Pipeline
Development Roadmap
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Development Roadmap
We carry research on new drug candidates through, stage by stage, to non-clinical work, manufacturing and CMC, and clinical development.
How far each programme advances is decided on the data obtained, the intellectual property position and the regulatory requirements.
Contents
01
Development roadmap
03
Assumptions and disclaimer
02
Key milestones
Contents
01
Development roadmap
02
Key milestones
03
Assumptions and disclaimer
Development Roadmap
DISCOVERY & RESEARCH
Research hypotheses are formed from what is observed in clinical practice and from basic research, and new drug candidates are characterised, evaluated and validated.
NON-CLINICAL
Non-clinical evaluation of efficacy, safety and mechanism of action, according to 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
Candidate selection, generation of the principal data, formation of intellectual property, non-clinical evaluation and CMC work, according to the progress of each programme.
Medium term
Accumulation of non-clinical and CMC data, clinical development, discussion with the regulatory authorities, and joint research and licensing, according to the maturity of each 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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