Toripalimab Approved in Singapore by Junshi Biosciences

On March 26, 2025, Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences), a prominent biopharmaceutical company focused on innovative therapies, announced that the Singapore Health Sciences Authority (HSA) approved the New Drug Application (NDA) for toripalimab. Marketed as LOQTORZI®, toripalimab is sanctioned for use alongside cisplatin and gemcitabine in treating adult patients suffering from recurrent or metastatic nasopharyngeal carcinoma (NPC) that are unsuitable for surgery or radiotherapy. This approval marks the debut of immuno-oncology treatment for NPC in Singapore, a significant milestone.

Nasopharyngeal carcinoma is a malignant tumor in the nasopharynx's epithelial mucosa, notably among common head and neck cancers. GLOBOCAN 2022 data indicates that over 120,000 new NPC cases surfaced worldwide in 2022. Toripalimab is the sole regimen endorsed for recurrent or metastatic NPC treatment in the National Comprehensive Cancer Network (NCCN) Guidelines (Version 1.2025) concerning head and neck cancers.

The approval stems from the JUPITER-02 study (NCT03581786), a groundbreaking international, multi-center, double-blind, randomized Phase 3 clinical trial in NPC immunotherapy featuring the largest sample size. JUPITER-02 is recognized as the foremost Phase 3 study with statistical validation showing substantial overall survival benefits for first-line immunotherapy paired with chemotherapy versus chemotherapy alone in NPC cases. The study's findings were showcased at the 2021 American Society of Clinical Oncology (ASCO) annual meeting and later highlighted in Nature Medicine and the Journal of the American Medical Association (JAMA). The study revealed that combining toripalimab with chemotherapy reduced disease progression risk by 48% and mortality risk by 37%. The median progression-free survival in the toripalimab plus chemotherapy cohort extended by 13.2 months compared to chemotherapy alone, jumping from 8.2 to 21.4 months. Additionally, patients undergoing this combined therapy exhibited a higher objective response rate and longer response duration, with a complete response rate of 26.7%, and no new safety concerns emerged. Long-term survival data presented at ASCO 2024 revealed a 5-year survival rate of 52%.

Dr. Jianjun ZOU, Junshi Biosciences' General Manager and CEO, expressed satisfaction over toripalimab's approval in Singapore, marking their Southeast Asian market entry. Given Southeast Asia's high NPC incidence, he emphasized the importance of introducing this groundbreaking therapy to fulfill unmet medical needs and revolutionize local treatment practices. Toripalimab has now secured marketing authorization in over 35 countries worldwide, aligning with Junshi Biosciences' "In China, For Global" strategy to advance innovative medicines from China globally.

The NDA submission was part of Project Orbis, led by the U.S. Food and Drug Administration's Oncology Center of Excellence (OCE). Project Orbis fosters collaborative frameworks among the FDA and international regulatory bodies to jointly review oncology drug registration applications. Toripalimab was the first domestic oncology drug included in Project Orbis. Prior approvals under Project Orbis came from Australia's Therapeutic Goods Administration for two New Chemical Entity applications related to toripalimab in NPC.

Toripalimab acts as an anti-PD-1 monoclonal antibody, obstructing PD-1 interactions with its ligands, PD-L1 and PD-L2, and facilitating PD-1 receptor internalization. This mechanism boosts the immune system's capacity to target and destroy tumor cells.

Junshi Biosciences has spearheaded over forty toripalimab clinical studies across more than fifteen indications globally, encompassing regions like China, the USA, Europe, and Southeast Asia. These trials, assessing toripalimab's safety and efficacy, cover various tumor types, including lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin cancers. In China, toripalimab was first approved domestically under the name TUOYI®, with eleven approved indications, including treatments for melanoma, NPC, urothelial carcinoma, esophageal carcinoma, lung cancer, renal carcinoma, breast cancer, and hepatocellular carcinoma. Ten indications feature in China's National Reimbursement Drug List (NRDL) 2024 Edition, with toripalimab being the sole anti-PD-1 monoclonal antibody listed for specific cancer treatments. Internationally, toripalimab has been approved in several countries, and its Biologics License Applications (BLAs) are under review in various regions globally.