Kyowa Kirin Signs Exclusive Latin America Distribution Deal With Knight Therapeutics for Poteligeo
核心洞察
Kyowa Kirin International and Knight Therapeutics (搜索) signed an exclusive distribution agreement covering mogamulizumab in Argentina, Brazil, Colombia and Mexico.
Knight will pursue regulatory approvals and commercialize the anti-CCR4 (搜索) antibody for mycosis fungoides (搜索) and Sezary syndrome (搜索), the two main CTCL subtypes.
The deal marks Kyowa Kirin's first Latin America collaboration for mogamulizumab, which is approved in the US and Europe for relapsed or refractory disease.
Kyowa Kirin International, a wholly owned subsidiary of Kyowa Kirin Co., Ltd., has signed an exclusive distribution agreement with Knight Therapeutics (搜索) Inc. for mogamulizumab (sold as POTELIGEO in the United States and Europe) in four Latin American markets. Under the terms announced on September 29, 2026, Knight will be responsible for obtaining regulatory approval and commercializing the medicine in Argentina, Brazil, Colombia and Mexico, and will hold exclusive distribution rights in those countries.
The agreement covers mogamulizumab for mycosis fungoides (搜索) (MF) and Sezary syndrome (搜索) (SS), two subtypes of cutaneous T-cell lymphoma (搜索) (CTCL), a rare form of non-Hodgkin lymphoma. Kyowa Kirin said the deal marks its first collaboration into Latin America with mogamulizumab and represents a milestone in its growth strategy, combining its rare disease expertise with Knight's regional presence.
Regulatory and Commercial Responsibility Shifts to Knight
Knight, a pan-American (ex-US) pharmaceutical company headquartered in Montreal, will seek the necessary regulatory approvals and handle commercialization across the four markets. Its Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM.
"We are thrilled to add Kyowa Kirin, a Japan-based global specialty pharmaceutical company, as a new Knight partner," said Samira Sakhia, President and CEO of Knight Therapeutics (搜索). "POTELIGEO represents an innovative advancement in the treatment of rare cancers, specifically mycosis fungoides (搜索) and Sezary syndrome (搜索). Its addition to our hemato-oncology portfolio addresses a significant unmet medical need and will provide patients across our key Latin American markets with access to a much-needed new therapeutic option."
Celine Rheame, Cluster General Manager, Emerging Growth Markets at Kyowa Kirin, said CTCL is more common in the region than many realize and that further work is needed to identify unmet needs and drive improvements in patient outcomes. "We have an opportunity, and a responsibility, to change that," she said, adding that the partnership with Knight can help increase patient access in Latin America.
Disease Burden and Diagnostic Delay
MF and SS are characterized by localization of cancerous white blood cells called T lymphocytes (T cells) to the skin. These malignant T cells consistently express CCR4 (搜索), a protein that enables them to move from the blood to the skin. Early skin symptoms include red patches or plaques that can resemble psoriasis or eczema; in some patients, skin involvement later evolves to tumors or erythroderma, a reddening of most of the skin surface.
MF is the most common CTCL subtype, accounting for approximately 60% of all CTCL cases, and is typically indolent. SS is much rarer, at around 5% of CTCL cases, and is more aggressive with high levels of blood involvement; it can cause severe itching, erythroderma, intense scaling of the skin and hair loss. CTCL can take, on average, between 2 and 7 years for individuals to receive a confirmed diagnosis. The disease is treatable but not generally considered curable, and Kyowa Kirin noted a clear unmet need for novel treatment options, with significant erosion of quality of life also reported among those caring for patients.
Epidemiological data for CTCL in Latin America is limited, but Knight said it is believed to be in line with the United States, where reported annual incidences of MF and SS are 5.42 per million and 0.21 per million, respectively. Together, MF and SS represent approximately 65% of all CTCL cases.
MAVORIC Data Underpin the Filing
Mogamulizumab is a first-in-class humanized monoclonal antibody directed against CC-chemokine receptor 4 (CCR4 (搜索)). Once it binds CCR4, it increases attraction of immune cells from the immune system to destroy the cancerous cells. POTELIGEO is approved in the United States and Europe for adult patients with relapsed or refractory MF or SS after at least one prior systemic therapy.
The approval is supported by the MAVORIC (Mogamulizumab anti-CCR4 (搜索) Antibody Versus ComparatOR In CTCL) study, described as the largest randomized trial in MF and SS and the first to compare systemic therapies using progression-free survival (PFS) as a primary endpoint. MAVORIC was a phase 3, open-label, multicenter, randomized study of mogamulizumab versus vorinostat in patients who had failed at least one prior systemic treatment, randomizing 372 patients.
Mogamulizumab demonstrated significantly superior PFS at a median of 7.7 months (95% CI: 5.7, 10.3) versus 3.1 months with vorinostat (95% CI: 2.9, 4.1), with a hazard ratio of 0.53 (95% CI: 0.41, 0.69; p<0.001). Confirmed overall response rates were 28% for mogamulizumab and 5% for vorinostat (risk ratio 23.1, 95% CI 12.8-33.1; p<0.001).
The most common side effects associated with mogamulizumab versus vorinostat included rash (36% vs 22%), infusion-related reactions (33% vs <1%), upper respiratory tract infections (22% vs 16%), musculoskeletal pain (22% vs 17%), fever (18% vs 6%) and mucositis (14% vs 6%).
Kyowa Kirin, which has invested in drug discovery and biotechnology innovation for more than 75 years, said it is working to engineer the next generation of antibodies and cell and gene therapies for severe and rare diseases. The company operates across three regions: JAPAC, North America and EMEA.