Nanjing, China — January 16, 2026 — Leads & Copy — Nanjing Leads Biolabs Co., Ltd. (HKE: 9887) has announced that its investigational PD-L1/4-1BB bispecific antibody, Opamtistomig (LBL-024), has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for treating extra-pulmonary neuroendocrine carcinoma (EP-NEC).
According to the company, this is the third major regulatory designation for Opamtistomig, following Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) and Orphan Drug Designation (ODD) from the FDA. The company notes that Opamtistomig has demonstrated 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.
Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated that receiving Fast Track Designation from the FDA, following Breakthrough Therapy Designation in China and Orphan Drug Designation in the United States, represents a “triple regulatory acceleration.” He added that this milestone indicates regulatory confidence in the molecule’s clinical potential and will accelerate global development, shorten approval timelines, and help bring this therapy to patients.
The FDA’s Fast Track Designation program is designed to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions or address unmet medical needs. The designation provides incentives, including frequent regulatory communication and guidance from the FDA, and eligibility to submit new drug applications for regulatory approval on a rolling basis.
Opamtistomig (LBL-024) is a bispecific antibody that targets PD-L1 and the co-stimulatory receptor 4-1BB. According to the company, it is the first 4-1BB-targeting bispecific antibody to advance to a single-arm pivotal trial as monotherapy, and it aims to become the first approved therapy for extrapulmonary neuroendocrine carcinoma (EP-NEC).
Developed using Leads Biolabs’ X-Body bispecific platform, Opamtistomig features a 2:2 molecular format, with two binding domains each for PD-L1 and 4-1BB with an optimized affinity ratio. This design reverses PD-L1-mediated immune suppression while enhancing T-cell activation, resulting in an anti-tumor immune response, the company said.
In clinical studies in China, Opamtistomig has demonstrated efficacy and a favorable safety profile in patients with advanced EP-NEC, both as monotherapy and in combination with chemotherapy. According to the company, these results support the advancement of a single-arm pivotal study toward potential accelerated approval.
Opamtistomig received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) in October 2024, and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) in November 2024.
4-1BB agonism can reactivate exhausted T cells and promote T-cell proliferation. Opamtistomig has received clinical trial approvals across multiple tumor types, including small cell lung cancer (SCLC), biliary tract cancer (BTC), ovarian cancer (OC), non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), gastric cancer (GC), triple-negative breast cancer (TNBC), and malignant melanoma. Clinical activity has been observed in NSCLC, SCLC, BTC, OC, and other indications.
Leads Biolabs, founded in 2012, is a clinical-stage biotechnology company focused on developing therapies for oncology, autoimmune, and other diseases. Leads Biolabs has a pipeline of 14 drug candidates, including seven clinical-stage candidates. Leads Biolabs has developed multiple technology platforms, including LeadsBody platform (a CD3 T-cell engager platform), X-body platform (a 4-1BB engager platform), TOPiKinectics (ADC platform).
Leads Biolabs
PR@leadsbiolabs.com
Yizi
Source: Leads Biolabs
