[Click eStock] "Caregen Rises as Leading KOSDAQ Bio Stock on 'Coglutaide' Commercialization and New Drug Prospects"

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On March 9, Hanyang Securities analyzed that Caregen is strengthening its presence as a major KOSDAQ-listed bio company by pushing ahead with the commercialization of its oral GLP-1 supplement and the development of new drug pipelines. The company is seen as having abundant growth momentum, as both the potential for global supply contracts and the anticipation for innovative therapeutic development are coming to the fore.

Byungyong Oh, a researcher at Hanyang Securities, stated, "On January 30, Caregen succeeded in registering its oral GLP-1 supplement, 'Coglutaide,' as a New Dietary Ingredient (NDI) with the US FDA," and added, "The key going forward will be its commercialization strategy."

According to the company, Caregen is currently in talks for a supply agreement with a multinational company in the United States, and negotiations appear to be in the final stages, as the inspection of its Hwaseong plant was recently completed. There is also a possibility that 'Myoki,' a myostatin inhibitor supplement for muscle growth, will be supplied alongside.

Researcher Oh explained, "'Coglutaide' is a health functional food but, as a synthetic peptide ingredient, it is the only product expected to deliver effects comparable to GLP-1 pharmaceuticals. The global GLP-1 industry is rapidly expanding, but less than 1 percent of the world's obese population has actually experienced GLP-1 drugs like Wegovy or Mounjaro so far." He continued, "Caregen's goal is to make GLP-1 mainstream. Of course, it remains to be seen how the contract negotiations will conclude, but there is hope for a major supply agreement."

The company’s new drug pipeline is also drawing attention. Its macular degeneration treatment candidate, 'GC-P5,' in the form of eye drops, demonstrated significant efficacy in phase 1 clinical trials and is now preparing for further clinical development. Researcher Oh stated, "'GC-P5' showed efficacy comparable to Eylea in wet macular degeneration even though it is administered as an eye drop in the phase 1 trial. The company is expected to apply for a US FDA phase 2 IND between March and April."

Notably, Caregen is aiming to expand the indication in this clinical trial to include not only wet but also dry macular degeneration. The number of patients with dry macular degeneration is about ten times that of wet macular degeneration, yet there is still no clearly effective treatment available in this field.

Researcher Oh commented, "If efficacy is confirmed in dry macular degeneration, the value of the new drug will increase significantly. Along with the IND application, the company also plans to apply for the FDA's Breakthrough Therapy Designation (BTD)." He emphasized, "Receiving BTD is a strong signal that the FDA recognizes early efficacy, and it is a critical event that opens the possibility of commercialization after phase 2."

Phase 1 clinical data for GC-P5 has been accepted for presentation at two international ophthalmology conferences-COPHy in March and RWC in May. According to the company, it is also in talks with three global big pharma companies for potential technology licensing deals.

The development of new peptide materials is also seen as a new growth story for the company. Researcher Oh explained, "The company has developed a new peptide called 'Hyalux,' which is composed of ten amino acids. This substance weakens the structure of hyaluronic acid in the skin, helping drugs to penetrate beneath the skin."

Hyaluronidase enzyme is generally used to convert intravenous (IV) drugs into subcutaneous (SC) injections, but Caregen is seeking to expand its use into the cosmetics market. The goal is to enable active ingredients with large molecular weights, such as those found in cosmetics and skin booster products, to be absorbed into the subcutaneous fat layer without injections.

Researcher Oh evaluated, "'Hyalux' is targeting the much larger cosmetics market. Although the business is still in its early stages, it is a story that could excite the stock market." He added, "The company plans to move forward with commercialization through global partnerships as early as this year."

Caregen's ability to continuously launch innovative products is attributed to its long-standing expertise in peptide research. The company has built up an extensive peptide library and holds hundreds of patents after decades of research.

Researcher Oh stated, "Just as 'Hyalux' suddenly emerged, it is impossible to predict what other innovative products Caregen will bring to the market in the future. This represents the company's strong scalability and growth potential." He also noted that the government's recent policy to revitalize the KOSDAQ market is increasing interest in large-cap KOSDAQ stocks, which is another positive factor.

Currently, out of the top 10 KOSDAQ stocks by market capitalization, six are bio companies. Caregen’s market capitalization stands at approximately 6.9 trillion won, placing it among the top 10 companies on the KOSDAQ.

Researcher Oh emphasized, "Compared to other leading bio stocks such as Samchundang Pharm, ABL Bio, and Kolon TissueGene, Caregen appears to have more short-term share price catalysts. Now is the time to pay attention to Caregen, which offers abundant momentum and remains relatively undervalued."

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