Pipeline
Development Roadmap
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Development Roadmap
We carry research on new drug candidates through early discovery stages, to non-clinical work, manufacturing and CMC, and clinical development.
How far each programme advances depends on the data obtained, the intellectual property position and the regulatory requirements.
Development Roadmap
DISCOVERY & RESEARCH
Research hypotheses are formed from basic research and scientific evidence, and new drug candidates are characterised, evaluated and validated.
NON-CLINICAL
Non-clinical evaluation of efficacy, safety and mechanism of action, depending on the characteristics of the candidate.
MANUFACTURING & CMC
Work on the manufacturing process, formulation, analysis, quality attributes, specifications and stability. CMC runs in parallel with research, non-clinical work and clinical development.
CLINICAL DEVELOPMENT
Study design, clinical trials and clinical research, data management and statistical analysis, leading to scientific evaluation in humans.
REGULATORY
Discussion with the regulatory authorities and consideration of a future application for approval, in the light of the development data and the regulatory requirements.
年度
2026年
2027年
2028年
主な研究・開発目標
開発プログラムの優先順位付け、基礎・非臨床研究、製造・CMC、知的財産戦略を各プログラムの進捗に応じて推進。規制当局相談やパートナリングに向けた準備を進めます。
選択した開発プログラムについて、非臨床・CMC 等のデータパッケージを充実させ、臨床開発への移行可能性を評価。共同研究・共同開発・ライセンスを含む外部連携を推進します。
各プログラムの研究・開発成果に基づき、臨床開発、共同開発、ライセンスその他の次段階への展開を目指します。
Key Milestones
Near term
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Prioritisation of the development programmes
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Scientific validation of the research hypotheses and accumulation of the principal data
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Detailed planning for non-clinical work and for manufacturing and CMC
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Strengthening of the intellectual property strategy for each programme
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Preparation for discussions with the regulatory authorities and for partnering
Medium term
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Transition of selected candidates into clinical development
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Advancement of joint research, co-development and licensing
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Development of the manufacturing, CMC and clinical development base
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Wider collaboration with academia and pharmaceutical companies in Japan and abroad
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Building a foundation that carries research results through to the next development programme
Assumptions
This roadmap sets out the general direction of our drug development. It is not a guarantee that any stage will be reached, or approval obtained, by any particular date.
The progress of each programme may change according to research results, safety, manufacturing and CMC, discussion with the regulatory authorities, intellectual property and other factors.
The development programmes on this page include new drug candidates that have not been approved as pharmaceutical products in Japan.
This roadmap does not apply a single schedule to every candidate. Each programme advances on its own terms, according to its scientific data, its stage of development, the nature of the technology and the regulatory requirements.
PIPELINE
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