IVD Raw Materials Industry Presents $35.8 Billion Valuation by 2030 – Expansion of POC and Home Diagnostics Strengthens Need for High-Quality Antibodies, Antigens, and Buffers – ResearchAndMarkets.com

IVD Raw Materials Industry Presents $35.8 Billion Valuation by 2030 – Expansion of POC and Home Diagnostics Strengthens Need for High-Quality Antibodies, Antigens, and Buffers – ResearchAndMarkets.com




IVD Raw Materials Industry Presents $35.8 Billion Valuation by 2030 – Expansion of POC and Home Diagnostics Strengthens Need for High-Quality Antibodies, Antigens, and Buffers – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “IVD Raw Materials – Global Strategic Business Report” has been added to ResearchAndMarkets.com’s offering.


The global market for IVD Raw Materials was valued at US$27.7 Billion in 2024 and is projected to reach US$35.8 Billion by 2030, growing at a CAGR of 4.3% from 2024 to 2030. This comprehensive report provides an in-depth analysis of market trends, drivers, and forecasts, helping you make informed business decisions.

Growth in the IVD raw materials market is driven by several factors including rising global demand for diagnostic testing, increasing complexity of assay formats, and heightened regulatory scrutiny of material quality. Advances in recombinant production, synthetic chemistry, and expression systems are enabling reliable, scalable supply of high-performance components.

End-use expansion in molecular diagnostics, infectious disease testing, and personalized medicine is creating recurring demand for highly specific and stable raw materials. Emergence of new pathogens, focus on decentralized testing, and growing investment in lab infrastructure are further boosting usage. As diagnostics become central to preventive and precision medicine, the need for high-quality IVD raw materials continues to grow in both established and emerging healthcare markets.

Scope of the Report

The report analyzes the IVD Raw Materials market, presented in terms of market value (USD). The analysis covers the key segments and geographic regions outlined below:

  • Segments: Product (IVD Antibody & Antigens, IVD Enzymes, IVD Proteins, IVD Biological Buffers, Other Products); Technology (Clinical Chemistry Technology, Immunochemistry Technology, Molecular Diagnostics Technology, Other Technologies); End-Use (Pharma & Biotech Companies End-Use, Diagnostic Laboratories End-Use, Other End-Uses).
  • Geographic Regions/Countries: World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; Spain; Russia; and Rest of Europe); Asia-Pacific (Australia; India; South Korea; and Rest of Asia-Pacific); Latin America (Argentina; Brazil; Mexico; and Rest of Latin America); Middle East (Iran; Israel; Saudi Arabia; United Arab Emirates; and Rest of Middle East); and Africa.

Key Insights:

  • Market Growth: Understand the significant growth trajectory of the IVD Antibody & Antigens segment, which is expected to reach US$13.0 Billion by 2030 with a CAGR of a 3.8%. The IVD Enzymes segment is also set to grow at 5.0% CAGR over the analysis period.
  • Regional Analysis: Gain insights into the U.S. market, valued at $7.6 Billion in 2024, and China, forecasted to grow at an impressive 7.8% CAGR to reach $7.3 Billion by 2030. Discover growth trends in other key regions, including Japan, Canada, Germany, and the Asia-Pacific.

Key Questions Answered:

  • How is the Global IVD Raw Materials Market expected to evolve by 2030?
  • What are the main drivers and restraints affecting the market?
  • Which market segments will grow the most over the forecast period?
  • How will market shares for different regions and segments change by 2030?
  • Who are the leading players in the market, and what are their prospects?

Report Features:

  • Comprehensive Market Data: Independent analysis of annual sales and market forecasts in US$ Million from 2024 to 2030.
  • In-Depth Regional Analysis: Detailed insights into key markets, including the U.S., China, Japan, Canada, Europe, Asia-Pacific, Latin America, Middle East, and Africa.
  • Company Profiles: Coverage of players such as Aalto Bio Reagents Ltd., AMSBIO (AMS Biotechnology), BBI Solutions, Bio-Rad Laboratories, Inc., Bio-Check (UK) Ltd and more.
  • Complimentary Updates: Receive free report updates for one year to keep you informed of the latest market developments.

Some of the 39 companies featured in this IVD Raw Materials market report include:

  • Aalto Bio Reagents Ltd.
  • AMSBIO (AMS Biotechnology)
  • BBI Solutions
  • Bio-Rad Laboratories, Inc.
  • Bio-Check (UK) Ltd
  • Bioporto Diagnostics
  • Diarect AG
  • EastCoast Bio
  • Fitzgerald Industries Intl.
  • Fujirebio
  • HyTest Ltd
  • Jena Bioscience GmbH
  • Medix Biochemica
  • Meridian Bioscience, Inc.
  • MyBiosource, Inc.
  • QuidelOrtho Corporation
  • RayBiotech, Inc.
  • Rockland Immunochemicals, Inc.
  • Scripps Laboratories, Inc.
  • Sekisui Diagnostics

Key Attributes

Report Attribute Details
No. of Pages 381
Forecast Period 2024-2030
Estimated Market Value (USD) in 2024 $27.7 Billion
Forecasted Market Value (USD) by 2030 $35.8 Billion
Compound Annual Growth Rate 4.3%
Regions Covered Global

Market Overview

  • Influencer Market Insights
  • World Market Trajectories
  • Tariff Impact on Global Supply Chain Patterns
  • IVD Raw Materials – Global Key Competitors Percentage Market Share in 2025 (E)
  • Competitive Market Presence – Strong/Active/Niche/Trivial for Players Worldwide in 2025 (E)

Market Trends & Drivers

  • Rising Demand for In Vitro Diagnostics Across Infectious Disease, Cancer, and Genetic Testing Drives Consumption of Raw Materials
  • Expansion of Point-of-Care and Home Diagnostics Strengthens Need for High-Quality Antibodies, Antigens, and Buffers
  • OEM Focus on Recombinant Protein Engineering and Monoclonal Antibody Production Enhances Specificity and Stability
  • Growth in Molecular Diagnostics and PCR-Based Assays Throws Spotlight on High-Fidelity Enzymes and Primers
  • Increasing Emphasis on Supply Chain Resilience and Material Traceability Supports Strategic Sourcing of IVD Inputs
  • OEM Investment in GMP-Compliant Raw Material Manufacturing Improves Quality Assurance for Diagnostic Kit Producers
  • Rising Adoption of Multiplex Assays and Rapid Diagnostic Tests Fuels Need for Custom Coating and Blocking Reagents
  • OEM Development of Bulk Supply Agreements With Test Kit Manufacturers Enhances Scalability and Delivery Reliability
  • Growth in Companion Diagnostics and Personalized Medicine Expands Use of Specialized Biomarker Reagents
  • OEM Innovation in Lyophilized and Room-Temperature Stable Raw Materials Supports Distribution in Low-Resource Settings

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

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
For E.S.T Office Hours Call 1-917-300-0470

For U.S./ CAN Toll Free Call 1-800-526-8630

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Cocaine Use Disorder Market Analysis, Trends and Outlook 2025-2032 by Treatment Modality, Treatment Setting, Indication, Diagnostic Tests and Region – ResearchAndMarkets.com

Cocaine Use Disorder Market Analysis, Trends and Outlook 2025-2032 by Treatment Modality, Treatment Setting, Indication, Diagnostic Tests and Region – ResearchAndMarkets.com




Cocaine Use Disorder Market Analysis, Trends and Outlook 2025-2032 by Treatment Modality, Treatment Setting, Indication, Diagnostic Tests and Region – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Cocaine Use Disorder Market – Global Forecast 2025-2032” has been added to ResearchAndMarkets.com’s offering.


