UK MHRA Approves Junshi's Toripalimab for Marketing

On November 16, 2024, Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences), along with its subsidiary TopAlliance Biosciences Inc., announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved toripalimab (UK trade name: LOQTORZI®) for two specific treatments. These approvals are significant for the treatment of certain cancers in the UK.

The first approval is for the use of toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, inoperable, or metastatic nasopharyngeal carcinoma (NPC). NPC is a type of cancer that originates in the nasopharyngeal mucosal epithelium and is one of the most prevalent head and neck cancers globally. The approval of this indication was based on the results from the JUPITER-02 study, a Phase 3 clinical trial. This trial demonstrated that the combination of toripalimab and chemotherapy reduced the risk of disease progression and death significantly compared to chemotherapy alone.

The JUPITER-02 study was notable for being the first international, double-blind, randomized Phase 3 clinical study in NPC immunotherapy with the largest sample size to date. The findings showed that the median progression-free survival (PFS) for patients treated with toripalimab and chemotherapy was extended by 13.2 months compared to those who received chemotherapy alone. Additionally, the overall survival (OS) and objective response rate (ORR) were markedly improved in the toripalimab group. These results were presented at the American Society of Clinical Oncology (ASCO) meeting and published in leading medical journals.

The second approval is for toripalimab in combination with cisplatin and paclitaxel for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). Esophageal cancer is one of the most common malignant tumors in the digestive tract, with ESCC being a major subtype. The approval of this indication was based on the JUPITER-06 study, another Phase 3 clinical trial. This study showed that the combination of toripalimab and chemotherapy significantly improved patient outcomes, including prolonged OS and reduced risk of disease progression or death.

The JUPITER-06 study results were first shared at the European Society of Medical Oncology (ESMO) Congress and later published in prominent oncology journals. The data indicated that toripalimab combined with chemotherapy had a significant positive impact on survival regardless of PD-L1 status, a biomarker often used in cancer treatment.

These approvals mark a major milestone for toripalimab, making it the first and only drug for the treatment of NPC in the UK and the only first-line treatment for advanced or metastatic ESCC irrespective of PD-L1 status. Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, expressed pride in introducing innovative Chinese biopharmaceuticals to Europe. He emphasized the company's commitment to globalizing their products to meet the medical needs of patients worldwide.

Toripalimab is an anti-PD-1 monoclonal antibody that works by blocking interactions between PD-1 and its ligands (PD-L1 and PD-L2), enhancing the immune system's ability to target and destroy tumor cells. Junshi Biosciences has conducted over forty clinical studies globally to evaluate toripalimab's effectiveness across various types of cancer.

In China, toripalimab was the first domestically developed anti-PD-1 monoclonal antibody to be approved and now has ten approved indications. These include treatments for melanoma, NPC, urothelial carcinoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), small cell lung cancer (SCLC), and triple-negative breast cancer (TNBC). Several of these indications are included in China's National Reimbursement Drug List (NRDL).

Internationally, toripalimab has been approved in multiple countries and regions, including the United States, European Union, India, and others. Additionally, regulatory applications are under review in Australia and Singapore.

Junshi Biosciences, founded in 2012, is dedicated to the discovery and commercialization of innovative therapeutics. The company has a robust R&D pipeline with over 50 drug candidates focused on various therapeutic areas. The company's mission is to provide patients with world-class, affordable, and innovative medicines, striving to address unmet medical needs globally.