As the first company in China to develop and manufacture cell therapy using induced pluripotent stem cell (iPSC) technology, Help Therapeutics insists on focusing on the fields of heart failure and tumor immune diseases to develop general-purpose cell therapy products to meet clinical demand.
The company’s founder, Dr. Wang Jiaxian, is a medical doctor from the University of Hong Kong and a postdoctoral fellow at Mount Sinai School of Medicine in the United States. During his time as a cardiologist, Dr. Wang became concerned that the population of heart failure patients in China has reached over 10 million, and there are about 3 million patients with severe heart failure waiting for heart transplants every year, but only about 600 people can find heart donor, a huge gap that has become a problem for the entire medical community. Dr. Wang chose to enter the field of iPSC cell therapy in 2010, convinced that iPSC technology is a groundbreaking technology for human medicine, and looking forward to saving heart failure patients through this innovative cutting-edge technology. After years of development, the company has developed several product pipelines based on iPSC technology, mastering advanced iPSC reprogramming technology while having the capability of large-scale automated production and cell quality inspection of iPSC drugs.
iPSC pipeline layout Break through the heart failure treatment dilemma
Help Therapeutics has laid out several R&D pipelines in the areas of heart failure and tumor immunity, among which iPSC technology therapy for the treatment of moderate to severe heart failure has entered several authoritative centers nationwide to conduct large-scale randomized controlled human clinical trials. Help Therapeutics has accumulated profound experience in the field of heart failure cell therapy: In 2020, Nature reported the world’s first human study of iPSC cells for end-stage heart failure conducted jointly by the company and Nanjing Drum Tower Hospital. Based on 24-month follow-up data from three patients in this clinical trial, the efficacy and safety of Help Therapeutics’s iPSC-derived cardiomyocyte drug for the treatment of severe heart failure were excellent.
The company has already obtained the first iPSC technology-based heart failure cell therapy clinical study filing from the National Health Care Commission in China, and is also actively preparing clinical registration filings for both the U.S. and China for its heart failure treatment pipeline. After clinical trials, this product is expected to be the first iPSC cell therapy drug for moderate to severe heart failure in China and the world, and its social and commercial value will be incalculable.
Artificial intelligence fully automated production line, the world’s first biopharmaceutical 4.0 era
With the development of the cell therapy industry, the quantity and quality of cell culture are in more refined and higher demand, both from the perspective of clinical demand and R&D exploration. The current manual culture of cell therapy products has long operation time, large variation between product batches, low batch culture capacity and other industry bottlenecks, and thus the cost and terminal selling price of cellular drugs remain high, and cannot really reach the majority of patients. Therefore, addressing the commercial mass production of cells has become central to the development of cell therapy companies.
Help Therapeutics is at the forefront of the world’s technology in terms of cell mass production and quality assurance. Its fully automated production line has reached the international leading position, improving the quality and stability of cellular products while significantly reducing production costs. The annual production capacity of a single production line can meet 100,000 doses, contributing to the popularization of cellular products. The company’s fully automated production pipeline was selected for the National “13th Five-Year Plan” Science and Technology Innovation Achievement Exhibition.
Taking the responsibility of the country as our own
Help Therapeutics has the first induced pluripotent stem cell (iPSC) biospecimen bank authorized by the Ministry of Science and Technology for the preservation of human genetic resources in China. Entrusted by the National Human Genetic Resources Sharing Service Platform and as the only officially recognized iPSC rare disease cell bank in the National 14th Five-Year Plan (National Science and Technology Heritage Office -BC0022), Help Therapeutics carries the heavy responsibility of human genetic material and makes every effort to promote the role of China’s iPSC technology platform and rare disease research and development treatment. Help Therapeutics will provide high-quality and diversified biological samples to research institutions and enterprises, accelerate rare disease research and orphan drug development, and help the rapid development of iPSC cell industry.