The Cocaine Use Disorder Market is experiencing substantial growth, expanding from USD 1.29 billion in 2024 to USD 1.36 billion in 2025, with projections indicating a CAGR of 5.82% reaching USD 2.03 billion by 2032. This comprehensive market research study sheds light on the evolving dynamics and strategic imperatives within the cocaine use disorder treatment landscape. The report provides essential insights for stakeholders navigating the complexities of treatment modalities, regulatory shifts, and external forces affecting patient outcomes since the late twentieth century.

Transformative Shifts in Treatment Innovation

Recent advances in neurobiological research and digital therapeutics have catalyzed a paradigm shift in treating cocaine use disorder, emphasizing personalized medicine and innovative care models. Regulatory agencies have adopted more adaptive frameworks, enabling expedited implementation of novel therapies. For decision-makers, these advancements present opportunities for strategic planning and capturing competitive advantages through emerging technologies.

Telehealth platforms and mobile solutions have further expanded the reach of behavioral therapies, generating real-world data to refine treatment algorithms. Such integrative approaches underscore the market’s progression toward sustainable outcomes.

Key Takeaways from This Report

  • Identifies high-impact opportunities for decision-makers within the cocaine use disorder treatment market.
  • Offers insights into emerging trends and innovative care models driving sustainable patient outcomes.
  • Highlights the importance of strategic partnerships and regional diversification in mitigating tariff impacts.
  • Provides direction for leveraging supply chain resilience and data-driven execution in market strategies.

Market Segmentation & Coverage

The report forecasts revenues and analyzes trends in segmentation by treatment modality, setting, indication, diagnostic testing, payer type, provider network, and regional dynamics. The following detailed breakdowns are examined:

  • Treatment Modality

    • Behavioral Therapy

      • Cognitive Behavioral Therapy
      • Contingency Management
      • Motivational Interviewing
    • Combined Therapy

      • Integrated Programs
      • Sequential Programs
    • Pharmacotherapy

      • Antidepressants

        • Selective Serotonin Reuptake Inhibitors
        • Serotonin-Norepinephrine Reuptake Inhibitors
      • Psychostimulants
  • Treatment Setting

    • Inpatient

      • Detoxification
      • Residential Rehabilitation
    • Outpatient
  • Indication

    • Acute
    • Chronic
  • Diagnostic Tests

    • Cardiovascular Examination
    • Neurologic Examination
    • Urine Toxicology Examination

Key Attributes

Report Attribute Details
No. of Pages 194
Forecast Period 2025-2032
Estimated Market Value (USD) in 2025 $1.36 Billion
Forecasted Market Value (USD) by 2032 $2.03 Billion
Compound Annual Growth Rate 5.8%
Regions Covered Global

The companies profiled in this Cocaine Use Disorder market report include:

  • Alkermes PLC
  • Alnylam Pharmaceuticals, Inc.
  • Camurus AB
  • Embera NeuroTherapeutics, Inc.
  • Indivior PLC
  • Johnson & Johnson Services, Inc.
  • KemPharm, Inc.
  • Kinoxis Therapeutics
  • Novartis International AG
  • Orexo AB
  • Otsuka Pharmaceutical Co., Ltd.
  • Pfizer Inc.
  • Polpharma SA
  • Revive Therapeutics Ltd.
  • Sage Therapeutics, Inc.
  • Saniona AB
  • Shionogi & Co., Ltd.
  • Sigmapharm Laboratories, LLC
  • STALICLA SA
  • Teva Pharmaceuticals USA, Inc.
  • Viatris Inc.
  • Mylan Pharmaceuticals Inc.

For more information about this report visit https://www.researchandmarkets.com/r/mg5h70

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

For E.S.T Office Hours Call 1-917-300-0470

For U.S./ CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

FDA Grants Breakthrough Therapy Designation to Investigational Drug Adrabetadex for Individuals with Infantile-Onset Niemann-Pick Disease Type C

FDA Grants Breakthrough Therapy Designation to Investigational Drug Adrabetadex for Individuals with Infantile-Onset Niemann-Pick Disease Type C




FDA Grants Breakthrough Therapy Designation to Investigational Drug Adrabetadex for Individuals with Infantile-Onset Niemann-Pick Disease Type C

  • Breakthrough Therapy Designation is based on FDA’s review of survival analyses comparing adrabetadex-treated patients with external controls and marks a significant regulatory milestone ahead of an NDA submission.

THOUSAND OAKS, Calif.–(BUSINESS WIRE)–Beren Therapeutics P.B.C.®, a Public Benefit Corporation and parent company of Mandos LLC®, today announced that Mandos received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for adrabetadex, an investigational drug for infantile-onset Niemann-Pick disease type C (NPC).


BTD is granted by the FDA to expedite the development of drugs for serious or life-threatening conditions when preliminary clinical evidence may indicate a substantial improvement over existing therapy. The FDA decision was informed by an externally controlled survival analysis that showed adrabetadex improves survival in individuals with infantile-onset NPC and was reviewed alongside supportive biomarker and nonclinical data.

Adrabetadex previously received BTD in 2016 under a prior sponsor, and the FDA rescinded the designation based on data from a 12-month Phase 2b/3 clinical trial. Beren, through its subsidiary Mandos, acquired the adrabetadex program from Mallinckrodt in 2021 and has worked closely with the FDA and NPC community to advance adrabetadex’s development and generate the data and analyses that supported the new BTD designation.

“This newly granted designation represents an important milestone in the evaluation of adrabetadex for people living with infantile-onset NPC,” said Jason Camm, Chief Executive Officer of Beren Therapeutics P.B.C. “We are grateful to the people living with NPC and their caregivers, clinicians, and advocates who have worked with us through a long development path.”

Dr. Elizabeth Berry-Kravis, Professor of Pediatrics at Rush University Medical Center and principal EAP investigator, noted: “Infantile-onset NPC is a devastating, rapidly fatal diagnosis. Seeing statistically significant improvements in survival signals a meaningful shift in what is achievable for these patients.”

Adrabetadex also has Orphan Drug and Rare Pediatric Disease designations. Beren plans to submit an NDA in the near future and expects adrabetadex to be eligible for Priority Review.

About Niemann-Pick Disease Type C

Niemann-Pick disease type C (NPC) is a rare, autosomal-recessive, severe, neurodegenerative disorder caused by pathologic variants in the NPC1 (~95% of cases) or NPC2 genes, leading to impaired cholesterol trafficking resulting in progressive neurological decline and premature death. Infantile-onset NPC refers to NPC in individuals who first experience neurological symptoms between 0 and 6 years of age. Earlier neurological onset is associated with more rapid progression and poorer prognosis, with mean survival of ~5.6 years for early-infantile-onset (age of neurological onset <2 years) and ~13.4 years for late-infantile-onset (2 to <6 years). Individuals with early- and late-infantile-onset NPC typically present with manifestations affecting multiple organs, with the most severe and debilitating effects occurring in the brain.

About Adrabetadex (VTS-270)

Adrabetadex (VTS-270) is a proprietary mixture of 2-hydroxypropyl-β-cyclodextrin isomers under investigation as a treatment for Niemann-Pick disease type C (NPC). By re-establishing intracellular cholesterol trafficking, adrabetadex directly addresses the underlying pathology of NPC. Adrabetadex is generally well tolerated. The main adverse events associated with adrabetadex include hearing impairment that can be managed with hearing aids when necessary, and post-dose fatigue and/or ataxia.

Adrabetadex has not been approved by the FDA or any other health authority at this time.

About Beren Therapeutics P.B.C. and Mandos

Beren Therapeutics P.B.C. is a founder-led, clinical-stage biotechnology company pioneering the discovery, development, and commercialization of cyclodextrin-based therapeutics for conditions characterized by defective cholesterol trafficking.

