Home Hope Medicine Announces Global Exclusive Licensing Agreement with Bayer for Prolactin Receptor Monoclonal Antibody

Hope Medicine Announces Global Exclusive Licensing Agreement with Bayer for Prolactin Receptor Monoclonal Antibody

Apr 08, 2019 00:00 CST Updated 00:00
Bayer

Pharmaceutical Product R&D Developer

Beijing, April 8, 2019 /PRNewswire/ -- Hope Medicine Inc. announced today that it has entered into a global exclusive licensing agreement with Bayer AG for the development and commercialization of a monoclonal antibody targeting the prolactin (PRL) receptor. Potential indications for this antibody include male and female pattern alopecia, endometriosis, and other chronic diseases. Committed to developing innovative pharmaceuticals to improve human quality of life, HopeMed is a novel biopharmaceutical company founded on the in-depth understanding and research of human biology and translational medicine by Professor Xiao Ruiping and her team at the Institute of Molecular Medicine (IMM), Peking University.

Under the license agreement, HOPE MEDICINE (HK) LIMITED will develop and commercialize novel antibodies targeting the prolactin (PRL) receptor globally, based on Bayer’s intellectual property; Bayer will receive an upfront payment, development milestones, commercialization milestones, and tiered sales royalties.

In connection with the signing of this global licensing agreement, Hope Medicine also announced the completion of its Series A financing. Trust Bridge Partners, a leading global private equity firm focused on China, provided the founding US dollar investment for this round. Nanjing Qirui Youkang, an RMB-denominated private equity fund based in the Jiangbei New Area of Nanjing, Jiangsu Province, has also committed RMB investment to support the global development program of this antibody. Mr. Ge Feng, Managing Partner of Trust Bridge Partners, will join the Board of Directors of Hope Medicine.

“We are delighted to partner with Bayer to translate the years of collaborative research and scientific understanding of this important pathway by scientists from the Peking University Institute of Molecular Medicine and Bayer into clinical applications, thereby further exploring the medical potential of this PRL receptor-targeting antibody. I also extend my gratitude to our investors for their generous financial support, which has made our vision possible: advancing the research and development of human biology into clinical medicine to create new drugs that benefit male and female patients worldwide,” commented Professor Ruiping Xiao, Co-founder, Chairman, and Founding CEO of Hope Medicine, who holds an M.D. and Ph.D. Professor Xiao is a Chair Professor at Peking University, Director of the Peking University Institute of Molecular Medicine, Deputy Editor of The New England Journal of Medicine, and a former tenured investigator at the National Institute on Aging of the U.S. National Institutes of Health.

“In recent years, China’s health needs and scientific and medical research have made significant progress. We are very excited about the development of China’s healthcare industry in recent years and its long-term prospects. It is an honor for Trustbridge Partners to be a founding investor and partner of HOPE MEDICINE (HK) LIMITED. This investment aligns with our vision to develop and provide internationally standardized medical products for the Chinese and global markets,” added Mr. Ge Feng, Managing Partner of Trustbridge Partners.

Mr. Lou Shi, Co-founder, President, and Chief Operating Officer of HOPE MEDICINE, commented on the company’s development strategy: “As an R&D scientist, I am honored to be a founding member of HOPE MEDICINE, dedicated to developing first-in-class novel drugs for the Chinese and global markets. Backed by visionary investors, HOPE MEDICINE boasts a leading biological sciences team, robust global intellectual property, and international quality and development partners committed to delivering superior medicines to the global market. We are assembling a top-tier innovative team across biological sciences, CMC, and clinical research and operations to unlock the therapeutic potential of this licensed antibody. The antibody has demonstrated excellent characteristics in animal models, including non-human primate (NHP) models, as well as in human safety studies. We look forward to initiating integrated global Phase II clinical trials in Europe, the United States, and China at an early date.”

On Male and Female Pattern Hair Loss

Male and female pattern hair loss, also known as androgenetic alopecia, is the most common type of hair loss, affecting 70% of men and 40% of women, respectively. Male pattern hair loss is generally considered to be associated with genetic factors and the androgen dihydrotestosterone (DHT), although the detailed mechanisms underlying hair loss remain not fully elucidated. Data published by Bayer’s scientific team, as well as unpublished data from collaborative studies, point to a prolactin/prolactin receptor (PRL-PRLR) signaling pathway—a mechanism not yet widely recognized—as being involved in the pathogenesis of this condition.

For male and female pattern hair loss, treatment options include minoxidil, finasteride (for males only), or hair transplantation surgery; however, a significant proportion of patients do not respond to these treatments. Constrained by limited therapeutic choices, many patients have no choice but to accept their condition. Furthermore, current treatment options may cause side effects such as orthostatic hypotension, edema, and sexual dysfunction.

About Endometriosis

Endometriosis is a common estrogen-dependent gynecological disorder characterized by the implantation of endometrial cells outside the uterine cavity, typically manifesting as a chronic inflammatory response. The endometrium is a layer of mucosal tissue lining the uterine cavity that undergoes hormone-dependent changes during the menstrual cycle. Endometriosis is prevalent among women of reproductive age, with a global incidence rate of approximately 10% in this population. Common symptoms include lower abdominal and pelvic pain, dysmenorrhea, dyspareunia, and infertility. Reports indicate that the prevalence of endometriosis is higher among Asian women than among European, American, and African women. Recent studies have reported a prevalence of 15.7% among women in the Philippines, India, and Japan, which is significantly higher than the 5.8% observed in European and American women. Endometriosis often leads to a reduced quality of life, affecting patients’ sexual health, psychological well-being, and social functioning. The etiology of endometriosis remains unclear, and there is currently no cure. Treatment primarily focuses on two approaches: pain management and treatment of infertility. Although current standard treatments with gonadotropin-releasing hormone (GnRH) analogs can alleviate pain, they are associated with inflammatory side effects, including osteoporosis and hot flashes, thereby precluding long-term use.

On Prolactin (PRL) Receptor Antibodies

Prolactin (PRL) receptor antibodies are monoclonal antibodies targeting the prolactin receptor, blocking downstream signaling pathways of prolactin through non-competitive inhibition. The administration method is subcutaneous injection. This antibody demonstrated good tolerability in Phase I clinical trials (including single-dose and multiple-dose regimens).

This antibody effectively promotes hair growth in aged rhesus macaques. After six months of treatment, the number of terminal hairs in alopecic areas nearly doubled, even in regions that were previously almost completely bald, with therapeutic effects persisting for more than two years after discontinuation. Of particular note, the rhesus macaque model is a rare and valuable predictive model for assessing efficacy in both male and female pattern hair loss. This study represents the outcome of close collaboration between scientists at Bayer and the Institute of Molecular Medicine at Peking University.