Summary by Futu AI
On December 4, 2024, Fosun Pharma announced that its controlling subsidiary, Henlius, had its independently developed biosimilar HLX11 monoclonal antibody drug registration application accepted by the National Medical Products Administration. The new drug is intended for the adjuvant treatment of HER2-positive breast cancer patients and the treatment of metastatic breast cancer patients. In September 2024, the new drug achieved the primary endpoint in an international multicenter Phase III clinical trial.
As of October 2024, Fosun Pharma has accumulated approximately RMB 183.77 million in research and development of this new drug. According to IQVIA CHPA data, in 2023, the sales of Pertuzumab injection in China amounted to approximately RMB 3.4 billion. Despite the acceptance of the registration application, the new drug still needs to pass Good Manufacturing Practice (GMP...Show More