SHANGHAI, China, Dec. 01, 2023 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the Therapeutic Goods Administration of the Australian Government Department of Health and Aged Care (TGA) has accepted the New Chemical Entity (NCE) application for toripalimab in combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC), and for toripalimab, as a single agent, for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy. Additionally, the TGA has also granted an orphan drug designation to toripalimab for the treatment of NPC.

This NCE application was submitted through Project Orbis, an initiative of the FDA’s Oncology Center of Excellence (OCE) that provides a collaborative mechanism and framework among the FDA and regulatory partners in other countries and regions, for concurrent submission and review of oncology drugs. At present, seven other regulatory agencies have joined Project Orbis, including the TGA, Singapore Health Sciences Authority (HSA), Health Canada (HC), MHRA, etc.

Project Orbis currently accepts applications for oncology indications. An application should generally qualify for FDA priority review, meaning that the drug must be intended to treat a serious disease and, if approved, would significantly improve the safety or efficacy of the treatment; furthermore, the drug should have a high impact and significant clinical benefits. Under the framework of Project Orbis, collaboration among international regulators may allow patients with cancer to receive earlier access to new treatments in other countries.