科伦药业：子公司核心产品芦康沙妥珠单抗获批第四项适应症

Core Viewpoint - Kelun Pharmaceutical's subsidiary, Kelun Biotech, received approval from the National Medical Products Administration for a new indication of Lukanasa (Lukangshatu) for treating specific adult breast cancer patients, marking the fourth approved indication for this drug in China [1] Group 1: Drug Approval and Clinical Research - The approval is based on the results of the OptiTROP-Breast02 Phase 3 clinical study, which showed a significant improvement in progression-free survival for the drug group compared to the chemotherapy group [1] - There is a trend of benefit in overall survival and a notable increase in objective response rate [1] - Phase 3 clinical studies for Lukanasa in combination with or without Pembrolizumab for related breast cancer have been initiated globally and in China [1] Group 2: Previous Indications and Recognitions - Two previous indications for Lukanasa have been included in the medical insurance coverage [1] - The drug has also received six breakthrough therapy designations [1]