On 17 January 2025, Junshi Biosciences announced that Australia’s Therapeutic Goods Administration (TGA) has approved Tuoyi® (toripalimab) for the treatment of adults with recurrent unresectable or metastatic nasopharyngeal carcinoma (NPC) with disease progression on or after a platinum-containing chemotherapy. The TGA has also approved Tuoyi® in combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or recurrent, locally advanced NPC.
In July 2023, Junshi and Dr Reddy’s entered into an exclusive licensing agreement for toripalimab, with Dr Reddy’s responsible for the development and commercialisation of toripalimab in Latin America, India, South Africa, and at the election of Dr. Reddy’s, also in Australia, New Zealand and nine other countries. According to Junshi, toripalimab has been approved for marketing in over 35 countries including China, Hong Kong SAR, the United States, the European Union, the UK, Australia, and India.
In March 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) will consider Dr Reddy’s application to PBS-list toripalimab for NPC.