Junshi Biosciences and its wholly owned subsidiary, TopAlliance Biosciences, have entered into a commercialisation partnership with LEO Pharma for toripalimab in Europe.
The collaboration will distribute toripalimab across 32 European countries to enhance patient access to cancer treatments.
Toripalimab, developed by Junshi Biosciences, is a PD-1 targeting monoclonal antibody used to treat various cancers. It has been approved in over 35 countries and regions.
In 2024, toripalimab received approval from the European Commission (EC) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for recurrent or metastatic nasopharyngeal carcinoma (NPC) and advanced or metastatic oesophageal squamous cell carcinoma (ESCC).
Ongoing and completed clinical trials for the drug evaluate its safety and efficacy across a broad range of cancers, including lung, nasopharynx, oesophagus, stomach, bladder, breast, liver, kidney, and skin cancers.
Junshi Biosciences senior vice president and TopAlliance Biosciences CEO Sheng YAO said: “As a century-old multinational pharmaceutical company headquartered in Europe, LEO Pharma has established a mature distribution network and rich marketing expertise in the local markets.
“By leveraging both parties’ strengths in R&D, manufacturing, and commercialisation, we believe toripalimab will be efficiently integrated into the Europe markets benefitting local patients-in-need.
“Moving forward, we will continue to implement our ‘In China, For Global’ strategy and work with partners to provide high-quality, innovative therapies from China to patients worldwide.”
As per the agreement, LEO Pharma will handle the distribution, promotion, and sales of toripalimab across 32 countries, including the European Union (EU), the European Economic Area (EEA), Switzerland, and the UK.
TopAlliance Biosciences Europe will maintain its role as the marketing authorisation holder (MAH) for toripalimab, overseeing product development, manufacturing, and registration.
Denmark-based LEO Pharma will make upfront payments, milestone payments for future indications, and a double-digit revenue share on toripalimab’s net sales within the collaboration territory.
LEO Pharma thrombosis business unit executive vice president Jean Monin 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 Loqtorzi brings an important new treatment option to areas of high unmet medical need and focuses on a speciality hospital product that complement our existing heparin-based anti-coagulation treatments for cancer-associated thrombosis and other speciality patients.”
