Leads Biolabs' Opamtistomig Wins Japan Orphan Drug Designation

Nanjing Leads Biolabs Co., Ltd. (9887.HK) said on September 28, 2026, that Japan's Ministry of Health, Labour and Welfare granted Orphan Drug Designation to Opamtistomig (LBL-024), its investigational PD-L1/4-1BB bispecific antibody. The designation covers the treatment of a rare cancer indication, though the company did not specify the exact tumor type in its announcement. Orphan Drug Designation in Japan provides regulatory and financial incentives, including expedited review, extended market exclusivity and research subsidies, aimed at accelerating development of therapies for rare diseases. Leads Biolabs, listed in Hong Kong, is developing Opamtistomig as part of its oncology pipeline. The company said the designation may support faster registration and commercialization in Japan.