Kim Jinsoo Companies such as Bio Solution Co.,Ltd.(086820), Chabiotech Co.,Ltd.(085660), CORESTEMCHEMON(166480), and ORGANOIDSCIENCES LTD. are expected to benefit from the UAE’s interest.

On the 8th, the Ministry of Food and Drug Safety announced that Dr. Fatima Al Kaabi, Director General of the Emirates Drug Establishment (EDE)—the UAE’s medical product regulatory agency—is visiting South Korea to receive briefings on the products and pipelines of major domestic CGT companies.

The event will bring together companies developing cell therapies, gene therapies, stem cell therapies, NK cell therapies, and organoid-based regenerative therapies in Korea, including Bio Solution Co.,Ltd., Helixmith Co., Ltd., ORGANOIDSCIENCES LTD., CORESTEMCHEMON, and Chabiotech Co.,Ltd.

As the UAE has recently expanded its focus on CGT as a national priority in the biotech industry and has officially recognized the Korean Ministry of Food and Drug Safety (MFDS) as a reference regulatory authority, this is expected to create new opportunities for Korean cutting-edge biotech to enter the UAE and the Middle East and Africa (MEA) markets.

According to market research firm Grand View Research, the MEA regenerative medicine market is projected to grow at a compound annual growth rate (CAGR) of 10.0%, expanding from $403.6 million in 2024 to $723.7 million in 2030. Within the regenerative medicine sector, therapeutics account for the majority of the overall market. Additionally, the MEA adult stem cell market is projected to expand from $595.1 million in 2024 to $1,094.1 million in 2030, recording a compound annual growth rate (CAGR) of 10.6%. Combined, these two markets total $1,817.8 million (approximately 2.43 trillion won).

UAE Actively Adopting CGT… Significance of the Visit

The UAE is more than just a country where future expansion of the

CGT

market is anticipated; it is already a market rapidly adopting cutting-edge global therapies. The UAE’s EDE has approved “CASGEVY,” a CRISPR/Cas9-based gene-editing therapy, and also granted accelerated approval in November 2025 to “ITVISMA,” a gene replacement therapy for spinal muscular atrophy (SMA).

The UAE is not only importing global therapeutics but is also taking steps to directly attract CGT clinical trials. In March of this year, the Abu Dhabi Health Authority announced plans to launch and support the UAE’s first clinical trial project for a MERTK-related retinitis pigmentosa gene therapy currently under development by the U.S.-based company Opus Genetics.

The UAE is moving beyond the simple introduction of foreign CGTs to build an ecosystem for advanced therapeutics that encompasses clinical trials, research, and future industrialization.

At the roundtable discussion hosted by the Korea Biopharmaceutical Association to be held today, companies such as Bio Solution Co.,Ltd., Helixmith Co., Ltd., ORGANOIDSCIENCES LTD., CORESTEMCHEMON, and Chabiotech Co.,Ltd. will participate to introduce their respective products and key pipelines.

Bio Solution Co.,Ltd. has successfully navigated the entire process from R&D to approval and commercialization of cell therapies and is now embarking on full-scale overseas expansion. Bio Solution Co.,Ltd. has commercialized the autologous cartilage cell therapy “CartiLife” in Korea and is expanding its development portfolio to include “Cartiroid,” an allogeneic cell therapy that can be mass-produced using donor cartilage cells, and “SperoCure,” an injectable cell therapy designed for non-surgical administration. Cartiroid is also advancing global development, having received approval for an Investigational New Drug (IND) application for Phase 1 and 2 clinical trials in Australia this year.

Helixmith Co., Ltd has experience in successfully securing overseas marketing authorization for gene therapy technologies developed in Korea. “NL003,” a VM202-based gene therapy developed by Helixmith Co., Ltd and licensed to China’s Northland Biotech, received marketing authorization from China’s National Medical Products Administration (NMPA) in May of this year as a treatment for critical limb ischemia (CLI). Building on this success, Helixmith Co., Ltd is exploring opportunities for joint development and technology transfer outside of China.

ORGANOIDSCIENCES LTD. possesses regenerative therapy technology based on “organoids,” which have recently begun to attract attention. Its flagship pipeline, “ATORM-C,” is a therapeutic agent that induces tissue regeneration by administering intestinal organoids—cultured in three dimensions from adult stem cells obtained from a patient’s intestinal tissue—to the damaged site. Last March, the company received approval for a Phase 1 clinical trial (IND) in South Korea targeting patients with Crohn’s disease accompanied by colonic ulcers.

CORESTEMCHEMON is developing mesenchymal stem cell-based therapeutics. “NeuronaTa-Alju,” used to treat amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig’s disease), is a therapy that utilizes autologous mesenchymal stem cells obtained from the patient’s bone marrow. It was approved in South Korea in 2014.

Chabiotech Co.,Ltd. possesses a pipeline of immune cell and stem cell therapies. The company is developing ‘CHANK-101,’ an autologous NK cell-based anti-cancer immunotherapy, and ‘CHAMSC,’ a therapy based on umbilical cord-derived MSCs from a global cell line, and has also gained experience in cell therapy manufacturing and the CGT CDMO business. CHANK-101 is a pipeline product that improves upon the existing CBT-101 manufacturing process, and a multicenter clinical trial for recurrent glioblastoma (rGBM) is currently underway.

The improved regulatory environment for entering the UAE market is a key factor fueling optimism about market entry.

In January of this year, the UAE recognized the Ministry of Food and Drug Safety (MFDS) as an official Reference Regulatory Authority in the medical product sector. Consequently, a regulatory framework has been established allowing medical products approved in Korea to utilize Korea’s review results during the UAE approval process. This recognition is expected to lead to shorter review periods and streamlined procedures.

For cell and gene therapies, the product and production process are closely intertwined—from cell collection and culture to the manufacturing process, quality control, administration sites, and long-term safety management—making regulatory easing particularly beneficial.

Although domestic pharmaceutical and biotech companies have previously attempted to enter the Middle Eastern market with CGTs, these efforts were all conducted on an individual basis, with companies signing licensing, export, or technology transfer agreements with local partners. However, analysts suggest that national-level cooperation is now a possibility, following the visit to South Korea by the UAE’s head of pharmaceuticals and the recent regulatory easing.

An industry official stated, “While we are not signing export contracts immediately, this is significant in that regulatory barriers have been lowered, paving the way for future contracts, clinical trials, and expedited approvals.”