Kyowa Kirin to Regain Control of Rocatinlimab Development and Commercialization Program, Demonstrating Strong Commitment to Address High Unmet Medical Need in Atopic Dermatitis

Core Viewpoint - Kyowa Kirin has announced the termination of its collaboration with Amgen regarding the development and commercialization of rocatinlimab, regaining full control over the program as part of Amgen's strategic portfolio prioritization [1] Group 1: Rocatinlimab Development - Rocatinlimab is an investigational anti-OX40 monoclonal antibody aimed at treating moderate-to-severe atopic dermatitis, with a unique mechanism targeting the OX40 receptor [6] - The Phase 3 ROCKET program includes eight pivotal studies that have enrolled over 3,300 patients, demonstrating a generally favorable benefit-risk profile [4] - The company plans to submit regulatory filings for rocatinlimab in the U.S. in the first half of 2026, followed by Japan and other markets [5][4] Group 2: Clinical Findings - Recent Phase 3 studies, ROCKET-IGNITE and ROCKET-HORIZON, published in The Lancet, showed that rocatinlimab met all co-primary and key secondary endpoints, including the revised Investigator's Global Assessment score [2] - The most common treatment-emergent adverse events included upper respiratory infections, aphthous ulcers, and headaches, which were consistent with previous trials [2] Group 3: Company Commitment and Expertise - Kyowa Kirin emphasizes its commitment to developing rocatinlimab as a differentiated asset with significant market potential, leveraging its expertise in immunology and antibody engineering [5][3] - The company has a long history of investment in drug discovery and biotechnology innovation, focusing on high unmet medical needs [7]