Shanghai Junshi Biosciences Co., Ltd.

LEO Pharma will be gaining the rights to commercialise Junshi Biosciences’ toripalimab in Europe under a new distribution and marketing partnership. The collaboration is aimed at increasing the accessibility of the PD-1 inhibitor, which is designed to help the immune system fight cancer. The drug, sold under the brand name Loqtorz, was approved by the European Commission (EC) and Medicines and Healthcare Products Regulatory Agency (MHRA) last year as part of a first-line combination treatment for certain adults with recurrent or metastatic nasopharyngeal carcinoma. More than 120,434 new cases of the rare form of cancer, which affects the part of the throat connecting the back of the nose to the back of the mouth, were reported globally in 2022. Toripalimab was also approved by both regulators in 2024 as part of a first-line combination treatment for adults with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma. LEO will now be responsible for toripalimab’s distribution, promotion and sales in all EU and European Economic Area member states, as well the UK and Switzerland. TopAlliance Biosciences Europe will remain the marketing authorisation holder for toripalimab in Europe and will receive an upfront fee from LEO. The Junshi subsidiary will also be eligible for milestone payments if LEO wants to pursue any subsequently approved indications for the drug. Jean Monin, executive vice president of LEO’s thrombosis business unit at LEO, said: “The distribution and marketing partnership for [toripalimab] brings an important new treatment option to areas of high unmet medical need and focuses on a specialty hospital product that complement our existing heparin-based anti-coagulation treatments for cancer-associated thrombosis and other specialty patients.” Sheng YAO, senior vice president of Junshi Biosciences and chief executive officer of TopAlliance Biosciences, added: “By leveraging both parties’ strengths in research and development, manufacturing and commercialisation, we believe toripalimab will be efficiently integrated into the Europe markets benefitting local patients-in-need.” The agreement comes less than two weeks after LEO partnered with Gilead Sciences to advance its small molecule oral STAT6 programme for inflammatory diseases. The deal, worth $1.7bn, gave Gilead global rights to develop, manufacture and commercialise the oral STAT6 programme. Meanwhile, LEO will hold exclusive global rights to STAT6 topical formulations in dermatology, and will have the option to co-commercialise oral programmes for dermatology indications outside the US.

Leo Pharma is paying an upfront fee to snag the European rights to toripalimab and will pay milestones if it wants to pursue subsequently approved indications. Leo Pharma has stepped up to commercialize toripalimab in Europe, inking a deal with Shanghai Junshi Biosciences to secure the rights to promote and sell the PD-1 inhibitor in its home region.Like Merck & Co.’s Keytruda and its slew of competitors, toripalimab is a checkpoint inhibitor designed to unleash immune attacks against cancer cells. Merck and its rivals make tens of billions of dollars a year from the mechanism and are now bracing for the loss of exclusivity on their molecules. Yet, Junshi and its collaborators see an opportunity for yet another PD-1/L1 drug.The European Medicines Agency approved toripalimab in nasopharyngeal and esophageal cancer last year. Toripalimab, which is sold as Loqtorzi, is the only drug in Europe in the nasopharyngeal setting and the only first-line treatment for metastatic esophageal cancer, regardless of PD-L1 expression. Leo is now responsible for distribution, promotion and sales of the antibody in up to 32 countries. Junshi subsidiary TopAlliance Biosciences Europe will remain responsible for manufacturing and other activities. Leo is paying an upfront fee to bag the rights and will pay milestones if it wants to pursue subsequently approved indications.TopAlliance CEO Sheng Yao discussed the division of labor between the partners in Monday’s announcement.“[TopAlliance] has already established a local operational center and is actively collaborating with local health authorities to prepare for the successful commercial launch of toripalimab in Europe,” 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.”Jean Monin, executive vice president of the thrombosis business unit at Leo, added details about how his team will handle the product, explaining that the drug complements the company’s “existing heparin-based anti-coagulation treatments for cancer-associated thrombosis and other specialty patients.”Coherus BioSciences, which previously secured U.S. rights to toripalimab in a deal worth up to $1.1 billion, sees the ability of the antibody to improve outcomes in patients with lower levels of PD-L1 expression as a point of difference versus other checkpoint inhibitors. Speaking at the J.P. Morgan Healthcare Conference this month, Coherus CEO Dennis Lanfear said the drug drives “disproportionately strong T-cell activation.”Lanfear said Coherus is targeting around 2,000 nasopharyngeal cancer patients a year in its markets, creating a $150 million to $200 million opportunity. Coherus, which won FDA approval for Loqtorzi in late 2023, is aiming to hit peak sales around four years after the launch.  

Junshi has conducted more than 40 company-sponsored clinical studies of the therapy. Credit: PeopleImages.com – Yuri A/Shutterstock. Shanghai Junshi Biosciences and its subsidiary TopAlliance Biosciences are set to enter a collaboration with LEO Pharma to distribute and market the monoclonal antibody, toripalimab, in Europe. The agreement focuses on expanding the accessibility of this cancer treatment to individuals in up to 32 nations. LEO Pharma will manage the distribution, promotion and sales of the antibody across European Union member states, Switzerland, the UK and the European Economic Area. TopAlliance Biosciences Europe will retain its role as the marketing authorisation holder, overseeing product development, manufacturing and other key responsibilities. The collaboration includes financial arrangements such as an upfront payment, milestone payments for potential future indications and a revenue share agreement based on net sales. LEO Pharma thrombosis business unit executive vice-president Jean Monin stated: “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 complements our existing heparin-based anti-coagulation treatments for cancer-associated thrombosis and other speciality patients. Leveraging our commercial platform, LOQTORZI will create valuable synergies and drive continued growth.” Developed by Junshi Biosciences, toripalimab targets programmed cell death protein 1 (PD-1), and is used in treating various tumours. Its mechanism involves blocking PD-1 interactions with PD-L1 and PD-L2, enhancing the immune system’s ability to eliminate malignant cells. It has gained marketing approval in more than 35 countries and regions globally. In 2024, the European Commission and the UK Medicines and Healthcare Products Regulatory Agency approved the therapy for two indications, making it the first treatment for nasopharyngeal carcinoma in Europe and a first-line treatment for advanced oesophageal squamous cell carcinoma. Junshi has conducted more than 40 company-sponsored clinical studies of the therapy. In May 2023, Shanghai Junshi Biosciences partnered with Dr. Reddy’s Laboratories to develop and commercialise toripalimab in 21 countries.