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Shanghai-based Junshi Biosciences has announced a significant partnership with Denmark’s LEO Pharma to distribute and commercialise toripalimab across Europe. The aim is to make the PD-1 monoclonal antibody treatment more accessible to patients in up to 32 European countries, including all EU member states, the UK and Switzerland.
Toripalimab, developed by Junshi Biosciences, targets the PD-1 pathway to boost the immune system’s ability to detect and attack tumour cells. It was approved by the European Commission and the UK Medicines and Healthcare Products Regulatory Agency in 2024 in combination therapies for specific indications.
The approved indications include as a first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC) and advanced esophageal squamous cell carcinoma (ESCC). Notably, toripalimab is the first approved drug in Europe for NPC and the only first-line treatment for advanced ESCC that does not depend on tumour PD-L1 expression.
LEO Pharma will handle distribution, sales and marketing of the drug, while Junshi’s European subsidiary, TopAlliance Biosciences, will retain the role of Marketing Authorisation Holder. Junshi will manage product development, manufacturing, regulatory affairs and pharmacovigilance. The agreement also includes upfront and milestone payments, with LEO Pharma receiving a revenue share based on net sales.
Dr Sheng Yao, Senior Vice President, Junshi Biosciences, and CEO, TopAlliance Biosciences, said: “The partnership with LEO Pharma has established a significant milestone for Junshi Biosciences in the European market and is closely aligned with the company’s global expansion strategy.” He also said: “By leveraging both parties’ strengths in R&D, manufacturing, and commercialization, we believe toripalimab will be efficiently integrated into the Europe markets benefitting local patients-in-need.”
Jean Monin, Executive Vice President, Thrombosis Business Unit, LEO Pharma, highlighted how the collaboration complements the company’s existing portfolio. He said: “We are excited to partner with Junshi Biosciences, supplementing LEO Pharma’s Thrombosis business, which already serves patients with cancer-associated thrombosis. The distribution and marketing partnership for [toripalimab] brings an important new treatment option to areas of high unmet medical need.”
This collaboration positions LEO Pharma within the increasingly competitive landscape of PD-1 and PD-L1 inhibitors, which have become a cornerstone in oncology treatment. The partnership also reflects growing interest in cross-regional partnerships as companies seek to broaden access to innovative therapies worldwide.
