China-based biopharmaceutical company Hope Medicine Inc. on Thursday said its lead candidate HMI-115 has received Fast Track Designation from the US Food and Drug Administration for moderate to severe endometriosis-associated pain.

HMI-115, a monoclonal antibody targeting the prolactin receptor, had previously been granted Breakthrough Therapy Designation by China's National Medical Products Administration for the same indication.

The FDA decision is supported by a completed global Phase II trial, a 12-week, randomised, double-blind, placebo-controlled study involving 108 women with surgically confirmed endometriosis across the United States, Poland, and China. The trial showed that the 240 mg every-two-weeks dose reduced mean dysmenorrhoea pain scores by 42% and non-menstrual chronic pelvic pain by 52%, with no drug-related serious adverse events.

Patients maintained normal menstrual cycles, and no peri-menopausal symptoms, meaningful shifts in bone mineral density, or significant changes in sex hormone levels were observed.

Hope Medicine said the designation is expected to accelerate the global development and review of HMI-115 for a disease that affects around 10% of women of reproductive age and represents a significant unmet medical need.