Company Category: CRO

BioDuro

BioDuro, an Advent International portfolio company is a trusted, leading contract research development, and manufacturing organization (CRDMO) for 30 years. We provide our biotech and pharmaceutical partners with fully integrated services to support their efforts from target identification through to commercial drug product manufacturing. The company is based in the US with operations in China, totaling 2,000+ scientists and 7 global sites across 6 cities. Core expertise includes small and large molecule discovery, development and scale-up, support for IND submission, and unique technology platforms such as bioavailability enhancement of insoluble compounds. The one-stop-shop operation helps biotech and pharma partners across the globe to significantly accelerate discovery and de-risk development to create higher value outcomes. We adhere to one global highest standard of compliance and business operation code. Science-driven, customer-oriented, flexible, people-focused culture enables us to provide top-tier integrated, fast and flexible tailored services to our customers to meet their unique needs and accelerate our development timeline. For more information about BioDuro, please visit our website at www.bioduro-sundia.com | BioDuro, an Advent portfolio company, is a CRDMO with a 30-year proven track record. Headquartered in Irvine, California, BioDuro employs more than 2,000 scientists with deep expertise in small- and large-molecule discovery, development, and manufacturing. We provide fully integrated drug discovery services spanning chemistry, biology, and pharmacokinetics (DMPK), along with comprehensive IND-enabling capabilities, including both drug substance and drug product development.

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Axcelead Drug Discovery Partners, Inc.

Axcelead Drug Discovery Partners is an integrated solutions provider in drug discovery and non-clinical research. We are uniquely positioned having carved out a Preclinical R&D Discovery Unit from Takeda Pharmaceuticals. We preserved the talent, the tools, the Pharma origin compound library and Legacy Data under the same roof. Our scientific team is pioneering disruptive and differentiated discovery solutions for diseases with high unmet needs. Axcelead’s integrated solution span the drug discovery continuum from early-stage exploration studies to candidate optimization and even a bridge process to clinical development. For example, hit identification service using pharma origin, huge, high-quality, and diverse compound library has more than 700 cases for multiple target classes with more than 90% hit rates. In the stage of lead generation/optimization, if your target of interest is in our legacy data, you can obtain a powerful jump start toward candidate selection. Legacy data, deep knowledge & extensive experience of the target enable generation of a high-quality candidate in the shortest approach. Our exceptional discovery engine improves success rates for your drug discovery campaigns. | Axcelead Drug Discovery Partners Inc. is an integrated drug discovery and development solution provider, serving biotechnology and pharmaceutical companies all over the world. Our well-experienced team works closely with you for every step of your drug discovery project, from target identification, hit identification/characterization, lead generation/optimization, candidate selection, to IND enabling and beyond. | Axcelead is a healthcare platform company that owns Axcelead Drug Discovery Partners, a Japan-based global drug discovery solution provider, and ARCALIS, a CDMO company capable of integrated manufacturing of mRNA pharmaceuticals. Axcelead Drug Discovery Partners offers integrated drug discovery services from target identification to IND enabling studies. With a mission to accelerate research as your drug discovery engine, Axcelead Drug Discovery Partners provides exceptional expertise, flexible partnerships, and access to valuable legacy data. We are uniquely positioned having carved out a Preclinical R&D Discovery Unit from Takeda Pharmaceuticals. | Axcelead Drug Discovery Partners (ADDP) is a Japan-based global provider of drug discovery solutions, established in 2017 as a spin-out from Takeda Pharmaceuticals. Our Drug Discovery Service offers a fully integrated, end-to-end approach, seamlessly connects all functions to advance drug discovery programs from target validation to IND enabling studies in wide-range therapeutic areas, including neuroscience, oncology, cardiovascular, metabolic diseases, immunology & inflammation, and musculoskeletal disorders. Leveraging legacy data from over 1,000 research projects inherited from Takeda—including hit and lead compounds as well as extensive biological datasets— we help clients accelerate progress and achieve success with their drug discovery programs. In addition to Drug Discovery service, each of our core technology platforms is also available as a standalone service, allowing clients to access specialized capabilities as needed: • Hit identification through high-throughput screening using our proprietary compound library • Proprietary in silico design tools supporting medicinal chemistry design and optimization • Validated in vivo and in vitro pharmacology evaluations delivering translational insights • Comprehensive DMPK, safety assessment, and bioanalysis capabilities • Expertise across multiple modalities, including small molecules, peptides, oligonucleotides, mRNA-targeted therapies, protein degraders, ADCs, and regenerative medicine This flexible model ensures that our clients benefit from world-class science—whether as part of a fully integrated program or by engaging individual, best-in-class services tailored to their specific needs.

