiary of Changchun GeneScience Pharmaceutical Co., Ltd. (“GenSci”), RTW Investments, LP (“RTW”), and Yarrow Bioscience, Inc. (“Yarrow”) today announced an exclusive global ex-China license agreement for GS-098, a clinical-stage, first-in-class, humanized monoclonal antibody targeting the thyroid-stimulating hormone receptor (TSHR) for the treatment of Graves’ disease (GD) and thyroid eye disease (TED). Founded in 1997, GenSci – a subsidiary of Changchun High‑Tech Industries Co., Ltd (“Changchun High-Tech”) – is a fully integrated, leading biopharmaceutical company based in China with a broad innovative pipeline across endocrinology, immune & pulmonary, oncology, and women’s health as well as commercial leadership in recombinant human growth hormone (rhGH) products. Yarrow was founded to develop transformative therapies for autoimmune thyroid diseases and backed by RTW, a preeminent global, full life-cycle life sciences investment firm based in New York.

GS-098, which will be continued as YB-101 outside of China, is designed to rapidly and efficiently block the pathogenic activity of thyroid-stimulating autoantibodies that drive disease progression in GD and TED. By selectively binding the TSHR and preventing autoantibody-induced receptor activation, YB-101 inhibits the biological pathway responsible for hyperthyroidism and orbitopathy. This targeted mechanism has the potential to provide meaningful clinical benefit while avoiding systemic immunosuppression.

Under the terms of the agreement, Yarrow receives exclusive global ex-China rights to develop, manufacture, and commercialize GS-098 (YB-101) for GD and TED. GenSci retains rights for development and commercialization in China. GenSci will receive a $70 million non-refundable upfront payment, a $50M near-term development milestone, and further development, regulatory and commercial milestone payments in a total deal value up to $1.365 billion with tiered double-digit royalties on future net sales in licensed territories.

“This landmark partnership with RTW Investments and Yarrow Bioscience, Inc is a strategic step in our vision of becoming a global pharma innovator. GS-098, originated from our Shanghai R&D center, is a first-in-class molecule and has demonstrated the best-in-class potential,” said Dr. Lei Jin, Founder, General Manager & Chief Scientist of GenSci and General Manager of Changchun High-Tech Industry Group. “Our partners RTW Investments and Yarrow Bioscience, Inc have demonstrated exceptional expertise and experience in developing innovative drugs in the field of immunology and shown great commitment and passion to develop GS-098 in the ex-China territory. We believe that our combined expertise and resources will bring this breakthrough medicine to the Graves’ Disease and Thyroid Eye Disease patients speedily and worldwide.”

“This collaboration represents a tremendous opportunity for Yarrow and GenSci to advance GS-098 (YB-101) toward meaningful clinical milestones in both Graves’ disease and thyroid eye disease,” said Rebecca Frey, Pharm.D., President and Chief Executive Officer of Yarrow Bioscience. “Patients suffering from these debilitating autoimmune conditions continue to face substantial unmet needs. YB-101’s highly targeted, TSHR-directed mechanism of action has the potential to transform the treatment landscape, and we look forward to working closely with GenSci to bring this promising therapy to patients worldwide.”

“Our partnership with GenSci reflects RTW’s commitment to advancing high-impact science through long-term, collaborative company creation,” said Peter Fong, Partner and President at RTW Investments, LP. “We are dedicated to building world-class biotechnology companies, and Yarrow represents a model example of this mission in action. Rebecca and the Yarrow leadership team bring exceptional scientific and operational expertise, and we look forward to working closely with them to advance GS-098 (YB-101) and realize its full potential for patients.”

About GS-098 (YB-101)

GS-098 (YB-101) is a clinical-stage, humanized monoclonal antibody targeting the thyroid-stimulating hormone receptor (TSHR). The antibody is designed to rapidly and efficiently block the pathogenic activity of thyroid-stimulating autoantibodies that drive disease progression in Graves’ disease (GD) and thyroid eye disease (TED). By binding selectively to the TSH receptor and blocking autoantibody-induced receptor activation, YB-101 directly inhibits the biological pathway responsible for hyperthyroidism and orbitopathy. This novel and targeted approach represents a potential breakthrough for patients who are inadequately controlled with first-line therapies and remain at high risk for complications of GD and TED. In 2025 Yarrow executed an exclusive license agreement with Changchun GeneScience Pharmaceutical Co., Ltd. to obtain global ex-China rights to develop GS-098 in GD and TED.

About Changchun GeneScience Pharmaceutical Co., Ltd. (“GenSci”)

GenSci is a leading biopharmaceutical company in China, specializing in pediatric and women’s health. Additionally, GenSci is active in four other therapeutic areas: Endocrinology, Metabolic, Immunology/Respiratory, and Oncology. The company has over 9,000 employees, and integrates research, development, production, and commercialization of innovative therapies for patients with unmet medical needs. Established in 1996, the company is a subsidiary of Changchun High‑Tech Industries Co., Ltd and is headquartered in Changchun, China.

For further information about GenSci, please visit http://www.genscigroup.com/

About RTW Investments, LP

RTW Investments, LP is a New York-based, global, full life-cycle investment firm that focuses on identifying transformational and disruptive innovations across the biopharmaceutical and medical technologies sectors. As a leading partner of industry and academia, RTW combines deep scientific expertise with a solution-oriented investment approach to advance emerging therapies by building and supporting the companies developing them.

