Chinese pharmaceutical company Shanghai MicuRx Pharmaceutical Co Ltd.(SH:688373) announced on Wednesday that MRX-5, its self-developed anti-infection drug, has been granted Orphan Drug Designation (ODD) by the US Food and Drug Administration (FDA) for the treatment of non-tuberculous mycobacteria (NTM) infections.

This designation is represents a significant milestone for MicuRx in the field of NTM infection treatment.

MRX-5 is a novel benzoxazole antibiotic developed for the treatment of mycobacteria infections, particularly infections caused by NTM. MicuRx says that in recent years, NTM diseases have been increasing rapidly and have become a major public health threat worldwide. Existing treatment options for NTM infections are limited, and traditional drugs face common challenges such as drug resistance, poor efficacy and numerous adverse effects.

A new drug specifically aimed at treating drug-resistant NTM infections, MRX-5 demonstrates good antibacterial activity against common NTM strains. It has also shown potent antibacterial activity against NTM pathogens in both animal studies and human trial, along with favourable safety and pharmacokinetic profiles. Additionally, the company claims that MRX-5 features minimal interactions, low potential for resistance and high oral bioavailability, making it suitable for long-term use in treating chronic infections.