China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has announced a licensing agreement with UK-headquartered Hikma MENA FZE, granting the latter exclusive development and commercialization rights to its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) in Jordan, Saudi Arabia, the United Arab Emirates, Qatar, Morocco, and Egypt, among a total of 20 countries in the Middle East and North Africa. Junshi Bio will receive a USD 12 million payment, along with 20% tiered sales commissions. Additionally, Hikma has the preferred option right to three other Junshi drug candidates in one or multiple countries.
Toripalimab’s Regulatory Milestones and Market Presence
Toripalimab was China’s first domestic PD-1 inhibitor to be approved (in December 2018) as a second-line treatment for melanoma. Further indication nods were granted in February 2021 as a second-line treatment of nasopharyngeal carcinoma (NPC), in April 2021 for locally advanced or metastatic urothelial cancer (UC) in previously treated patients, in November 2021 as a first-line treatment for NPC, and in May 2022 as a first-line treatment of esophageal squamous cell carcinoma (ESCC). The molecule was included on the National Reimbursement Drug List (NRDL) for the three indications last year, the only PD-1 inhibitor to treat melanoma and NPC on the list.
Global Regulatory Approvals and Future Prospects
In the US, Junshi has obtained two breakthrough therapy designations (BTDs), one fast-track status, and one priority review status, along with five orphan drug designations (ODDs) for toripalimab’s use in mucosal melanoma, nasopharyngeal carcinoma, soft tissue sarcoma, esophageal cancer, and small-cell lung cancer. A Biologic License Application (BLA) for the drug as a treatment for second-line NPC and with chemo for first-line NPC was accepted for review by the US FDA in July of this year, with a PDUFA date set as December 23, 2022. A market approval filing for the drug in NPC and ESCC was accepted for review earlier this month by the European Medicines Agency (EMA).-Fineline Info & Tech
