Junshi Biosciences Partners with LEO Pharma for Toripalimab Distribution in Europe
Monday, January 20, 2025
Shanghai Junshi Biosciences has entered a partnership with LEO Pharma for the distribution and marketing of its monoclonal antibody toripalimab across Europe.
Toripalimab has been extensively studied globally, with over 40 clinical trials conducted for more than 15 indications. Approved indications include therapies for melanoma, lung, gastric, liver, and breast cancers, among others.
The agreement covers up to 32 European countries, including EU member states, the EEA, Switzerland, and the UK. This collaboration aims to enhance the accessibility of toripalimab, a therapy for multiple malignant tumours, within these regions.
Toripalimab, developed by Junshi Biosciences, targets the PD-1 protein to improve the immune system’s ability to combat cancer cells. It is approved in more than 35 countries and regions, including recent approvals in 2024 by the European Commission and the UK Medicines and Healthcare Products Regulatory Agency.
In China, it was the first domestically developed PD-1 monoclonal antibody to receive approval and is marketed as TUOYI®. Its approved uses span ten indications, many of which are included in China’s National Reimbursement Drug List for 2024.
Approved indications include its use in combination therapies for recurrent or metastatic nasopharyngeal carcinoma (NPC) and advanced or metastatic oesophageal squamous cell carcinoma (ESCC).
Notably, toripalimab is the only approved treatment in Europe for NPC and the first-line treatment for advanced ESCC, irrespective of PD-L1 tumour expression.
Under the terms of the agreement, LEO Pharma will oversee the product’s distribution, sales, and promotion in Europe. Meanwhile, Junshi Biosciences’ subsidiary, TopAlliance Biosciences, will retain the role of Marketing Authorization Holder, responsible for product development, manufacturing, regulatory compliance, and quality management.
Junshi Biosciences has identified Europe as a key strategic region for its global growth and has established a local operational hub to facilitate the commercial launch of toripalimab. The partnership leverages LEO Pharma’s established distribution network and expertise in hospital-based specialty treatments.
Internationally, toripalimab has been approved in countries such as the United States, India, Australia, and Jordan, and it is undergoing regulatory review in other markets, including Singapore.
The collaboration with LEO Pharma is expected to accelerate the integration of toripalimab into European healthcare systems, expanding access to innovative treatments for patients.
Source: globenewswire.com
