By Fineline Cube China-based Shanghai Henlius Biotech, Inc. (HKG: 2696) has entered into a licensing and supply agreement with US-based Organon (NYSE: OGN), granting Organon exclusive commercialization rights to Henlius’s biosimilars of Perjeta (pertuzumab, HLX11) and Prolia/Xgeva (denosumab, HLX14). The deal excludes Greater China and covers global territories.
Deal Structure and Financials
The agreement includes an upfront payment of USD 73 million, with additional development, regulatory, and commercial milestones. In total, the deal could reach USD 541 million. Henlius will handle development and supply the products to Organon if approved. The deal also includes an option to negotiate further exclusive licenses for Henlius’s biosimilar of Yervoy (ipilimumab, HLX13).
Perjeta Biosimilar (HLX11)
Pertuzumab is an anti-HER2 domain II humanized monoclonal antibody used in combination with trastuzumab and chemotherapy for HER2-positive early breast cancer and metastatic or locally recurrent breast cancer. Henlius’s biosimilar has met the primary endpoint in a Phase I clinical trial, showing similar pharmacokinetic and safety profiles to the reference drug.
Prolia/Xgeva Biosimilar (HLX14)
Denosumab is a recombinant anti-RANKL human monoclonal antibody used for osteoporosis in postmenopausal women, giant cell tumor of bone, multiple myeloma, and bone metastases from solid tumors.
Yervoy Biosimilar (HLX13) Option
Ipilimumab is a CTLA-4 inhibitor used for unresectable or metastatic melanoma, renal cell carcinoma, colorectal cancer, hepatocellular carcinoma, non-small cell lung cancer, malignant pleural mesothelioma, and esophageal cancer. The option for its biosimilar’s global commercialization rights is part of the agreement.-Fineline Info & Tech