Pharma Focus Asia
KP - Sustainable Packaging Solutions

Junshi Biosciences Has Revealed That the Singapore Health Sciences Authority Has Accepted the New Drug Application for Toripalimab

Saturday, February 03, 2024

Shanghai Junshi Biosciences Co., Ltd (HKEX: 1877; SSE: 688180) has disclosed that the Singapore Health Sciences Authority (HSA) accepted the New Drug Application (NDA) for toripalimab. This application includes the use of toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC). Additionally, it covers the use of toripalimab as a single agent for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression after platinum-containing chemotherapy. The HSA has granted priority review designation to the NDA.

The NDA was submitted through Project Orbis, an initiative led by the US Food and Drug Administration's Oncology Center of Excellence (OCE). Project Orbis facilitates concurrent submission and review of oncology drugs by regulatory partners globally. Toripalimab is the first Chinese oncology drug included in Project Orbis, aiming to expedite patient access to new cancer treatments internationally.

Toripalimab, an anti-PD-1 monoclonal antibody, has been approved for seven indications in China, with three supplementary new drug applications currently under regulatory review. The drug has also received approvals for two NPC indications in the US, with marketing approval applications under review in the European Union, UK, Australia, and Singapore.

The NDA is supported by data from JUPITER-02, a Phase 3 clinical study for first-line NPC treatment, and POLARIS-02, a Phase 2 study for recurrent or metastatic NPC. Results from JUPITER-02 demonstrated that toripalimab, in combination with chemotherapy, significantly improved progression-free survival and overall survival compared to chemotherapy alone, with a manageable safety profile. POLARIS-02 showed durable antitumor activity in patients with recurrent or metastatic NPC who had failed previous chemotherapy.

Toripalimab's broad clinical trials cover various tumor types, reflecting its potential in treating cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin.

NPC is a malignant tumor affecting the nasopharyngeal mucosal epithelium, with limited treatment options due to its location. Toripalimab's potential in treating NPC aligns with its inclusion in Project Orbis, demonstrating its significance in the global oncology landscape.



Latest Issue
Get instant
access to our latest e-book
MFA + MMA 2024CPHI Chine || PMEC China 2024Asia Healthcare Week 2024Gibco Adherent Kidney Media PanelCPHI Korea 2024Equinix accelerated medical research...CHEMICAL INDONESIA 2024Thermofisher - Antibody Therapeutic PolishingINALAB 2024 Thermo Scientific - DynaDrive and DynaSpinDigital Health Asia 2024Rehab Expo 2024ISPE Singapore Affiliate Conference & Exhibition 20242024 PDA Pharmaceutical Manufacturing & Quality Conference2024 PDA Cell and Gene Pharmaceutical Products Conference 2024 PDA Aseptic Manufacturing Excellence Conference2024 PDA Aseptic Processing of Biopharmaceuticals ConferencePharma Quality Excellence Awards 20244th Annual Pharma GMP Quality Management 20243rd World ADC Asia 2024
Searching for an end-to-end patient tech solution?