For further information about RTW, please visit www.rtwfunds.com

About Yarrow Bioscience, Inc.

Yarrow Bioscience is a clinical-stage biotechnology company focused on developing transformative therapies for autoimmune thyroid diseases. The company’s lead candidate, YB-101, is a humanized monoclonal antibody targeting the thyroid-stimulating hormone receptor (TSHR) for the treatment of Graves’ disease and thyroid eye disease. Yarrow is headquartered in New York and is backed by leading healthcare investor RTW Investments, LP.

Contacts

PR contact: info@yarrowbioscience.com

Hercules Pharmaceuticals Appoints Ali Ahmed as Chief Commercial Officer




Hercules Pharmaceuticals Appoints Ali Ahmed as Chief Commercial Officer

PORT WASHINGTON, N.Y.–(BUSINESS WIRE)–Hercules Pharmaceuticals today announced the appointment of Ali Ahmed as Executive Vice President, Chief Commercial Officer. Ahmed will lead commercial strategy, enterprise growth, and strategic partnerships as Hercules scales its national platform and expands its role as a strategic partner within the U.S. pharmaceutical distribution ecosystem.

Ahmed brings deep experience across healthcare and enterprise technology, including leadership roles at Fresenius Kabi and Salesforce. He previously served on the executive team at Fresenius Kabi as Senior Vice President and General Manager of the BioPharma Business Unit, where he led commercialization of biosimilars to expand access to high-quality care. Ahmed also served as Global Head of Life Sciences Innovation at Salesforce, partnering with pharmaceutical companies to modernize commercial execution, launch strategy, and patient engagement through data, analytics, and digital platforms. His background combines pharmaceutical commercialization expertise with modern customer and data-platform fluency, positioning him to help Hercules scale responsibly while accelerating value creation for partners across the ecosystem.

Hercules has built a patient-centric, data-led distribution model designed to help partners operate more effectively in an increasingly consolidated and constrained market. The company has embedded artificial intelligence across its commercial, supply chain, and customer engagement workflows to generate insights that supports both upstream manufacturers and downstream providers. These capabilities enable more precise demand forecasting, smarter inventory placement, dynamic pricing insights, and earlier visibility into market shifts that affect access and continuity of supply.

From its inception, Hercules has operated with a clear ethical mandate. The company applies technology and data intelligence with intentional guardrails, ensuring that growth, automation, and optimization are aligned with transparency, fairness, and responsible market participation. Technology is applied not simply to drive efficiency, but to strengthen trust, protect access for patients and providers, and support long-term sustainability across the healthcare supply chain.

“As consolidation continues to place pressure on every participant in healthcare, value creation depends on intelligence, flexibility, and principled execution,” said Sara Amani, Founder and CEO of Hercules Pharmaceuticals. “Our AI-enabled platform is designed to help partners make better decisions while operating with integrity in a complex market. Ali brings the strategic leadership, legal fluency, and judgment required to expand that model responsibly and advance a more resilient standard for protecting patient access at scale.”

“Hercules has built an infrastructure that recognizes the responsibility that comes with scale,” said Ali Ahmed. “The company already uses AI to translate data into insights across the supply chain. My focus is to expand how those insights are applied and shared in ways that create value, protect access, and uphold the standards required for long-term trust in an unpredictable market environment.”

Hercules continues to gain momentum as health systems, specialty pharmacies, and manufacturers seek partners that offer more than transactional distribution. With a national footprint, global sourcing access, and an AI driven operating model grounded in disciplined governance, Hercules supports a more adaptive and resilient healthcare supply chain in a market shaped by consolidation.

About Hercules Pharmaceuticals

Hercules Pharmaceuticals is a national pharmaceutical distributor and steward of AriaGPO, providing manufacturers with a differentiated, provider-aligned route to market across the U.S. healthcare system. Purpose-built to address drug shortages and structural concentration in pharmaceutical distribution, Hercules enables manufacturers to diversify channel exposure, expand provider access, and deliver critical therapies with greater speed, transparency, and reliability.

Through a technology-enabled operating platform, AI-powered decision intelligence, and direct relationships with health systems, specialty pharmacies, and community-based providers nationwide, Hercules supports responsible competition, sustainable market access, and long-term supply continuity for manufacturers and their provider partners.

Contacts

Media Contact:

press@herculesrx.com
1-800-815-5800

Strategies to Succeed in the $5+ Billion Tourette Syndrome Drugs Market, 2026-2034 – ResearchAndMarkets.com




Strategies to Succeed in the $5+ Billion Tourette Syndrome Drugs Market, 2026-2034 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Tourette Syndrome Drugs Market Outlook 2026-2034: Market Share, and Growth Analysis” has been added to ResearchAndMarkets.com’s offering.

The Tourette Syndrome Drugs Market is projected to witness significant expansion in the coming years, escalating from a valuation of USD 2.76 billion in 2025 to approximately USD 5.03 billion by 2034, with a notable CAGR of 6.9%. The market predominantly caters to the pharmacological management of tic disorders, inclusive of vocal and motor tics associated with TS, and often addresses co-morbidities such as ADHD and OCD.

The market’s growth is driven by an enhanced rate of diagnosis, improved awareness among medical professionals and caregivers, and better access to specialized neurology and psychiatry care. Ongoing research and development efforts are directed towards creating safer, more effective, and targeted therapies.

