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As the global pharmaceutical industry grapples with rising ethical concerns and regulatory changes around animal testing, Korean biotech Organoid Sciences is positioning itself to disrupt the status quo with its innovative organoid-based platform, ODISEI.
The company said ODISEI promises to replace traditional animal testing and accelerate drug development by tapping into the rapidly growing market for ethical, human-centric alternatives. As regulatory pressure mounts, the demand for such alternatives is rapidly expanding, particularly with moves like the U.S. FDA’s 2022 decision to exempt certain new medicines from animal testing.
“ODISEI is the most promising solution for accurate, human-centric drug testing, especially for novel modalities and advanced pharmaceuticals,” said CEO Yoo Jong-man during the company’s IPO press conference on Thursday. With the U.S. advancing stem cell and 3D organoid models for neurological disorders, Yoo is confident that ODISEI will meet the increasing demand for more precise and ethical drug testing methods.
The Ministry of Food and Drug Safety (MFDS) is also backing the shift, investing 47.5 billion won ($33 million) in a five-year initiative, running through 2028, to develop organoid-based testing technologies. This research, focused on using organoids to assess pharmaceutical safety, is expected to drive market growth and further validate the demand for ODISEI’s capabilities.
CEO Yoo Jong-man of Organoid Science speaking at an IPO press conference on Thursday at CCMM Building in Yeouido, Seoul. (Credit: Korea Biomedical Review)
CEO Yoo Jong-man of Organoid Science speaking at an IPO press conference on Thursday at CCMM Building in Yeouido, Seoul. (Credit: Korea Biomedical Review)
ODISEI uses patient-derived organoids to simulate human-like microenvironments, offering a powerful tool for evaluating drug efficacy and side effects.
"By replicating tumor microenvironments, we’re able to test immune-oncology drugs and assess treatment mechanisms that traditional testing methods can’t replicate,” Yoo explained, highlighting the platform’s value in evaluating complex treatments like cancer therapies and gastrointestinal products.
Since ODISEI was commercialized in 2020, it has seen robust growth, securing over 40 contracts with domestic and global pharmaceutical, biotech, and food companies. Organoid Sciences' revenue from ODISEI has surged more than 10-fold in the past three years, reaching approximately 2 billion won last year. The company is targeting 10 billion won in annual sales by 2027. “The global demand for more accurate, ethical drug testing is only increasing, and we expect this momentum to continue as we expand internationally,” Yoo projected during the press conference.
He further highlighted that Organoid Sciences, as the first organoid-focused drug development firm listed under Korea’s “super gap technology” special program, is “primed to make waves” in both regenerative medicine and pharmaceutical research. This program simplifies the technology evaluation process for companies in sectors requiring national support, such as deep tech and science, that have demonstrated growth potential.
Organoid Sciences is also advancing its regenerative therapeutic pipeline, led by ATORM, an organoid-based platform targeting intractable diseases. The lead product, ATORM-C, is aimed at treating Crohn’s disease. After initiating clinical trials in 2022, Organoid Sciences plans to complete phase 1 trials in Korea by 2026, with commercialization slated for 2027. Global expansion is targeted for 2029, following phase 2 trials in Europe and the U.S.
Alongside its expanding therapeutic pipeline, Organoid Sciences is broadening its global reach. Its Vietnam branch will serve as a hub for organoid production and ODISEI services, while the company’s U.S. and German operations will focus on marketing and commercialization. “We’re confident that 2027 will mark the beginning of our domestic sales for regenerative therapeutics, with overseas sales starting in 2028,” Yoo said.
Organoid Sciences is preparing for its Kosdaq listing, with plans to raise 25.2 billion won. The company will offer 1.2 million shares, priced between 17,000 won and 21,000 won per share. The funds will be used for research and development, including 8.1 billion won for clinical trials and 11.8 billion won to further develop the ODISEI platform and advance new drug development.
From March 7 to 13, the company will conduct a demand forecast for institutional investors and finalize the public offering price. Public subscriptions will take place on March 19 and 20, with a Kosdaq listing expected later in March. Korea Investment & Securities is managing the IPO.
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Kim Ji-hye jkim404@docdocdoc.co.kr
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