Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that it has received two indication approvals from the European Commission (EC) for its PD-1 inhibitor, Loqtorzi (toripalimab). This marks a significant expansion of the drug’s utility in the European Union, where it can now be used in combination with chemotherapy for the first-line treatment of recurrent, inoperable, or metastatic nasopharyngeal carcinoma (NPC) and unresectable advanced/recurrent or metastatic esophageal squamous cell carcinoma (ESCC). With these approvals, Loqtorzi becomes the first and only treatment for NPC in the region and a first-line treatment option for ESCC, regardless of PD-L1 expression status.
Toralipimab, the active component of Loqtorzi, made history as the first domestically developed PD-1 inhibitor in China to receive approval in December 2018 for use as a second-line treatment for melanoma. Since then, it has garnered ten indication approvals in China. The drug has also received approval in the United States for the treatment of NPC and is anticipated to gain regulatory decisions in Australia and Singapore.- Flcube.com