Among major emerging trends is the introduction of novel drug classes such as VMAT-2 inhibitors. The treatment paradigm is evolving from severe case management to earlier intervention and broader therapy application, including pediatric and adult care segments. There is notable growth in outpatient and specialty clinic prescriptions, paralleling the expanding geographical access to neurology treatments.

The competitive landscape consists of leading pharmaceutical companies, biotech firms focusing on innovative tic treatment solutions, and generic manufacturers providing older, often less costly therapies. Challenges include the side-effect profile of older medications, regulatory hurdles, and regional healthcare disparities.

Market Insights:

• The diagnostics and awareness improvements are expected to expand patient volume, especially as TS is increasingly detected early in children transitioning to adult care.
• Older antipsychotic therapies, despite their dominance, face constraints due to adverse effects, spurring demand for more tolerable medications.
• The emergence of newer therapies like VMAT-2 inhibitors presents opportunities for differentiation in the treatment space.
• The pediatric segment, the largest for TS drugs, sees adults as a growing focus due to the persistence of TS symptoms and evolving care paradigms.
• Hospital and specialty clinic channels remain crucial for prescribing, heavily influencing market dynamics.
• While mature markets lead in treatment adoption, emerging markets present a significant growth opportunity as they enhance diagnostic access and infrastructure.

Regional Analysis

North America, with its robust neurology infrastructure, leads in market size and sophistication, while Europe presents mature but varied opportunities. Asia-Pacific and Latin America offer growth prospects influenced by expanding healthcare investments and rising awareness but face challenges like limited infrastructure.

Market Segmentation:

• By Product: Antipsychotics, Non-antipsychotics
• By Distribution Channel: Offline, Online

The report employs comprehensive analytical tools like Porter’s Five Forces and scenario-based modeling to evaluate market dynamics. It also considers macroeconomic indicators, policy influences, and consumer trends in forecasting, alongside recent deal flows and technology innovations.

Competitive Intelligence

The competitive landscape is examined through frameworks detailing business models, product offerings, financial performance, and strategic advancements of key players. Emerging innovators and startups are identified for their potential to disrupt the market.

The report provides a granular outlook on market trends, opportunities, and challenges through 2034, supported by detailed regional insights and strategic recommendations.

Key Attributes

Key Companies Featured in the Report:

• Otsuka Pharmaceutical
• Lundbeck
• Teva Pharmaceutical
• Neurocrine Biosciences
• Emalex Biosciences
• Supernus Pharmaceuticals
• Janssen (Johnson & Johnson)
• AbbVie (Allergan)
• Ipsen
• Roche
• Novartis
• Pfizer
• Sunovion Pharmaceuticals
• Medtronic (DBS therapy)
• UCB

For more information about this report visit https://www.researchandmarkets.com/r/pwewx2

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

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The OpenFold Consortium Names Dr. Jan Domanski as Senior Science Lead to Drive the Next Generation of Open Source AI Models for Structural Biology and Drug Discovery




The OpenFold Consortium Names Dr. Jan Domanski as Senior Science Lead to Drive the Next Generation of Open Source AI Models for Structural Biology and Drug Discovery

DAVIS, Calif.–(BUSINESS WIRE)–The OpenFold Consortium, a leading open-science initiative developing AI foundation models for biomolecular structure prediction, today announced that Dr. Jan Domanski has joined the consortium as senior science lead. In this role, Dr. Domanski will spearhead scientific innovation, engineering excellence, and ecosystem growth as OpenFold advances its mission to democratize access to high-performance AI models for structural biology and drug discovery. He will work closely with Dr. Jennifer Wei, OpenFold’s senior technical lead, and a global network of academic and industry contributors to build an open, modular software stack that links state-of-the-art AI models with rich experimental and simulation data to improve model generalization and robustness for drug discovery.

“Dr. Domanski embodies the spirit of OpenFold: a deep scientific understanding of proteins coupled with professional engineering expertise and a builder’s mindset,” said Dr. Woody Sherman, Chair of the OpenFold Executive Committee. “His experience architecting AI-driven platforms to drive drug discovery programs from concept to clinic will be invaluable as we expand OpenFold’s reach beyond structure prediction toward accurate biomolecular interactions, dynamics, and generative design.”

As part of the Open Molecular Software Foundation (OMSF), OpenFold is committed to advancing open and reproducible science across molecular modeling. Following the preview release of OpenFold3, an open-source model capable of predicting protein, nucleic acid, and small-molecule interactions with near–AlphaFold 3 accuracy, the consortium is now focused on building the next generation of foundation models that integrate AI and physics-based approaches for biomolecular understanding and drug discovery.

“OpenFold has already proven that open collaboration can match or exceed the capabilities of proprietary AI models,” said Dr. Domanski. “The next phase is to make these models truly usable and extensible—to enable every scientist, from academia to biotech, to contribute, adapt, and apply them across new frontiers of biology and medicine.”

Dr. Domanski brings over a decade of experience at the intersection of machine learning, molecular simulation, and scientific software development. With a Ph.D. obtained through the NIH Oxford-Cambridge Scholars Program, a joint program between the University of Oxford and the NIH, he studied membrane protein folding under the supervision of Professors Mark Sansom and Philip Stansfeld at Oxford and Dr. Robert Best at the NIH. Dr. Domanski has dedicated his career to building tools that bridge cutting-edge computation with experimental science to accelerate drug discovery and innovation in the life sciences. Dr. Domanski also worked at D. E. Shaw Research where he applied the long timescale molecular dynamics simulations to small-molecule discovery, understanding the relationship between protein structure and function.

