HMI-115 received FDA Fast Track Designation based on results from a Phase II clinical trial for endometriosis
Mean dysmenorrhea pain score reduced by 42%
Mean non-menstrual chronic pelvic pain score reduced by 52%
Most patients maintained normal menstrual cycles
No typical peri-menopausal symptoms were reported in patients
No significant changes in bone mineral density or sex hormone levels
SHANGHAI, Dec. 4, 2025 /PRNewswire/ — Hope Medicine Inc. (“HopeMed”), a clinical-stage innovative biopharmaceutical company, today announced that its lead pipeline product, HMI-115, a monoclonal antibody targeting the prolactin receptor, has been 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.
Previously, HMI-115 had been included in the Breakthrough Therapy Designation (BTD) list by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA), intended for the treatment of moderate to severe pain associated with endometriosis. This FDA Fast Track Designation marks a significant milestone in the global development of HMI-115, highlighting its outstanding clinical potential.
The FDA Fast Track Designation is a special program established by the U.S. Food and Drug Administration (FDA), an internationally authoritative regulatory agency, to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need. According to FDA guidelines, drug candidates granted FTD qualify for more frequent interactions and timely feedback from the FDA during subsequent development and review processes.
The granting of Fast Track Designation was based on the results of a completed global Phase II clinical trial for HMI-115. This trial was an international, multicenter, randomized, double-blind, placebo-controlled dose-finding study designed to evaluate the safety and efficacy of HMI-115 in patients with moderate to severe endometriosis-associated pain over a 12-week treatment period. The study enrolled 108 female patients with surgically diagnosed endometriosis across the United States, Poland, and China. Results showed that HMI-115 achieved statistically significant improvement in moderate to severe endometriosis-associated pain and was well-tolerated overall, with no drug-related serious adverse events reported. Specifically, at the end of the treatment, the least-square-mean dysmenorrhea pain score in the 240 mg every two weeks (q2w) dose group decreased by 42% from baseline, and the non-menstrual chronic pelvic pain score decreased by 52%, both with statistical significance. No typical peri-menopausal symptoms were reported during the study; there were no significant changes in menstrual cycle, bone mineral density, or levels of sex hormones such as estradiol, luteinizing hormone (LH), follicle-stimulating hormone (FSH), and progesterone. The results of this proof-of-concept global Phase II clinical trial have been formally published in The Lancet Obstetrics, Gynaecology & Women’s Health.
Endometriosis is a common gynecological disease characterized by the implantation of endometrial cells outside the uterine cavity, typically presenting as a chronic inflammatory response. The endometrium is the mucosal tissue lining the uterine cavity, which undergoes hormone-dependent changes during the menstrual cycle. Endometriosis is common in women of reproductive age, with symptoms including lower abdominal and pelvic pain, dysmenorrhea, painful intercourse, and infertility. Comprehensive literature reports indicate that approximately 10% of women of reproductive age globally are affected by endometriosis, equating to about 190 million women worldwide; 20%-50% of women with infertility have endometriosis, and 71%-87% of women with chronic pelvic pain have endometriosis. Endometriosis is one of the leading causes of dysmenorrhea, infertility, and chronic pelvic pain. The disease often leads to decreased quality of life, affecting patients’ sexual health, psychological well-being, and social behavior. Globally, the disease represents a potential market size of approximately US$200 billion (according to McKinsey report), with significant unmet medical needs. As a potential first-in-class global treatment for endometriosis, the FDA Fast Track Designation for HMI-115 is expected to accelerate its development, review, and approval process, potentially bringing it to patients worldwide sooner.
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.
Forward-Looking Statements
This press release contains forward-looking statements that are primarily based on the current outlook, expectations, estimates, and projections of the company’s management team. When using “anticipate,” “believe,” “may,” “design,” “effect,” “assess,” “expect,” “predict,” “target,” “aim,” “purpose” and any other similar words and expressions, in references to the company, the intention of the statement is forward-looking. Forward-looking statements are not guarantee of future performance and subject to risks and uncertainties, many of which are difficult to predict and often beyond the company’s control, which could cause actual results to differ materially from the Company’s expectations discussed in the forward-looking statements. These statements are subject to uncertainties and risks including, but not limited to, the following: the Company’s goals and strategies; the Company’s future business development; changes in technology; economic conditions; reputation and brand; the impact of competition and pricing; government regulations; changes in applicable laws or regulations. The company undertakes no public announcement obligation to update or revise any forward-looking statement in this press release, or to publicly announce any such updates or revisions, to reflect changes in our expectations or any events, circumstances or assumptions that affect these statements.
SOURCE Hope Medicine
