18 July 2025
The CEL-SCI corporation (NYSE American CVM) has approached an agreement with a known Saudi Arabian premier healthcare and pharmaceutical company for a strategic partnership that includes commercial and regulatory activities for Multikine (leukocyte interleukin injection) in Saudi Arabia. The official agreement is expected to be sealed with the Saudi pharmaceutical partner that will showcase the excellent medicine designation application for multikine with the Saudi Food and Drug Authority (SFDA) within a few weeks.
The SFDA predicts the response time to the remarkable medicine designation application will take around 60 days. After its granting, Multikine will be accessible for reimbursement/sale and patients in Saudi Arabia. Various key players of Saudi funds have attracted investors to invest in Multikine. CEL-SCI, a strong joint venture, will be serving the vast Middle East and North Africa (MENA) market.
CEL-SCI holds an option to file for an excellent medicine designation directly. As the company has initiated a popular decision of collaboration with the company’s local partner for commercial distribution and regulatory filing in Saudi Arabia. During the meeting with SFDA, the Saudi regulatory agency was empowered and guided to see the multikine approval as a solution to cancer.
CEL-SCI and its Saudi pharma partner see Multikine’s potential to meet all requirements for a commendable medicine designation as introduced by the SFDA, which is now highlighted as a brilliant commercialization plan. The plan accelerates the partners' understanding and expertise in the very local healthcare market to continuously approach Multikine via distribution and regulatory clearance. This strategy and collaboration will lead to an advancement in the healthcare market.
Multikine is an immunotherapy that is considered before surgery as a treatment for untreated neck and head cancer. In this massive head and neck cancer study, multikine is capable of increasing the five-year survival rate of the patient population competing 73% vs 45% in patients who received standard treatment alone.
The SFDA's excellent medical program focuses on the development, evaluation, and review of new drugs that identify medical needs for the treatment of severe or dangerous conditions in line with the vision of the Saudi Arabia 2030 initiative. The program is voluntary and is based on early discussion with drug developers to quickly evaluate and improve development plans. The program's motive is to promise effective medicines that will be beneficial to their health, diminishing the risk.
18 July 2025
18 July 2025
18 July 2025
18 July 2025