Prior to joining OpenFold, Dr. Domanski was Founder and CTO of Labstep, a pioneering digital lab automation platform acquired by STARLIMS. In 2022, Dr. Domanski joined Charm Therapeutics, where he was among the first five employees. There, he built and scaled the company’s machine learning and software engineering teams, collaborated closely with medicinal chemists and structural biologists, and led the development of DragonFold, a state-of-the-art co-folding model that powered Charm’s integrated small-molecule discovery platform. This technology contributed to the identification of CHM-029, Charm’s next-generation menin inhibitor expected to enter the clinic in 2026.

The OpenFold Consortium is supported by member organizations and philanthropic partners. By investing in OpenFold today, you have a unique opportunity to shape the future of open, trustworthy AI infrastructure in the life sciences, ensuring that state-of-the-art models remain freely accessible to scientists everywhere.

If you or your organization are excited to support open, community-driven AI for science, please contact Dr. Mallory Tollefson at mallory.tollefson@omsf.io. Your support helps accelerate discovery, empower the next generation of scientists, and sustain critical tools that the entire biomedical ecosystem relies on.

Contacts

Media Contact:

Mallory Tollefson, Ph. D.

OpenFold Consortium

mallory.tollefson@omsf.io

Atelerix Enters Agreement with Cherry Biotech to Integrate Non-cryogenic Transport Solutions With Advanced Organoid Models




Atelerix Enters Agreement with Cherry Biotech to Integrate Non-cryogenic Transport Solutions With Advanced Organoid Models

Partnership brings together proven non-cryogenic biosample preservation technology and advanced organoid models to support growth in preclinical research and biotech sectors

NEWCASTLE, England–(BUSINESS WIRE)–Atelerix, a biotech company revolutionising cell preservation and biological transport with its pioneering hydrogel encapsulation technology, today announced it has entered a partnership with Cherry Biotech, a French company specialising in organ-on-chip and organoid technologies for biomedical research.

The initial agreement will explore the integration of Atelerix’s patented hydrogel technology with Cherry Biotech’s advanced 3D organoid models to facilitate global extended-duration shipment. In collaboration, the companies aim to improve the reliability and consistency of transporting these temperature-sensitive materials without the complications of cold-chain logistics, enabling significant growth and expanded customer access to high-quality, human-relevant preclinical data worldwide. Through an initial 12-month trial period, both parties will validate their strategic and technical alignment, establishing the groundwork for a scalable, long-term commercial partnership.

Cherry Biotech’s in vitro product range combine AI analysis, high-resolution live imaging and precisely controlled organoid culture to better predict the efficacy and safety of drugs, generating real life-like preclinical data. As part of the partnership, Atelerix’s hydrogel technology will also be validated for the stable shipment of Cherry Biotech’s recently released organoidPlate – an advanced multiwell plate with ready to use organoids for adipose tissue, breast cancer, liver and lung, which is now available for worldwide shipping.

The MoU builds on a test period whereby Cherry Biotech demonstrated strong performance of Atelerix’s biosample preservation technology across multiple organ models, preserving membrane integrity and biological function at ambient or controlled temperatures.

Alastair Carrington, CEO, Atelerix, commented: “This latest partnership with Cherry Biotech is a key step in expanding our commercial traction, broadening market reach, and increasing visibility for Atelerix’s solutions. It is fantastic to work alongside such an innovative CRO, we are delighted that our preservation technology has already proven itself in delivering organoid models reliably and hassle-free to researchers worldwide. This partnership provides key validation, reinforcing the potential of ambient logistics to support the adoption of assay-ready animal model alternatives, advancing drug testing and better predicting human responses.”

Pierre Gaudriault, Chief Business Development Officer, Cherry Biotech, added: “Partnering with Atelerix strengthens our ability to deliver cutting-edge organoid models to researchers in pharma and academia worldwide. The hydrogel preservation technology maintains cell viability for days at room temperature, removing cold-chain constraints and reducing environmental footprint. This innovation brings unprecedented convenience and reliability to our customers. In short, Aterelix is making easy global shipping for our product possible.”

Contacts

Media
Jake Brown

jake.brown@zymecommunications.com

GENESIS Pharma announces a new partnership with Otsuka Pharmaceutical Europe Ltd. for the commercialization of donidalorsen for hereditary angioedema in Central and Eastern Europe




GENESIS Pharma announces a new partnership with Otsuka Pharmaceutical Europe Ltd. for the commercialization of donidalorsen for hereditary angioedema in Central and Eastern Europe

ATHENS, Greece–(BUSINESS WIRE)– 

ANNOUNCEMENT FOR EUROPEAN MEDICAL & PHARMACEUTICAL TRADE MEDIA AND EUROPEAN FINANCIAL MEDIA ONLY

GENESIS Pharma, a regional biopharma company focused on the commercialization of innovative medicines in Central and Eastern Europe, announces an exclusive agreement with Otsuka Pharmaceutical Europe Ltd. (OPEL), the European operation of global healthcare company Otsuka Pharmaceutical Co., Ltd., for donidalorsen. Under the terms of the agreement, GENESIS Pharma will exclusively distribute and commercialize donidalorsen in fourteen markets: Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Greece, Hungary, Latvia, Lithuania, Malta, Poland, Romania, Slovakia and Slovenia.

