MZ Solution "FDA Reviewing Approval for Xenotransplantation Clinical Trials... Accelerating Preclinical Studies for Artificial Blood and Diabetes Treatments"

Director Kang Jeong-taek of MGen Solution Biotechnology Research Institute. / Photo by MGen Solution

"The U.S. Food and Drug Administration (FDA) is preparing to allow clinical trials of xenotransplantation for general patients, and favorable winds are blowing domestically as well. Our company plans to establish an advanced breeding system for source pigs by the first half of next year, conduct transplantation experiments on monkeys, and then proceed with domestic clinical trials targeting diabetic patients."

On the 29th, Kang Jeong-taek, head of the Biotechnology Research Institute at MGen Solution, presented the roadmap for the company's core bio sector in an interview with Asia Economy. Kang was appointed as an inside director in March and is concurrently serving in this role.

MGen Solution, a specialized xenotransplantation company, is recognized for its unparalleled technology based on the longest research experience in Korea. It succeeded in developing the world's first cloned pig that secretes human insulin and is developing special-purpose pigs for research on intractable human diseases alongside the xenotransplantation field.

This includes genetically modified pigs for islet transplantation to treat diabetes (for xenotransplantation), disease model pigs for new drug development and human disease research, and pigs for artificial blood. Kang said, "Especially, pig-derived islet transplantation products and artificial corneas are expected to be commercialized the fastest," adding, "We are considering technology transfer (LO) after completing Phase 1 or Phase 2 clinical trials."

Previously, MGen Solution transplanted islets from pigs with two genes knocked out into monkeys, maintaining normal blood glucose levels for over seven months, and after corneal transplantation, maintained transparency for more than two months. He stated, "We are currently preparing experiments for isolating islets and corneas from pigs with six gene modifications and transplanting them into monkeys," and added, "The ultimate goal is to modify 12 genes."

The development status of pigs for artificial blood is also positive. Recently, MGen Solution succeeded in developing pigs that have lost their own hematopoietic function and is currently attempting to equip them with 'human hematopoietic function,' which is in the final stage. Once artificial blood production is confirmed, full-scale product manufacturing processes will commence.

Kang explained, "Due to the global shortage of organs and blood, the number of transplant waitlists is increasing while donors are severely lacking. Accordingly, xenotransplantation research is actively progressing worldwide, and the FDA is reportedly preparing to approve related clinical plans."

He added, "The Ministry of Food and Drug Safety is also improving market conditions by providing support measures and guidelines related to xenotransplantation product development," and stated, "Depending on the results of the xenogeneic islet transplantation experiments in monkeys scheduled for the first half of next year, we plan to proceed with domestic clinical trials targeting actual diabetic patients."

MGen Solution plans to self-fund research and development through the production and sale of diagnostic kits for infectious viruses such as African swine fever and disease model pigs for research purposes. The new research facility in the Osong Bio Science Complex, to be completed in September, will establish a transgenic pig breeding system and serve as a specialized production base.

Kang said, "We will lead the global market through the synergy of our continuously advanced unique proprietary technology and the new infrastructure facilities scheduled to be established within this year."