Pharmicell's bold vision for healthcare transformation

Dr. Hyunsoo Kim, you have a long experience in the development of stem cells and their application. Could you explain more about your expertise?

I would like to share the story of how I initially founded the company and conceived the idea. During that time, I pursued a major in pharmacology with a specialization in bone marrow transplant. From 1994 onward, I served as a medical professor at the university. Given my focus on bone marrow transplant, my involvement with stem cells naturally evolved to enhance the efficacy of the transplant procedure.

Undoubtedly, bone marrow transplant is a high-risk process, particularly for patients facing significant risks. The recovery process is both demanding and lengthy, primarily involving cancer and elderly patients. This challenging scenario prompted us to explore alternative methods for patient recovery.

In the initial stages, due to the possibility of relapses among some cancer patients, we experimented with various types of stem cells. This was essential to mitigate potential damage to the patient's brain or heart. Our pursuit led us to utilize interleukin-activated killer cells initially. However, dissatisfied with the outcomes of lymphokine-activated killer (LAK) cells and natural killer (NK) cells, I embarked on a quest for a new form of immunotherapy, ultimately discovering dendritic cells.

In the past, Dr. Ralph M. Steinman in New York received the Nobel Prize for his work on dendritic cells. In 1995, after reading his article in the Journal of Hematology, I developed dendritic cell therapy. Over the years, I have conducted more than five clinical trials in Korea. Recently, the Korean government approved a new trial for autologous dendritic cell therapy with double WT1 antigen for pancreatic cancer. We anticipate commencing a new phase one clinical trial in Korea this month or the next.

When assessing the field of regenerative medicine, stem cells, and pharmaceuticals, there's a common observation that while drugs or novel solutions often exhibit promising potential during animal testing, their efficacy tends to diminish when progressing to human clinical trials. A decade ago, there was significant optimism about the revolutionary impact of stem cells in veterinary medicine. However, progress has been slower than anticipated. What, in your opinion, has contributed to this delay?

The nature of cell therapy products differs significantly from traditional chemical counterparts. Chemical products are small in size, with minimal species variation, whereas stem cells are bio cells, presenting a much more complex scenario. Unlike the U.S. FDA, which adapts swiftly to changing environments, the Korean regulatory system tends to be sluggish in implementation. This has prompted companies like Pharmicell to adopt an agile approach, moving swiftly in a landscape where regulatory catch-up is challenging for the Ministry of Food and Drug Safety.

For instance, in immunological testing, animal trials precede clinical testing. However, assessing effectiveness on animals poses challenges, considering the diverse array of species involved. Balancing both efficacy and safety becomes particularly challenging during animal testing due to the variety of species involved. This complexity stands as a significant hurdle.

Immunotherapy represents a major global trend and is a cutting-edge aspect of our product. The U.S.-approved CAR-T drug bypassed certain animal testing requirements. Its success in the initial clinical trial phase prompted rapid FDA approval and market release. In Korea, regulatory constraints make such expeditious progress more challenging.

A recurring criticism we've encountered in interviews regarding the Korean regulatory framework is the perceived slowness of the approval process. Critics argue that numerous ministries and organizations are involved in shaping and executing policies, systems, and support grants, resulting in redundancy and overlap. How do you perceive the evolution of the regulatory framework in Korea to date, and what changes would you personally advocate for?

Japan's recent regulatory innovation, the Sakigake system, was spearheaded by the Mitsubishi Research Institute (MRI). Interestingly, I played a pivotal role in suggesting the fast-track process to MRI, leading to the implementation of the Sakigake system in Japan. MRI interviewed me three times, seeking insights on expediting the process and achieving leadership in the stem cell industry. I offered three recommendations to streamline the entire procedure, all of which were incorporated into the system.

Firstly, I proposed a classification process, categorizing patients into high, intermediate, and low-risk groups. Secondly, I suggested that the government should gather and share clinical trial results. Lastly, I recommended the establishment of a government-run core lab for early drug production. Additionally, I proposed a temporary approval after the completion of phase two, bypassing the need for a full clinical phase three, which was also embraced by the Sakigake system.

How do you envision the evolution of Korea in this context?

Pharmicell operates as a private company, distinct from any government organization. Initially, when we observed regulatory shifts in Japan, we took a wait-and-see approach regarding changes in Korea. However, seeing minimal progress, I decided to proactively share the developments and advocate for similar changes. Consequently, we are now laying the foundations for cutting-edge medical industries, although the journey remains slow and challenging.

