LEADS BIOLABS-B (09887) rose more than 4%. As of the time of writing, the stock was up 4.26% to HK$56.3, with a turnover of HK$3.0003 million. On the evening of January 14, LEADS BIOLABS announced that its self-developed anti-PD-L1/4-1BB bispecific antibody, Velsin® (LBL-024), has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of extra-pulmonary neuroendocrine carcinoma (EP-NEC). This marks the third regulatory designation obtained for Velsin®, which has currently 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. Dr. Cai Shengli, Chief Medical Officer of LEADS BIOLABS, stated that following the previous Breakthrough Therapy Designation from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) and the FDA's Orphan Drug Designation, this latest accelerated review recognition from an international authoritative regulatory agency highlights the significant clinical potential and market prospects of the drug. This milestone will strongly propel its global development process, accelerate the drug's market entry, and benefit patients worldwide at an earlier date.