Fosun Pharma subsidiaries gain approvals for cancer drug trials

Shanghai Fosun Pharmaceutical Group's subsidiary, Shanghai Henlius Biotech, has received US FDA approval to commence a Phase I clinical trial in the United States for HLX17, a recombinant anti-PD-1 humanized monoclonal antibody injection. HLX17, a biosimilar of pembrolizumab developed internally by Fosun Pharma, is intended for multiple resected solid tumors, including melanoma and various lung and gastrointestinal cancers. The cumulative R&D investment for HLX17 by Fosun Pharma is approximately RMB 176 million as of July 2025. Pembrolizumab’s global sales reached approximately $32.056 bn in 2024.

Additionally, another controlled subsidiary, Fosun Pharmaceutical (Jiangsu) Group, received approval from China's National Medical Products Administration (NMPA) to conduct a Phase III clinical trial for SAF-189, an innovative small molecule chemical drug. This drug is intended for adjuvant treatment of patients with ALK-positive or ROS1-positive non-small cell lung cancer after radical tumor resection. The cumulative R&D investment for SAF-189 by Fosun Pharma is approximately RMB 453 million as of July 2025. Sales of major ALK-positive NSCLC drugs in China totaled approximately RMB 3.164 bn in 2024.

Both drugs face the inherent risks associated with pharmaceutical R&D, including potential termination of clinical trials due to safety or efficacy issues, and the long lead time to market. Both announcements caution investors about these uncertainties.