由于商业潜力低和安全问题,Amgen退出后,Kyowa Kirin重新获得了实验性湿疹药物rocatinlimab的全球权利.
Kyowa Kirin regains global rights to experimental eczema drug rocatinlimab after Amgen exits due to low commercial potential and safety concerns.
由于战略优先事项, Amgen 终止了他们的合作, Kyowa Kirin 已经重新获得了对罗卡丁利马布 (rocatinlimab) 的全球权利,
Kyowa Kirin has regained global rights to rocatinlimab, an experimental atopic dermatitis treatment, after Amgen ended their collaboration due to strategic priorities.
尽管Rocatinlimab满足了第3阶段关键试验终点,并显示出持续的效力,但Amgen指出,由于商业潜力和安全关切薄弱,包括高烧伤率和寒冷率,是退步的原因。
Despite rocatinlimab meeting key Phase 3 trial endpoints and showing sustained efficacy, Amgen cited weak commercial potential and safety concerns, including high rates of pyrexia and chills, as reasons for stepping back.
Kyowa Kirin(Kyowa Kirin)现在将在美国和日本牵头提交监管文件,争取在2026年初获得批准,该药物的新颖的OX40目标机制被认为对长期疾病控制很有希望。
Kyowa Kirin will now lead regulatory submissions in the U.S. and Japan, aiming for approval in early 2026, with the drug’s novel OX40-targeting mechanism seen as promising for long-term disease control.