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Avance Clinical

About Avance Clinical Avance Clinical is the largest premium full-service Australian and US CRO delivering quality clinical trials, with globally accepted data, in Australia, New Zealand and the US for international biotechs. The company’s clients are biotechs in their early phases of drug development that need fast, agile, and adaptive solution-oriented clinical research services. Frost & Sullivan Awards Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past three years, has been providing CRO services in the region for more than two decades. Pre-clinical through to Phase 1 and 2 Avance Clinical offers pre-clinical services with their experienced ClinicReady team right through to Phase 1 and 2 clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes. With experience across more than 110 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review. Technology Avance Clinical uses state-of-the-art technology and gold-standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, IBM Watson and Medrio are just some of the technology partners. www.avancecro.com | Avance Clinical is a full-service CRO for biotechs with a proven track-record for delivering clinical excellence in Australia, New Zealand, and North America. As the largest premium full-service CRO in Australia and North America, Avance Clinical specializes in delivering top-tier clinical trials that yield globally accepted data. Avance Clinical has been recognized for the fourth consecutive year by Frost & Sullivan in 2023, being awarded the Best Practices Customer Value Leadership for Biotech’s award, for its continuous exceptional performance. Avance Clinical offers pre-clinical consultancy services with their experienced ClinicReady team right through to Phase I and beyond clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes that are available in Australia and highly qualified sites and networks within the United States. With experience across more than 110 therapeutic indications, Avance Clinical can deliver world-class, high-quality, internationally accepted data suitable for FDA and EMA review. Avance Clinical uses state-of-the-art technology and gold-standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, Zelta, Veeva and Medrio are just some of Avance Clinical’s technology partners. www.avancecro.com | THE AUSTRALIA-BASED GLOBAL CRO FOR BIOTECHS Avance Clinical is a full-service Contract Research Organization (CRO) headquartered in Australia, with extensive operations across New Zealand, Asia, North America, and Europe. As the market leaders in Early Phase clinical trials, we leverage the unique advantages of the Australian market, including rapid ethics approval, no IND requirement, and the 43.5% R&D tax rebate, to provide biotechs with an accelerated pathway to clinical success. Specializing in world-class operations, we guide biotechs from early pre-clinical development through to late-phase studies. With a focus on agility, innovation, and cost-effectiveness, we deliver fast results backed by robust, globally accepted data. With expertise spanning over 250+ indications, across all therapeutic areas, over the last three decades, Avance Clinical consistently delivers data recognized by key global regulators, including the TGA, FDA, EMA, MHRA, MFDS, and PDMA. What sets us apart is our personalized service tailored to each client, ensuring customized, flexible solutions rather than a one-size-fits-all approach. | Avance Clinical is a leading, full-service Contract Research Organization (CRO) specialising exclusively in the delivery of high-quality clinical trial services for biopharmaceutical companies. With deep expertise across early- to late-phase clinical development, Avance Clinical partners with innovative biotech companies globally to accelerate the development of novel therapeutics. Founded in Australia, Avance Clinical is recognised for its strong scientific leadership, agile operating model, and consistent delivery of high-quality clinical trial data accepted by major global regulatory authorities, including the FDA and EMA. The company provides end-to-end clinical development services, including clinical operations, project management, regulatory affairs, biostatistics, data management, medical writing, pharmacovigilance, and biometrics, across a broad range of therapeutic areas. A key differentiator of Avance Clinical is its Centres of Excellence (CoEs) model, which embeds deep therapeutic and functional expertise across the organisation. These CoEs are designed to support complex clinical programs through specialised scientific leadership, proven operational execution, and consistent global quality standards. The Early Phase Centre of Excellence supports rapid transition from preclinical development into first-in-human and early clinical studies. Leveraging Australia’s favourable regulatory framework—where no IND is required and study start-up timelines can be as short as five to six weeks—this CoE provides integrated expertise in protocol design, regulatory strategy, clinical pharmacology, PK/PD, dose escalation, and early safety evaluation. Sponsors also benefit from Australia’s 43.5% R&D tax rebate on eligible clinical trial expenditure, delivering significant cost efficiencies while maintaining world-class quality. Avance Clinical’s Oncology Centre of Excellence delivers specialised support across solid tumours and hematological malignancies, with particular strength in early-phase oncology trials. This CoE brings together scientific leadership and operational expertise in complex study designs, including adaptive trials, biomarker-driven studies, and multi-regional oncology programs. The team works closely with leading investigators, specialist oncology sites, and key opinion leaders to ensure efficient study execution and high-quality, regulatory-ready data. The Central Nervous System (CNS) Centre of Excellence provides dedicated expertise across neurological and psychiatric indications. The CNS CoE supports trials requiring complex endpoint selection, specialised rating scales, and rigorous data quality oversight, with a strong focus on rater training, consistency, and patient safety. The team has experience across both early- and late-phase CNS programs, supporting sponsors through regulatory interactions and clinical execution. Avance Clinical’s Renal and Metabolic Centre of Excellence focuses on clinical development programs in kidney disease, metabolic disorders, and related systemic conditions. This CoE brings deep experience in managing trials with complex patient populations, comorbidities, and long-term endpoints. The team supports protocol design, patient recruitment strategies, biomarker integration, and global site engagement to ensure efficient delivery of renal and metabolic studies across regions. Complementing its therapeutic CoEs, Avance Clinical operates functional Centres of Excellence across Biostatistics, Data Management, Medical Writing, Pharmacovigilance, and Regulatory Affairs. These functional CoEs ensure consistency, quality oversight, and regulatory compliance across all programs, enabling scalable and efficient global trial delivery. Avance Clinical’s Australian operations provide a strategic advantage for early-phase and complex clinical trials, offering rapid start-up timelines, cost efficiencies, and access to highly experienced investigators and clinical sites. The company’s global footprint spans Australia, North America, Asia, and Europe, enabling seamless execution of regional and multi-regional clinical trials. North America represents Avance Clinical’s largest market outside Australia, supporting the majority of its biotech clients, while its Asia hub in Seoul, South Korea, provides access to Asia-Pacific patient populations and supports later-phase multi-regional development strategies. Led by an experienced executive and scientific leadership team with extensive backgrounds in drug discovery, clinical development, and regulatory strategy, Avance Clinical is recognised for its commitment to quality, transparency, and long-term partnerships. The company works as a true extension of its sponsors’ teams, delivering flexible, biotech-focused solutions tailored to the needs of emerging and mid-size biopharmaceutical companies. As a trusted CRO partner, Avance Clinical is dedicated to advancing innovative therapies from first-in-human through to late-stage development, helping biopharmaceutical companies bring new medicines to patients faster, more efficiently, and with confidence in the quality of their clinical data.

