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SCM Life Science, a bio-venture specializing in cell therapy (KOSDAQ 298060, CEO Lee Byung-gun, hereinafter SCM Life Science), is speeding up the development of cell sheets with cell therapy and tissue engineering for rare diseases in line with the enforcement of the Advanced Regenerative Medicine and Advanced Bio-medicine Safety and Support Act. (abbreviated: Advanced Regenerative Bio Act, hereinafter referred to as the Advanced Regenerative Bio Act)

The government plans to implement advanced regenerative bio laws from the 28th to focus on fostering the domestic bio-industry and reduce the pain of patients suffering from rare diseases.

In the process of developing new biopharmaceuticals, ▲ It includes pre-examination of clinical license data in advance according to the development schedule ▲ pre-examination of innovative biopharmaceuticals that treat rare diseases without treatment means over other drugs ▲ conditional marketing permission after phase 2 clinical trials ▲ researcher-led clinical support.

Earlier, the Ministry of Health and Welfare and the Ministry of Food and Drug Safety announced that the enactment of the Enforcement Decree of the Advanced Regenerative Bio Act was approved at a Cabinet meeting on the 25th. The enforcement ordinance classified the scope of advanced regenerative medicine into four categories: ▲ cell therapy ▲ gene therapy ▲ tissue engineering therapy ▲ convergence therapy by treatment method.

Furthermore, the government established basic plans for high-tech regenerative bio and annual implementation plans, related ministries, and government-wide public-private partnership policy review committees every five years and specified specific procedures and methods necessary for deliberation.

As a result, uncertainties have been resolved as laws related to cell therapy, which have been abstractly defined, have been revised in the bio industry. As regulations on conditional item permits and quick screening become clearer, the development schedule of various biopharmaceuticals such as cell therapy is expected to be advanced, and more patients are expected to benefit.

With the implementation of the Advanced Regenerative Bio Act, SCM Life Science is expected to accelerate the development of various pipelines based on cell therapy. As the screening period is shortened, the time spent on clinical trials is reduced and the commercialization process is simplified.

Chronic GVHD treatments are considered a representative pipeline for SCM Life Science, which will benefit from the advanced regeneration bio method. Chronic GVHD is an intractable rare disease caused by immune rejection when leukemia patients transplant bone marrow, with a whopping 25% mortality rate. Half of hematopoietic stem cell transplant patients suffer from the disease, but there is no effective treatment other than steroids with severe side effects.

The treatment for chronic GVHD under phase 2 clinical trials in SCM Life Science has already been designated as a rare drug in the development stage in 2019. After the enforcement of the Advanced Regenerative Bio Act, the treatment is expected to be able to enter the market with conditional item permission in 2023.

Acute pancreatitis stem cell therapy is also expected to be commercialized more quickly due to the advanced regenerative bio-law. The disease is a disease with high unmet medical needs because no customized treatment has been developed now despite the mortality rate of 15%. Globally, the number of patients reaches 2.35 million, and the global market size is estimated to be about 5 trillion won.

SCM Life Science applied to the Ministry of Food and Drug Safety in July this year for acute pancreatitis treatment as a rare drug in the development stage and is currently conducting phase 2a clinical trials. After successful phase 2b clinical trials, conditional item approval is expected around 2024.

Furthermore, it is analyzed that the practical use of stem cell therapy for spinocerebellar ataxia, a brain nervous system disease that has no cure so far, could be accelerated. Patients with the disease are rare and intractable diseases that gradually lead to death with impaired cerebellum function in charge of exercise in the human body, various symptoms of muscle atrophy, stiffness symptoms, vision loss, and peripheral neuropathy.

SCM Life Science plans to conduct phase 2 clinical trials after introducing a stem cell treatment for spinal encephalopathy, designated as a rare drug by the U.S. Food and Drug Administration (FDA) and the Japanese Pharmaceutical and Medical Device Organization (PMDA), in Korea as a license contract. It is expected that conditional item permission will be obtained around 2023 according to the implementation of the Advanced Regenerative Bio Act.

In addition, after the implementation of the advanced regenerative Bio Act, SCM Life Science plans to speed up research and development in the field of tissue engineering treatment in addition to cell therapy.

Since the end of 2018, SCM Life Science has joined hands with the Center for Cell Sheet Tissue Engineering (CSTEC) of Utah University in the United States to conduct joint research on the treatment of stem cell sheets by attaching them to damaged tissues. It plans to expand cell sheet indications to kidney fibrotic, uterine wall fibrotic, burns, and diabetic foot ulcers that occur after cesarean section.

Lee Byung-gun, chairman of the Advanced Regenerative Medical Industry Council, said, "It is very meaningful in the bio industry that the Advanced Regenerative Bio law will be implemented, but the improvement of subordinate laws and regulations will be more important in the future."