Issues & Trends

"Oral Insulin Developed After 35 Years of Waiting… Set to Be a Game-Changer"

Kim Kwang-hoon, Chairman of the Korea Diabetes Federation Starting on the 1st, People with Pancreatic Disorders Can Also Register as Persons with Disabilities "Oral Insulin Expected to Improve Patients' Lives"

[Edaily Reporter Kwon Oh Seok ] Every morning, as a child gets ready for school, their stomach and arms are marked with needle pricks and bruises. For those with Type 1 diabetes, insulin injections are not a choice but a necessity for survival. For people with Type 1 diabetes—who have low insulin production and must administer insulin via injection—today, the first day of July, has become a very special day. This is because, following the Ministry of Health and Welfare’s revision of the disability assessment criteria under the Enforcement Decree of the Welfare of Persons with Disabilities Act, individuals with pancreatic disorders can now register as persons with disabilities starting today, July 1.
(Photo courtesy of the Korean Diabetes Association)

Type 1 diabetes is a condition in which the beta cells in the pancreas that produce insulin are destroyed, leading to an absolute deficiency in insulin secretion. As a result, glucose cannot enter the cells and accumulates in the blood, causing persistent hyperglycemia.
For patients living with pancreatic disorders and their families, the Ministry of Health and Welfare’s implementation of the pancreatic disorder registration system is truly a source of new hope. On the 1st, we met with Kim Kwang-hoon (pictured), Chairman of the Korea Diabetes Federation, who has been fighting tirelessly to improve the treatment of many patients and their families, to hear about the significance of this new system and areas that need improvement in the future.
Chairman Kim, who has been living with type 1 diabetes for 35 years, welcomed the implementation of the system but explained, “For type 1 diabetes, these two pillars of hope—the system and treatment—must go hand in hand.”
◇A 21-Year Journey Culminating in Pancreatic Disorder Registration
The history began in the 1990s with a small gathering of children with Type 1 diabetes and their families who came together for mutual support, centered around Seoul National University Children’s Hospital. Later, with the development of the internet, the group gradually expanded into online communities such as online forums, and as camps in the Gyeongin region gained momentum, the need for an official association became apparent.
The decisive factor in establishing the association was an incident in which Chairman Kim himself was arrested on the spot by the Songpa Police Station while administering insulin and subsequently questioned. “Back then, there was very little public awareness about insulin injections, so when I administered my own injections, I was often met with unintended misunderstandings,” he said. “To address this issue, I initially joined forces with a few others to form the Korean Association of Children with Diabetes, which later evolved into the Korea Diabetes Federation.”
He further noted, “It was a time when there was a lack of social awareness about Type 1 diabetes, even though it is a condition that requires insulin to be administered via the pancreas,” and added, “Many people believed that diabetes was a disease caused by poor health management, regardless of whether the person was an adult or a child, so our work began with combating these social misconceptions.”
Subsequently, as tangible achievements emerged—such as improvements to the environment for insulin administration in schools, the administration of glucagon by school nurses, priority enrollment for children with diabetes at nearby public and national kindergartens, improved social awareness, and reforms to insurance and healthcare systems—the organization gradually expanded and grew into the Korea Diabetes Federation, a policy advocacy group. These efforts continued, and patients, experts, the National Assembly, and the government joined forces; as a result, it took 21 years for the pancreatic disorder registry to be implemented.
During that time, type 1 diabetes was confined to the framework of an “incurable or chronic disease,” forcing patients and their families to bear the full brunt of social isolation and financial burdens. The registration of pancreatic disorders is a declaration that the state and society will finally recognize this suffering as a “disability” and share the burden together. Chairperson Kim stated, “The implementation of this disability registration goes beyond a simple expansion of welfare; it is a source of warm comfort for patients like myself and their families who have endured for 35 years,” adding, “It will serve as a solid pillar of support to ensure a better life.”
◇Systemic Improvements Achieved, but… Improving the Treatment Environment Remains a Challenge
