LEADS BIOLABS-B (09887): Veltisim (PD-L1/4-1BB bispecific antibody Optatisomab monoclonal antibody, LBL-024) has been granted fast track designation by the US FDA.

LEADS BIOLABS-B (09887) announced that on January 14, 2026, the PD-L1/4-1BB bispecific antibody VelixinTM (atezolizumab, LBL-024) has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of extrapulmonary neuroendocrine cancer. Fast Track designation by the FDA is a method of accelerating the review and approval of drugs that treat serious or life-threatening conditions or address unmet medical needs to expedite drug development. It provides several important procedural incentives, including more frequent regulatory interactions and guidance from the FDA, as well as the ability to submit new drug applications on a rolling basis for regulatory approval. VelixinTM is a bispecific antibody that targets both PD-L1 and 4-1BB, and is the first therapy worldwide to target the 4-1BB receptor in the registration clinical stage for the treatment of extrapulmonary neuroendocrine cancer. In phase II or registration clinical trials for non-small cell lung cancer, small cell lung cancer, and extrapulmonary neuroendocrine cancer, VelixinTM has demonstrated first-in-class or best-in-class clinical activity potential. VelixinTM also has the potential to become the first approved drug for the treatment of advanced extrapulmonary neuroendocrine cancer. Using our proprietary and patented X-body platform, VelixinTM is designed with an optimal 2:2 structure to release PD-1 / L1 immune inhibition and enhance 4-1BB-mediated T cell activation, achieving a synergistic effect in tumor elimination with stronger potential for cancer treatment than PD-1 / L1 inhibitors. In two clinical trials in China, VelixinTM showed promising efficacy signals and good safety as monotherapy or in combination therapy with chemotherapy for advanced extrapulmonary neuroendocrine cancer patients. In April 2024, our company received approval from the National Medical Products Administration (NMPA) to conduct a single-arm registration clinical trial. In October 2024, VelixinTM received Breakthrough Therapy Designation (BTD) from the NMPA for the treatment of late-stage extrapulmonary neuroendocrine cancer, and in November 2024, the FDA granted Orphan Drug Designation (ODD) for the treatment of neuroendocrine cancer. As an agonist, 4-1BB can re-activate apoptotic T cells and expand them significantly, making it particularly suitable for the treatment of "cold tumors" resistant or refractory to PD-1/PD-L1. In addition to extrapulmonary neuroendocrine cancer, VelixinTM has shown promising clinical signals in several cancers with unmet medical needs, including small cell lung cancer, cholangiocarcinoma, ovarian cancer, non-small cell lung cancer, esophageal squamous cell carcinoma, hepatocellular carcinoma, gastric cancer, triple-negative breast cancer, and melanoma. Encouraging clinical effects have been observed in multiple cancers such as small cell lung cancer, cholangiocarcinoma, and ovarian cancer, making it a promising candidate for an effective anti-tumor drug with broad indications.