[Edaily Reporter KIM JI-WAN ] ORIENTBIO(002630) Doubts are growing regarding the company’s capabilities to conduct non-clinical trials (CRO) involving non-human 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 its CRO operations, specialized personnel, and disease models.

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

A Month of Consecutive Promotions for Primate CRO… “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 an Exclusive Agreement with Orientcam for Primate CRO Business… Full-Scale Launch of Global Preclinical Platform.”

At the time, the company stated, “We will exclusively pursue 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 outlined in detail. According to the company, ORIENTBIO will oversee client contracts, the conduct of preclinical trials, quality assurance (QA), regulatory affairs, data analysis, and the development of an AI-based preclinical platform. Orient Kam will be responsible for primate breeding and production.

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

This release provided specific figures on the prices of macaques in China. The intent was to highlight that 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 integrating our capabilities in the production and supply of laboratory animals with our non-clinical testing (CRO) services, we are strengthening our research support system, which spans the entire process from production and supply to testing and analysis of laboratory animals for research purposes.”

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 trial involving more than 100 primates during the development of the hair loss treatment OND-1.

Conducting trials involving more than 100 primates requires a corresponding level of stable production and supply capacity.
Although

the company mentioned “trials involving over 100 animals”… the number of animals in stock and production volume remain undisclosed.

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

An ORIENTBIO official stated, “Primate production volume and specific supply capacity constitute the company’s trade secrets,” adding, “The total number of animals in breeding, the number of breeding-age 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 ascertain what scale the company meant by its emphasis on a “stable supply chain.”

A company official explained, “This means we have secured sufficient capacity to reliably receive 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 crab-eating macaques in China had risen to between 180,000 and 200,000 yuan (37.07 million to 41.19 million won).

Accordingly, we asked the affiliated company, Orient Kam, how much it actually pays to procure primates and whether it maintains 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 was lower than the general market price, the company replied, “The supply price is determined through mutual agreement between the two companies after comprehensively considering market conditions and supply terms at the time of the 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 operations. 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 authorities after the trial concludes, but received no response.

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

The same was true for toxicopathology. Although we inquired about how many staff members are qualified to professionally interpret primate tissue and whether the company can independently generate clinical pathology, anatomical pathology, and toxicopathology data, no response was provided.

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

While the original questionnaire contained nine questions (numbers 8 through 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 nonclinical trials but also QA, regulatory compliance, 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 non-human 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 supporting 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, as well as be verified for similarity to human diseases and response to standard treatments, 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 newspaper also asked how many primate disease models—among those for cancer, metabolic diseases, neurological disorders, ophthalmic conditions, autoimmune diseases, and infectious diseases—the company can currently provide immediately.

Regarding the level of validation for these models, E-Daily inquired 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 had been confirmed when standard therapies were administered; however, no response was received.

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

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

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