{"id":12305,"date":"2023-10-30T21:43:00","date_gmt":"2023-10-30T13:43:00","guid":{"rendered":"https:\/\/flcube.com\/?p=12305"},"modified":"2024-11-12T21:54:52","modified_gmt":"2024-11-12T13:54:52","slug":"junshi-biosciences-pd-1-inhibitor-loqtorzi-approved-by-fda-for-nasopharyngeal-carcinoma","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=12305","title":{"rendered":"Junshi Biosciences’ PD-1 Inhibitor Loqtorzi Approved by FDA for Nasopharyngeal Carcinoma"},"content":{"rendered":"\n

China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877<\/a>; SHA: 688180<\/a>) 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.<\/p>\n\n\n\n

Approval Details and Treatment Indications<\/strong>
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.<\/p>\n\n\n\n

Historical Context and Regulatory Journey<\/strong>
Junshi\u2019s 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.<\/p>\n\n\n\n

Orphan Drug Designation and Future Prospects<\/strong>
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.<\/p>\n\n\n\n

Conclusion<\/strong>
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<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

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