The government and the bio industry welcomed the parliament’s passage of a bill that adds regenerative medicine organizations to the list of those considered for human cell management business licenses.
The National Assembly passed the “Amendment to the Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals” in a plenary session on Thursday.
The amendment aims to add regenerative medicine organizations to those considered for licensure to manage human cells. The management business collects, imports, tests, processes human cells, and supplies them as raw materials for advanced biopharmaceuticals. In addition to existing product manufacturers and umbilical cord blood banks, advanced regenerative medical institutions will be recognized as licensees for managing human cells.
If the revised advanced regenerative biotech law is enforced, advanced regenerative medical institutions with facilities, equipment, and manpower similar to the standards for licensing human cells and other management businesses will be recognized as licensed as a management business.
As a result, advanced regenerative medical institutions can supply raw materials for advanced biopharmaceuticals through simple separation, washing, freezing, and thawing of cells derived from patients.
It has also opened the way for patients, not research subjects, to receive regenerative medicine services. Even if a patient is not a participant in a clinical trial, he or she can receive cell therapy according to the standards set by law. Until now, domestic regenerative medicine could only be used for research purposes for diseases without treatment or rare and incurable diseases.
The Ministry of Food and Drug Safety (MFDS) expects the amendment to expand patient treatment opportunities using advanced biopharmaceuticals, including gene therapy drugs. Domestic biotechnology companies developing cellular therapies, including NKMAX, CHA Biotech, and GI Cell, also welcomed the Assembly's passage of the revised law.
"With the passage of the amendment to the Advanced Regenerative Biotech Act, we will be able to use SNK as a customized treatment for severe, rare, and incurable diseases, such as cancer and Alzheimer's, in Korea," said an official at NKMAX, which has been developing its NK cell therapy SNK through its U.S. subsidiary, NKGen Biotech. "We already have GMP facilities, so we expect to generate tangible sales of SNK in Japan and Korea."
A CHA Biotech official said, "We expect to accelerate clinical trials and shorten the commercialization period of our pipeline of therapeutics, including CBT101, an immune cell therapy currently under development.”
The official added that uncertainties have been resolved with the revision of the laws related to cell therapy drugs. The regulations for conditional item approval and expedited review systems have also been clarified, which can accelerate the development schedule of various biopharmaceuticals, such as cell therapy drugs.
GI Cell, which submitted an IND (investigational new drug application) for a domestic phase 1/2a clinical trial to the MFDS on Friday, also showed expectations. The company plans to evaluate the safety and potential efficacy of the combination therapy of its allogeneic NK cell therapy, “T.O.P. NK,” and “GI-101A,” an immuno-oncology drug candidate from GI Innovation, in patients with recurrent and refractory solid tumors.
"This opens the door to cell and gene therapies for patients with advanced cancer and those with early-stage cancer and post-surgery," said Jang Myoung-ho, Chief Clinical and Scientific Advisor at GI Cell. "We look forward to the successful development of GI-101A/GI-102 in combination with T.O.P. NK so that more patients can benefit."