On February 9, the global first PD-1/TGFβRⅡ dual-functional protein LBL-015 freeze-dried preparation for injection developed by Nanjing Leads Biolabs gained the approval of the U.S. Food and Drug Administration (FDA) for clinical trial.

Leads Biolabs, established in Nanjing by antibody R&D team consisting of experienced members who have received education in the US, is a clinical-stage biopharma company. Since its establishment in 2014, the company has been dedicated to the R&D of antibody drugs with independent IPR for the treatment of cancer and other major diseases, focusing on unmet medical needs, especially problems and challenges in tumor immunotherapy. LBL-015, the dual-functional protein developed by the company and to which it also owns IPR, is composed of high affinity anti-PD-1 monoclonal antibody and TGFβRⅡ protein and can block both PD-1/PD-L1 and TGFβ immunosuppression paths. With good application prospects in the treatment of lung cancer, digestive tract malignancies, liver cancer, bladder cancer and many other solid tumors, LBL-015 will be able to satisfy the currently unmet clinical needs of patients.