LEADS BIOLABS-B (09887.HK): Vilasumu Wins FDA Fast Track for Biliary Tract Cancer

NewTimeSpace News: On 12 October 2026, Nanjing Leads Biolabs Co., Ltd. (stock code: 09887) announced that its core product vilasumu (a PD-L1/4-1BB bispecific antibody) received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the first-line treatment of advanced biliary tract cancer (BTC).

This is the second FDA Fast Track designation for vilasumu, following extrapulmonary neuroendocrine carcinoma (EP-NEC). Based on data from the first-line BTC clinical study, the designation took only nine days from submission to grant. The FDA also advised the Company to expedite communication on the registration plan for vilasumu in combination with chemotherapy for BTC. The designation is expected to accelerate the development, registration and commercialisation of vilasumu for BTC in the United States.

The Company said vilasumu conditionally activates 4-1BB to expand T cells, with the differentiated potential to overcome the limited benefit of immunotherapy in "cold" tumours and deliver long-tail survival benefits. The first-line BTC clinical study is progressing, with the Phase II study for first-line advanced BTC advanced to the expansion stage in April 2026 based on a favourable safety profile and efficacy data, with all patients enrolled.