After a significant decline in the morning session, LEADS BIOLABS-B (09887) gradually turned positive, with its gains expanding to over 5% by the late trading period. At the time of writing, the stock was up 5%, trading at HK$58.85, with a turnover of HK$45.73 million.

The movement follows news that Leads Biolabs announced its core product, VELISIN (LBL-024), has been granted Orphan Drug Designation by the European Commission for the treatment of extrapulmonary neuroendocrine carcinoma (EP-NEC). This marks another significant milestone in the global development of VELISIN, which has already demonstrated first-in-class (FIC) or best-in-class (BIC) potential in Phase II or registrational clinical trials for three indications: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and EP-NEC.

According to the announcement, the Orphan Drug Designation provides VELISIN with several incentives, including a 10-year period of market exclusivity and regulatory fee reductions. VELISIN is a bispecific antibody that simultaneously targets PD-L1 and 4-1BB, and it has shown promising efficacy signals in two clinical trials conducted in China. The company received approval from the National Medical Products Administration in April 2024 to initiate a single-arm registrational clinical trial and was granted Breakthrough Therapy Designation in October 2024 for the treatment of advanced, later-line extrapulmonary neuroendocrine carcinoma.