NANJING, China, May 11, 2026 /PRNewswire/ -- Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs"; Stock Code: 9887.HK) successfully held its R&D Symposium in Shanghai. Under the theme "Leads Innovation, Future Forward", the event comprehensively presented the Company's strategic elevation from "multi-platform synergy" to "multi-mechanism integration". Leads Biolabs highlighted its innovation ecosystem propelled by four proprietary technology platforms—IO 2.0, TCE, ADC, and the world-first TDC—alongside milestone advancements in core clinical pipelines, a preclinical pipeline matrix with global first-in-class potential, and forward-looking development roadmaps.

Dr. Xiaoqiang Kang, Founder, Chairman, and CEO of Leads Biolabs, said: "Focusing on the prevailing unmet clinical needs and core challenges in immuno-oncology (IO), Leads Biolabs has established a differentiated layout by deeply integrating three frontier technologies: IO 2.0, TCE, and ADC. We have constructed a clinical pipeline matrix characterized by multi-mechanism fusion. By adhering to a phased development strategy encompassing single-agent validation, platform iteration, and combination expansion, we aim to systematically surmount clinical barriers such as 'cold tumors', immune resistance, and poor response. The year 2027 is poised to witness the launch of the Company's first commercial product, marking its official transition into the inaugural year of commercialization. Propelled by our robust technology platforms, we aim to advance 20+ novel molecules into clinical trials, progress 4 to 8 assets into late-stage development, and achieve commercialization for 3 products by 2030. These milestones will drive us steadily toward our ultimate vision: 'Transforming cancer into a manageable chronic disease'."

Clinical Breakthroughs & Value Realization: From Clinical-Stage Biotech to Integrated Biopharma

Since its inception, Leads Biolabs has remained committed to an "asymmetric competition" strategy, taking unaddressed clinical gaps left by PD-(L)1 inhibitors as its strategic cornerstone. By proactively anchoring its research in IO 2.0, the Company has pioneered the synergistic mechanism of "immune checkpoint inhibition plus co-stimulatory signal activation". This approach has successfully propelled LBL-024—a potential global first-in-class (FIC) PD-L1/4-1BB bispecific antibody—to the BLA (Biologics License Application) submission stage.

LBL-024: A Potential IO 2.0 Pan-Tumor Backbone Therapy with Survival Benefit. Utilizing the unique 2:2 molecular structure design of the X-body platform, LBL-024 releases PD-L1-mediated immunosuppression while conditionally activating the 4-1BB co-stimulatory pathway, achieving the synergistic effect of "releasing the brakes and stepping on the accelerator". Clinical studies have confirmed that LBL-024 not only overcomes the global technical challenge of the 4-1BB target, where no drugs have been marketed due to uncontrollable hepatotoxicity, but also demonstrates breakthrough efficacy across multiple cancer types and "cold tumors":

• Safety: With over 600 patients enrolled, liver enzyme abnormalities in LBL-024 monotherapy or combination with chemotherapy occurred only in the early stages. No cumulative hepatotoxicity was observed with long-term treatment, and the overall safety profile is similar to that of PD-(L)1 monoclonal antibodies. Dose escalation up to 25.0 mg/kg did not reach the maximum tolerated dose (MTD), and no dose-limiting toxicities (DLTs) were observed.
• Pan-cancer Efficacy: LBL-024 has demonstrated global first- or best-in-class potential in registrational or Phase II clinical studies for extrapulmonary neuroendocrine carcinoma (EP-NEC), non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and biliary tract cancer (BTC).
• Cold Tumor Efficacy: LBL-024 is poised to become the first approved drug for EP-NEC, a typical cold tumor. In first-line SCLC combined with chemotherapy, the objective response rate (ORR) reached 88.1%, significantly superior to the approximately 60% of standard of care (SoC). It is also effective in PD-L1 low-expression NSCLC, achieving an efficacy breakthrough in populations difficult to cover with PD-1 monoclonal antibodies.
• Durable Response: In late-line EP-NEC, the median overall survival (mOS) reached 11.9 months, doubling that of existing regimens. A clear survival benefit trend was also observed in first-line patients, offering the potential for long-term functional cure.

