Shanghai Securities News China Securities Network News On April 30, the official website of the National Medical Products Administration showed that Qilu Pharmaceutical's targeted anti-tumor drug Rudaxin® (Denosumab Injection) has officially received marketing approval. It is used to treat giant cell tumor of bone that cannot be surgically removed or where surgical removal may lead to severe functional impairment, including adult and adolescent patients with mature skeletal development (defined as having at least one mature long bone and weighing ≥45kg).
According to Qilu Pharmaceutical, Rudaxin® is a 120mg denosumab biosimilar developed by the company. It can bind RANKL with high affinity, inhibit osteoclast activation, and reduce the recurrence of giant cell tumor of bone. The latest analysis shows that the prognosis of patients with giant cell tumor of bone treated with denosumab has significantly improved. For patients whose tumors can be surgically removed, after treatment with Rudaxin®, they only need surgery with less functional impact or even may avoid surgery altogether; for those whose tumors cannot be surgically removed, treatment with Rudaxin® can achieve long-term disease control and significantly improve disease-free survival. (He Xinyi)