SHANGHAI—Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its HLX17, a biosimilar version of MSD’s (Merck & Co., known as MSD outside the US) blockbuster drug Keytruda (pembrolizumab). The biosimilar targets all indications that the originator drug has been approved for, encompassing a wide range of cancers including melanoma, non-small cell lung cancer, esophageal cancer, head and neck squamous cell cancer, colorectal cancer, hepatocellular carcinoma, bile duct cancer, triple negative breast cancer, microsatellite highly unstable or mismatch repair gene defective tumors, and gastric cancer.
Keytruda, a PD-1 inhibitor, was first approved in China in July 2018, following BMS’s Opdivo (nivolumab) as the second PD-1 inhibitor in the country. The drug has been a significant revenue generator, with global sales exceeding USD 25 billion in 2023, and it achieved sales of RMB 1.425 billion in China alone. HLX17 has demonstrated equivalence to the originator in preclinical pharmacology, pharmacodynamics, pharmacokinetics, and immunogenicity studies, positioning it as a potential competitor in the immuno-oncology space.
The clinical trial approval for HLX17 is a significant milestone for Henlius Biotech, reflecting the company’s commitment to expanding access to advanced biosimilar therapies and enhancing treatment options for patients in China and beyond. – Flcube.com
