LEADS BIOLABS-B (09887.HK): VELIXIN™ Granted Priority Review by NMPA for Advanced Extrapulmonary Neuroendocrine Carcinoma

NewTimeSpace News: On 10 July 2026, LEADS BIOLABS-B (09887.HK) released a voluntary announcement. The Biologics License Application (BLA) for self-developed VELIXIN™ (Opamtistomig, LBL-024), a PD-L1/4-1BB bispecific antibody, for monotherapy treatment of advanced extrapulmonary neuroendocrine carcinoma (EP-NEC) has been approved for Priority Review procedure by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The review period will be 130 working days, compared with the standard timeline of 200 working days.

EP-NEC represents a highly malignant immunologically “cold tumour”. No therapeutics have obtained global regulatory approval for this indication. Objective response rates for second-line and later treatment range merely from 0% to 10%, with median overall survival of only 3–4 months, resulting in substantial unmet clinical needs. VELIXIN™ is the world’s first bispecific molecule targeting co-stimulatory receptor 4-1BB to advance into single-arm pivotal clinical trials. It has obtained Breakthrough Therapy Designation from CDE, Orphan Drug Designation and Fast Track Designation from the FDA, as well as Orphan Drug Designation from the European Commission. The Company is actively advancing pre-launch commercial preparations. The Company cautions that there can be no assurance that the product will be successfully developed or ultimately marketed.