Beren and its subsidiary, Mandos, are committed to the development of adrabetadex for individuals living with Niemann-Pick disease type C (NPC), a condition characterized by defects in intracellular cholesterol trafficking. Beren and Mandos have supported the NPC community by providing access to adrabetadex* through an Expanded Access Program (EAP). Beren will continue working closely with patients, families, researchers, regulators and others on a path to bring forth this potentially transformative, investigational therapy for NPC.

Beren is headquartered in Thousand Oaks, CA, and will launch its website out of stealth mode in Q1 2026. For more information, please visit our public-facing subsidiary Mandos.

* Adrabetadex is an investigational drug that has not been approved by the U.S. Food and Drug Administration and has not been found safe and effective to treat NPC or any other condition.

Contacts

Amanda Eckel

BGB Group

Aeckel@bgbgroup.com

Plant Breeding and CRISPR Plants Industry Trends and Market Outlook 2025-2030 – Increasing Regulatory Support for Gene-Edited Crops Spurs Adoption of CRISPR in Mainstream Plant Breeding Programs – ResearchAndMarkets.com

Plant Breeding and CRISPR Plants Industry Trends and Market Outlook 2025-2030 – Increasing Regulatory Support for Gene-Edited Crops Spurs Adoption of CRISPR in Mainstream Plant Breeding Programs – ResearchAndMarkets.com




Plant Breeding and CRISPR Plants Industry Trends and Market Outlook 2025-2030 – Increasing Regulatory Support for Gene-Edited Crops Spurs Adoption of CRISPR in Mainstream Plant Breeding Programs – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Plant Breeding and CRISPR Plants – Global Strategic Business Report” has been added to ResearchAndMarkets.com’s offering.


The global market for Plant Breeding and CRISPR Plants was valued at US$21.7 Billion in 2024 and is projected to reach US$50.1 Billion by 2030, growing at a CAGR of 15% from 2024 to 2030. This comprehensive report provides an in-depth analysis of market trends, drivers, and forecasts, helping you make informed business decisions. The report includes the most recent global tariff developments and how they impact the Plant Breeding and CRISPR Plants market.

The growth in the plant breeding and CRISPR plants market is driven by several critical factors that are transforming the agriculture and biotech industries. First, the increasing demand for food security in a world facing population growth and resource constraints is a major driver. CRISPR technology enables the development of crops that can deliver higher yields and resist environmental stressors, helping to meet the rising food demand. Advances in genetic research and biotechnology have made CRISPR more accessible and efficient, reducing the time and cost associated with developing new crop varieties.

Another factor is the growing focus on sustainable agriculture, as both consumers and governments demand more environmentally friendly farming practices. CRISPR allows for the creation of crops that require fewer inputs, such as water and fertilizers, reducing the environmental footprint of farming. Furthermore, regulatory support is playing a crucial role in the market’s expansion, as several countries are moving towards less stringent regulations for CRISPR-edited plants compared to traditional GMOs, which helps to accelerate the adoption of CRISPR technologies.

The increasing investment in agricultural biotechnology, driven by both public and private sectors, is further fueling the market’s growth. Major agricultural biotech companies, research institutions, and startups are heavily investing in CRISPR-based research to create new crop varieties with desirable traits.

Additionally, consumer preferences for healthier, non-GMO food products are influencing market dynamics, as CRISPR plants are often viewed more favorably by consumers compared to traditional GM crops. Together, these factors are creating a strong growth environment for the plant breeding and CRISPR plants market, positioning it as a key component of the future of agriculture.

Report Scope

The report analyzes the Plant Breeding and CRISPR Plants market, presented in terms of market value (US$ Thousand). The analysis covers the key segments and geographic regions outlined below.

  • Segments: Type (Conventional Breeding, Biotechnological Method); Trait (Herbicide Tolerance, Disease Resistance, Yield Improvement, Other Traits); Application (Cereals & Grains, Oilseeds & Pulses, Fruits & Vegetables, Other Applications).
  • Geographic Regions/Countries: World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; and Rest of Europe); Asia-Pacific; Rest of World.

Regional Analysis

Gain insights into the U.S. market, valued at $5.9 Billion in 2024, and China, forecasted to grow at an impressive 14.4% CAGR to reach $7.8 Billion by 2030. Discover growth trends in other key regions, including Japan, Canada, Germany, and the Asia-Pacific.

Key Questions Answered:

  • How is the Global Plant Breeding and CRISPR Plants Market expected to evolve by 2030?
  • What are the main drivers and restraints affecting the market?
  • Which market segments will grow the most over the forecast period?
  • How will market shares for different regions and segments change by 2030?
  • Who are the leading players in the market, and what are their prospects?

Report Features:

  • Comprehensive Market Data: Independent analysis of annual sales and market forecasts in US$ Million from 2024 to 2030.
  • In-Depth Regional Analysis: Detailed insights into key markets, including the U.S., China, Japan, Canada, Europe, Asia-Pacific, Latin America, Middle East, and Africa.
  • Company Profiles: Coverage of players such as Advanta Seeds, Bayer, Benson Hill Biosystems, Bioconsortia, DLF and more.
  • Complimentary Updates: Receive free report updates for one year to keep you informed of the latest market developments.

Some of the 23 companies featured in this Plant Breeding and CRISPR Plants market report include:

  • Advanta Seeds
  • Bayer
  • Benson Hill Biosystems
  • Bioconsortia
  • DLF
  • Dow, Inc.
  • DuPont de Nemours, Inc.
  • Equinom
  • Eurofins
  • Evogene
  • Groupe Limagrain
  • Hudson River Biotechnology
  • KWS
  • Land O’lakes
  • Pacific Biosciences
  • SGS
  • Syngenta

This edition integrates the latest global trade and economic shifts into comprehensive market analysis. Key updates include:

  • Tariff and Trade Impact: Insights into global tariff negotiations across 180+ countries, with analysis of supply chain turbulence, sourcing disruptions, and geographic realignment. Special focus on 2025 as a pivotal year for trade tensions, including updated perspectives on the Trump-era tariffs.
  • Adjusted Forecasts and Analytics: Revised global and regional market forecasts through 2030, incorporating tariff effects, economic uncertainty, and structural changes in globalization. Includes historical analysis from 2015 to 2023.
  • Strategic Market Dynamics: Evaluation of revised market prospects, regional outlooks, and key economic indicators such as population and urbanization trends.
  • Innovation & Technology Trends: Latest developments in product and process innovation, emerging technologies, and key industry drivers shaping the competitive landscape.
  • Competitive Intelligence: Updated global market share estimates for 2025, competitive positioning of major players (Strong/Active/Niche/Trivial), and refined focus on leading global brands and core players.
  • Expert Insight & Commentary: Strategic analysis from economists, trade experts, and domain specialists to contextualize market shifts and identify emerging opportunities.