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Ardena

Ardena is as a fully integrated Contract Development and Manufacturing Organization (CDMO), with a core focus on bringing molecules to the clinics. Our comprehensive suite of services caters to every stage of pharmaceutical development, ensuring a smooth progression from initial idea to clinical application. From small-molecule API projects, to drug product development, navigating phase-appropriate processes under cGMP conditions, and facilitating clinical packaging and logistics. Furthermore, as experts in nanomedicine development, we offer scalable formulation, process, and analytical development, alongside GMP manufacturing, ensuring our partners meet their clinical schedules effectively. Ardena is also recognized for its expertise in bioanalysis solutions that cater to diverse drug products and biomarkers, spanning small molecules to proteins, including antibodies, ADCs, oligonucleotides, and vaccines. As your trusted CDMO partner connect with our team at the California Pavilion and let us assist you on your journey towards clinical success. | Ardena is a specialist CDMO and bioanalytical CRO advancing precision medicines and other complex therapies from early development through to commercial supply. The company supports biotech and pharmaceutical partners in translating challenging molecules into scalable, robust therapies. Its strength lies in combining complex drug product development and GMP manufacturing, bioanalytical services, and specialized expertise in nanomedicine and conjugates within one integrated framework. This approach reduces complexity, shortens timelines, and supports efficient progression across development stages. Ardena focuses on modalities that demand advanced formulation and analytical precision, including nanoparticles, conjugates, and other complex drug products. In nanomedicine, the company supports lipid-based, polymer-based, and metal-based systems, optimizing formulation, scalability, and manufacturability. Drug product capabilities span formulation development, process scale-up, and GMP manufacturing for clinical and commercial supply. Enabling technologies such as spray drying and hot melt extrusion address solubility, stability, and bioavailability challenges, alongside expertise in highly potent and complex dosage forms. Ardena also supports the development of conjugates, including antibody-drug conjugates (ADCs) and other novel conjugates (XDCs). These programs require tight integration of chemistry, formulation, and analytics, combined with containment and GMP expertise to ensure consistency from early development through to commercial manufacturing. Bioanalytical services are a central pillar, delivering pharmacokinetic, biomarker, and immunogenicity analysis to support clinical development and regulatory submissions. Ardena operates established bioanalytical laboratories in Europe and has expanded into the United States with a new lab in Somerset. Ardena’s international network spans Europe and the US, enabling regional flexibility and continuity from development to commercialization. The Somerset site plays a key role, offering GMP drug product manufacturing for clinical and commercial supply, alongside integrated bioanalytical capabilities. As an FDA-approved facility, it provides a strong foundation for programs targeting the US market, with clear advantages in supply chain efficiency and market access. What differentiates Ardena is the integration of its expertise. Multidisciplinary teams align development, manufacturing, and analysis from the outset, reducing rework and supporting consistent execution. Supporting capabilities in solid-state research and CMC development further strengthen programs and de-risk critical decisions. At this event, Ardena brings practical insight across the full development lifecycle, supporting focused discussions on how to advance complex therapies with speed, control, and confidence. Visit Ardena at booth 3253. Ardena enables progress where complexity defines the challenge.

