Swiss pharma giant Roche pics Malaysia for FIH clinical trial

PUTRAJAYA, Jan 5: Swiss healthcare giant, Roche Pharmaceuticals, has picked Malaysia’s Sarawak General Hospital as its global First-in-Human (FIH) clinical trial site.

Malaysia will be the seventh country included by Roche for the study and the first within the Asia Pacific region.

Health Minister Datuk Seri Dr Dzulkefly Ahmad said Roche becomes the first top multinational company to bring its FIH trials under a rheumatology indication to Malaysia.

He said Malaysia’s clinical trial ecosystem has developed rapidly with over 2,300 sponsored clinical research conducted since the establishment of Clinical Research Malaysia (CRM) in 2012.

“Malaysia has great potential in delivering multi regional clinical trials, whereby we have world class investigators, mature and comprehensive infrastructure as well as a robust regulatory landscape that ensures trials to be carried out safely for our patients,” he said.

Dzulkefly said this at the CRM’s Clinical Research Excellence in Early Phase and People Development and witnessed the exchange of a memorandum of understanding (MoU) between CRM and Roche, here today.

He said Roche’s global FIH trial in Malaysia was a testament to the country’s growing clinical trial capabilities, and only within two years from the completion of the CRM Phase 1 Realisation Project (P1RP) which enabled the FIH ecosystem in the country.

 Following the completion of P1RP in 2021, Malaysia has conducted one FIH and two First-in-Patient studies, with Roche’s study being the first FIH in Malaysia under a rheumatology indication, he said.

The FIH is on a new experimental drug to treat patients with Systemic Lupus Erythematosus (SLE), an autoimmune condition that affects joints, skin, brain, lungs, kidneys and blood vessels.

Roche has invested around RM190 million in clinical trials in Malaysia since 2012.

Meanwhile, another MoU was exchanged today between CRM and the Pharmaceutical Association of Malaysia (PhAMA) to propel the development of clinical research talents and skills in Malaysia.