24Development Pipelines (Includes late-stage development products after Phase II)1.Maruho’s Meaning of ExistenceThe business model of dividing research, development, and sales globally has now become mainstream, with the number of companies that have all of these functions domestically in Japan is shrinking. As such, one of the challenges we face going forward in terms of R&D is creating projects that involve partnerships with academia or venture companies inside or outside of Japan. Therefore, we need to enhance our development planning globally along with our management capabilities, i.e., functions to promote joint international clinical trials, while building a solid network with KOLs*3 and CROs.*4*3 Key Opinion Leader: In this context, KOL refers to specialist physicians who are at the forefront of disease diagnosis, treatment, and research.2.Value Creation Prospects3.Strategy for Value Creation4.Foundation for Sustainable Growthcompanies, venture companies, and academia, we will work to identify and acquire new products that are also needed in global markets.Anticipating market trends, we will formulate an R&D portfolio serving as a pillar for short-, medium-, and long-term earnings, prioritize and create products while appropriately managing resources. In terms of licensing activities, we will be mindful of strategy and activity, and aim to acquire new growth drivers that can leverage our knowledge in dermatology. We will also focus on drug repositioning to strengthen our ability to create new active ingredients that lead to application patents and formulation patents.In regard to our business foundation in global markets, we will focus on China and other regions in Asia to expand our development and sales functions. In addition to collaborating with external parties, we will develop global human resources who can promote these new business strategies.Dosage FormInjectionInjectionInjectionTopicalTopicalInjectionTopical5.Financial/ Company InformationDevelopment PhaseFiled for approvalFiled for approvalPIIIPIIIPIIIPIIIPIIMaruho Report 2023*4 Contract Research OrganizationProduct CodeTarget IndicationM5250Pruritus with atopic dermatitis (pediatric)M5250BPrurigo nodularisM5250EPruritus with atopic dermatitis (infants)M6050CAcne vulgarisM6100Atopic dermatitisM6110Verruca vulgarisM6050FAxillary osmidrosisAssessment of the fiscal year ended September 2023Positive results in licensing activities and development pipeline expansionIn the fiscal year ended September 2023, we planned and executed diversified licensing activities. In an effort to obtain rights, the entire company thoroughly explored candidates for in-licensed products and promoted science-based assessment, leading to the acquisition of multiple projects as well as the identification of multiple candidates for potential licensing in the fiscal year ending September 2024. We also expanded our development pipeline through integrated efforts between business development and R&D.Plan for the fiscal year ending September 2024 and beyondSpeeding up efforts to strengthen R&D capabilities and acquire development pipelinesIn the Fifth Medium-Term Plan, we aim to strengthen our efforts in the creation and acquisition of candidate phase projects and the promotion function of R&D, in addition to the previous core functions of introduction of late-stage development drugs and late-stage clinical development. While strengthening our network with such partners as domestic and overseas pharmaceutical *Please visit our corporate website for the latest information. (https://www.maruho.co.jp/english/about/activities/pipeline/)We focus on developing the skills to personalize our Mission and Values and to build our careers autonomously. We also encourage our employees to interact with partners and the companies we do business with to identify product development opportunities that address unmet needs, and to publish their research results externally. We aim to be an organization that continues to engage in R&D and business development that adds value by enhancing creativity through repeated future-oriented and hypothetical thinking, and by empowering our people to take action on their own.Masahiro AkatsukaGlobal Business Development, Research & Development(As of Semptember 2023)Deepening outside interactions for research and development with greater value
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