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

2024-02-01 Download

SHANGHAI, China, February 1, 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.

Results from JUPITER-02, the first international, multi-center, double-blind, randomized, placebo-controlled Phase 3 clinical study using immunotherapy for the treatment of NPC with the largest sample size, were presented at the plenary session of the 2021 American Society of Clinical Oncology (ASCO) annual meeting (#LBA2), and published in Nature Medicine and the Journal of the American Medical Association (JAMA). The study found that compared to chemotherapy alone, toripalimab in combination with chemotherapy for the first-line treatment of metastatic or recurrent NPC significantly improved progression-free survival (PFS) and overall survival (OS), with a median PFS of 21.4 months, and a 3-year OS rate of 64.5%; it also reduced the risk of disease progression or death by 48% and the risk of death by 37%, all while demonstrating a manageable safety profile.

The POLARIS-02 results were published online in January 2021 in the Journal of Clinical Oncology. These findings showed that toripalimab demonstrated durable antitumor activity in patients with recurrent or metastatic NPC who failed previous chemotherapy, with an objective response rate (ORR) of 20.5%, a median duration of response (DoR) of 12.8 months, and a median OS of 17.4 months while maintaining a manageable safety profile.

So far, toripalimab has been approved for 7 indications in China, with 3 supplementary new drug applications (sNDA) currently under regulatory review. Internationally, it has been approved for 2 NPC indications in the US, and marketing approval applications are currently under regulatory review in the European Union, UK, Australia and Singapore.

About NPC

NPC is a malignant tumor that occurs in the nasopharyngeal mucosal epithelium and is one of the most common types of head and neck cancer. According to the World Health Organization, the number of newly diagnosed NPC cases in 2020 exceeded 130,000 worldwide. Due to the location of the primary tumor, surgery is rarely an option, while radiotherapy alone or in combination with chemotherapy are the main treatment options for localized cancers.

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