Jinwu Financial News | China National Pharmaceutical Group (01177) announced that the group’s self-developed Class 1 Innovative Drug, Bemosituzumab Injection, in combination with Anlotinib Hydrochloride Capsules, has communicated with the China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) regarding a new application for marketing approval for the indication of advanced Alveolar Soft Part Sarcoma (ASPS) and has received written consent from the CDE to submit the application. The group will submit the application shortly.
ASPS is the 12th indication for which Anlotinib is about to be submitted for marketing approval and the 5th indication for which Bemosituzumab is about to be submitted for marketing approval, potentially providing new treatment options for ASPS patients.
ASPS is an extremely rare and highly malignant soft tissue sarcoma, with a Global incidence rate of less than 0.01 per 1 million, accounting for 0.5% to 1% of all soft tissue sarcomas, classified as ultra-rare sarcomas by the Connective Tissue Oncology Society. ASPS mostly occurs in adolescents; although it has a slow progression, the prognosis is poor, with a high tendency for early metastasis and diffusion, and it is highly insensitive to chemotherapy. Currently, treatment options are very limited, with a 5-year overall survival rate of only 20% to 46%, necessitating more effective treatment solutions.
