[Edaily Reporter NA EUN-KYUNG ] Humic, a company specializing in efficacy evaluations using humanized mouse models, has expanded its business scope to include toxicity testing through a merger with H&H Bio, a non-clinical contract research organization (CRO). The company’s vision is to evolve into an “anti-cancer specialized integrated CRO” where researchers with experience in new drug development design comprehensive non-clinical strategies tailored to the characteristics of candidate compounds, rather than simply providing efficacy evaluations and toxicity testing under one roof.

On the 4th, we met with CEOs Seo Ki-ho and Son Seung-hwan at H&H Bio’s headquarters in Asan, South Chungcheong Province. H&H Bio completed its merger with Humic on the 1st of last month and has begun integrated operations. This was an absorption merger in which H&H Bio remained the surviving entity and Humic was dissolved. Seo Ki-ho and Son Seung-hwan, who previously led Humic, have assumed the roles of co-CEOs of the merged entity, which now has approximately 70 employees.

Efficacy Results Lead Directly to Toxicity Test Design

Before the merger

,

the strengths of the two companies were clearly distinct. Hyosung evaluated the efficacy of anticancer drugs and treatments for immune disorders using humanized mice, which partially replicate the human immune system. H&H Bio possesses infrastructure for general toxicity and safety evaluations—using not only rodents but also beagles, rabbits, and guinea pigs—as well as for environmental toxicity testing.

The merged entity can now immediately incorporate toxicity signals identified during the efficacy evaluation of new drug candidates into the design of follow-up toxicity studies. Previously, even if potential toxicity emerged during efficacy testing, Humic would merely recommend additional testing to its clients; now, however, it can discuss appropriate dosages with them and actually conduct the toxicity studies itself.

CEO Seo Ki-ho explained, “When collaborating with external partners, we had to go through a process of delivering results and then receiving feedback, but since the merger, our efficacy and toxicology research teams can discuss and respond immediately.” He added, “As the speed of feedback has increased, we can also shorten the overall development period.”

Another distinguishing factor is the research team’s experience in new drug development. Among the merged entity’s key researchers are many who have gained experience—from candidate discovery through clinical trials—at biotech companies such as Helixmith Co., Ltd. The company plans to design trials that go beyond merely complying with regulations to also consider the candidate’s mechanism of action and future clinical development strategies.

Targeting Immuno-Oncology Drugs and Cancer Vaccines with Humanized PDX Models

H&H Bio plans to maintain Humic’s expertise in the field of anticancer drugs as a core competitive advantage even after the merger. The company explained that approximately 70–80% of the contracts previously received by Humic were for anticancer drugs, and recently, there has been a notable increase in demand for the evaluation of next-generation anticancer drugs, including antibody-drug conjugates (ADCs).

The company has begun establishing a “humanized patient-derived xenograft (PDX)” model, in which patient tumor tissue is transplanted into humanized mice. While standard PDX models can reflect the characteristics of a patient’s tumor, they use immunodeficient mice, which limits their ability to evaluate the efficacy of immuno-oncology drugs—where the human immune response is critical. Humanized PDX models combine the characteristics of the patient’s tumor with the human immune system within a single animal model.

H&H Bio is systematically acquiring patient tumor tissues in collaboration with hospitals. Going forward, the company plans to utilize humanized PDX models for preclinical evaluations not only of immune checkpoint inhibitors but also of cancer vaccines, T-cell engagers, and combination therapies. It is also developing PDOX models, in which patient-derived organoids are transplanted into mice.

CEO Son stated, “Cancer vaccines or immuno-oncology drugs that act specifically on human immune cells may not function properly in standard mice,” adding, “Our goal is to increase the likelihood of clinical success by evaluating candidate compounds in models that replicate the clinical environment as closely as possible.”

The company is also strengthening its ADC analysis capabilities. H&H Bio has acquired equipment and analytical methods capable of analyzing not only changes in tumor size following ADC administration but also the concentrations of the drug and payload in the blood, as well as the drug’s persistence and elimination patterns in the body. The company plans to provide the data necessary for designing dosages and dosing intervals by integrating the drug-to-antibody ratio (DAR), biological sample analysis, and efficacy and toxicity testing.

For tissue analysis, the company applies artificial intelligence (AI)-based digital pathology technology. Unlike the traditional method where pathology experts select and examine portions of tissue slides, this approach performs quantitative analysis of whole-slide images (WSI) to reduce observer-dependent variability.

Expanding

into

Medical Device Safety Assessment…Taking on the BEP Challenge

The company is preparing to launch a new revenue stream: biological safety

assessments

for

medical devices

. H&H Bio expects to obtain the relevant testing and certification in October or November of this year and plans to launch services such as cytotoxicity, sensitization, and skin irritation testing upon certification. It will subsequently expand its scope to include medical device testing using mini-pigs.

The strategy is to generate synergy within the group by having the parent company, HCT(072990)(HCT), test and certify the performance and specifications of medical devices, while H&H Bio evaluates their biological safety in relation to human contact. An H&H Bio official projected the merged entity’s annual business volume to be in the range of 3 to 4 billion won for Humic efficacy evaluations and 5 to 6 billion won for Hyosung’s existing business.

Although the merger has increased the company’s scale, translating this into improved profitability remains the next challenge. The original H&H Bio had been operating at a loss while making proactive investments in testing facilities and personnel. Since Humic’s performance will be reflected only for the period starting from the merger date—last month’s 1st—the company plans to achieve the break-even point (BEP) within the year by growing its existing business and securing new revenue streams.

CEO Seo stated, “Since it is not easy to reach the break-even point simply by combining the two companies’ revenue, we are focusing on creating new revenue streams.” He added, “We will fully launch our medical device safety evaluation and PDX businesses and leverage our existing consulting capabilities to strive to reach the break-even point within this year.”