Key Attributes

Report Attribute Details
No. of Pages 209
Forecast Period 2024-2030
Estimated Market Value (USD) in 2024 $21.7 Billion
Forecasted Market Value (USD) by 2030 $50.1 Billion
Compound Annual Growth Rate 15%
Regions Covered Global

Market Overview

  • Trade Shocks, Uncertainty, and the Structural Rewiring of the Global Economy
  • How Trump’s Tariffs Impact the Market? The Big Question on Everyone’s Mind
  • Global Economic Update
  • Plant Breeding and CRISPR Plants – Global Key Competitors Percentage Market Share in 2025 (E)
  • Competitive Market Presence – Strong/Active/Niche/Trivial for Players Worldwide in 2025 (E)

Market Trends and Drivers

  • Rising Demand for High-Yield, Climate-Resilient Crops Drives Adoption of CRISPR and Gene-Editing Technologies in Plant Breeding
  • Growing Global Focus on Food Security and Crop Optimization Expands Market for Advanced Plant Breeding Tools and CRISPR Technologies
  • Increasing Regulatory Support for Gene-Edited Crops Spurs Adoption of CRISPR in Mainstream Plant Breeding Programs
  • Emergence of CRISPR as a Game-Changer in Precision Plant Breeding Propels Demand for Gene-Editing Solutions
  • Growing Demand for Pest-Resistant and Disease-Resilient Crops Expands Market for CRISPR Applications in Plant Breeding
  • Technological Advancements in Genomics and DNA Sequencing Drive Growth in Precision Plant Breeding Using CRISPR
  • Increasing Focus on Reducing Pesticide and Herbicide Use Drives Market for Gene-Edited Crops with Built-In Pest Resistance
  • Rising Demand for Biofortified Crops to Address Nutritional Deficiencies Expands Market for CRISPR-Enhanced Plant Breeding
  • Increasing Interest in Developing Drought-Resistant and Climate-Adapted Crops Drives Growth of CRISPR Applications in Plant Breeding
  • Growing Investment in Agricultural Biotechnology and Gene Editing Expands Opportunities for CRISPR Technology in Commercial Plant Breeding
  • Increasing Consumer Demand for Non-GMO, Gene-Edited Crops Spurs Growth of CRISPR Plant Breeding Solutions
  • Advances in Molecular Breeding Techniques and Marker-Assisted Selection Expand Applications of CRISPR in Plant Genetics

For more information about this report visit https://www.researchandmarkets.com/r/vg1d9p

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
For E.S.T Office Hours Call 1-917-300-0470

For U.S./ CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

New Frontiers for Early-life Nutrition: All G and Armor Protéines Announce Joint Venture to Scale Human and Bovine Lactoferrin as All G Closes A$10 Million Round

New Frontiers for Early-life Nutrition: All G and Armor Protéines Announce Joint Venture to Scale Human and Bovine Lactoferrin as All G Closes A$10 Million Round




New Frontiers for Early-life Nutrition: All G and Armor Protéines Announce Joint Venture to Scale Human and Bovine Lactoferrin as All G Closes A$10 Million Round

SYDNEY–(BUSINESS WIRE)–Australian biotech All G has raised over A$10 million in a convertible note round ahead of its Series B raise, injecting additional capital for commercial-scale production of its first bovine lactoferrin product due to launch in Q1 2026.


In parallel, All G and French global bioactives leader Armor Protéines have established a joint venture (JV) to produce and commercialise human and bovine lactoferrin.

One of the most powerful functional milk proteins, lactoferrin’s antimicrobial properties and ability to support iron absorption have led to applications across infant nutrition, nutraceuticals, personal care, and therapeutics.

The JV will combine All G’s world-leading precision fermentation platform and deep scientific capabilities, with Armor Protéines’ expertise in high-value, bioactive functional milk proteins, to transform how lactoferrin is made, purchased and consumed. The inclusion of human lactoferrin in the JV represents a pathway to creating infant formulas that more closely reflect the protein profile of breast milk.

A new way to meet global lactoferrin demand

Lactoferrin is a multifunctional protein found in both human and cow’s milk. It offers health benefits across the lifespan, playing critical roles in immune function, iron homeostasis, and gastrointestinal and dermatological health.

Lactoferrin is traditionally extracted from cow’s milk, requiring thousands of litres of milk to yield just one kilogram of lactoferrin. As a result, lactoferrin remains one of the most expensive functional ingredients and is used only in a limited proportion of infant formula products, primarily in premium and super premium formulations.

The development of recombinant lactoferrin as an alternative to animal-based production has long been constrained by technical barriers – notably replicating native glycosylation patterns and achieving yields sufficient for commercial viability. All G has overcome these hurdles, enabling the production of lactoferrin with high purity, consistent quality, scalable production, and ultimately greater global accessibility.

Bringing human milk proteins to market

All G’s human lactoferrin will be bio-equivalent to the native form with greater than 95% purity. As the company’s first recombinant human milk protein, it marks a step toward improving early life nutrition, bringing infant formula closer to the composition of human milk.

Armor Protéines’ deep expertise in bioactives, large-scale ingredient manufacturing and commercialization of infant formula ingredients, and long-standing relationships with world-leading nutrition companies position the JV to scale human lactoferrin production rapidly and reliably across global nutrition markets.

Progressing quickly to commercial launch

Pilot-scale production of All G’s recombinant bovine lactoferrin is already complete. The company has already self-affirmed GRAS status for adult nutrition sales in the US and approval for personal care sales in China, with further filings underway.

About All G

All G is an Australian biotech developing next-generation human and bovine milk proteins using precision fermentation technology. Focusing on high-value recombinant proteins, the company has filed multiple patents covering its proprietary compositions and processes, including micelle assembly, scalable manufacture, and applications in human milk compositions.

All G’s first product, a bovine lactoferrin powder, will launch in late 2025 and will be followed by human lactoferrin in early 2026.

About Armor Protéines

Armor Protéines, a subsidiary of Savencia Fromage & Dairy, is a global producer of lactoferrin, supplying high-purity proteins to the infant formula, adult nutrition, and health supplement industries for over 30 years. Armor Protéines’ long-standing customer relationships, scientific expertise and deep experience in distribution make it a preferred partner for next-generation nutrition ingredients.

Contacts

ALL G CO PTY LIMITED

723-725 ELIZABETH ST WATERLOO NSW AUSTRALIA 2017

shae@allg.com

Hims & Hers Brings Comprehensive Weight Loss Programme to the UK

Hims & Hers Brings Comprehensive Weight Loss Programme to the UK




Hims & Hers Brings Comprehensive Weight Loss Programme to the UK

Expansion Debuts Hers, Unlocking Personalised Care for British Women

LONDON–(BUSINESS WIRE)–Hims & Hers is deepening its commitment to the UK by bringing access to its comprehensive Weight Loss Programme to customers. This expansion includes the official introduction of the Hers platform, helping eligible women across the UK receive access to this holistic weight management care.




Sixty four percent of UK adults are overweight or living with obesity, yet access to GLP-1 treatment plans remains challenging on the NHS, and via the private sector due to surging demand and escalating costs. Removing barriers to care, the Hims & Hers digital platform provides eligible British women and men seamless access to its comprehensive, doctor-designed Weight Loss Programme.

Following a thorough, and clinically robust intake assessment conducted by GMC-registered doctors, eligible customers now have access to transparent pricing and personalised weight management programmes, which may include branded GLP-1 options, such as Mounjaro or Wegovy, and the oral non-prescription treatment option, Orlos. Licensed clinicians assess each individual’s medical history, suitability, and contraindications to guide appropriate treatment decisions. Critically, all customers have access to comprehensive support, including 24/7 care team access and content to help improve nutrition, movement, and sleep-based habits along their weight loss journey. This holistic programme is designed to support long-term health, helping customers manage their weight and adopt sustainable lifestyle habits.

Now for the first time through Hers, women in the UK deemed clinically suitable can access a new standard of weight management care that blends convenience with personalised support at every step of their journey. Hers’ customers receive ongoing clinician support through follow-ups and asynchronous messaging, along with treatment adjustments when necessary, keeping care seamless, conversational, and customer-centered. Hers is more than just a telehealth platform; it’s where clinical experience meets thoughtful care, resetting women’s expectations and standards for comprehensive and convenient care.

“The launch of Hims & Hers’ comprehensive Weight Loss Programme and the vital introduction of the Hers platform, our dedicated platform for women, represents a significant deepening of our commitment to the UK,” said David Meinertz, GM International of Hims & Hers. “Our doctor-designed treatment plans will complement the NHS by providing accessible, evidence-based, and sustainable long-term weight management care to those who need it, discreetly and conveniently. Our proven model is grounded in clinical excellence, oversight, and convenience, ensuring that every customer receives the thoughtful, thorough, and high-quality care they deserve.”

