Core Viewpoint - The company has received FDA fast track designation for its bispecific antibody, ViliXinTM (Opa-Tisumi Monoclonal Antibody, LBL-024), for the treatment of pulmonary neuroendocrine carcinoma, indicating significant potential in addressing unmet medical needs in oncology [1][2] Group 1: FDA Designation and Drug Development - ViliXinTM has been granted fast track designation by the FDA, which accelerates the review process for drugs that treat serious conditions or fill unmet medical needs [1] - The fast track designation allows for more frequent regulatory interactions and the ability to submit a rolling new drug application [1] Group 2: Clinical Trial Results - In clinical trials in China, ViliXinTM has shown encouraging efficacy signals and good safety profiles as both a monotherapy and in combination with chemotherapy for patients with advanced pulmonary neuroendocrine carcinoma [2] - The company received approval from the National Medical Products Administration (NMPA) in April 2024 to conduct a single-arm registration clinical trial and was granted breakthrough therapy designation (BTD) in October 2024 [2] Group 3: Broader Implications and Potential - ViliXinTM targets both PD-L1 and 4-1BB, showing potential as the first approved drug for advanced pulmonary neuroendocrine carcinoma and demonstrating first-in-class or best-in-class clinical activity in various indications [1] - The drug has also shown promising clinical signals in multiple cancers with high 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 [2]
维立志博-B：维利信 (PD-L1/4-1BB双特异性抗体奥帕替苏米单抗，LBL-024)获美国FDA授予快速通道资格认定