HLB BioStep Signs MOU with Nexel: "Combining Organoids and Non-Clinical Testing"

HLB BioStep has signed a "Memorandum of Understanding (MOU) for collaboration on alternative testing and non-clinical business based on organoids" with Nexel.

On the 2nd, Baek Seongjin, CEO of HLB BioStep (left), and Woo Donghoon, Vice President of Nexel, are posing for a commemorative photo at the HLB BioStep headquarters in Songdo, Incheon. HLB BioStep

According to HLB BioStep on September 3, Nexel is a biotech company that commercializes cells and organoids derived from human-induced pluripotent stem cells (hiPSC) and possesses technologies for evaluating the toxicity and efficacy of drugs based on these products. Recently, the company's cardiomyocyte platform had its Letter of Intent (LOI) for a new drug development tool (DDT) officially accepted under the U.S. Food and Drug Administration (FDA)'s "Innovative Science and Technology Approaches for New Drugs (ISTAND)" Qualification Program, further cementing its position as a leading company recognized by regulators in the DDT field.

This collaboration aims to compare and validate drug toxicity and efficacy evaluation results obtained from Nexel's hiPSC-based organoids through HLB BioStep's non-clinical testing. Based on this, the two companies plan to provide more precise non-clinical evaluation data and services to domestic and international pharmaceutical and biotech companies.

The two companies will jointly pursue new customer acquisition and market expansion by connecting each company's services through joint sales and marketing efforts. They also plan to work together on research and development for new alternative testing services, advance evaluation platforms, standardize alternative testing methods, jointly secure government projects, and expand business areas through cooperation between industry, academia, and research institutes. In addition, they will share domestic and international regulatory and technical information, jointly utilize their research facilities and testing equipment, and cooperate technologically for the validation and commercialization of new evaluation methods.

Through this partnership, HLB BioStep aims to strengthen its expertise in the organoid field and continuously expand its NAMs (New Approach Methodologies)–based non-clinical evaluation ecosystem, integrating alternative testing technologies such as traditional animal testing, artificial intelligence (AI), and organ-on-a-chip solutions.

Sungjin Baek, CEO of HLB BioStep, stated, "There is growing demand to utilize both non-clinical testing and alternative testing technologies in the new drug development process. By combining the expertise and infrastructure of both companies, we will be able to offer broader evaluation services to our clients and actively pursue the development of new evaluation methods and the expansion of business opportunities."

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