“Obesity is a global epidemic, and the scale of the challenge in the UK requires a comprehensive solution that prioritises long-term health over quick fixes,” said Craig Primack MD, Head of Weight Loss at Hims & Hers. “Bringing our trusted, comprehensive approach to the UK will help people lead fuller and healthier lives. And with the launch of the Hers platform, we are ensuring women have access to the dedicated, personalised care they need. Pairing clinically-proven treatments like GLP-1s with holistic support across nutrition and exercise helps make sustainable weight management achievable for the millions battling obesity today.”

Launching its Weight Loss Programme marks the company’s continued progress in its mission to make personalised care accessible to millions of people across the UK. Hims & Hers plans to continue to expand into more offerings as demand for access to personalised care continues to grow.

About Hims & Hers Health, Inc

Hims & Hers is the leading health and wellness platform on a mission to help the world feel great through the power of better health. We believe how you feel in your body and mind transforms how you show up in life. That’s why we’re building a future where nothing stands in the way of harnessing this power. Hims & Hers normalises health & wellness challenges—and innovates on their solutions—to make feeling happy and healthy achievable. No two people are the same, so the company provides access to personalised care designed for progress. For more information, please visit www.forhims.co.uk and www.forhers.co.uk

Cautionary Note Regarding Forward-Looking Statements

This communication includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements can be identified by the use of forward-looking terminology, including the words “believes,” “estimates,” “anticipates,” “expects,” “intends,” “plans,” “assume,” “may,” “will,” “likely,” “potential,” “projects,” “predicts,” “continue,” “goal,” “strategy,” “future,” “forecast,” “target,” “outlook,” “opportunity,” “project,” “confidence,” “foundation,” “groundwork,” or “should,” or, in each case, their negative or other variations or comparable terminology. There can be no assurance that actual results will not materially differ from expectations. Such statements include, but are not limited to, statements regarding our launch and expansion of the program, the introduction of the Hers platform in the UK, our expectations regarding customer adoption and subscriber growth, the pricing and availability of GLP-1 or other treatment options, our market opportunity in the UK, the growth of our weight management offering internationally, and our ability to comply with applicable legal, regulatory, and clinical requirements in the UK and other markets. These statements are based on management’s current expectations, but actual results may differ materially due to various factors.

Forward-looking statements are neither historical facts nor assurances of future performance. Instead, the forward-looking statements contained in this communication are based on our current expectations, assumptions, and beliefs concerning future developments and their potential effects on us. Future developments affecting us may not be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) and other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the performance and acceptance of our weight loss specialty in the UK; our ability to successfully launch and scale the Hers platform in the UK; uncertainties relating to the availability, pricing, or supply of GLP-1 medications; changes in medical guidelines or regulatory requirements in the UK; competitive developments; operational and marketing costs; the impact of macroeconomic conditions on consumer demand; and other factors described in the Risk Factors and other sections of our most recently filed Quarterly Report on Form 10-Q, our most recently filed Annual Report on Form 10-K, and other reports we file from time to time with the Securities and Exchange Commission.

Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. The forward-looking statements contained in this communication are made only as of December 10, 2025. We undertake no obligation (and expressly disclaim any obligation) to update or revise any forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required under applicable securities laws. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. We caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from those made in or suggested by the forward-looking statements in this communication.

Contacts

Susan Cadrecha

press@forhims.com

Poxel Publishes Its Financial Results for the First Half of 2025

Poxel Publishes Its Financial Results for the First Half of 2025




Poxel Publishes Its Financial Results for the First Half of 2025

  • Revenue nearly doubled (+88%) and net loss reduced to €2.6 million in the first half of 2025
  • Change in governance on August 1, 2025, following the filing of a declaration of insolvency and a request to open receivership proceedings with the Lyon Commercial Court (Tribunal des activités économiques)
  • Commencement of receivership proceedings decided at the hearing on August 5, 2025, with a six-month observation period running until February 5, 2026
  • Poxel’s recovery plan, now finalized, is subject to the decision of the Lyon Commercial Court, which is expected early 2026
  • The Statutory Auditors are expected to issue a disclaimer opinion (impossibilité de certifier) regarding Poxel’s 2025 half-year condensed financial statements, given the pervasive uncertainty that could call into question the going concern assumption resulting from the aforementioned receivership proceedings – their report will be issued on Poxel’s website at a later date
  • As a reminder, the shareholders’ general meeting will be held on December 11, 2025

LYON, France–(BUSINESS WIRE)–Regulatory News:


POXEL SA (Euronext: POXEL – FR0012432516), a clinical-stage biopharmaceutical company developing innovative treatments for serious chronic diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare metabolic diseases (the “Company“), announces today its condensed consolidated half-year financial results for the period ended June 30, 2025 and provides an update on recent events ahead of its annual general meeting on December 11, 2025.

First Half 2025 Consolidated Financial Statements (IFRS Standards)

Income statement (limited review procedures by auditors still ongoing)

EUR (in thousands)

H1 2025

6 months

H1 2024

6 months

Revenue

2,183

1,162

Costs of sales

(1,877)

(1,146)

Gross margin

306

16

Net research and development expenses*

(508)

(521) *

General and administrative expenses

(1,762)

(3,205)

Operating income (loss)

(1,964)

(3,710)

Financial income (loss)

(653)

(3,548)

Income tax

Net income (loss)

(2,617)

(7,258)

*Net of R&D tax credit.

Poxel generated revenue of €2.183 million in the first half of 2025, compared to €1.162 million during the same period in 2024, corresponding mainly to ¥345 million in royalties received from Sumitomo Pharma, representing 10% of net sales of TWYMEEG® in Japan for the first quarter and 8% for the second quarter of 2025.

Cost of sales amounted to €1.877 million as of June 30, 2025, corresponding to the 8% royalties on net sales of Imeglimine in Japan due to Merck Serono, under the Merck Serono license agreement.

Net R&D expenses amounted to €508 thousand for the first half of 2025, compared to €521 thousand for the same period in 2024.

General and administrative expenses amounted to €1.762 million for the first half of 2025, compared to €3.205 million for the same period in 2024, reflecting in particular the cost-saving plan implemented by the Company.

The financial result was negative at €653 thousand for the first half of 2025, compared with a loss of €3.548 million in the first half of 2024. This is mainly due to interest on the Company’s indebtedness (€5.037 million), offset by a foreign exchange gain related to the valuation of the OrbiMed debt at the close of June 30, 2025 (€4.317 million).

The net loss for the financial period ending June 30, 2025, came to €2.617 million, compared with a net loss of €7.258 million for the corresponding half-year period in 2024.

The Company will make the half-year financial report available after the limited review procedures have been completed, enabling the Statutory Auditors to issue their report, in which they are expected to state that they are unable to conclude on the condensed consolidated half-year financial statements due to significant uncertainty that may call into question the Company’s ability to continue as a going concern.

Context for the preparation of the condensed consolidated half-year financial statements as of June 30, 2025

Following the commencement of receivership proceedings on August 5, 2025, the Company will continue to operate during the six-month observation period (starting August 5, 2025), with financing provided by IPF Partners under the following conditions:

  • temporary waiver, for the observation period, of the current defaults under the IPF agreement preventing the release of tranche D;
  • provision of a portion of tranche D in increments of €500,000 up to a maximum amount of €2.5 million, with the objective of covering cash requirements for the observation period ending February 5, 2026. These drawdowns are conditional upon the presentation of justified financing requirements.

