HLB BioStep Launches Organoid-Based Drug Evaluation Platform Development

HLB BioStep announced on the 24th that it has signed a tripartite Memorandum of Understanding (MOU) with HLB BioCode and Kangstem Biotech to establish a safety and efficacy evaluation platform for organoid-based pharmaceuticals and to promote the development of organoid-based cell therapy drugs.

Through this MOU, the three companies agreed to collaborate on building and commercializing a pharmaceutical safety and efficacy evaluation platform utilizing Kangstem Biotech's skin organoid and islet organoid technologies. They also decided to pool their capabilities to develop organoid regenerative therapeutics.

As the largest efficacy-focused non-clinical specialized institution in Korea, HLB BioStep will complement animal testing results and commercialize an evaluation platform that can dramatically improve the predictability of pharmaceuticals for humans. HLB BioCode, a non-clinical safety evaluation specialized institution, will leverage its existing capabilities to develop alternative testing methods applicable in the safety evaluation field. Kangstem Biotech will produce and provide optimal organoids through the advancement of organoid technology.

The three companies will strengthen cooperation to ensure that Kangstem Biotech’s skin organoid-based alopecia treatment and islet organoid-based type 1 diabetes treatment receive early IND (Investigational New Drug) approval.

Moon Jeong-hwan, CEO of HLB BioStep, said, "Following the recent acquisition of HLB BioCode, we have secured capabilities not only in efficacy evaluation but also in safety evaluation, establishing a system that can provide one-stop services throughout the entire non-clinical process." He added, "In response to changing policy directions, we plan to develop a sustainable non-clinical service company by building an innovative organoid-based platform."

Globally, efforts to promote animal alternative testing continue. In 2022, the United States explicitly allowed the submission of data using animal alternative methods when reviewing pharmaceuticals through the FDA Modernization Act 2.0. Earlier this year, the U.S. National Institutes of Health (NIH) announced the Complement-ARIE (Animal Research in Experimentation) program, a cross-agency strategic project that will support a budget of approximately KRW 50 billion annually for 10 years.

In Korea, efforts to develop animal alternative testing technologies are ongoing across ministries. This year’s projects supported by central government agencies include: ▲ Development of gut-liver biomimetic chips to replace animal testing in the preclinical stage by the Ministry of SMEs and Startups ▲ Establishment of an animal alternative testing evaluation platform using bioprinting by the Ministry of Trade, Industry and Energy ▲ Standardization research for the practical application of animal alternative testing by the Ministry of Food and Drug Safety.