Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has taken a significant step forward with the submission of another indication filing for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The company has announced that the National Medical Products Administration (NMPA) in China has accepted the filing for review. This filing seeks to expand the use of Loqtorzi in combination with bevacizumab as a first-line treatment for unresectable or metastatic hepatocellular carcinoma (HCC), which would mark the eleventh indication filing for the molecule in China.
The basis for this filing is the HEPATORCH study, a multi-center, randomized, open, positive controlled Phase III trial that assessed the efficacy and safety of the toripalimab/bevacizumab regimen against the standard of care sorafenib. Conducted across 57 centers in China, the study demonstrated that the Loqtorzi regimen significantly outperformed sorafenib in terms of progression-free survival (PFS) and overall survival (OS), which were the primary endpoints of the study.
As China’s first domestic PD-1 inhibitor to be approved, Loqtorzi was initially approved as a second-line treatment for melanoma in December 2018. Since then, it has received ten indication approvals in China and has six indications covered under the National Reimbursement Drug List (NRDL), which is a significant achievement considering the competitive landscape of PD-1 inhibitors in the country.
The potential approval of Loqtorzi for the first-line treatment of HCC would not only be a milestone for Junshi Biosciences but also a significant development for patients in China and globally. It would provide an alternative treatment option with the potential for better survival outcomes for those suffering from this aggressive form of cancer. The company is expected to submit a supplemental new drug application based on these promising results, with the aim of securing approval for this new indication in the near future.- Flcube.com