While South Korea has excelled in fields like semiconductors, electronics, shipping, automobile, construction, and nuclear energy, the bio industry lags behind. Advanced countries are raising entry barriers, seemingly reluctant to see Korea match their prowess in this domain. To bridge this gap, it's crucial to enhance the competency of bio industry leaders and professors. Unlike in sectors like shipping, where success stories abound, the bio industry still lacks a comparable level of expertise. This growth in competency must be coupled with increased investment. Looking ahead, I foresee a trend of more substantial investment in the bio industry.

You mentioned that some Korean biopharmaceuticals have achieved success, serving as a potential avenue for international promotion. However, the industry is still relatively young and fragile. Notably, Samsung and Celltrion have experienced significant success. Despite these achievements, why do Korean biotech companies that have tasted success seem to progress slowly?

Since the early stages, products from Samsung Biologics primarily consisted of biosimilars rather than genuinely innovative drugs. This approach faced criticism, with suggestions that given Samsung's substantial capital, they could have pursued more groundbreaking and novel endeavors.

Regarding exports and imports in the biopharma sector, while you mentioned a similarity, it's crucial to note that these exports are primarily directed toward relatively developing countries rather than advanced nations. From my perspective, we are not yet making significant inroads into advanced countries.

As a medical professional, one of the initial challenges I faced was the exorbitant cost of the medicines my patients needed. A significant portion of the funds spent on these medicines flowed to the U.S. due to a reliance on non-domestic technologies. This realization compelled me to seek change, particularly through the use of stem cell treatments. This motivation led me to initiate my own venture. However, the challenge lay in securing the necessary capital. As a medical professor at the time, my resources were limited, prompting attempts to attract investment from pharmaceutical companies. Unfortunately, due to their lack of knowledge in this field, securing investment proved challenging. Determined to make a difference, I opted to establish my own company. Over the years, I have focused on stem cell therapeutics, anti-cancer treatments, and, drawing from my experience in patient care, I decided to expand into chemical medicine by acquiring a chemical medicine company.

Pharmicell initially began with the development of stem cell drugs and has since expanded its portfolio to include cosmetics. Additionally, the company is involved in creating advanced raw materials for drugs and operates its own stem cell bank. How does this diversified portfolio contribute to the growth and development of Pharmicell? What are the key drivers for the company's growth in the next five years?

In the business landscape, creating synergy can be challenging if everything is kept separate. Recognizing this, we decided to diversify our portfolio. We also contemplated the types of chemical medicine that could complement our stem cell treatments, leading us to engage in both stem cell and chemical medicine development. Currently, we supply more than 20 types of RNAs to Thermo Fisher, ST Pharm, a Korean company, and UCB. Looking ahead, our goal is to expand further by supplying to foreign companies, driven by a commitment to leveraging my medical background to help patients clinically.

Half-SerumTM DMEM

Our newly launched product, Half-Serum, is a basal culture medium (DMEM) that addresses current challenges. Typically, 10% of FBS is used for cell culturing, but Half-Serum achieves cell growth and functions with only half the amount of FBS. By utilizing specific types and concentrations of nucleosides to reduce FBS, Half-Serum not only promotes environmental sustainability but also has the potential to reduce costs in the future. Currently, we are exploring the application of our expertise to cultured meat. Our studies indicate that cultured meat can thrive with just 2% of FBS, a highly effective approach. We hold a patent related to this innovation, which is expected to lead to reduced time and costs. I anticipate that these developments will yield positive outcomes in the future.

It's quite unique to see that, in addition to all these developments, you're also a practicing doctor at your hospital. I'd like to better understand the advantages you believe being a doctor brings to your overall development.

Being a doctor offers a unique perspective because I'm not solely a research professional; I actively practice medicine. In my role, I treat high-risk patients, which makes me highly attuned to factors such as cost, potential side effects, and various other considerations. This firsthand experience allows me to identify areas that require improvement, constituting the most significant advantage of being a doctor.

Moreover, I have previously delivered lectures at Charite - Medical University of Berlin, the largest medical school in Europe located in Germany. Charite is an amalgamation of various universities.

Even as alcohol consumption in western countries has significantly decreased over the last century, recent heavy drinking episodes still affect a segment of the population. Pharmicell is currently developing a new drug, CellgramLC, as a treatment for liver disease, specifically targeting Cirrhosis. Could you provide more insights into CellgramLC and its development? Additionally, can you elaborate on the anticipated benefits of these features?

We have successfully concluded the phase two clinical trial and are advancing to phase three. Upon comparing our internal real-world data, encompassing 1.3 million individuals, with the data from the Korean Health Insurance Review & Assessment Service (HIRA), we observed a survival rate increase of more than 25%.

In contemporary medical practice, Hepatitis is not a primary focus due to the availability of widespread treatments. However, as individuals persist in heavy drinking, diseases related to this behavior remain significant areas of concern.