In November 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for donidalorsen in the routine prevention of recurrent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older. The CHMP opinion is currently under review by the European Commission (EC), to determine donidalorsen’s authorisation in the European Union (EU). Donidalorsen is an investigational RNA-targeted medicine designed to reduce the production of prekallikrein (PKK), interrupting the pathway that leads to HAE attacks^1,2.

Mr. Constantinos Evripides, Managing Director of GENESIS Pharma stated: “We are excited to expand our international partnerships in the CEE region through this new collaboration with Otsuka Pharmaceutical Europe Ltd., a company focusing on some of the world’s unresolved health issues. The addition of donidalorsen to our robust rare disease medicines portfolio is another step forward in our mission to support patients with rare and serious conditions, ensuring access to innovative treatments in our region. Thus, we look forward to the forthcoming decision from the European Commission.”

Donidalorsen was discovered and developed by Ionis Pharmaceuticals, Inc. (Ionis). In December 2023, Otsuka acquired exclusive rights to commercialize donidalorsen in Europe through a licensing agreement with Ionis.

About Hereditary Angioedema (HAE)

HAE is a rare, chronic and potentially life-threatening genetic condition that involves recurrent, unpredictable attacks of swelling episodes that can affect the extremities, face, abdomen, genitals and even the larynx, posing serious risk for patients.³ Symptoms of HAE usually begin in childhood or early adulthood, with some individuals experiencing their first episodes as young as two years old.^4,5 HAE imposes a significant burden on patients and their families, with unpredictable and often debilitating attacks which can disrupt daily life, limit activities and reduce productivity at work or school. ^6-8 HAE is most commonly caused by an inherited deficiency or dysfunction of C1 esterase inhibitor, which leads to uncontrolled activation of the plasma kallikrein-kinin system and excessive production of bradykinin.^5,9,10 Approximately 15,000 individuals are living with HAE in Europe with a worldwide prevalence estimated to be 1 in 50,000.^3,5,11

About GENESIS Pharma

GENESIS Pharma is a regional biopharma company focused on the commercialization of innovative biopharmaceutical products targeting severe and rare diseases in Central and Eastern Europe. Established in 1997, GENESIS Pharma was among the first pharmaceutical companies in Europe to specialize in the marketing, sales and distribution of biopharmaceutical products. GENESIS Pharma maintains a strong portfolio in therapeutic areas with high unmet medical need through long standing strategic alliances with some of the leading global biopharma companies. For more information, please visit www.genesispharma.com and follow us on LinkedIn.

REFERENCES

1. Riedl MA, et al. N Engl J Med 2024;391(1):21–31.
2. Riedl MA, et al. J Allergy Clin Immunol Pract 2025;13(9):2381–2389.
3. Raasch J, et al. World Allergy Organ J 2023;16(6):100792.
4. Busse P, et al. J Allergy Clin Immunol Pract 2021;9(1):132–150.e3.
5. Maurer M, et al. Allergy 2022;77(7):1961–1990.
6. Aygoren-Pursun E, et al. Orphanet J Rare Dis 2014;9:99.
7. Chong-Neto HJ, World Allergy Organ J 2023;16(3):100758.
8. Mendivil J, et al. Orphanet J Rare Dis 2021;16:94.
9. Santacroce R, et al. Review J Clin Med 2021:10(9):2023.
10. Longhurst HJ, Bork K. Br J Hosp Med (Lond) 2019:2;80(7):391–398.
11. Lumry WR. Hereditary angioedema: the economics of treatment of an orphan disease. Front Med (Lausanne). 2018;5:22.

Contacts

For more information, please contact:
Natalia Karahaliou, Communications Manager

nkarahaliou@genesispharma.com
+30 210 87 71 605

LEO Pharma Submits Adolescent Label Expansion Application for Anzupgo® to EMA




LEO Pharma Submits Adolescent Label Expansion Application for Anzupgo® to EMA

• LEO Pharma has submitted a label expansion application to EMA to expand Anzupgo® (delgocitinib) cream to adolescent patients (12–17 years) with moderate to severe chronic hand eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate – the application has been accepted for review.
• The application is supported by results from DELTA TEEN, a phase 3 trial investigating efficacy and safety of Anzupgo® in adolescents with moderate to severe chronic hand eczema (CHE).¹
• The label expansion submission for adolescent patients demonstrates LEO Pharma’s commitment to investigating use within relevant sub-populations where treatments can help make a fundamental difference for patients with skin diseases.

BALLERUP, Denmark–(BUSINESS WIRE)–NOT FOR UK USE – NOT INTENDED FOR UK MEDIA

LEO Pharma A/S, a global leader in medical dermatology, today announced submission of a label expansion application to the European Medicines Agency (EMA) to expand the use of Anzupgo^® (delgocitinib) cream to adolescents aged 12 to 17 years, living with moderate to severe chronic hand eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate in the European Union. The label expansion application has been accepted for review by EMA.

“With the submission of our label expansion application for Anzupgo^®, LEO Pharma is reinforcing our commitment aiming at improving the lives of patients with skin diseases,” said Sophie Lamle, Executive Vice President, Development. “Adolescents living with this debilitating disease, in the EU, currently have no treatment options specifically approved for moderate to severe CHE, and we are proud to take this important step toward addressing that unmet need. Backed by our global expertise and dedication to innovation, we are excited about the potential to bring a treatment that can help make a meaningful difference in the everyday lives of adolescent patients.”

