HK Stock Market Move | LEADS BIOLABS-B(09887) up more than 4%, PD-L1/4-1BB dual antibody granted FDA fast track qualification.

LEADS BIOLABS-B(09887) rose more than 4%, as of the time of writing, it increased by 4.26% to 56.3 Hong Kong dollars, with a turnover of 3.003 million Hong Kong dollars. On the news front, on the evening of January 14, Vertis Biotechnologies announced that their independently developed anti-PD-L1/4-1BB bispecific antibody Verlixin (LBL-024) has been granted Fast Track Designation by the US Food and Drug Administration (FDA) for the treatment of Extra-pulmonary Neuroendocrine Cancer (EP-NEC). This is the third regulatory approval for Verlixin, which has shown global first-in-class (FIC) or best-in-class (BIC) potential in Phase II or registration clinical trials for non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and EP-NEC. Dr. Cai Shengli, Chief Medical Officer of Vertis Biotechnologies, stated that after receiving breakthrough therapy designation from the China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) and orphan drug designation from the FDA, this latest recognition from an international authority further demonstrates the huge clinical potential and market prospects of Verlixin. This milestone will strongly promote its global development process, accelerate drug approval, and benefit patients worldwide sooner.