MPB-1523, an MRI contrast medium developed by MegaPro Biomedical Co. for the detection of hepatocellular carcinoma, has been approved as an orphan drug by the US FDA and will be granted administrative assistance by the US authorities and market exclusivity for the new drug. 

MPB-1523 is a liver-specific MRI contrast medium, which is mainly targeted at the MRI market for hepatocellular carcinoma. Currently, all MRI contrast agents for hepatocellular carcinoma are gadolinium-based contrast agent, which are heavy metals with the potential to remain in the body.

According to Jusheng Medical, after MPB-1523 has been granted Orphan Drug status by FDA, it will receive more administrative assistance from the US authorities, as well as seven years of US market exclusivity for the new drug, which will help save MPB-1523's clinical trial costs and speed up its launch in the US.

According to MegaPro's plan, it will apply to FDA for an end-of-phase 2 meeting in the third quarter to propose a clinical phase 3 trial plan and negotiate for authorisation to accelerate the commercialisation process.

According to a report by Global Industry Analysts, Inc, the global contrast agent market will reach US$4.9 billion in 2020, with a compounded growth rate of 3.9% from 2021 to 2027, and is estimated to reach US$6.4 billion in 2027.