About

About 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.