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Junshi Biosciences Gets NDA Approval for Toripalimab in Hong Kong

Thursday, April 25, 2024

Junshi Biosciences, a leading biopharmaceutical company dedicated to innovative therapies, has announced the acceptance of its New Drug Application (NDA) by the Drug Office of the Hong Kong Special Administrative Region. This NDA relates to toripalimab, proposed for use in combination with cisplatin and gemcitabine as a first-line treatment for adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC). Additionally, it is being considered as a standalone therapy for adults with recurrent, unresectable, or metastatic NPC following disease progression on or after platinum-containing chemotherapy.

The NDA submission is supported by data from two key clinical studies: JUPITER-02 and POLARIS-02. JUPITER-02, a Phase 3 trial, demonstrated significant improvements in progression-free survival (PFS) and overall survival (OS) with toripalimab in combination with chemotherapy compared to chemotherapy alone. POLARIS-02, a Phase 2 study, showed toripalimab's effectiveness as a second-line or later treatment for recurrent or metastatic NPC.

Toripalimab has already received approval in China and the United States, with regulatory reviews underway in various other regions including the European Union, UK, Australia, Singapore, Malaysia, and Hong Kong SAR, among others. The drug has shown promising results across multiple tumor types in over forty company-sponsored clinical trials globally.

NPC, a prevalent form of head and neck cancer, poses challenges for treatment due to its location and limited surgical options. Toripalimab, an anti-PD-1 monoclonal antibody, works by enhancing the immune system's ability to target and destroy tumor cells by blocking PD-1 interactions with its ligands.

Toripalimab's success extends beyond NPC, with approvals and ongoing studies covering indications such as melanoma, urothelial carcinoma, esophageal squamous cell carcinoma, non-small cell lung cancer, and renal cell carcinoma. Its inclusion in various national drug lists underscores its significance in cancer treatment.

The FDA has granted toripalimab multiple designations, including Breakthrough Therapy and Orphan Drug status, recognizing its potential in addressing unmet medical needs. In Europe, marketing authorization applications have been accepted, indicating progress toward approval in the region. Similar advancements are underway in Australia, Singapore, and Hong Kong SAR, with regulatory agencies showing interest in expediting reviews for this promising therapy.



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