In August 2017, a phone call was made to the new product development department of Hanmi Pharmaceutical. It was Professor Lee Mu-yong of Dongguk University College of Medicine, attending the European Society of Cardiology Congress in Barcelona, Spain. Professor Lee proposed a new paradigm for hypertension treatment by administering drugs with various ingredients in low doses.
Hanmi Pharmaceutical plans to launch the low-dose three-drug combination hypertension treatment "Amoprel" in the second half of this year, making it the world's first. The drug has enhanced efficacy while minimizing potential side effects that can occur with single-agent treatment for hypertension.
Hanmi Pharmaceutical stated it immediately began developing the three-drug combination upon receiving Professor Lee's suggestion. More than 10 billion won has been invested over eight years to develop the low-dose three-drug combination. The research workforce has included over 200 people. The company has also concentrated on securing clinical evidence through two phase 2 trials and two phase 3 trials.
Hanmi Pharmaceutical has led the development of combination agents for hypertension in Korea. In 2009, it launched the country's first hypertension medication, "Amosalvan," which combines the angiotensin II receptor blocker (ARB) component rosuban and the calcium channel blocker (CCB) amlodipine. Since then, it has continued to introduce the Amosalvan product family.
Developing combination agents goes beyond simply mixing different drug components. It requires careful consideration of drug interactions, drug-related adverse reactions, medication convenience, and the analysis of prescribing patterns by health professionals in real clinical situations.
Im Ho-taek, director of formulation research at Hanmi Pharmaceutical, noted, "Considering the convenience of medication for elderly patients, we designed the tablet size to be significantly smaller than the total of each single agent, improving swallowability. We designed it to be a product that patients of various age groups can take more comfortably, so it can also be utilized as a first-line treatment for mild and moderate patients."
Kim Na-young, executive director of new product development at Hanmi Pharmaceutical, who led the development of the low-dose three-drug combination Amoprel, stated, "I deeply resonated with the voices from the medical field suggesting a new paradigm for hypertension treatment, and through the process of realizing it, we were able to showcase Hanmi Pharmaceutical's technological capabilities and clinical development strengths. Amoprel will not just be a simple combination agent; it will establish itself as an innovative treatment that can simultaneously enhance patient adherence to medication and treatment effectiveness."
Professor Lee Mu-yong, who first proposed the product development idea, participated in the entire process from clinical trial planning to data analysis and paper presentation. He said, "By analyzing trends and directions in the latest hypertension treatment at various overseas conferences, I was able to discover the importance and potential of low-dose three-drug combinations as blood pressure-lowering agents for patients starting hypertension treatment. The first pharmaceutical company that came to my mind in relation to product development was Hanmi Pharmaceutical, which is ahead in formulation research among domestic corporations."
Park Jae-hyun, CEO of Hanmi Pharmaceutical, said, "Amoprel is preparing to write a new history in hypertension treatment in 2025, and we are focusing our corporate capabilities for a stable market launch as a next-generation innovative treatment following Rosujet. Hanmi Pharmaceutical will continue to develop innovative products centered on patients and leap forward as a global research and development-focused pharmaceutical company."