This situation creates significant uncertainty about the Company’s ability to continue as a going concern beyond this point, as it does not currently have sufficient financial resources to cover a twelve-month period.

On December 9, 2025, the Board of Directors approved the Company’s condensed consolidated financial statements for the six months ended June 30, 2025, in accordance with the going concern principle, based on the assumption that the continuation plan developed by the Company with the support of its long-standing financial partner IPF, which was presented in the press release dated November 24, 2025, will be deemed sufficient and approved by all parties concerned, including the shareholders meeting on December 11, 2025, to approve, in particular, the financial delegations necessary to implement the plan and obtain new sources of financing.

As previously indicated in connection with the approval of the financial statements for the year ended December 31, 2024, due to the uncertainties surrounding the going concern of the Company, which is currently in receivership, and after the completion of their limited review procedures, the Statutory Auditors will issue their report in which they are expected to express their inability to conclude on the condensed consolidated half-year financial statements.

Significant events after the balance sheet date

Commencement of receivership proceedings

On July 29, 2025, POXEL announced in a press release that it had filed for receivership with the Lyon Commercial Court (Tribunal des activités économiques de Lyon) and requested the commencement of receivership proceedings.

Following a hearing held on August 5, 2025, the Lyon Commercial Court decided to initiate receivership proceedings.

The Company will continue to operate during the six-month observation period, in accordance with legal provisions. During this period, POXEL will examine all options that would enable it to continue its activities, including a continuation plan.

Change in governance

At its meeting on July 31, 2025, the Company’s Board of Directors decided to replace them individually by co-optation, with immediate effect, with the following new directors:

  1. Sophie Jacq Lapointe;
  2. Nicolas Trouche, also appointed Chief Executive Officer, replaced on October 31, 2025 by Yves Decadt;
  3. Amit Kohli;
  4. Alexandre Bragadir.

These co-optations will be submitted for ratification at the Company’s next Annual General Meeting of Shareholders, scheduled for December 11, 2025.

Appointment of Yves Decadt as member of Poxel’s Board of Directors

On October 31, 2025, POXEL announced the appointment of Yves Decadt as a member of the Board of Directors, with the prior resignation of Nicolas Trouche from his position as director in order to comply with the minimum proportion of directors of each gender.

Yves Decadt has over 25 years of international experience in the pharmaceutical industry. He spent nearly 20 years at Johnson & Johnson in the international business development department, where he was responsible for licensing and agreement negotiations, particularly in Asia. He has also held several management positions at renowned biopharma and medtech companies. Yves brings to Poxel both scientific and strategic expertise, as well as access to a vast international network. Under a consulting agreement, Yves has been working with the POXEL teams since August 2025 on ongoing partnership discussions and on evaluating the commercial development potential of Poxel’s key assets.

TWYMEEG® sales for the quarter ended September 30, 2025

For the quarter ended September 30, 2025, gross sales of TWYMEEG® in Japan reached ¥2.6 billion (€15 million1), compared to ¥1.8 billion (€11.4 million) for the third quarter of 2024.

As a reminder, for the full financial year 2025, Sumitomo Pharma forecasts gross sales of TWYMEEG® of ¥11.2 billion (€64.4 million4), which would represent an increase of 47% compared to 2024.

Based on these forecasts for financial year 2025, TWYMEEG® would therefore reach the milestone of net sales of ¥10 billion (€57.5 million), enabling Poxel to receive royalties of 12% on all net sales of TWYMEEG® as well as a second payment of ¥1 billion (€5.8 million3) based on sales. However, in accordance with the monetization agreement entered into with OrbiMed, these cash flows will be allocated in full to the repayment of the bond loan. Beyond 2025, Poxel anticipates double-digit royalty growth and additional payments contingent upon the achievement of contractual milestones. However, in accordance with the monetization agreement entered into with OrbiMed, these cash flows will be allocated entirely to the repayment of the bond loan.

Finalization of the recovery plan

Poxel’s draft recovery plan has been finalized and remains subject to the decision of the Lyon Commercial Court. As a reminder, Poxel has a new management team and a board of directors with experience in biotech, whose role is to implement the draft recovery plan. This includes Yves Decadt who has conducted a strategic review of Poxel’s portfolio to help develop this draft plan, whose priorities in terms of commercial development are as follows:

  • Establish new partnerships to commercialize Imeglimine in Asia, with priority given to China and countries that do not require new clinical studies;
  • Promote PXL770 in ADPKD; and
  • Promote PXL065 in HCM.

Poxel’s new management team is fully committed to implementing this recovery plan and seeking partnerships to monetize Poxel’s assets in order to recreate value for the Company’s shareholders.

Annual General Meeting of the Company to be held this Thursday, December 11, 2025

As a reminder, on November 5, 2025, Poxel published a meeting notice and on November 26, 2025, a notice of meeting to convene its shareholders on December 11, 2025, for its Annual General Meeting, to decide, in particular, on the 2024 annual and consolidated financial statements, as well as on various financial delegations to the Board of Directors, some of which are intended to enable the implementation of certain capital transactions aimed at strengthening the Company’s financial structure in order to support its business plan.

The full text of the resolutions submitted to the shareholders’ meeting of December 11, 2025, was published in the Bulletin des Annonces Légales Obligatoires (BALO) No. 142 of November 26, 2025.

All preparatory documents and information relating to this General Meeting are available to shareholders in accordance with legal and regulatory requirements and can be found on the Company’s website, under the heading “General Meeting.”

In accordance with current regulations, Poxel shareholders may cast their votes prior to the General Meeting from November 26, 2025, by mail, proxy, or electronically, in accordance with the procedures set out in the meeting notice published in the BALO on November 5, 2025, as reproduced in the notice of meeting published on November 26, 2025.

The option to vote or grant proxy electronically is available via the secure voting platform Votacess, which will open on November 26, 2025, at 9:00 am (Paris time) and close on December 10, 2025, at 3:00 pm (Paris time).

Voting instructions are also detailed in the practical guide available to shareholders on the Company’s website.

For any questions regarding voting procedures, you may contact the Investor Relations team by email: investors@poxelpharma.com.

Shareholders willing to follow the General Meeting but unable to attend in person are invited to connect via the following link (the General Meeting will be held in French): click here.

About Poxel SA

Poxel is a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare disorders. For the treatment of MASH, PXL065 (deuterium-stabilized Rpioglitazone) met its primary endpoint in a streamlined Phase 2 trial (DESTINY-1). In rare diseases, development of PXL770, a first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator, is focused on the treatment of adrenoleukodystrophy (ALD) and autosomal dominant polycystic kidney disease (ADPKD). TWYMEEG® (Imeglimin), Poxel’s first-in-class product that targets mitochondrial dysfunction, is now marketed for the treatment of type 2 diabetes in Japan by Sumitomo Pharma and Poxel expects to receive royalties and 5 sales-based payments. Poxel has a strategic partnership with Sumitomo Pharma for Imeglimin in Japan. Listed on Euronext Paris, Poxel is headquartered in Lyon, France, and has subsidiaries in Boston, MA, and Tokyo, Japan.

For more information, please visit: www.poxelpharma.com

All statements other than statements of historical fact included in this press release concerning future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, but are not limited to, any statements preceded, followed or including words such as “objective,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “may have,” “likely,” “should,” “could” and other words and terms of similar meaning, or the negative form of these words and terms. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results or performance to differ materially from the results or performance expected, expressed or implied in such forward-looking statements. Actual events or results may differ from those described in this document due to a number of risks or uncertainties described in the Company’s 2024 Universal Registration Document available on the Company’s website and on the website of the AMF (https://www.amf-france.org/fr). The Company does not endorse or accept responsibility for the content of external hyperlinks mentioned in this press release.

This press release is for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to purchase securities in any jurisdiction.

