[Edaily Reporter KIM JI-WAN ] ORIENTBIO(002630) Doubts are growing regarding the company’s capabilities to conduct non-clinical trials (CRO) involving primates.

The company has repeatedly emphasized its proprietary primate supply chain, large-scale trial plans, and a research support system that encompasses everything from production to testing and analysis. However, it has not provided specific answers regarding key issues that gauge its business competitiveness, such as actual supply capacity, the scope of CRO services, specialized personnel, and disease models.

On the 26th, Edaily examined the company’s claimed business competitiveness and actual operational capabilities based on a recent press release regarding ORIENTBIO’s non-human primate CRO business and explanations provided by the company.

A Series of Promotions for the Primate CRO Business Over the Past Month… “Comprehensive Management of Testing, QA, Regulatory Compliance, and Data Analysis”

ORIENTBIO has been actively promoting its primate

CRO

business since

last month

.

On the 15th of last month, the company distributed a press release titled “Signing of an Exclusive Primate CRO Business Agreement with Orient Kam… Full-Scale Launch of Global Preclinical Platform.”

At the time, the company stated, “We will exclusively pursue the CRO business targeting domestic and international pharmaceutical and biotech companies as well as research institutions by utilizing the non-human primate production facilities owned by OrientCam.”

The roles of both companies were also specified in detail. According to the company, ORIENTBIO will oversee client contracts, the conduct of nonclinical trials, quality assurance (QA), regulatory affairs, data analysis, and the development of an AI-based nonclinical platform. Orient Kam will be responsible for the breeding and production of nonhuman primates.

Five days later, on the 20th of last month, the company released an additional press release titled “ORIENTBIO Expected to Benefit from Supply Shortage of Research Primates… Value of Preclinical Business Highlighted.”

This release provided specific figures on the prices of macaques in China. The intent was to highlight how the shortage of research primates and rising prices could enhance the competitiveness of ORIENTBIO, which has secured its own supply chain.

In a press release distributed on the 4th regarding the production of SPF laboratory rabbits, the company once again emphasized the competitiveness of its CRO business.

ORIENTBIO stated, “By linking our laboratory animal production and supply capabilities with our non-clinical testing (CRO) services, we are strengthening our research support system, which spans from the production and supply of laboratory animals to testing and analysis.”

Research Institute Director Kim Sang-nyeon provided a more detailed explanation.

In an interview with E-Daily on the 14th of last month, Director Kim emphasized the company’s ability to produce primates in-house through its affiliates and revealed plans for a large-scale animal study involving more than 100 primates during the development of the hair loss treatment OND-1.

Conducting trials involving more than 100 primates requires corresponding, stable production and supply capabilities.
Although

the company mentioned “trials involving over 100 primates”… the total number of animals in captivity and production volume remain undisclosed

. However, no specific figures were disclosed to gauge this capacity. When asked about Orient Kam’s total number of animals in captivity, the number of breeding-age individuals, the annual number of offspring born, and the number of 2- to 5-year-old individuals currently available for immediate use in trials, the company did not disclose specific numbers.

An ORIENTBIO official stated, “Primate production volume and the specific scale of available supply constitute the company’s trade secrets,” adding, “The total number of animals in stock, the number of breeding individuals, annual production volume, and the number of animals immediately available for testing are pieces of information directly linked to our competitiveness in primate production and supply.”

It was also difficult to determine the scale implied by the “stable supply chain” emphasized by the company.

A company official explained, “This means we have secured sufficient capacity to reliably supply the necessary animals in accordance with test conditions and schedules should we need to conduct primate testing.”

Ultimately, while the company disclosed plans for large-scale trials involving more than 100 primates, it made no specific mention of the production and supply capacity actually required to support them.

China’s 200,000 yuan price disclosed… but in-house procurement price is a “trade secret”

It was also difficult to verify price competitiveness in concrete terms. In a previous press release, ORIENTBIO directly stated that the price of macaques in China had risen to between 180,000 and 200,000 yuan (37.07 million to 41.19 million won).

