Health

US biotech seeks Saudi approval for cancer treatment

April 25, 2025, 7:41 AM

CEL-SCI wants approval to test Multikine in Saudi Arabia

CEL-SCI to test drug in Saudi Arabia
Treats head and neck cancer
Partnerships with Saudi companies

US-listed biotech company CEL-SCI Corp plans to file for regulatory approval in Saudi Arabia for its experimental cancer treatment Multikine, part of a push to tap growing demand for advanced treatments and expand in the Middle East and North Africa (Mena).

The Virginia-headquartered company, which develops immunotherapies for cancer and infectious diseases, is also in talks to manufacture the drug in the kingdom to serve the wider region, it said in a statement.

CEL-SCI is applying for conditional approval from the Saudi Food and Drug Authority for its breakthrough therapy, which can be used as pre-surgical treatment for newly diagnosed head and neck cancer patients, it said.

“We are currently evaluating potential partnerships with local Saudi companies to commercialise Multikine, conduct clinical trials in Saudi hospitals and to establish a local Multikine manufacturing facility that would serve the entire Middle East and North Africa market,” CEL-SCI CEO Geert Kersten said on Wednesday.

The move comes as Riyadh ramps up investment in domestic biotech under its Vision 2030 strategy to diversify the economy away from oil and develop new sectors.

A national biotech strategy launched last year includes plans to scale up production of biologics and biosimilars – advanced, lab-made medicines used to treat complex diseases like cancer and cheaper versions of these drugs with similar effectiveness – for local use and export.

The kingdom aims to reduce reliance on imported medicines and position itself as a regional biomanufacturing hub.The goal is to make Saudi Arabia the Middle East’s biotech leader by 2030 and a global player by 2040, contributing $35 billion – or about 3 percent of non-oil GDP – to the economy.