UK Approves Groundbreaking Cancer Drug Toripalimab
London, Saturday, 16 November 2024.
Junshi Biosciences’ Toripalimab receives UK approval, marking a significant advancement in cancer treatment. The drug offers new hope for nasopharyngeal and esophageal cancer patients, demonstrating impressive survival benefits in clinical trials.
A Milestone Approval
On November 16, 2024, Shanghai Junshi Biosciences Co., Ltd. (HKEX: 1877; SSE: 688180) announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for their cancer drug, Toripalimab. This pivotal approval marks Junshi Biosciences’ entry into the European market with Toripalimab, known by its trade name LOQTORZI®, a first for the treatment of nasopharyngeal carcinoma (NPC) and esophageal squamous cell carcinoma (ESCC) in the UK. The approval of Toripalimab is particularly significant as it is the only drug approved for NPC treatment in the UK and the only first-line treatment for advanced or metastatic ESCC, irrespective of PD-L1 status[1][2].
Clinical Trial Success
The approval is backed by the results of the JUPITER-02 and JUPITER-06 studies. The JUPITER-02 study, the largest Phase 3 clinical trial in NPC immunotherapy, demonstrated that Toripalimab combined with chemotherapy reduced the risk of disease progression by 48% and mortality by 37%. Specifically, the median progression-free survival (PFS) was extended from 8.2 months with chemotherapy alone to 21.4 months with the addition of Toripalimab, showcasing a remarkable increase of 13.2 months. Meanwhile, the JUPITER-06 study indicated that for ESCC, Toripalimab plus chemotherapy improved median overall survival by 6 months, reaching 17 months, and reduced the disease progression or death risk by 42%[1].
Global Impact and Future Prospects
Junshi Biosciences, founded in December 2012, has rapidly expanded its footprint in the biopharmaceutical sector. With more than 40 clinical studies globally covering over 15 indications, Toripalimab represents a significant stride in cancer treatment innovation. The drug is approved in multiple regions, including the US, EU, India, UK, and Jordan, with ongoing applications in additional territories such as Australia and Singapore. The company remains committed to its mission of providing world-class, trustworthy, affordable, and innovative drugs, employing approximately 2,500 staff across the US and China. As Toripalimab continues to gain approvals worldwide, it heralds a new era of hope for patients battling NPC and ESCC[1][2].