Accordingly, we asked Orient Kam, an affiliated company, how much they actually pay to procure primates and whether they are securing price competitiveness compared to purchasing on the open market.

The company did not disclose specific procurement prices. ORIENTBIO officials stated, “The specific procurement prices and costs of primates are trade secrets pertaining to transaction terms and the company’s cost structure,” adding, “Actual prices are highly variable depending on market supply and demand conditions.”

When asked whether the procurement price through the affiliate is lower than the general market price, the company replied, “The supply price is determined through mutual agreement between the two companies, taking into comprehensive consideration market conditions and supply terms at the time of contract.”

While the company emphasized its competitiveness by citing specific figures regarding high prices in the external market, it remains unclear to what extent the supply chain through affiliated companies actually translates into price competitiveness.

No Response to Questions on CRO Core Competencies Such as PK, Pathology, and Statistics

A more critical issue is the actual scope of the CRO’s services. E-Daily inquired whether the company’s so-called “primate CRO” is limited to simple drug administration and toxicity testing, or whether it can comprehensively perform pharmacokinetics (PK), toxicokinetics (TK), immunogenicity, anti-drug antibodies (ADA), cytokine analysis, electrocardiograms, ophthalmic examinations, imaging tests, necropsies, and histopathology.

We also asked whether the company could independently prepare the final statistical analysis and reports for submission to regulatory agencies after the trial concludes, but received no response.

Regarding statistical analysis capabilities, we asked whether the company employs in-house statistical experts, whether it independently determines sample sizes and develops statistical analysis plans during the study design phase, or whether it outsources these tasks to external firms; however, the company did not respond.

The same was true for toxicopathology. We asked how many staff members were qualified to professionally interpret primate tissue samples and whether the company could independently generate clinical pathology, anatomical pathology, and toxicopathology data, but received no response.

Notably, the company’s response did not even include an explanation such as “unable to answer” regarding these questions. The relevant questions—asking about the scope of CRO services, statistical and toxicopathological capabilities, and disease models—were entirely omitted.

While the original questionnaire included nine questions (numbers 8–15) covering these topics, all of them had been deleted from the company’s response.

ORIENTBIO had previously stated in a press release that it directly oversees not only the conduct of preclinical trials but also QA, regulatory affairs, and data analysis. Therefore, the extent to which the company can actually perform these tasks in-house serves as a key benchmark for assessing the competitiveness of its primate CRO business. However, based solely on the company’s response, it was difficult to ascertain the specific scope of its operations and the professional capabilities required to support them.

Possession of disease models also unconfirmed… No response to detailed questions on lung cancer, stomach cancer, etc.

It was also difficult to verify the specific level of commercialization regarding non-human primate disease models.

A disease model does not constitute a commercial CRO service merely by inducing a specific disease in animals. It must demonstrate repeatability and reproducibility, and its similarity to human diseases and response to standard treatments must be verified before it can be used in actual efficacy trials.

Accordingly, E-Daily inquired whether ORIENTBIO’s CRO was limited to evaluating the safety and toxicity of candidate compounds by administering them to healthy primates, or whether it was capable of conducting efficacy evaluations of candidate compounds using disease models that mimic human diseases.

The publication also asked how many primate disease models—among those for cancer, metabolic diseases, neurological disorders, ophthalmic conditions, autoimmune diseases, and infectious diseases—are currently available for immediate use.

Regarding the level of validation for these models, the inquiry asked whether there was data demonstrating similarity to human diseases through histopathology, imaging, blood biomarkers, and gene expression, and whether treatment responses similar to those in humans were confirmed when standard therapies were administered; however, no response was received.

Regarding lung cancer, given that spontaneously occurring primary lung cancer is rare in non-human primates, the company was asked whether any relevant models it possesses are spontaneous models, carcinogen-induced models, or genetically modified or tumor cell-graft models.

We also requested confirmation on whether the stomach cancer model is standardized enough to repeatedly be contracted out for efficacy testing to a CRO, and which cancer types—including colorectal cancer—the company plans to prioritize for commercialization; however, the company did not respond.

These questions regarding the disease models were also entirely omitted from the company’s response.