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Agricultural Technology Research Institute

Agricultural Technology Research Institute

To strengthen the commercialization and industrialization of agricultural research results, the Council of Agriculture (COA) completed the preparatory works and established Agricultural Technology Research Institute (ATRI) on January 1, 2014. Under the ATRI there are Animal Technology Research Center, Plant Technology Research Center, Aquatic Technology Research Center, Business Promotion Center, and Agricultural Policy Research Center respectively in charge of related affairs. ATRI was formed by combining the following agencies: DPIAB – Development Program of Industrialization for Agricultural Biotechnology AgriTI – Office for Agricultural Technology Industry ATIT – Animal Technology Institute Taiwan COAT – Commercialization Office of Agricultural Technology Mission and Task To create a framework for the industrialization of agricultural technology and the development of entrepreneurship, provision of agricultural technology and commercialization/industrialization service to agribusiness, agricultural groups and farmers. 1.To work collaboratively with academia, other research institutes, and private sectors to develop innovative and useful technologies for commercial production. 2.To commercialize and industrialize agriculture research results. To provide assistances to private sectors in strengthening competitiveness and promoting international markets. 3.To serve as an intermediary platform for policy think-tanks. 4.To combine all efforts in promoting the common interests in agricultural area. Facilitations of decision-making process to provide solid foundation for agricultural policies in all forms. | x | To strengthen the commercialization and industrialization of agricultural research outcomes, the Ministry of Agriculture (MOA) completed the preparatory work and established the Agricultural Technology Research Institute (ATRI) on January 1, 2014. Under the ATRI there are Planning and Development Department, Administrative Services Department, Animal & Plant Health and Production Research Center, Agricultural Facilities and Environment Research Center, Agricultural Input and Product Valorization Research Center, Agricultural Policy Research Center and Industrial Development Center respectively in charge of related affairs. ATRI was formed by combining the following agencies: DPIAB – Development Program of Industrialization for Agricultural Biotechnology AgriTI – Office for Agricultural Technology Industry ATIT – Animal Technology Institute Taiwan COAT – Commercialization Office of Agricultural Technology

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Accelsiors-logo-2016

Accelsiors Gmbh

Accelsiors is a global, full-service CRO accelerating clinical development with AI-driven insights, Quality by Design (QbD), and patient-centric solutions. From Phase I to regulatory approvals, we optimize trial execution, ensuring speed, compliance, and success. Visit us at BIO 2025 in the German Pavilion to explore how we can advance your next clinical breakthrough. At Accelsiors CRO, we accelerate biopharmaceutical innovation through a science-driven, patient-centric approach. As a global, full-service CRO, we provide tailored clinical trial solutions designed to de-risk development, optimize timelines, and bring transformative therapies to market faster. With a proven track record in global clinical development, we navigate the complexities of modern drug research—from early-stage clinical development to regulatory approvals and patient-centric trials. Our strategic approach, cutting-edge AI analytics, and deep therapeutic expertise ensure seamless execution and measurable outcomes. | Accelsiors CRO – Science-Driven Clinical Excellence Accelsiors is a global, full-service CRO accelerating clinical development with AI-driven insights, Quality by Design (QbD), and patient-centric solutions. From Phase I to regulatory approvals, we optimize trial execution, ensuring speed, compliance, and success. Visit us at BIO 2026 in the German Pavilion to explore how we can advance your next clinical breakthrough. Let’s discuss how we can accelerate your next clinical breakthrough with Accelerant™, our proprietary Penta-Helix approach—a unique integration of science, patient-centricity, Quality by Design, AI-driven state-of-the-art technologies, and speed with cost-effectiveness at every stage of clinical development.

