HLB's 'Liboceranib' Designated as an Orphan Drug in Europe

HLB announced on the 1st that its liver cancer new drug, the combination therapy of Lenvatinib and anti-cancer drug Camrelizumab, has been designated as an Orphan Medicinal Product (OMP) in Europe, allowing for simplified review procedures in the future and exclusive sales benefits for 10 years after approval.

According to HLB, the European Commission (EC) recently designated the Lenvatinib combination therapy as an orphan drug for the treatment of liver cancer. Following the United States, it has been designated as an orphan drug in Europe as well, which not only provides various tax benefits but also strengthens its position for stable sales worldwide after approval.

To be designated as an orphan medicinal product in Europe, the treatment must be for a life-threatening or chronically debilitating condition with a prevalence of no more than 5 in 10,000 people within the European Union (EU), or there must be no satisfactory method of treatment for the condition. Once designated as an orphan drug, all or a significant portion of the approval-related fees are waived, and along with tax benefits, exclusive marketing rights are granted for 10 years after drug approval, protecting the drug from similar medicines during this period and enabling stable sales.

Jung Se-ho, CEO of Elevate Therapeutics, HLB’s U.S. subsidiary, said, “With the Lenvatinib combination therapy designated as an orphan drug in Europe following the United States, it once again highlights that liver cancer is an area with a significant unmet need and that new treatment options are urgently needed. We will properly prepare and proceed with the new drug approval application process in Europe so that our liver cancer drug can become a new hope for liver cancer patients worldwide.”