Junshi Biosciences Secures Approval for Toripalimab (LOQTORZI®) for Nasopharyngeal Carcinoma
Thursday, March 27, 2025
Junshi Biosciences has received approval from the Singapore Health Sciences Authority (HSA) for toripalimab (marketed as LOQTORZI® in Singapore).
Nasopharyngeal carcinoma is a malignant tumour that originates in the epithelial mucosa of the nasopharynx and is one of the most prevalent head and neck cancers. According to GLOBOCAN 2022 data, over 120,000 new cases were recorded globally in that year.
Toripalimab is the only recommended treatment for recurrent or metastatic NPC in the National Comprehensive Cancer Network (NCCN) Guidelines (Version 1.2025) for head and neck cancers.
Toripalimab is an anti-PD-1 monoclonal antibody designed to block PD-1 interactions with its ligands, PD-L1 and PD-L2, thereby enhancing the immune system’s ability to target and destroy cancer cells.
More than 40 company-sponsored clinical studies evaluating toripalimab for over 15 indications have been conducted worldwide, including in China, the United States, Europe, and Southeast Asia.
These trials cover various cancers, such as those affecting the lungs, nasopharynx, oesophagus, stomach, bladder, breast, liver, kidneys, and skin.
The approval of toripalimab in Singapore strengthens its availability in the Southeast Asian market, where NPC is particularly prevalent. The therapy has now secured marketing authorisation in over 35 countries and regions across four continents.
The drug, in combination with cisplatin and gemcitabine, is now authorised for the first-line treatment of adult patients with recurrent, inoperable, or metastatic nasopharyngeal carcinoma (NPC).
Toripalimab was the first domestically developed oncology drug included in this programme. Previously, Australia’s Therapeutic Goods Administration (TGA) approved two New Chemical Entity applications for toripalimab in NPC under the same framework.
The New Drug Application (NDA) was submitted through Project Orbis, an initiative led by the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA).
This marks the first immuno-oncology therapy approved for NPC in Singapore.
Source: globenewswire.com
