Junshi Biosciences Announces Toripalimab’s NDA Accepted by the Singapore Health Sciences Authority

SHANGHAI, China, Feb. 01, 2024 (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 Singapore Health Sciences Authority (“HSA") had accepted the New Drug Application (“NDA”) for toripalimab, both in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (“NPC”), and 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 HSA has also granted priority review designation to the NDA.

This NDA was submitted through Project Orbis, an initiative of the US Food and Drug Administration (FDA)’s Oncology Center of Excellence (OCE). Project Orbis provides a collaborative mechanism and framework between the FDA and regulatory partners in other countries and regions for concurrent submission and review of oncology drugs. At present, eight regulatory agencies have joined Project Orbis, including the FDA, the Australia Therapeutic Goods Administration (“TGA”), HSA, Health Canada (HC), the U.K. Medicines and Healthcare products Regulatory Agency (“MHRA”), etc.

Project Orbis currently accepts applications for oncology indications. An application should generally qualify for FDA priority review, meaning that the drug is intended to treat a serious disease and, if approved, would significantly improve the safety or efficacy of the treatment and offer notable clinical benefits. Under the framework of Project Orbis, collaboration between international regulators may expedite patient access to new cancer treatments in other countries.

Toripalimab for the treatment of NPC meets these application requirements and is the first Chinese oncology drug to be included in Project Orbis. Previously, two NDAs for toripalimab for the treatment of NPC had been submitted to the TGA through Project Orbis and were successfully accepted. Junshi Biosciences will explore accelerated marketing opportunities in countries and regions where it is applicable.

The NDA is supported by results from JUPITER-02, a randomized, double-blind, placebo-controlled, multinational multi-center Phase 3 clinical study (NCT03581786), for the first-line treatment of NPC, as well as results from POLARIS-02, a multi-center, open-label, pivotal Phase 2 clinical study (NCT02915432), for second-line or later treatments for recurrent or metastatic NPC.