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LEO pharma gains EU rights to Junshi Biosciences’ PD-1 inhibitor toripalimab

The drug was approved by the EC last year to treat nasopharyngeal and oesophageal cancer
- PMLiVE

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.

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