LBL-024 adopts a clear and progressive development strategy: advancing from late-line to first-line, from monotherapy to combination therapy, and from orphan diseases to major indications. Currently, LBL-024 covers 13 solid tumor indications, with one pivotal registrational study and eight proof-of-concept (PoC) studies underway.

LBL-024 is set to reach a series of intensive milestones in the second half of 2026. Regarding data readouts, data from a large patient cohort for first-line NSCLC will be presented at the World Conference on Lung Cancer (WCLC) in September. In October, the European Society for Medical Oncology (ESMO) Annual Meeting will feature the pivotal single-arm registrational clinical trial data for late-line EP-NEC, alongside the latest clinical results for first-line EP-NEC, SCLC, and BTC. On the commercialization front, LBL-024 has garnered Breakthrough Therapy Designation (BTD) from the CDE, as well as Fast Track Designation (FTD) and Orphan Drug Designation (ODD) from the U.S. FDA, and ODD from the European Union. The Company expects to submit the BLA for LBL-024 to the CDE in Q3 2026. The approval of LBL-024 will signify a pivotal milestone in the Company's transition from a clinical-stage Biotech to an integrated Biopharma.

Platform-Driven, Innovation from the Source: An In-house R&D System Integrating High-Efficiency Multi-functional Platforms and Technical Capabilities

The future of oncology treatment lies in synergy, with combinations such as IO + ADC and TCE + ADC emerging as essential expansion pathways under this prevailing trend. Leads Biolabs is dedicated to expanding the reach of immunotherapy through the deep integration of its platforms. Currently, the Company has established four core technology platforms:

• X-body (4-1BB Engager) Platform (IO 2.0): This platform utilizes advanced antibody engineering to create differentiated bispecific antibodies with a 2:2 molecular architecture, successfully addressing the hepatotoxicity and narrow therapeutic window typically associated with 4-1BB agonists.
• LeadsBody (CD3 T-cell Engager) Platform (TCE): Designed to enhance efficacy and overcome treatment resistance, the next-generation LeadsBody platform has been clinically validated in hematologic malignancies by the potential best-in-class (BIC) LBL-034 (GPRC5D/CD3 bispecific antibody). For solid tumors, the platform is advancing in three strategic directions: multi-TAA (Tumor-Associated Antigen) targeting, co-stimulatory trispecific TCE, and TCE-ADC.
• TOPiKinectics Platform in the ADC Field: The differentiated TOPiKinectics platform possesses full-chain, in-house design capabilities, including payload release within the tumor microenvironment (TME). It enables targeted tumor killing while minimizing off-target toxicity, thereby resolving industry pain points such as the narrow therapeutic window and frequent resistance associated with traditional ADC treatments. Furthermore, it offers advantages such as synergistic anti-tumor effects between ADC and IO.
• World-First TDC Platform ImBiTDC™ (TCE-ADC): Leveraging proprietary antibody platforms and the TOPiKinectics platform, this technology deeply integrates TCE modules targeting tumor-specific antigens with ADC technology. This pioneers a completely new therapeutic track designed to address challenges such as overlapping toxicities and patient compliance issues associated with separate administration in traditional combination regimens. The TDC platform offers two key advantages: broad-spectrum efficacy and optimized safety. Unconstrained by the single mechanisms of either ADC or TCE, it is adaptable to diverse tumor scenarios with varying T-cell infiltration levels, T-cell functional states, and antigen expression abundance. It can efficiently kill high-antigen, high-payload-sensitive tumors, while also covering low-antigen, immunosuppressive patient populations through bystander effects and T-cell redirection. This significantly expands the eligible patient population and substantially reduces the risk of CRS, enhancing efficacy while simultaneously improving safety.

Through the progressive synergy of its technology platforms and the deep integration of multiple mechanisms, Leads Biolabs is constructing an innovative R&D ecosystem characterized by the cross-empowerment of multiple targets, molecule types, and technological routes. This ecosystem aims to lead the next generation of immuno-oncology, ensuring more cancer patients benefit from the continuous evolution of immunotherapy.