Hope Medicine Inc. Announces Successful Completion of a Global Phase 2 Study of a Potential First-in-Class Endometriosis Treatment

HMI-115 demonstrated statistically significant improvement in endometriosis pain

The mean dysmenorrhea pain score was reduced by 42%

The mean non-menstrual pelvic pain score was reduced by 52%

Most of the patients had normal menstrual periods

No typical peri-menopausal symptoms were reported

There were no significant changes in bone mineral density and sex hormone levels

About 190 million women worldwide have endometriosis, making up a market size of $200billion

SHANGHAI, Oct. 7, 2025 /PRNewswire/ -- Hope Medicine Inc. ('HopeMed'), a clinical-stage innovative biopharmaceutical company, announced successful completion of a global Phase 2 study, " A Randomized, Multicenter, Double Blind, Placebo Controlled Phase 2 Study to Evaluate the Safety and Efficacy of HMI-115 in Women with Moderate to Severe Endometriosis Associated Pain Over a 12-Week Treatment Period". HMI-115 is a monoclonal antibody that blocks the prolactin receptor. It is a potential first-in-class treatment for endometriosis.

This study included 108 female patients with surgically diagnosed endometriosis in US, Poland and China. HMI-115 demonstrated statistically significant improvement of endometriosis associated pain. HMI-115 was well-tolerated with no treatment-related serious adverse events. Specifically, at the end of the study treatment, the least-square-mean dysmenorrhea pain score was reduced by 42% in the 240 mg q2w group, compared to that of the baseline. The least-square-mean non-menstrual pelvic pain score was reduced by 52%. These reductions are statistically significant. No typical peri-menopausal symptoms were reported. There were no significant changes in menstrual patterns, bone mineral density and sex hormone levels including estradiol, LH, FSH and progesterone.

"Endometriosis is a common and debilitating disease. The findings from this proof-of-concept study are exciting," said Lan Zhu, Director of Gynecology at Peking Union Medical College Hospital and leading investigator of this Phase 2 study, "HMI-115 relieved endometriosis pain in women without disturbing their sex hormones. It can potentially shift the treatment paradigm. We will be able to treat women without menopausal side effects or even infertility."

"HMI-115 is the first prolactin receptor blocker that can treat women with endometriosis," said Professor Rui-Ping Xiao, founder of Hope Medicine, "it is also first non-hormonal treatment worldwide that cleared proof-of-concept. Hope Medicine is a leading company in this global consortium to improve women's health."

"HMI-115 is Phase 3 ready," said Nathan Chen, CEO, "we are communicating with key regulatory agencies, including FDA and NMPA, to finalize the Phase 3 protocol and to initiate Phase 3 studies worldwide."

About Endometriosis

About approximately 190 million women worldwide have endometriosis, making up a global market size of approximately $200 billion dollars. Endometriosis is a common gynecological disease characterized by the implantation of endometrial cells in locations outside the endometrium, typically presenting as chronic inflammation. The endometrium is a layer of mucosal tissue within the uterine cavity that undergoes hormone dependent changes during the menstrual cycle. Endometriosis is common in women of childbearing age, and its global incidence rate is about 10% in women of childbearing age. Symptoms include lower abdominal and pelvic pain, dysmenorrhea, painful intercourse, and infertility. Endometriosis negatively impacts patients' quality of life and sex, psychology, and social behavior.

About Hope Medicine

Hope Medicine Inc. is a science-driven clinical-stage biopharmaceutical company with research laboratories and offices in Beijing, Shanghai, and Nanjing, China. HopeMed is established on the in-depth expertise in translational medicine and decades of research of Professor Rui-Ping Xiao's laboratory at the Institute of Molecular Medicine of Peking University. Based on excellent scientific research and to improve the quality of life, HopeMed is committed to the research, development, and commercialization of first-in-class medicines for common and major diseases that threaten human health.

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SOURCE Hope Medicine Inc.