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Abzena

Abzena is a bioconjugate- and biologics-focused CDMO that pushes development of novel treatments forward at every stage from discovery through commercial launch. With the ability to tailor its strategy and customer experience to each project, Abzena develops and implements innovative solutions that enable biotech and biopharma companies to realize the full potential of their investments in human health. The company has research, development, and cGMP facilities across locations in San Diego, CA, Bristol, PA, and Cambridge, UK. #bioconjugation #linkerpayloads #ADCs #Biologics # | Abzena is the leading end-to-end bioconjugate and complex biologics CDMO + CRO. From discovery through commercial launch, we support customers with fully integrated programs or individual services designed to de-risk and streamline the development of new treatments for patients in need. With the ability to tailor its strategy and customer experience to each project, Abzena develops and implements innovative solutions that enable biotech and biopharma companies to realize the full potential of their molecule and move medicines forward faster. The company has research, development, and cGMP facilities across locations in San Diego, CA, Bristol, PA, and Cambridge, UK. We provide comprehensive support for multiple modalities including: Antibodies (mAbs), FAbs, ADCs, Bispecifics, Radioconjugates, Fusion Proteins, Growth Factors, Vaccines, mRNA, Biosimilars, Peptide Oligonucleotides. Our capabilities range from: Early-Stage Research & Discovery, Design and Lead Selection, Robust Analytics, Bioassays and Immunogenicity, Antibody Engineering and Developability, Mammalian Cell Line Development, Linker Payload Design and Synthesis, Analytical Method & Formulation Development, Process Development and cGMP Manufacturing up to 2000L, Technology Transfer & Scale-Up, Regulatory Support Our extensive toolkit of services is designed to ensure our customers achieve their Target Product Profile (TPP). With early-stage research, process development and GMP manufacturing capabilities all under a single organization, we can leverage our vast capabilities and knowledge of the product, along with the requisite In Vitro and In Vivo criteria to ensure that the desired TPP can be accomplished from the project outset. | Abzena is the leading end-to-end bioconjugate (ADCs, AOCs, RDCs) and complex biologics CDMO + CRO. From discovery through commercial, we support customers with fully integrated programs or individual services that de-risk and streamline the development of new medicines. With over two decades of experience, 2000+ conjugates developed and over 200+ cell lines developed, we have the expertise and technical know-how to rapidly progress your biopharmaceutical to IND and beyond. And with footholds in the US and UK, we offer a simplified and secure supply chain. Fully integrated CDMO+CRO support across multiple modalities: Monoclonal Antibodies (mAbs), Antibody-Drug Conjugates (ADCs), Antibody-Oligonucleotide Conjugates (AOCs), Radionuclide Antibody-Conjugates (RACs) & Radionuclide Drug-Conjugates (RDCs),Bispecific Antibodies (bsAbs), Fusion Proteins, Cytokines, Recombinant & Conjugate Vaccines, Nanoparticles With Capabilities Ranging From: Early-Stage Research & Discovery, Design and Lead Selection, Robust Analytics, Bioassays and Immunogenicity, Bioconjugation & Chemistry, Antibody, Engineering and Developability, Mammalian Cell Line Development, Linker Payload Design and Synthesis, Analytical Method & Formulation Development, Process Development and cGMP Manufacturing up to 2000L, Technology Transfer & Scale-Up, Regulatory Support. Key Facts & Highlights: Over 24 years of experience developing 2000+ conjugations and 200+ cell lines. Champion Award Winner in Global Biologics at the 2025 CDMO Leadership Awards. Unique end-to-end value proposition ranging from antibody discovery to clinical-scale GMP biologic drug substance manufacture. Scientific expertise to deliver at high quality, low cost and compressed timelines. Global customer base, including most of the top 20 biopharmaceutical companies. Supply chain security with fully integrated US & UK facilities that can handle highly potent and cytotoxic molecules. 14 products utilizing Abzena’s technologies in clinical trials. Biologics discovery, design, optimization, characterization, lead selection, cell line development, process development & GMP manufacture for supply from preclinical through commercial scale. Bioconjugate (including ADCs, AOCs, RDCs) discovery, design, optimization, characterization, lead selection, cell line development, process development & GMP manufacture for supply from preclinical through commercial scale. Synthesis, analysis and GMP manufacture of APIs, payloads and highly potent compounds (HPAPI) and cytotoxic. Discovery to Phase II accelerated development for antibody-drug conjugates, including antibodies, linkers, and payloads. Tech transfer and commercial scale manufacturing up to 2000L for biologics and bioconjugates.

