Collen Pharmaceuticals: Subsidiary Core Product Luconituzumab Monoclonal Antibody Approved for Fourth Indication

date
06/02/2026
Korea Pharmaceutical announced that its controlling subsidiary, Kolon BoTech's Lusutuzumab govitecan, has received approval from the National Medical Products Administration for a new indication for the treatment of specific adult patients with breast cancer. This is the fourth indication approved for the drug in China. The approval was based on the results of the OptiTROP - Breast02 phase III clinical study, which showed significant improvement in progression-free survival in the drug group compared to the chemotherapy group, with a trend towards improved overall survival and a significant increase in objective response rate. Currently, global and Chinese phase III clinical studies on Lusutuzumab govitecan in combination with or without Palbociclib have been initiated for the treatment of breast cancer. The drug has previously been included in medical insurance for two indications and has also received recognition as a breakthrough therapy for six indications.