Opamtistomig (LBL-024) Granted Orphan Drug Designation in Japan
Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, commented: “The orphan drug designation in Japan represents an important milestone in the global development of opamtistomig and further strengthens its regulatory recognition across the four key markets of China, the United States, Europe, and Japan. It underscores the innovative value and global development potential of opamtistomig, particularly in EP-NEC, a tumor type with substantial unmet medical needs. We look forward to leveraging the regulatory incentives associated with this designation to accelerate the development and registration of opamtistomig in Japan, while advancing additional high-potential indications and bringing this innovative therapy to more patients in Japan and around the world.”
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