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A2 Healthcare

A2 Healthcare(A2), a Japan-Taiwan industry leader for clinical development, spearheads global new drug development in Japan from its new US office in Boston area. A2 is the expert for clinical development in Japan and Taiwan. We are interested to invest in our partner’s pipeline for entering drug development, especially for drugs which are already marketed or under development outside of Japan. Clinical Development: A2 is the leading Japanese CRO providing contracted services in the clinical stage. A2 have the capability and experience to support our partners from early to late phases in any therapeutic area, as well as regulatory consultation and submission. A2 is a subsidiary of ITOCHU Corporation which is one of the largest Japanese company and were awarded the Best CRO of the Citeline Intelligence Award 2023. Pipeline Investment A2’s “Pipeline Accelerator Program (PAP)” supports the development of novel drug candidates enter Japanese market by becoming co-developers with the sponsor. In other words, we will invest in your clinical development cost. Through the program, we will enable domestic and foreign biotech startups as well as pharmaceutical companies for entering the Japanese market with a much lower hurdle. | A2 Healthcare Corporation (A2) is a Japan-based full-service CRO and a core member of the ITOCHU Group, one of the largest Japanese trading and investment conglomerates. With approximately 1,300 employees and offices in Tokyo (HQ), Osaka, Taiwan, and Boston, we focus on helping overseas biotech and pharma companies enter and succeed in the Japanese and Taiwanese markets. A2 has been recognized for excellence in clinical operations and partner satisfaction, receiving the Best CRO/CDMO award (2023) and Best Contract Research Organization award (2025) at the Citeline Pharma Intelligence / Citeline Japan Awards. Key points about A2, the ITOCHU Group and our Japan-entry platform: ◆A2 operates J-STEP (Japan Strategic Entry Platform), a one-stop service platform developed together with ITOCHU to support overseas companies across the full product lifecycle in Japan. ◆J-STEP services include: -Japan market and regulatory assessment, PMDA / ICCC strategy, and early pricing and access considerations. -Japan clinical development planning and execution aligned with global programs. -CMO/CDMO coordination and supply chain support tailored to modality. -NDA support, PMS, real-world evidence (RWE) studies, safety, logistics, and MAH services. -Business development and out-licensing support to Japanese pharma companies using ITOCHU’s local network. ◆In 2026, ITOCHU Corporation acquired 100% of CoreMed Co., Ltd., a leading Japanese regulatory and development-strategy consulting firm. ◆CoreMed provides consulting from early development strategy and CMC evaluation through PMDA consultations and marketing authorization applications, supported by a strong network with EU and US regulatory experts. ◆By combining CoreMed’s regulatory and scientific expertise with A2’s clinical operational capabilities, the ITOCHU Group offers integrated “Strategy + Execution” support for Japan, from first regulatory assessment to approval and post-marketing. ◆Therapeutic area experience spans oncology, rare diseases, regenerative medicine and ATMPs, infectious diseases and vaccines, as well as major and specialty indications. ◆Phase I through Phase III, PMS, and RWE studies, including: -Regulatory and clinical strategy development. -PMDA meeting preparation and briefing packages. -Site selection, site management, monitoring, data management, biostatistics, medical writing, safety, and project management. -ICCC coordination and regulatory submissions. -Post-marketing surveillance and observational research. ◆As part of the ITOCHU Group, A2 can also support: -Partnering and out-licensing between overseas biotech and Japanese pharma. -Flexible collaboration models such as co-development, risk sharing, and selective financial support for Japan-focused assets. -Strategic use of ITOCHU’s global networks, including ITC Venture Partners in Silicon Valley and A2’s Boston office. ◆We are looking to connect with: -Overseas biotech and pharma companies seeking a Japan development and regulatory partner. -Companies interested in one-stop Japan market entry using J-STEP. -Partners exploring co-development, risk sharing, or out-licensing opportunities for the Japanese market. Our goal is Your Goal.

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