LEADS BIOLABS-B (09887) shares climbed more than 2%, trading up 1.69% at HK$51.25 as of press time, with a turnover of HK$3.5403 million.

On the news front, on September 28, LEADS BIOLABS-B issued an announcement that its core product Vilixin (Opatasumimab, 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 obtained by Vilixin, following those from the U.S. Food and Drug Administration (FDA) and the European Commission (EC), signaling that Vilixin's global regulatory recognition has further expanded into a major Asian market.

With this designation, Vilixin will enjoy a series of incentives in Japan, including clinical development funding subsidies, professional guidance and advice from MHLW and other institutions, priority consultation and priority review channels, reduced consultation and marketing application fees, and an extended re-examination period.

These incentives are expected to accelerate the development, registration, and commercialization process of Vilixin in Japan.