Hikma and Junshi Biosciences sign exclusive licensing agreement for cancer treatment drug toripalimab for the Middle East and North Africa region

Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, today announces a new exclusive licensing and commercialization agreement with Junshi Biosciences, an innovation-driven biopharmaceutical company, for toripalimab in the Middle East and North Africa (MENA). Under the terms of the agreement, Hikma has an exclusive license to develop and commercialize toripalimab injection in all its MENA markets. In addition, Hikma has the right of first negotiation for the future commercialization of three under development drugs in MENA.

Toripalimab is an innovative anti-PD-1 monoclonal antibody approved for marketing in China for six indications to date. Over thirty toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China, the United States, Southeast Asia, and Europe. Ongoing or completed pivotal clinical studies evaluating the safety and efficacy of toripalimab cover a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin, among others.

“We believe Hikma is the ideal partner for us in the MENA region. As the third largest pharmaceutical company in MENA, with a history of more than 40 years, Hikma is well established and respected and offers deep-rooted expertise, with unparalleled local knowledge. The company has also demonstrated strong commercial capabilities, particularly in areas such as oncology and biotechnology,” said Dr. Ning LI, CEO of Junshi Biosciences. “We anticipate that toripalimab could be the first marketed Chinese anti-PD-1 antibody in MENA. We look forward to working closely with Hikma to establish toripalimab’s position in the MENA markets in order to provide patients with high-quality innovative care.”

Commenting on this landmark agreement, Mazen Darwazeh, Hikma’s Executive Vice Chairman and President of MENA, said: “Anti-PD-1s have changed the way cancer is treated over the past few years but, unfortunately, patient access to these treatments in the region has been sub-optimal. Toripalimab has a compelling clinical profile with impressive efficacy and safety data, and we are thrilled to be collaborating with Junshi Biosciences to equip doctors and patients in MENA with this innovative treatment.” He added, “This agreement strengthens our biotech and oncology portfolio and enables us to increase patients’ access to PD-1s, an important milestone in delivering on our purpose of putting better health, within reach, every day.”

As part of this collaboration, Hikma has acquired rights to commercialize any combination product that comprises any therapeutically active pharmaceutical agent co-formulated or co-packaged with toripalimab. Hikma has also acquired exclusive rights of first negotiation to three of Junshi Biosciences’ novel oncology molecules.