Leads Biolabs' GPRC5D/CD3 Bispecific T-Cell Engager LBL-034 Earns FDA Fast Track Designation-Accelerating Launch of Potential Best-in-Class Therapy for Relapsed/Refractory Multiple Myeloma

Nanjing, China - January 28, 2026 - Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) today announced that its key investigational asset LBL-034, a GPRC5D/CD3 bispecific antibody with a unique 2:1 structure and conditional activation, independently developed using the proprietary CD3 T-cell engager platform--LeadsBody platform, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory multiple myeloma (RRMM).

Executive Commentary

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

"The sequential regulatory achievements of LBL-034-including Orphan Drug Designations from FDA, followed by FDA Fast Track Designation-underscore its strong global competitiveness and further validate the differentiated capabilities of our proprietary LeadsBody platform. These milestones will meaningfully accelerate LBL-034's global clinical development and bring innovative treatment options to patients with relapsed or refractory multiple myeloma sooner."

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 but not limited to:

* More frequent interactions and guidance from the FDA on clinical development, trial design, and data requirements.
* Eligibility for rolling review, allowing completed sections of a marketing application to be submitted and reviewed on an ongoing basis; and
* Potential eligibility for Priority Review, subject to meet relevant criteria.

These mechanisms are designed to help accelerate development timelines and facilitate earlier patient access to promising therapies.

AboutLBL-034

LBL-034 is a bispecific T-cell engager (TCE) that targets both GPRC5D and CD3, developed using the Company's proprietary LeadsBody platform. Designed with a 2:1 binding format-two sites for GPRC5D and one for CD3-LBL-034 can selectively target GPRC5D+ cancer cells, conditionally activate T cells, reduce the risk of cytokine release, minimize the risk of systemic toxicity, and lower the risk of T cell exhaustion, thereby exerting anti-tumor effects in an efficient, low-toxic, and long-term stable manner. In October 2024, LBL-034 received Orphan Drug Designation from the U.S. FDA for the treatment of multiple myeloma.

LBL-034 has demonstrated promising efficacy signals in both preclinical and clinical studies. It is currently being evaluated in a Phase I/II clinical trial for RRMM and other malignant plasma cell neoplasms in China. Notably, breakthrough clinical data from LBL-034 monotherapy in RRMM were presented as the first oral presentation on the opening day of the ASH 2025 Annual Meeting, highlighting its emerging clinical profile and therapeutic potential.

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.

We 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.

We 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. We 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 our continued innovation and have been validated by the clinical outcomes of our bispecific antibody portfolios.

We have established integrated capabilities across early discovery, translational medicine, clinical development, CMC and business development. The innovative nature and competitive strengths of our drug candidates, coupled with our global perspectives, proactive strategy, and efficient clinical validation, have made us an attractive partner for leading industry players and investment institutions.

For more information, please visit https://en.leadsbiolabs.com/
Media Contact
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Contact Person: Yizi
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Country: China
Website: https://www.leadsbiolabs.com/

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