Global Development Accelerates: Leads Biolabs' PD-L1/4-1BB Bispecific Antibody Granted Fast Track Designation by FDA

Nanjing, China--(Newsfile Corp. - January 15, 2026) - Nanjing Leads Biolabs Co., Ltd. (HKE: 9887) ("Leads Biolabs" or the "Company") today announced that Opamtistomig (LBL-024), its core investigational PD-L1/4-1BB bispecific antibody, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of extra-pulmonary neuroendocrine carcinoma (EP-NEC). This marks the third major regulatory designation secured by Opamtistomig, following Breakthrough Therapy Designation (BTD) from China's National Medical Products Administration (NMPA) and Orphan Drug Designation (ODD) from the FDA. To date, Opamtistomig has demonstrated first- or best-in-class potential in Phase II or registrational clinical trials across three indications: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and EP-NEC.

Executive Commentary

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated:

"With Opamtistomig now receiving Fast Track Designation from the FDA—following Breakthrough Therapy Designation in China and Orphan Drug Designation in the United States—we have achieved a rare triple regulatory acceleration. This milestone reflects strong regulatory confidence in the molecule's clinical potential and will meaningfully accelerate global development, shorten approval timelines, and help bring this innovative therapy to patients with high unmet needs worldwide."

About Fast Track Designation

Fast Track Designation is an FDA program designed to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening condition or address unmet medical needs to facilitate the development of drugs. It provides several important procedural incentives, including more frequent regulatory communication and guidance from the FDA, as well as the eligibility to submit new drug applications for regulatory approval on a rolling basis.

About Opamtistomig (LBL-024)

Opamtistomig (LBL-024) is a potential first-in-class bispecific antibody that simultaneously targets PD-L1 and the co-stimulatory receptor 4-1BB. It is the first 4-1BB-targeting bispecific antibody globally to advance to a single-arm pivotal trial as monotherapy, and it aims to become the first approved therapy specifically for extrapulmonary neuroendocrine carcinoma (EP-NEC)—a rare malignancy with substantial unmet clinical need.