By Fineline Cube 
Lee’s Pharmaceutical Holdings Ltd. (HKG: 0950) announced that its in-licensed programmed-death ligand 1 (PD-L1) monoclonal antibody (mAb), socazolimab, has been approved by China’s National Medical Products Administration (NMPA) for an additional indication. The approval allows the use of socazolimab in combination with carboplatin and etoposide for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).
Socazolimab’s Background and Previous Approval
Socazolimab, originated by US-based Sorrento Therapeutics (NASDAQ: SRNE), was the focus of a USD 46 million licensing deal between Lee’s Pharma and Sorrento in October 2014. The product received its initial approval from the NMPA in December 2023 for the treatment of recurrent-metastatic cervical cancer. This new approval expands its therapeutic applications to address another critical area of unmet medical need.
Clinical Trial Results Supporting New Indication
The approval for the ES-SCLC indication is supported by positive results from a Phase 3 study. The study demonstrated that socazolimab significantly improved both overall survival (mOS: 13.90 months vs. 11.58 months) and progression-free survival (mPFS: 5.55 months vs. 4.37 months) in patients. These results highlight the potential of socazolimab to enhance treatment outcomes for patients with this aggressive form of lung cancer.-Fineline Info & Tech