Shanghai Henlius Biotech, Inc (HKG: 2696) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its HLX13, a biosimilar of US major Bristol-Myers Squibb’s (BMS, NYSE: BMY) Yervoy (ipilimumab), for the treatment of liver cancer.
HLX13: A CTLA-4 Monoclonal Antibody for Cancer Treatments
HLX13 is a cytotoxic T-lymphocyte antigen 4 (CTLA-4) monoclonal antibody (mAb) under development by Henlius Biotech. The drug is intended to treat a range of cancers, including liver cancer, melanoma, advanced renal cell carcinoma, and metastatic colorectal cancer with highly unstable microsatellite or mismatch repair defect. This development marks a significant step in expanding access to immunotherapeutic options for patients in China.
Yervoy’s Market History and Indications
Yervoy, the originator product, was first approved to treat advanced melanoma in 2011 and has since gained additional indications. In June 2021, Yervoy received market approval in China for use in non-epithelioid malignant pleural mesothelioma combined with nivolumab. The approval of HLX13 for clinical trials in liver cancer indicates Henlius Biotech’s commitment to providing alternative treatment options for patients in need.-Fineline Info & Tech