Research on adolescents with CHE shows that the disease can impact far beyond the skin. CHE can have considerable negative impact on quality of life, affecting psychosocial well-being, school performance and participation in leisure activities.²

The label expansion application is supported by results from DELTA Teen, a phase 3 trial with Anzupgo^® (delgocitinib) 20mg/g cream, that investigated the efficacy and safety of twice-daily applications of Anzupgo^® compared with cream vehicle in adolescents 12-17 years of age with moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate .¹ The detailed results were presented as a late breaking presentation at European Academy of Dermatology and Venereology 2025 in Paris, France.

Anzupgo^® is currently approved in adult patients with moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate in the European Union³, as well as several additional markets, including the US, Switzerland and the UK.

About Chronic Hand Eczema

Chronic Hand Eczema (CHE) is defined as hand eczema (HE) that lasts for more than three months or relapses twice or more within a year.^4,5 CHE is one of the most common skin diseases of the hands with a global prevalence rate of approximately 4.7%.^6,7 In a substantial number of patients, HE can develop into a chronic disease.⁶ CHE is a fluctuating disease characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists.⁸

CHE has been shown to cause psychological and functional burdens that impact patient quality of life,^9,10 with approximately 70% of individuals who live with severe CHE admitting to problems in performing everyday activities, and suffering disruption in their daily life due to the condition.¹¹ Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE.¹²

About Anzupgo^® (delgocitinib) Cream

Anzupgo^® cream is a topical pan-Janus kinase (JAK) inhibitor for the treatment of moderate to severe CHE in adults. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE.¹³

Anzupgo^® is approved in the European Union, United Kingdom, Switzerland, Canada, Australia, South Korea, and the United Arab Emirates for the treatment of moderate to severe Chronic Hand Eczema (CHE) in adults for whom topical corticosteroids are inadequate or inappropriate. Anzupgo^® cream is also under investigation in other markets.

Anzupgo^® (delgocitinib) cream is FDA approved in the U.S. for moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Use of Anzupgo^® in combination with other JAK inhibitors or potent immunosuppressants is not recommended by the U.S. FDA.¹⁴

Please click here for full U.S. Prescribing Information, including Patient Information and Instructions for Use.

In 2014, LEO Pharma obtained the exclusive rights to develop and commercialize delgocitinib for topical use in dermatological indications worldwide, excluding Japan, where Shionogi Inc. owns the rights.

About the DELTA TEEN Trial

DELTA TEEN was a 16-week, phase 3, randomized, double-blind, vehicle-controlled, parallel group, multi-site trial to evaluate the efficacy and safety of twice-daily applications of Anzupgo^® compared with cream vehicle in adolescents 12-17 years of age with moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate.¹

The primary endpoint of DELTA TEEN was the Investigator’s Global Assessment for chronic hand eczema treatment success (IGA-CHE TS) at Week 16. Treatment success was defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with at least a two-step improvement from baseline.¹

About LEO Pharma

LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people’s lives, and our broad portfolio of treatments serves close to 100 million patients in over 70 countries annually. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. Headquartered in Denmark, LEO Pharma has a team of 4,000 people worldwide. Together, we reach far beyond the skin.

For more information, visit www.leo-pharma.com.

References

1. ClinicalTrials.gov. National Library of Medicine (U.S.). Efficacy and Safety of Delgocitinib Cream in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema (DELTA TEEN). Identifier: NCT05355818. https://clinicaltrials.gov/study/NCT05355818.
2. Haft MA, Park HH, Lee SS, Sprague JM, Eichenfield LF. Pediatric chronic hand eczema: Epidemiology, clinical presentation, and management. JAAD Int. 2023;11:165-173.
3. European Medicines Agency. Anzupgo 20 mg/g cream: summary of product characteristics. Amsterdam: EMA; 2024 [updated 2025 Jan 22; cited 2025 Dec 9]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/anzupgo
4. Lynde C, Guenther L, Diepgen TL, et al. Canadian hand dermatitis management guidelines. J Cutan Med Surg . 2010;14(6):267-284. Erratum in: J Cutan Med Surg. 2011 Nov-Dec;15(6):360.
5. Diepgen TL, et al. Guidelines for diagnosis, prevention and treatment of hand eczema. J Dtsch Dermatol Ges. 2015 Jan;13(1):e1–22.
6. Bissonnette R, et al. Redefining treatment options in chronic hand eczema (CHE). JEADV. 2010;24;1–20.
7. Apfelbacher C, Bewley A, Molin S, et al. Prevalence of chronic hand eczema in adults: a cross-sectional survey of over 60 000 respondents from the general population of Canada, France, Germany, Italy, Spain and the UK. Presented at the 2024 European Society of Contact Dermatitis (ESCD) congress; September 04-07 2024; Dresden, Germany. Poster presentation #3
8. Thyssen JP, Schuttelaar MLA, Alfonso JH, et al. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis. 2022;86(5):357-378.
9. Grant L, Seiding Larsen L, Burrows K, et al. Development of a Conceptual Model of Chronic Hand Eczema (CHE) Based on Qualitative Interviews with Patients and Expert Dermatologists. Adv Ther. 2020;37(2):692-706.
10. Dalgard FJ, Gieler U, Tomas-Aragones L, et al. The psychological burden of skin diseases: a cross-sectional multicenter study among dermatological out-patients in 13 European countries. J Invest Dermatol. 2015;135(4):984-991.
11. Cortesi PA, Scalone L, Belisari A, et al. Cost and quality of life in patients with severe chronic hand eczema refractory to standard therapy with topical potent corticosteroids. Contact Dermatitis. 2014;70(3):158-168.
12. Voorberg AN, Loman L, Schuttelaar MLA. Prevalence and Severity of Hand Eczema in the Dutch General Population: A Cross-sectional, Questionnaire Study within the Lifelines Cohort Study. Acta Derm Venereol. 2022;102:adv00626.
13. Dubin C, Del Duca E, Guttman-Yassky E. Drugs for the Treatment of Chronic Hand Eczema: Successes and Key Challenges. Ther Clin Risk Manag. 2020;16:1319-1332. Erratum in: Ther Clin Risk Manag. 2021 Mar 18;17:233.
14. ANZUPGO^® (delgocitinib) cream. Prescribing Information. FDA. July 2025.

