Citius Oncology Expands LYMPHIR™ Distribution to Turkey and Middle East Countries Through Exclusive Agreement with Er-Kim
Rhea-AI Summary
Citius Oncology (Nasdaq: CTOR) announced on December 4, 2025 an exclusive distribution agreement with Er-Kim to commercialize LYMPHIR (denileukin diftitox-cxdl) in Turkey and Gulf Cooperation Council countries: Bahrain, Qatar, Oman, Kuwait, Saudi Arabia, and the United Arab Emirates.
The partnership expands LYMPHIR international availability to 19 markets outside the U.S., using Named Patient Programs where permitted by local law. LYMPHIR is an FDA-approved IL-2 receptor-directed cytotoxin for adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma after at least one prior systemic therapy. Under the agreement, Er-Kim will handle sales, marketing and reimbursement while Citius Oncology supplies finished product and provides support.
Positive
- Exclusive distribution agreement covering Turkey and six GCC countries
- International reach expanded to 19 markets outside the U.S.
- Er-Kim partnership adds local regulatory and market expertise
Negative
- Access via Named Patient Programs does not equal commercial approval outside the U.S.
- Commercial rollout depends on local laws and reimbursement decisions in each territory
Insights
Citius Oncology's exclusive Er-Kim deal meaningfully broadens LYMPHIR access across Turkey and key GCC markets while remaining non‑commercial outside the U.S.
The agreement makes Er-Kim the sole distributor for LYMPHIR in Turkey and Bahrain, Qatar, Oman, Kuwait, Saudi Arabia, and the United Arab Emirates, using Named Patient Programs to reach patients. This extends international availability to 19 markets outside the United States and leverages Er-Kim's local regulatory and market capabilities for sales, marketing, and reimbursement under applicable laws.
Risks and limits are clear: Named Patient Programs provide access where permitted but do not equal regulatory approval or routine commercial supply outside the U.S. Success depends on local law allowances, Er-Kim's reimbursement negotiations, and Citius Oncology's ability to supply finished product reliably. Monitor execution milestones and any shift from Named Patient Programs toward formal approvals over the next 12–24 months, and track reported uptake or reimbursement decisions in the named countries.
Partnership expands access to LYMPHIR for patients with cutaneous T-cell lymphoma across
LYMPHIR international availability extends to 19 markets outside the
The agreement expands Citius Oncology's international strategy to a total of 19 markets outside the
"This agreement represents a significant milestone in our global expansion strategy," said Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharmaceuticals. "Er-Kim has deep industry experience and a strong track record of providing access to oncology therapies in complex international markets. Their local expertise and regulatory capabilities make them an ideal partner as we work to expand access to LYMPHIR in support of patients and providers across
Er-Kim will be responsible for sales, marketing and reimbursement activities, under applicable laws, in each territory. Citius Oncology will supply finished product and support Er-Kim's efforts as part of the agreement.
This partnership underscores Citius Oncology's ongoing commitment to broaden access to innovative oncology therapies through strategic collaborations with experienced global partners.
About LYMPHIR™ (denileukin diftitox-cxdl)
LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin (DT) fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors.
In 2021, denileukin diftitox received regulatory approval in
About Cutaneous T-cell Lymphoma
Cutaneous T-cell lymphoma is a type of cutaneous non-Hodgkin lymphoma (NHL) that comes in a variety of forms and is the most common type of cutaneous lymphoma. In CTCL, T-cells, a type of lymphocyte that plays a role in the immune system, become cancerous and develop into skin lesions, leading to a decrease in the quality of life of patients with this disease due to severe pain and pruritus. Mycosis Fungoides (MF) and Sézary Syndrome (SS) comprise the majority of CTCL cases. Depending on the type of CTCL, the disease may progress slowly and can take anywhere from several years to upwards of ten to potentially reach tumor stage. However, once the disease reaches this stage, the cancer is highly malignant and can spread to the lymph nodes and internal organs, resulting in a poor prognosis. Given the duration of the disease, patients typically cycle through multiple agents to control disease progression. CTCL affects men twice as often as women and is typically first diagnosed in patients between the ages of 50 and 60 years of age. Other than allogeneic stem cell transplantation, for which only a small fraction of patients qualify, there is currently no curative therapy for advanced CTCL.
About Citius Oncology, Inc.
Citius Oncology, Inc. (Nasdaq: CTOR) is a platform to develop and commercialize novel targeted oncology therapies. In December 2025, Citius Oncology launched LYMPHIR, approved by the FDA for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Management estimates the initial market for LYMPHIR currently exceeds
About Citius Pharmaceuticals, Inc.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. Citius Pharma owns
About Er-Kim
Established in 1981, Er-Kim stands at the forefront of biopharmaceutical innovation, setting new commercialization and patient access standards. Through strategic partnerships with over 40 global leaders, Er-Kim distributes more than 68 products to 50+ countries, revolutionizing patient care in international markets by solving complex distribution challenges. Er-Kim has a dedicated team of over 300 professionals worldwide and revenues exceeding
Forward-Looking Statements
This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Oncology. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated, and, unless noted otherwise, that apply to Citius Oncology, are: our need for substantial additional funds and our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; our ability to successfully commercialize LYMPHIR and establish a sustainable revenue stream; the estimated markets for LYMPHIR and our product candidates and the acceptance thereof by any market; our ability to secure strategic partnerships and expand international access to LYMPHIR; our ability to use the latest technology to support our commercialization efforts; physician and patient acceptance of LYMPHIR in a competitive treatment landscape; our reliance on third-party logistics providers, distributors, and specialty pharmacies to support commercial operations; our ability to educate providers and payers, secure adequate reimbursement, and maintain uninterrupted product supply; post-marketing requirements and ongoing regulatory compliance related to LYMPHIR; the ability of LYMPHIR and our product candidates to impact the quality of life of our target patient populations; risks relating to the results of research and development activities, including those from our existing and any new pipeline assets; our ability to procure cGMP commercial-scale supply; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; our ability to maintain Nasdaq's continued listing standards; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; government regulation; as well as other risks described in our Securities and Exchange Commission ("SEC") filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our SEC filings which are available on the SEC's website at www.sec.gov, including in Citius Oncology's Annual Report on Form 10-K for the year ended September 30, 2024, filed with the SEC on December 27, 2024, as amended on January 27, 2025, as updated by our subsequent filings with the SEC. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.
Investor Contact:
Ilanit Allen
ir@citiuspharma.com
908-967-6677 x113
Media Contact:
STiR-communications
Greg Salsburg
Greg@STiR-communications.com
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SOURCE Citius Oncology, Inc.
FAQ
What did Citius Oncology (CTOR) announce on December 4, 2025 about LYMPHIR?
Which countries are included in the LYMPHIR distribution deal for CTOR?
Does the CTOR–Er-Kim agreement mean LYMPHIR has commercial approval in those countries?
How many international markets does LYMPHIR now reach after the December 4, 2025 announcement?
What responsibilities will Er-Kim have under the LYMPHIR distribution agreement with CTOR?
