LEADS BIOLABS-B (09887) announced that its core product VELIXIN (opaptisumab, a PD-L1/4-1BB bispecific antibody) has been granted orphan drug designation by Japan's Ministry of Health, Labour and Welfare (MHLW) for the treatment of extrapulmonary neuroendocrine carcinoma (EP-NEC).

This marks the third orphan drug designation for VELIXIN, following those granted by the U.S. Food and Drug Administration (FDA) and the European Commission (EC), signaling a further expansion of VELIXIN's global regulatory recognition footprint into a major Asian market.

With this designation, VELIXIN will enjoy a series of incentives in Japan, including clinical development funding subsidies, professional guidance and advice from the MHLW and other institutions, priority consultation and priority review channels, reduced consultation and marketing application fees, and an extension of the re-examination period. These incentives are expected to accelerate the development, registration, and commercialization of VELIXIN in Japan.

In 2025, Japan is the world's fourth-largest pharmaceutical market, with a market size exceeding US$73 billion. Its oncology immunotherapy market exceeds US$8 billion, ranking behind only the United States, China, and Europe. VELIXIN's entry into this strategic market through orphan drug designation represents not only a breakthrough for the EP-NEC indication, but also means the company has established a policy channel for priority communication and accelerated review within Japan's regulatory system, which will facilitate the subsequent development and registration of VELIXIN for other oncology indications in Japan.