MAT-88642 December 2025

Contacts

Jes Broe Frederiksen

Global Corporate Communication

+45 53 60 59 48

jebfe@leo-pharma.com

Christian Bundgaard

Global Corporate Communication

+45 53 74 88 49

chbun@leo-pharma.com

Mitsubishi Electric Achieves World’s First Mechanism for Elucidating Ozone Oxidation Enhanced with Negative Ions




Mitsubishi Electric Achieves World’s First Mechanism for Elucidating Ozone Oxidation Enhanced with Negative Ions

Reduces surface-bound viruses, bacteria and odors for safe, secure, and comfortable indoor environment

TOKYO–(BUSINESS WIRE)–Mitsubishi Electric Corporation (TOKYO: 6503) announced today that in collaboration with Professor Toshiaki Kamachi and colleagues from the School of Life Science and Technology at Institute of Science Tokyo (Science Tokyo) they have achieved the world’s first mechanism for elucidating the combined use of negative ions to enhance the oxidative action of ozone. In their joint study, they discovered that dissolving negative ions in the moisture surrounding viruses and other microorganisms lowers the pH due to nitrate-containing components derived from the negative ions, which in turn enhances the oxidative action of ozone in the moisture, enabling a strong reduction of viruses and bacteria even at low ozone concentrations. Mitsubishi Electric confirmed the reduction of bacteria and odors in low ozone concentrations of 50 parts per billion (ppb) in addition to specific viruses reported previously.

Buildings are becoming more airtight and better insulated, raising concerns about inadequate indoor ventilation and unhygienic conditions. Ozone’s oxidative action has traditionally been used to maintain indoor hygiene, but ozone alone has faced challenges in terms of the durability and stability of its sanitizing effects. It is also known that ozone’s reduction of viruses and bacteria increases when used with negative ions and varies with pH. However, the specific chemical species of the negative ions and their pH-controlling effects had not been clarified.

For the full text, please visit: www.MitsubishiElectric.com/news/

Contacts

Customer Inquiries
Advanced Technology R&D Center

Mitsubishi Electric Corporation

Fax: +81-6-6497-7285

www.MitsubishiElectric.com/ssl/contact/company/rd/form.html
www.MitsubishiElectric.com/en/about/rd/

Media Inquiries
Takeyoshi Komatsu

Public Relations Division

Mitsubishi Electric Corporation

Tel: +81-3-3218-2332

prd.gnews@nk.MitsubishiElectric.co.jp
www.MitsubishiElectric.com/en/pr/

Immunome to Announce Topline Results from Phase 3 RINGSIDE Trial of Varegacestat in Patients with Desmoid Tumors




Immunome to Announce Topline Results from Phase 3 RINGSIDE Trial of Varegacestat in Patients with Desmoid Tumors

Company to host webcast Monday, December 15, 2025 at 8:30 a.m. ET

BOTHELL, Wash.–(BUSINESS WIRE)–Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, today announced the company will host a conference call and webcast on Monday, December 15, 2025 at 8:30 am ET to disclose the topline results from the global pivotal Phase 3 RINGSIDE trial of varegacestat, an investigational, oral, once-daily gamma secretase inhibitor, in patients with progressing desmoid tumors.

Webcast, Presentation Slides and Conference Call Information

Immunome will host a webcast and conference call on Monday, December 15, 2025, at 8:30 a.m. ET / 5:30 a.m. PT to discuss the Phase 3 RINGSIDE trial topline results. A live webcast, which will include presentation slides, can be accessed using this link or by visiting the Events and Presentations section of the Immunome website at https://investors.immunome.com/events. The conference call can be accessed by clicking on the call link and completing the online registration form, which will enable the selection of a dial-in number or callback from the system. A live question-and-answer session will follow the prepared remarks. Participants wishing to ask a question must do so via the conference call; the webcast will be listen-only. After the live webcast, the event will remain archived on the Immunome website for 90 days. 

About Immunome, Inc.

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugate therapies. Our pipeline includes varegacestat, a late-clinical stage GSI; IM-1021, a clinical-stage ROR1 ADC; and IM-3050, a FAP-targeted radiotherapy that recently received IND clearance. We are also advancing a broad portfolio of early stage ADCs pursuing undisclosed solid tumor targets. For more information, visit www.immunome.com.