Glossary

You will find below a list of words and/or expressions that are used in this press release or in Poxel’s communication, with the aim to bring clarification and transparency:

  • Sumitomo Pharma financial year runs April to March. As an example, Financial Year 2025 is April 1, 2025, through March 31, 2026.
  • TWYMEEG® royalties: As per the Sumitomo Pharma’s agreement, Poxel is entitled to receive royalties from the sales of TWYMEEG® (Imeglimin) in Japan

    • Sumitomo Pharma communicates gross sales of TWYMEEG®, while TWYMEEG® royalties are calculated on net sales.
    • Net sales represent the amount of gross sales to which are deducted potential rebates, allowances, and costs such as prepaid freight, postage, shipping, customs duties and insurance charges.
    • Poxel is entitled to receive escalating royalties of 8-18% on TWYMEEG® net sales from Sumitomo Pharma.
  • Positive net royalties: as part of the Merck Serono licensing agreement, Poxel 6 will pay Merck Serono a fixed 8% royalty based on the net sales of TWYMEEG®, independent of the level of sales. All royalties that Poxel receives from TWYMEEG® net sales above that 8% level are considered as positive net royalties. Net royalties will therefore be positive for Poxel when TWYMEEG® net sales exceed JPY 5 billion in a financial year and royalties reach 10% and above.

1 Based on an exchange rate of 1 euro to 173.8 yen as of September 30.

4 Sumitomo Pharma’s 2025 financial year ends on March 31, 2026.

Contacts

Contacts – Investor relations / Media

NewCap

Théo Martin / Arthur Rouillé

investors@Poxelpharma.com
+33 1 44 71 94 94

Polpharma Biologics and Libbs Farmacêutica Sign Licensing Agreement for a Biosimilar for Autoimmune Diseases

Polpharma Biologics and Libbs Farmacêutica Sign Licensing Agreement for a Biosimilar for Autoimmune Diseases




Polpharma Biologics and Libbs Farmacêutica Sign Licensing Agreement for a Biosimilar for Autoimmune Diseases

ZUG, Switzerland–(BUSINESS WIRE)–Polpharma Biologics, a leading biopharmaceutical company specializing in the development and manufacturing of biosimilars, is thrilled to announce the signing of a landmark licensing agreement with the Brazilian company Libbs Farmacêutica! Through this strategic partnership, Libbs Farmacêutica will gain exclusive rights to commercialize a cutting-edge biosimilar for autoimmune diseases in the rapidly growing Brazilian market.


Polpharma Biologics retains full responsibility for the development and manufacturing of the biosimilar. Libbs Farmacêutica will hold an exclusive license for the commercialization, marketing and distribution of the biosimilar in Brazil. This collaboration opens up exciting new opportunities and demonstrates the shared commitment of both companies to delivering innovative and accessible therapies to patients.

“Entering the Brazilian market with a biosimilar is a significant step for Polpharma Biologics and reflects our ongoing mission to expand access to high-quality, affordable biological treatments worldwide,” said Anjan Selz, CEO of Polpharma Biologics. “Our collaboration with Libbs Farmacêutica, a company with deep knowledge of the Brazilian market, provides us with strong commercial expertise. Combined with our development and manufacturing capabilities, this partnership will significantly increase access to biological therapies for people in Brazil who are living with autoimmune diseases.”

“We currently treat more than 15 million patients with our products. This partnership with Polpharma Biologics is fully aligned with Libbs’ strategy of investing in a diversified portfolio of medicines with potential to further expand the Brazilian population’s access to healthcare,” says Alcebíades de Mendonça Athayde Junior, CEO of Libbs.

This modern therapy offers an effective and well-tolerated option for patients living with autoimmune conditions. The biosimilar medicine is still under development and is expected to be submitted to Anvisa for approval within three years.

About Polpharma Biologics

Polpharma Biologics is a biopharmaceutical company focused on the development and manufacturing of biopharmaceuticals and biosimilars for global markets. Our Swiss-based biosimilars-focused entity manages the entire value chain: from product selection and investment allocation to program execution to asset monetization. This ensures rapid progress from concept to launch in close collaboration with our global partners.

Polpharma Biologics’ biosimilar portfolio includes a range of high-value programs spanning early development to commercial stages. Our international team of senior experts has extensive experience in program leadership, regulatory strategy, CMC integration, device development, clinical oversight, and quality assurance. By working with trusted CDMOs, we provide end-to-end biosimilars, from cell line development to finished products, across a variety of major therapeutic areas. Our commercial partners help ensure that patients worldwide gain access to these medicines.

Our mission is to accelerate access to biologics. To achieve this, we maintain a robust and expanding pipeline of biosimilars in development. More information: https://polpharmabiologics.com/

About Libbs

Libbs is a 100% Brazilian pharmaceutical company with the purpose of transforming knowledge into health. To offer high-quality products and solutions, we work collaboratively in a process of continuous improvement and invest in research and innovation. With 67 years of history and 4,000 employees, we have been, for the eighth consecutive year, among the best companies to work for in Brazil, according to GPTW (Great Place to Work). Our specialties include cardiology, dermatology, gastroenterology, gynecology, hematology, oncology, central nervous system, and respiratory system.

In 2024, we brought healthcare to more than 15 million people through a portfolio comprising 97 product brands in over 200 presentations, across reference, similar, chemotherapeutic, and biosimilar (monoclonal antibodies) categories. Our Biotec is the first industrial-scale monoclonal antibody plant in Brazil, and, in 2024, it gained a Pilot Plant dedicated to the development of biomolecules, scaling up bioprocesses, and producing clinical material for studies through partnerships or as a CDMO.

We invest approximately 10% of our revenue in R&D and maintain initiatives such as the Research Incentive Program (PIP), which supports independent clinical studies. We support causes and campaigns that guide the population regarding prevention, early diagnosis, and treatment. We are always open to developing new partnership projects. More information can be found at www.libbs.com.br.

Contacts

Rupert Birkett-Eyles

Rupert.birketteyles@ruderfinn.com
+44(0) 7876163218

Biocytogen Completes STAR Market IPO, Becoming the First “H+A” Global Drug Innovator

Biocytogen Completes STAR Market IPO, Becoming the First “H+A” Global Drug Innovator




Biocytogen Completes STAR Market IPO, Becoming the First “H+A” Global Drug Innovator

BEIJING & SHANGHAI & HONG KONG–(BUSINESS WIRE)–Biocytogen (Beijing) Pharmaceutical Technology Co., Ltd. (“Biocytogen,” SSE: 688796; HKEX: 02315), a global biotechnology company advancing innovative drug discovery, today announced its successful listing on the Shanghai Stock Exchange STAR Market. This follows the Company’s listing on the Hong Kong Stock Exchange in September 2022 and marks a significant milestone in establishing Biocytogen as the first “H+A” dual-listed global drug innovator, reinforcing its mission to become the global headstream of new drugs.




The Company’s IPO price was set at 26.68 RMB per share, with an opening price of 58 RMB, representing a 117% increase over the offering price. Based on the opening price, Biocytogen’s market capitalization exceeds 25.9 billion RMB.

Biocytogen’s proprietary RenMice® platforms (RenMab™, RenLite®, RenNano®, RenTCR-mimic™) enable the discovery of fully human monoclonal, bispecific, multispecific, ADC, VHH, and TCR-mimic antibodies across more than 1,000 druggable targets. Leveraging a library of over one million authentic antibody sequences, these platforms provide partners with grab-and-go access to high-quality therapeutic molecules—significantly accelerating antibody drug discovery timelines. To date, the Company has advanced more than 40 PCC-to-IND stage assets and established over 280 global discovery partnerships, including more than 10 clinical or near-clinical programs successfully out-licensed. Complementing this, Biocytogen offers a globally leading portfolio of more than 4,390 off-the-shelf target-humanized mouse models, supporting the preclinical evaluation of bispecific antibodies, antibody–drug conjugates (ADCs), nucleic acid–based therapeutics, and other innovative modalities.

