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.
Developed using Leads Biolabs' proprietary X-Body bispecific platform, Opamtistomig features a 2:2 molecular format, incorporating two binding domains each for PD-L1 and 4-1BB with an optimized affinity ratio. This unique design enables dual functionality: reversing PD-L1-mediated immune suppression while selectively enhancing T-cell activation, resulting in a potent and synergistic anti-tumor immune response.
In two ongoing clinical studies in China, Opamtistomig has demonstrated promising efficacy and a favorable safety profile in patients with advanced EP-NEC, both as monotherapy and in combination with chemotherapy. Given the absence of a globally accepted standard of care for EP-NEC, these results support the advancement of a single-arm pivotal study toward potential accelerated approval.
Recognizing its clinical potential, Opamtistomig received Breakthrough Therapy Designation (BTD) from China's National Medical Products Administration (NMPA) in October 2024, Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) in November 2024.
Mechanistically, 4-1BB agonism can reactivate exhausted T cells and promote robust T-cell proliferation, offering significant development for PD-1/PD-L1-resistant or immunologically "cold" tumors. Beyond EP-NEC, Opamtistomig has received clinical trial approvals across multiple tumor types with high unmet medical needs, 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. Encouraging clinical activity has already been observed in NSCLC, SCLC, BTC, OC, and other indications, underscoring Opamtistomig's potential as a broad-spectrum immuno-oncology therapy.
About Leads Biolabs
Founded in 2012, Leads Biolabs is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of innovative therapies to address underserved medical needs in oncology, autoimmune, and other severe diseases both in China and globally.
Leads Biolabs are a front-runner in next-generation immuno-oncology treatments with a differentiated pipeline of 14 innovative drug candidates, including seven clinical-stage drug candidates, of which four lead products are among the top-tier clinically advanced candidates globally.
Leads Biolabs adopt a science-driven R&D approach and have successfully established comprehensive R&D capabilities spanning antibody discovery and engineering, in vivo and in vitro efficacy evaluation, as well as druggability assessment. Leads Biolabs have also developed multiple proprietary technology platforms, including LeadsBody platform (a CD3 T-cell engager platform), X-body platform (a 4-1BB engager platform), TOPiKinectics (ADC platform), which serve as the cornerstone for continued innovation and have been validated by the clinical outcomes of bispecific antibody portfolios.
Leads Biolabs have established integrated capabilities across early discovery, translational medicine, clinical development, CMC and business development. The innovative nature and competitive strengths of drug candidates, coupled with global perspectives, proactive strategy, and efficient clinical validation, have made an attractive partner for leading industry players and investment institutions. For more information, please visit https://en.leadsbiolabs.com/.
Leads Biolabs
PR@leadsbiolabs.com
Yizi
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/280455
Source: Global News