Contacts

Investor Contact:

Max Rosett

Chief Financial Officer, Immunome

investors@immunome.com

Media Contact:
Nicole Foderaro

Real Chemistry

media@immunome.com

GMP Cytokine Market and Competition Outlook to 2031: Growing at 8.4% CAGR, Led by Bio-Techne, PeproTech, CellGenix Among Others – ResearchAndMarkets.com




GMP Cytokine Market and Competition Outlook to 2031: Growing at 8.4% CAGR, Led by Bio-Techne, PeproTech, CellGenix Among Others – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “GMP Cytokine Market Report: Trends, Forecast and Competitive Analysis to 2031” has been added to ResearchAndMarkets.com’s offering.

The global GMP cytokine market is expected to grow with a CAGR of 8.4% from 2025 to 2031. The major drivers for this market are the increasing demand for immunotherapies, the rising adoption of personalized medicine, and the growing focus on cancer research. The future of the market looks promising with opportunities in the cell/gene therapy and tissue-engineered product markets.

• Within the type category, interleukin is expected to witness the highest growth over the forecast period.
• Within the application category, cell/gene therapy is expected to witness higher growth.
• In terms of region, APAC is expected to witness the highest growth over the forecast period.

Emerging Trends in the GMP Cytokine Market

The GMP cytokine market is evolving as advanced therapeutics expand, focusing on personalized medications and innovative manufacturing techniques. Key trends include the move towards personalized medicine, bioprocess optimization, growth of contract manufacturing services, better delivery technologies, and the adoption of advanced analytics and AI. These trends are transforming the market into a technologically advanced sector prioritizing precision and efficiency.

Recent Developments in the GMP Cytokine Market

Recent developments include the shift to animal-free expression systems to enhance safety, expansion of commercial-scale production, regulatory harmonization, and strategic alliances. These factors increase reliability, safety, and accessibility while fostering efficient global collaboration in the GMP cytokine market.

Strategic Growth Opportunities in the GMP Cytokine Market

The market is poised for strategic growth within cell and gene therapy, cancer immunotherapy, regenerative medicine, vaccine development, and biosimilars. These opportunities leverage the unique benefits of GMP cytokines, emphasizing innovation and specialization in therapeutic applications.

GMP Cytokine Market Drivers and Challenges

Growth is driven by rising chronic diseases, expanding cell and gene therapy markets, technological advances, supportive regulatory environments, and increased R&D investments. Challenges include high manufacturing costs, stringent regulatory compliance, and supply chain risks. Navigating these factors will shape a dynamic and innovative market landscape.

Country-Wise Outlook for the GMP Cytokine Market

Countries are advancing in GMP cytokine production tailored to their economic and regulatory contexts. The US leads with robust R&D and regulatory support. China’s emphasis on local manufacturing boosts accessibility. Germany focuses on high-quality production and regulation. India and Japan invest in local R&D, aiding market growth through cost-efficiency and strategic focuses respectively.

Key Topics Covered

1. Executive Summary

2. Market Overview

2.1 Background and Classifications

2.2 Supply Chain

3. Market Trends & Forecast Analysis

3.1 Global GMP Cytokine Market Trends and Forecast

3.2 Industry Drivers and Challenges

3.3 PESTLE Analysis

3.4 Patent Analysis

3.5 Regulatory Environment

4. Global GMP Cytokine Market by Type

4.1 Overview

4.2 Attractiveness Analysis by Type

4.3 TNF: Trends and Forecast (2019-2031)

4.4 Interleukin: Trends and Forecast (2019-2031)

4.5 Growth Factor: Trends and Forecast (2019-2031)

4.6 Others: Trends and Forecast (2019-2031)

5. Global GMP Cytokine Market by Application

5.1 Overview

5.2 Attractiveness Analysis by Application

5.3 Cell/Gene Therapy: Trends and Forecast (2019-2031)

5.4 Tissue-Engineered Products: Trends and Forecast (2019-2031)

5.5 Others: Trends and Forecast (2019-2031)

6. Regional Analysis

6.1 Overview

6.2 Global GMP Cytokine Market by Region

7. North American GMP Cytokine Market

8. European GMP Cytokine Market

9. APAC GMP Cytokine Market

10. RoW GMP Cytokine Market

11. Competitor Analysis

11.1 Product Portfolio Analysis

11.2 Operational Integration

11.3 Porter’s Five Forces Analysis

11.4 Market Share Analysis

12. Opportunities & Strategic Analysis

12.1 Value Chain Analysis

12.2 Growth Opportunity Analysis

12.2.1 Growth Opportunities by Type

12.2.2 Growth Opportunities by Application

12.3 Emerging Trends in the Global GMP Cytokine Market

12.4 Strategic Analysis

12.4.1 New Product Development

12.4.2 Certification and Licensing

12.4.3 Mergers, Acquisitions, Agreements, Collaborations, and Joint Ventures

13. Company Profiles of the Leading Players Across the Value Chain

13.1 Competitive Analysis

13.2 Bio-Techne

13.3 PeproTech

13.4 CellGenix

13.5 Miltenyi Biotec

13.6 Cytiva

13.7 Lonza

13.8 ReproCELL

13.9 Sino Biological

13.10 Akron Biotech

13.11 Creative Bioarray

For more information about this report visit https://www.researchandmarkets.com/r/42l1pl

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