I'm aware of the various applications of stem cells, and I noticed that you have a treatment in your pipeline for erectile dysfunction in men. Could you provide insights into how this product works and how stem cells contribute to treating erectile dysfunction?

Essentially, our product elevates the baseline of erectile function. Typically, for such dysfunctions, medicinal consumption is required. However, through stem cell treatment, we aim to enhance the baseline functionality itself. This approach could potentially minimize the need for extensive medication. All these findings have been validated through rigorous animal testing, a challenging process that we successfully navigated.

Pharmicell's international recognition has been steadily increasing, fueled by its ability to supply 80% of the global nucleoside market. A notable example of this success is the recent collaboration with Thermo Fisher, involving the reprocessing of nucleosides supplied by Pharmicell and joint development of new products from the initial research stage. How critical are international markets to Pharmicell's overall strategy?

We previously supplied nucleosides to Thermo Fisher in the U.S. and Merck in Europe. However, during the COVID-19 pandemic, Merck faced significant challenges, while Thermo Fisher experienced dramatic growth. Thermo Fisher's plant in Milwaukee has been expanding for commercialization purposes, and last year, they requested 13 tons of our materials. In contrast, Merck is currently facing significant challenges.

Anticipating a quick recovery in China post-pandemic, we encountered a different reality due to the containment measures against China initiated by President Biden. As a result, companies like Merck and Thermo Fisher are scrutinizing the sources of their materials, with India being a more acceptable option.

UCB, a company with a history of over 100 years, founded by Emmanuel Janssen, has surprised us with the remarkable growth of Cimzia. They are scaling up production to the extent that we will need to provide 2.5 tons next year. The market response has been positive, even surpassing expectations when compared to a Novartis product with an expected increase after the patent expiration. Interestingly, Cimzia has shown a more substantial increase.

UCB appears to be expanding in the field of mRNA vaccines and drugs, particularly with Inclisiran. With the construction of a new manufacturing facility in Belgium, we anticipate an increased supply to UCB.

So, looking ahead, your primary markets for future growth will mainly be the U.S. and Europe?

Yes, we recognize the necessity of expanding beyond the domestic market. Domestic companies may not directly consume our products as Pharmicell primarily provides source materials. It is our clients who derive higher added value by utilizing these materials. Hence, Pharmicell's growth strategy aims to eventually evolve into a company capable of producing end products.

Additionally, we emphasize the significance of adapting and preparing for the post-COVID era. This focus has led us to explore new business avenues, including cultured meat and other alternative options.

Please share some insights into your role and how you incorporate AI into your work.

I lead the research team and oversee AI analytics within the organization. Leveraging omics technology, Pharmicell is actively focusing on Multi-Omics technology. Instead of solely examining genes, RNAs, or proteins, our approach involves creating a gene map through comprehensive screening to identify common targets. This technology is a recent development. For instance, when conducting stem cell treatments for patients in our hospital, we observe varying responses, with some experiencing positive results while others do not. To pinpoint the fundamental root cause, we conduct analyses to understand why outcomes differ among patients.

Our goal is to integrate our products with cutting-edge AI technology to identify viable targets and ensure we can validate and verify findings beyond that point.

What are the effects of incorporating stem cells into cosmetic products, particularly the skincare products offered by your company? What advantages do these products have over more traditional cosmetic formulas?

The initial motivation behind developing cosmetics with stem cells was driven by the need to introduce a product for company profitability. Stem cell cosmetics leverage the properties of stem cells to increase epidermal growth factor, which plays a role in reducing inflammation and promoting rejuvenation. To assess the efficacy, we conducted a blind test on both sides of the cheeks – one treated with stem cell cosmetics and the other without. The results revealed a significant improvement in wrinkles on the side where stem cell cosmetics were applied.

Interestingly, the positive outcomes have attracted affluent individuals from overseas to come to Korea for direct stem cell treatments, despite the associated high costs.

You mentioned that your motivation to create the company stemmed from your perspective as a doctor, recognizing a market need, and a desire to provide improved healthcare solutions. As the president of Pharmicell, do you have specific goals or ambitions you'd like to achieve during your tenure?

I established a Bio Intelligence (BI) department, potentially forming the foundation for advancements in biomedical and biochemical sectors. Simultaneously, our goal is to ensure that this department has the capability to develop its own unique products—an area we are keen to focus on as an emerging department within the company.

On a lighter note, it might sound like a joke, but I have a personal aspiration to retire within the next 10 years. Before reaching that milestone, my ambition is to see the company's value reach 10 trillion KRW.

For more details, explore their website a www.pharmicell.com/eng