It is true that the treatment environment for diabetes patients has improved compared to the past; the variety of insulin types has increased, and their effectiveness has improved. In the past, patients managed their condition with NPH and RI insulins and had to prick their fingers multiple times a day to check blood sugar levels, sometimes developing calluses as a result. Now, however, they can monitor real-time changes using continuous glucose monitors (CGMs) and check the data via their smartphones. It is also possible to precisely adjust insulin doses using a multi-hormone insulin pump. The fact that parents can now monitor their children’s blood sugar levels even from a distance is undoubtedly a major advancement. However, the most fundamental limitation remains an unresolved challenge that has yet to be overcome.
Insulin is, after all, an injectable medication. No matter how much technology advances or how sophisticated the tools become, the method of delivering insulin into the body still requires a needle. Although technological advancements over the past 100 years of insulin history have made needles thinner, people are still not free from the pain of piercing the skin, the inconvenience of carrying the equipment, or negative social stigma. Children must inject themselves with a needle several times a day for their entire lives. Many children hide in the bathroom to avoid getting an injection in front of their friends, and many teenagers are embarrassed by the marks and bruises left by the injections. A life spent injecting oneself daily is, in itself, a massive constraint.
Therefore, there is an urgent need to develop oral treatments to replace injectable medications for these patients. However, despite numerous attempts by global pharmaceutical companies, there has yet to be a successful case of oral insulin.
According to industry sources, oral insulin has been an unsolved challenge for over 100 years. Since insulin is a protein, it is digested and broken down in the stomach and intestines when swallowed. In effect, it disappears before its therapeutic effects can be absorbed. Due to this susceptibility to breakdown in the stomach and intestines, the development of oral insulin has long been considered a technical challenge, and the fact that no commercially available oral insulin exists to date underscores just how difficult this task is.
An expert in the pharmaceutical industry explained, “If technology for oral insulin that is not destroyed by digestive enzymes and is absorbed directly into the liver is perfected, it could produce effects most similar to the body’s natural insulin secretion mechanism,” adding, “Literally, oral insulin will be a game-changer for the pharmaceutical industry, raising quality of life from the lowest to the highest level.”
◇“SAM CHUN DANG PHARM CO. LTD’s Oral Insulin: Hope for Patients”
Chairman Kim noted that many patients are watching SAM CHUN DANG PHARM CO. LTD’s oral insulin ( SAM CHUN DANG PHARM CO. LTD(000250)) with hope. “We have high expectations following the news that SAM CHUN DANG PHARM CO. LTD’s oral insulin has begun Phase 1 clinical trials,” he said. “The development of oral insulin will go beyond the conventional meaning of a drug to become a treatment that improves patients’ lives.”
As he mentioned, SAM CHUN DANG PHARM CO. LTD is currently conducting clinical trials for its oral insulin “SCD0503” in Europe. Initially, the company had planned to conduct Phase 1 and Phase 2 trials simultaneously; however, since Phase 1 was approved first, it will proceed with that phase first, and Phase 2 will be conducted at a later date following approval through consultation.
The Phase 1 clinical trial is being conducted at “Profil,” a world-renowned clinical research organization specializing in diabetes in Germany, with patients with Type 1 diabetes. Unlike typical Phase 1 trials, which assess safety in healthy adults, this trial will administer the drug to actual patients to verify its pharmacokinetic characteristics and efficacy at an early stage. This is interpreted as SAM CHUN DANG PHARM CO. LTD’s strategy to simultaneously ensure ease of administration and efficacy compared to existing injectable formulations.
Chairman Kim expressed his gratitude for the pharmaceutical companies’ relentless efforts, noting that such challenges offer great hope to patients and their families. “Thanks to pharmaceutical companies that are investing immense clinical resources and making great efforts to develop oral insulin or new drugs, patients are able to hold onto that thread of hope,” he said. “I am always grateful for their dedicated efforts.”
He continued, “When I was first diagnosed with type 1 diabetes 35 years ago, my doctor told me not to lose hope, saying that oral insulin would be available within five years, or at the latest, within ten years.” He added, “Those five years have now turned into 35, but I haven’t given up. “If we can take insulin orally instead of via injection, it won’t just be a matter of convenience—it will be a fundamental change that transforms our daily lives and self-esteem,” he added.

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