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[Yonhap News] Cell and Gene Therapy Companies Welc
[Yonhap News] Cell and Gene Therapy Companies Welcome Revision to Advanced Regenerative Bio Act
GC Cell, CHA Biotech and Others: “Domestic Treatment Data Will Accelerate R&D and Commercialization”
First Advanced Regenerative Medicine and Advanced Biopharmaceuticals Policy Review Committee Meeting
(SEOUL=Yonhap News) The 2023 First Advanced Regenerative Medicine and Advanced Biopharmaceuticals Policy Review Committee meeting is held at the Korea Press Center in Jung-gu, Seoul, on July 12, 2023. (Photo courtesy of the Ministry of Food and Drug Safety. No redistribution or database use permitted.) photo@yna.co.kr
(SEOUL=Yonhap News) Reporters Na Hwak-jin and Kim Hyun-soo — Korea’s pharmaceutical and biotechnology industries have welcomed the National Assembly’s passage of revisions to the Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals, which expands access to advanced regenerative treatments, including stem cell therapies for patients with refractory diseases.
Although the revised law will take effect one year after promulgation, industry officials expect it to accelerate development by broadening eligibility for clinical research involving advanced biopharmaceuticals such as cell and gene therapies, while also allowing patients to receive certain treatments outside clinical research settings when sufficient safety and other requirements have been established.
According to the Ministry of Food and Drug Safety and pharmaceutical and biotech industry sources on the 5th, since 2020 only four cell and gene therapy products developed overseas have received marketing approval in Korea. No newly developed domestic product in this category has received approval during the same period.
Like other medicines, therapies developed using human-derived cells or genes, including stem cells, must undergo clinical trials involving a substantial number of participants before receiving marketing authorization. Industry officials noted that commercialization has been difficult because of stringent safety requirements. Access to advanced regenerative medicine for research purposes has also been limited largely to diseases with no available treatment options or to rare and refractory conditions.
The revised law, passed by the National Assembly on the 1st, expands the range of patients eligible to participate in clinical research and also creates a pathway for patients who are not research participants to receive cell and gene therapies on a self-pay basis.
Eligibility for such treatment will be introduced in stages according to risk and other factors. Still, companies developing cell and gene therapies expect that broader patient access to advanced regenerative medicine will create more opportunities to accumulate real-world data needed for product development.
GC Cell, which manufactures and markets the anticancer immune cell therapy Immuncell-LC, approved by the Ministry of Food and Drug Safety in 2007, said in a statement, “We expect the passage of the amendment to create positive momentum for Korea’s cell and gene therapy market. The ability to secure treatment data domestically is expected to accelerate our ongoing R&D and commercialization efforts.”
CHA Biotech also expressed expectations that its investigational immune cell therapy CBT101 could become available to a broader group of patients, including those with malignant brain tumors.
The industry also expects clearer rules governing conditional marketing authorization and expedited review to shorten development timelines for various biopharmaceuticals, including cell therapies, while supporting growth in the cell and gene therapy contract development and manufacturing organization (CDMO) sector.
Cell therapy developer NKMAX said it plans to accelerate commercialization of its natural killer (NK) cell therapy pipeline, while immune cell therapy company Curocell said the passage of the law is expected to expand Korea’s market for CAR-T therapies.
However, some industry observers caution that the legislative revision alone may not immediately trigger rapid commercialization across Korea’s cell and gene therapy sector.
Seung-Kyu Lee, Vice Chairman of the KoreaBIO Association, said, “The core significance of the revised law is that it broadens opportunities for investigator-initiated clinical research using cell and gene therapies. It may be difficult to view this as an immediate and dramatic expansion from an industrial perspective, but it is meaningful that clinical research can now include patients beyond those with rare or refractory diseases, creating greater opportunities to accumulate data.”