Apotex Receives Health Canada Approval for LOQTORZI® -- The First and Only Immuno-Therapy for Recurrent Unresectable or Metastatic Nasopharyngeal Cancer

TORONTO, Oct. 23, 2025 /PRNewswire/ - Apotex Inc. ("Apotex" or the "Company"), the largest Canadian-based pharmaceutical company, today announced that Health Canada has granted a Notice of Compliance (NOC) for LOQTORZI® (toripalimab) for the treatment of nasopharyngeal carcinoma (NPC), an ultra-rare and aggressive cancer. 

This approval marks a significant milestone. LOQTORZI is the first and only Health Canada-approved immuno-therapy for patients with recurrent unresectable or metastatic nasopharyngeal cancer (R/M NPC), offering an effective new immuno-therapy option to patients facing this challenging malignancy.

LOQTORZI is indicated:

• In combination with cisplatin and gemcitabine for adults with metastatic or recurrent locally advanced NPC.
• As a monotherapy for adults with recurrent unresectable or metastatic NPC who have progressed following platinum-based chemotherapy.¹

This approval introduces Apotex's first novel biologic therapy – a targeted immuno-therapy, underscoring the company's commitment to expanding access to innovative oncology treatments in Canada. It represents a strategic evolution of Apotex's portfolio, which includes providing options for patients with rare and hard-to-treat cancers. Apotex secured the Canadian rights to LOQTORZI through an agreement with Coherus BioSciences.

"LOQTORZI exemplifies our commitment to Canadian patients and the healthcare system," said Allan Oberman, President & CEO, Apotex. "As the first and only Health Canada-approved immuno-therapy for both the first and later-line treatment of this unique cancer, it delivers a transformative therapy where none previously existed, addressing a critical unmet need."

"The availability of LOQTORZI in Canada is a meaningful step forward for patients diagnosed with nasopharyngeal carcinoma," said Dr. Nathaniel Bouganim, Medical Oncologist and Division Director of Medical Oncology, McGill University Health Centre. "Having this therapy accessible through a Canadian-based pharmaceutical company like Apotex helps promote equitable care for those facing this rare disease.

As a Force for Health, Apotex continues to build on its strategic vision, expanding its presence in pharmaceutical and consumer health products while maintaining its core focus on improving everyday access to critical medicines for patients.

Please consult the product monograph available at: https://pdf.hres.ca/dpd_pm/00082094.PDF for complete prescribing information, warnings and precautions, adverse reactions, and contraindications.

About Apotex
Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people around the world, with a broad portfolio of generic, biosimilar, and innovative branded pharmaceuticals, and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico, and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

Learn more at www.apotex.com.

SOURCE Apotex Inc.