Hope Medicine begins phase 3 endometriosis trial dosing

SHANGHAI, March 25, 2026 /PRNewswire/ -- Hope Medicine Inc., a science-driven, clinical-stage innovative biopharmaceutical company, announced that the first patient has been dosed in the Phase III clinical trial of HMI-115, its first-in-class monoclonal antibody with global rights, for the treatment of endometriosis. The dosing took place at the leading study site in China, Peking Union Medical College Hospital. This Phase III trial is a multicenter, randomized, double-blind, placebo-controlled study designed to confirm the safety and efficacy of HMI-115 in treating moderate-to-severe pain associated with endometriosis, with a treatment period of 24 weeks. HMI-115 is currently the first and only non-hormonal therapy globally to have entered Phase III clinical development.

Previously, HMI-115 was granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of moderate-to-severe pain associated with endometriosis. Additionally, HMI-115 was granted the Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). These recognitions from global regulatory authorities were primarily based on the results from a previously completed global multicenter Phase II clinical trial for HMI-115 in endometriosis, which demonstrated that HMI-115 achieved statistically significant improvement in moderate-to-severe pain associated with endometriosis, with no significant impact on key female hormones and no menopausal side effects. These findings have been published in The Lancet Obstetrics, Gynaecology, & Women's Health. Furthermore, Hope Medicine was nominated as "Best Startup" for the prestigious Prix Galien Award.

Regarding this significant clinical milestone, Professor Xiao Ruiping, Founder of Hope Medicine, stated:
"The initiation of the Phase III clinical trial for HMI-115 in endometriosis, marks a milestone achievement in our clinical development. Peking Union Medical College Hospital, as the leading site, is at the forefront of this Phase III study. Hope Medicine remains unwavering in its original commitment to bringing truly differentiated first-in-class medicines to patients worldwide."

Chen Xi, Chief Executive Officer of Hope Medicine, also commented:
"The launch of the Phase III trial signifies that the global development of HMI-115 for endometriosis has entered its final stage. Women's health is a key focus area for Hope Medicine, and we will drive this trial with the best speed and quality to bring this innovative treatment to patients as soon as possible."