Group 1: Rocatinlimab and Clinical Trials - Kyowa Kirin announced the presentation of Phase 3 ROCKET-SHUTTLE trial results for rocatinlimab at the EADV 2025 Annual Meeting, focusing on its efficacy and safety in treating moderate-to-severe atopic dermatitis [1][3] - The ROCKET program consists of eight global studies aimed at establishing the safety and efficacy profile of rocatinlimab in adults and adolescents with moderate to severe atopic dermatitis [4] Group 2: Atopic Dermatitis Overview - Moderate-to-severe atopic dermatitis is a chronic inflammatory skin disease characterized by severe itching and pain, with a significant unmet need for effective treatments [2][5] - Atopic dermatitis affects 15-20% of children and up to 10% of adults, with T-cell imbalance being a root cause of the disease [5] Group 3: Rocatinlimab Mechanism and Development - Rocatinlimab is an anti-OX40 monoclonal antibody that targets the OX40 receptor on activated T cells, potentially being the first T-cell rebalancing therapy for atopic dermatitis [6] - The drug is also being investigated for other conditions related to T-cell imbalance, including uncontrolled asthma and prurigo nodularis [7] Group 4: Collaboration and Commercialization - Kyowa Kirin and Amgen entered a collaboration agreement for the joint development and commercialization of rocatinlimab, with Amgen leading the global efforts except in Japan [8]

Company Overview - Kyowa Kirin Co., Ltd. is a Japan-based Global Specialty Pharmaceutical Company with over 70 years of experience in drug discovery and biotechnology innovation [7] - The company focuses on developing novel medicines and treatments for high unmet medical needs, including bone & mineral diseases, hematological diseases, and rare diseases [7] Product Development - Rocatinlimab is an investigational anti-OX40 human monoclonal antibody targeting moderate to severe atopic dermatitis, with the potential to be the first T-cell rebalancing therapy [5][6] - The Phase 3 ROCKET IGNITE trial results for rocatinlimab will be presented at the EADV 2025 Annual Meeting in Paris from September 17-20, 2025 [1][3] - The ROCKET program consists of eight studies aimed at establishing the safety and efficacy profile of rocatinlimab in adults and adolescents with moderate to severe atopic dermatitis [3] Market Context - Atopic dermatitis affects 15-20% of children and up to 10% of adults, characterized by chronic symptoms and unpredictable flare-ups [4] - The disease is driven by T-cell imbalance, which is a root cause of its inflammatory nature [2][4] Collaboration - Kyowa Kirin has a collaboration agreement with Amgen to jointly develop and commercialize rocatinlimab, with Amgen leading development globally except in Japan [8]