The successful STAR Market listing positions Biocytogen for further global expansion, platform commercialization, and strategic capital deployment. Leveraging the synergies of its “H+A” dual-listing structure, the Company will continue deepening collaborations with international partners, strengthening its technology platforms, and driving the discovery of novel therapies to benefit global healthcare.

About Biocytogen

Biocytogen (HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Founded on gene editing technology, Biocytogen leverages genetically engineered proprietary RenMice® platforms for fully human monoclonal/bispecific/multispecific antibody discovery, bispecific antibody-drug conjugate discovery, nanobody discovery and TCR mimic antibody discovery, and has established a sub-brand, RenBiologics™, to explore global partnerships for an off-the-shelf library of >1,000,000 fully human antibody sequences against over 1000 targets for worldwide collaboration. As of June 30, 2025, approximately 280 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements and over 50 target-nominated RenMice® licensing projects have been established around the globe, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen pioneered the generation of drug target knock-in humanized models for preclinical research, and currently provides a few thousand off-the-shelf animal and cell models under the company’s sub-brand, BioMice™, along with preclinical pharmacology and gene-editing services for clients worldwide. Headquartered in Beijing, Biocytogen has branches in China (Haimen Jiangsu, Shanghai), USA (Boston, San Francisco, San Diego), and Germany (Heidelberg). For more information, please visit https://biocytogen.com.

Contacts

Biocytogen Contact
Media: pr@bbctg.com.cn

Oncolytics Biotech® Reschedules Special Meeting of Shareholders to Change Jurisdiction of Incorporation to Nevada

Oncolytics Biotech® Reschedules Special Meeting of Shareholders to Change Jurisdiction of Incorporation to Nevada




Oncolytics Biotech® Reschedules Special Meeting of Shareholders to Change Jurisdiction of Incorporation to Nevada

SAN DIEGO–(BUSINESS WIRE)–Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced it has filed an amended registration statement on Form F-4 (the “Registration Statement”) with the Securities and Exchange Commission (the “SEC”) that includes a management circular/prospectus and other relevant documents related to various proposals contained therein, and that the Registration Statement has been declared effective by the SEC. The Company has rescheduled its special meeting of shareholders (the “Special Meeting”), as described in previous news releases, to January 15, 2026 at 10:00 a.m. (Eastern Time). The record date for shareholders entitled to attend and vote at the Special Meeting is December 9, 2025.


The Special Meeting will be held to vote on, among other things, a series of transactions that will change the jurisdiction of Oncolytics from the Province of Alberta in Canada to the State of Nevada in the United States of America (the “Domestication”). In order to facilitate the Domestication, the Company expects to, prior to the Domestication, continue its existence from the Province of Alberta to the Province of British Columbia (the “Continuance”). The Continuance and the Domestication require approval by the affirmative vote of not less than two-thirds of the votes cast at the Special Meeting by proxy or in person. If approved, the Domestication is expected to occur on or around April 1, 2026. There are not expected to be any material changes to the Company’s operations or financial results as a result of the Continuance or Domestication. The Company will continue to be subject to SEC reporting requirements and, as applicable, Canadian securities laws, and its common equity securities will continue to trade on the Nasdaq Capital Market under the symbol “ONCY.” In connection with the Domestication, shareholders will also be asked to vote on a proposal approving a new incentive award plan.

The Domestication is intended to reduce the regulatory burden and cost of being subject to the laws and regulations of both the United States and Canada and to facilitate shareholder value creation over the long term by, among other things, reducing operating costs and enabling the Company to compete effectively in raising the capital necessary to continue to implement the strategic plan. In addition, most of the Company’s operations are located in the United States, and a large percentage of shareholders are located in the United States. Oncolytics chose the State of Nevada to be the proposed domicile because of its favorable corporate environment and because the Nevada Revised Statutes expressly accommodate a continuance authorized by the Business Corporations Act (British Columbia). Canadian income tax liability considerations were taken into account as well.

Additional details about the Special Meeting and proposals are included in the Registration Statement and in the definitive management circular/prospectus filed with the SEC, as well the Company’s other definitive meeting materials, each of which will be distributed to shareholders eligible to vote at the Special Meeting and in relevant regulatory filings. The Company encourages all shareholders to review this information when it is available.

About Oncolytics Biotech Inc.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically “cold” tumors “hot” through the activation of innate and adaptive immune responses.

The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic pancreatic and breast cancers, of which both development programs have received Fast Track designation from the FDA, and other gastrointestinal tumors. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: www.oncolyticsbiotech.com or follow the Company on social media on LinkedIn and on X @oncolytics.

Additional Information and Where to Find It

The Company has filed the Registration Statement, a definitive management circular/prospectus and other relevant documents in connection with the proposed Continuance and Domestication. ONCOLYTICS SHAREHOLDERS ARE URGED TO READ CAREFULLY THESE DOCUMENTS, WHEN FILED AND MAILED, BECAUSE THEY CONTAIN AND WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED CONTINUANCE AND DOMESTICATION. Investors may obtain a free copy of the management circular/prospectus and other filings containing information about Oncolytics and the proposed Continuance and Domestication from the SEC at the SEC’s website at http://www.sec.gov. In addition, copies of the management circular/prospectus and other filings containing information about Oncolytics and the proposed Continuance and Domestication can be obtained without charge by directing a request to Oncolytics Biotech Inc., Suite 804, 322 11th Avenue SW, Calgary, Alberta T2R 0C5 (telephone (403) 670-7377) or accessing them on the Company’s corporate website at www.oncolyticsbiotech.com.

Oncolytics, its directors, executive officers, certain other members of management and employees may be deemed to be participants in the solicitation of proxies from the shareholders of Oncolytics in favor of the proposed Continuance and Domestication. In addition, Oncolytics has engaged Laurel Hill Advisory Group to aid in the solicitation of proxies for the Special Meeting, and Laurel Hill Advisory Group may solicit proxies by personal interview, mail, telephone, facsimile, email or otherwise. Oncolytics will pay Laurel Hill Advisory Group approximately CAD $35,000 for its proxy solicitation services, plus reasonable out-of-pocket expenses incurred in the process of soliciting proxies. Solicitations also may be made by mail, email, personal interview, telephone or other electronic transmission by directors, officers and other employees of Oncolytics without additional compensation.

Additional information regarding the interests of potential participants in the proxy solicitation is included in the management circular/prospectus and other relevant documents that the Company has filed and intends to file with the SEC in connection with the Special Meeting.

Forward-looking statements

This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding the Company’s intention to hold a special meeting of shareholders to vote on, among other things, the Continuance, Domestication, and new incentive award plan, including the timing of the special meeting; the timing, implementation and adoption of the Continuance, Domestication, and new incentive award plan; the anticipated benefits of the Continuance and the Domestication; beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; Oncolytics’ plan to continue actively pursuing strategic partnerships; its goals, strategies and objectives; and its belief in the clinical promise of pelareorep in metastatic pancreatic and other gastrointestinal cancers. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, market dynamics and the impact of any prolonged shutdown of the U.S. government. Please refer to Oncolytics’ public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law.

Contacts

Company Contact
Jon Patton

Director of IR & Communication

jpatton@oncolytics.ca

Investor Relations for Oncolytics
Mike Moyer

LifeSci Advisors

+1-617-308-4306

mmoyer@lifesciadvisors.com

Media Contact for Oncolytics
Owen Blaschak

LifeSci Communications

oblaschak@lifescicomms.com