SHANGHAI, Oct. 26, 2023 /PRNewswire/ -- Chime Biologics, a leading CDMO that enables its partners' success in biologics, and Hope Medicine Inc. (HopeMed), a science-driven, patient-centric, clinical-stage biotech company, announced on September 28 that the companies are collaborating to develop and manufacture the first-in-class monoclonal antibody drug HMI-115.
Under the terms of the agreement, Chime Biologics will provide one-stop-shop CMC solution for Hope Medicine's HMI-115 monoclonal antibody from technology transfer, process optimization, scale-up, clinical phase III GMP production, process characterization, process validation, BLA filing support, to commercial manufacturing. Hope Medicine will leverage Chime Biologics' extensive experience in 2000L cGMP manufacturing, late-stage CMC development and BLA filings to jointly accelerate HMI-115 mAb development and manufacturing for speedy clinical advancement of targeting endometriosis and androgenetic alopecia, benefiting more female patients and alopecia patients.
Dr. Damian Tu, President of Hope Medicine, said, "HMI-115 is Hope Medicine's most critical and advanced clinical antibody drug asset. We are very pleased to enter this strategic collaboration with Chime Biologics, a leading CDMO service company with strong experience in late stage biologics development, manufacturing, and regulatory support, as well as with strong customer-centric culture and mindset. With the help from Chime Biologics, I am confident that we will be able to launch HMI-115 mAb in a fast pace and benefit patients that are suffering from EM and AGA. Hope Medicine's vision is to bring more first-in-class drugs and highly differentiated products to the world, especially to China. We look forward to more collaborations with Chime Biologics!"
Dr. Jimmy Wei, President of Chime Biologics, said, "We are pleased to be a strategic partner of Hope Medicine. We are fully committed to driving the commercialization of HMI-115 mAb for the treatment of endometriosis and androgenetic alopecia to ensure the successful launch of this novel antibody drug. Currently, Chime Biologics has completed several late-stage CMC projects and is also in the process of commercial manufacturing for several post-market drugs. We are proud to empower our global partners to deliver clinical value for the benefit of patients."
About HMI-115
HMI-115 is a first-in-class monoclonal antibody drug that Hope Medicine owns the global rights. In April 2019, Hope Medicine and Bayer AG signed an exclusive global license agreement for the development and commercialization of HMI-115, a monoclonal antibody targeting the prolactin receptor (PRLR), for multiple indications globally. Potential indications for the antibody include Endometriosis (EM), Androgenic Alopecia (AGA), and other chronic diseases.
In 2021, Hope Medicine received approval from the FDA and EMA to conduct MRCT Phase II clinical trials for the treatment of endometriosis Hope Medicine has now completed patient enrollment and dosing at all clinical trial centers in the US and Europe. In November 2022, HMI-115 received clinical trial approval from the NMPA, and is currently conducting MRCT Phase II clinical trial in China for the treatment of endometriosis. In March 2023, Hope Medicine announced that HMI-115 received approval for a Phase II clinical trial in China for the treatment of androgenetic alopecia.
About Endometriosis
Endometriosis is a chronic estrogen-dependent gynecological disease defined by the presence of endometrium-like tissue outside the uterus, which induces a chronic inflammatory reaction. The endometrium is a layer of mucous tissue, which lines the uterus cavity and undergoes hormone-dependent changes during the menstrual cycle. Endometriosis is a common disease among women of reproductive age. The prevalence is estimated to be up to 10% in women of childbearing age worldwide. Lower abdominal and pelvic pain, cramping menstrual pains (dysmenorrhea), painful sexual intercourse (dyspareunia) and infertility are well recognized symptoms of endometriosis. It has been reported that Asian women have a higher endometriosis prevalence in comparison to Caucasians and African Americans. A recent study found the prevalence to be higher among Filipino, Indian, Japanese and Korean women (15.7%) when comparing to Caucasian women (5.8%). Endometriosis is typically associated with a lower quality of life and significant physical, sexual, psychological and social impact. The cause of endometriosis is not entirely clear, and there is no cure for endometriosis. Typically, there are two types of interventions: treatment of pain and treatment of endometriosis-associated infertility.
About Androgenic Alopecia
Androgenetic Alopecia is the most common type of hair loss and affects up to 70% of men and 40% of women. While male and female pattern hair loss is commonly believed to be due to a combination of genetics and the male hormone dihydrotestosterone, the detailed mechanism remains unclear. Data published by a Bayer team as well as data generated jointly point to a yet hardly recognized role of prolactin/prolactin-receptors signaling in the disorder.
About Hope Medicine
Hope Medicine (HopeMed) is a science-driven, patient-centric, clinical-stage biotech company with research and development bases in major innovation hubs in China. The company was established on the foundation of deep understanding of disease biology and translational medicine, and decades of scientific research in the laboratory of the founder, Professor Rui-Ping Xiao, at Peking University. With a management team of highly accomplished industry veterans combining entrepreneurship and global pharma experience, HopeMed is committed to the discovery, development, and commercialization of innovative, safe, effective, affordable medicines for large, underserved patient populations. Strategically, we are building a robust pipeline in the field of endocrine, cardiovascular and metabolic diseases, with a special focus on women's health, through internal R&D capabilities, access to external technology platforms to enable a variety of molecular modalities, as well as in-license of complementary and differentiated assets to address unmet medical needs. For more information, please visit www.hopemedinc.com.
About Chime Biologics
Chime Biologics is a leading CDMO that has introduced the first modular biopharmaceutical plant KUBio in the world to empower its partners' success in biologics in the whole process from cell line development to commercial manufacturing. Relying on cell line development and advanced technology development from our Shanghai Innovation Center and proven success in IND-enabling through BLA filing at its Wuhan plant, Chime Biologics is providing a one-stop CMC solution for biopharmaceutical customers around the world. We share a common goal to make cutting-edge biomedicines affordable and accessible to all patients globally, fulfilling its commitment to human health. For more information, please visit www.chimebiologics.com.