HELP Therapeutics, a global leader in regenerative medicine, has announced a strategic partnership with China Resources Sanjiu Pharmaceutical Company to co-develop and commercialize the investigational cell therapy HiCM-188 for advanced heart failure in Mainland China. The collaboration marks a significant advancement in addressing one of medicine's most pressing unmet needs.
Breakthrough iPSC-Derived Therapy
HiCM-188 represents a groundbreaking achievement as the world's first iPSC-derived regenerative therapy for advanced heart failure to receive IND clearance in both China and the United States. The investigational treatment is currently advancing through multiple clinical trials, with Phase II studies underway in China and Phase I/II trials proceeding in the U.S., Singapore, and Thailand.
The therapy has demonstrated robust safety and efficacy profiles across more than five years of long-term follow-up, positioning it as a potential game changer for patients with advanced heart failure. This extended safety data provides crucial evidence for the therapy's long-term viability and therapeutic potential.
Addressing Critical Medical Need
Heart failure remains a major unmet medical need with prevalence increasing at double-digit rates as populations age globally. Currently, heart transplantation serves as the last resort for advanced heart failure patients, but donor deficiency severely limits clinical application. HiCM-188 presents a promising alternative that could transform treatment options for these patients.
"This co-development agreement with China Resources Sanjiu marks a significant milestone for HELP Therapeutics," said Dr. Eugene Wang, Founder and CEO of HELP Therapeutics. "Their exceptional clinical network, innovation mindset, and commercial capabilities will accelerate the availability of our therapies to patients and contribute to the growth of China's cell therapy industry."
Strategic Partnership Benefits
The collaboration leverages China Resources Sanjiu's position as one of China's largest pharmaceutical companies, bringing extensive clinical networks and commercial capabilities to accelerate patient access to the therapy. Mr. Qiu Huawei, Chairman of China Resources Sanjiu, emphasized the strategic importance of the partnership.
"Cell therapy represents the future of life sciences, offering immense clinical potential for aging-related and refractory diseases," remarked Qiu Huawei. "Our partnership with HELP Therapeutics strengthens our commitment to cell therapy innovation. HELP's globally leading iPSC platform and defined clinical pipeline make them an ideal partner. Together, we aim to bring new hope to heart failure patients."
Industry Recognition
Professor Junbo Ge, Academician of the Chinese Academy of Sciences, lauded the collaboration as a milestone in China's Cell and Gene Therapy (CGT) landscape. He noted that HELP Therapeutics' focus on heart failure addresses a critical clinical need and bridges the gap between heart transplantation and targeted myocardial repair.
"This partnership has the potential to reshape treatment paradigms for patients worldwide," Professor Ge stated, highlighting the global implications of this therapeutic advancement.
The partnership represents a significant step forward in regenerative medicine, combining HELP Therapeutics' innovative iPSC platform with China Resources Sanjiu's extensive commercial and clinical capabilities to bring this potentially transformative therapy to patients with advanced heart failure.
