China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the US FDA has approved its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab), for the treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC). The approval marks a significant milestone as Loqtorzi becomes the first homegrown PD-1 inhibitor from a China-based firm to gain the FDA’s approval.
Approval Details and Treatment Indications
The FDA has approved Loqtorzi in combination with cisplatin and gemcitabine as a first-line treatment for adults with metastatic or recurrent locally advanced NPC. Additionally, it has been approved as a monotherapy for adults with recurrent, unresectable, or metastatic NPC who have experienced disease progression following chemotherapy treatment.
Historical Context and Regulatory Journey
Junshi’s toripalimab was the first domestically developed PD-1 inhibitor to gain approval in China in December 2018. It was also the first to initiate the approval filing process in the US with a rolling BLA submission in March 2021. Despite facing setbacks, including a complete response letter (CRL) in May 2022 and delays due to COVID-related disruptions, Junshi and its US partner Coherus Biosciences Inc., (NASDAQ: CHRS) have successfully navigated the regulatory landscape to achieve this approval.
Orphan Drug Designation and Future Prospects
The US FDA has awarded toripalimab orphan drug designation (ODD) for five indications, including NPC, mucosal melanoma, soft tissue sarcoma, esophageal cancer, and small-cell lung cancer. This designation underscores the drug’s potential in treating rare diseases and positions it for further expansion in the US market.
Conclusion
The FDA’s approval of Loqtorzi represents a significant achievement for Junshi Biosciences, highlighting the company’s commitment to bringing innovative cancer treatments to patients globally. With this approval, Junshi Biosciences continues to solidify its position as a leader in the development of PD-1 inhibitors and cancer therapies.-Fineline Info & Tech
