[Edaily Reporter NA EUN-KYUNG ] On the 26th, stock prices of medical artificial intelligence (AI) companies rose across the board in the domestic pharmaceutical, biotech, and healthcare sectors. Following Lunit Inc.’s announcement of a collaboration with U.S.-based Summit Therapeutics to conduct AI biomarker research for the development of next-generation immuno-oncology drugs, investor interest spread to companies such as VUNO, Inc., NEUROPHET Inc., SEERS, Noul Co., Ltd., and 3billion Inc. This is interpreted as reflecting expectations that the scope of medical AI applications is expanding from diagnostic assistance to new drug development by global pharmaceutical companies.

The follow-up business schedules of individual companies are also drawing attention. VUNO, Inc. is awaiting the results of the New Medical Technology Evaluation for its flagship product, “VunoMed DeepCAS.” NEUROPHET Inc. is pursuing overseas supply and collaborations with big pharma in line with the expanding market for Alzheimer’s disease treatments, but discussions on commercialization agreements appear to be taking longer than initially expected.

Lunit Inc. Moves Beyond Cancer Diagnosis to Anticancer Drug Development

At the heart of the day’s rally was news of a collaboration between Lunit Inc.(328130)and the U.S. biotech firm Summit Therapeutics. According to KG Zeroin MP Doctor (MP DOCTOR, formerly Marketpoint) on that day

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Lunit Inc. closed at 14,690 won, up 3,390 won (30.00%) from the previous trading day. The two companies agreed to apply Lunit Inc.’s AI biomarker platform, “Lunit Scope IO,” to the research and development process of Summit’s immuno-oncology drug “Ibonecimab.”

Ibonecimab is a bispecific antibody that simultaneously targets PD-1, which suppresses the anticancer activity of immune cells, and vascular endothelial growth factor (VEGF), which is involved in tumor angiogenesis. Summit acquired the rights to develop and commercialize this compound in key overseas markets from China’s Akeso. The company has recently garnered attention after AstraZeneca invested $2 billion in Summit and agreed to pursue co-development with its antibody-drug conjugates (ADCs).

Lunit Inc. analyzes the distribution of cancer cells and immune cells, as well as the structure of surrounding tissues, in existing tissue slides. Through this, the company plans to identify characteristics of patient groups that respond well to treatment and provide the evidence needed to understand treatment responses. In effect, the role of AI—previously used in hospitals to detect cancer—is expanding to include clinical trial design and patient selection by pharmaceutical companies.

In the U.S. stock market, companies that supply the data and analytical equipment necessary for AI-driven drug discovery are also drawing attention. According to a report published today by Han Seung-yeon, an analyst at NH INVESTMENT & SECURITIES, 10x Genomics—a company specializing in single-cell and spatial biology analysis equipment—has seen its stock price rise by approximately 339% year-to-date. Researcher Han explained, “As the importance of precise data increases with the advancement of AI-driven drug development, 10x Genomics, which supplies analytical equipment, is viewed as a beneficiary of this trend.”

Lunit Inc. also began collaborating with 10x Genomics last September to identify biomarkers for anticancer drugs. This approach combines molecular information—such as genes within tissue—produced by 10x Genomics with Lunit Inc.’s AI-powered pathology analysis to identify characteristics related to treatment response and resistance. One analyst stated, “SCOPE is a clear example of how the scope of application for analytical technologies necessary for AI-driven new drug development is expanding,” adding, “We believe Lunit Inc. is the stock with the highest potential for a revaluation of its business value in the domestic AI healthcare sector by 2027.”

One analyst noted that the investment scope for AI-driven drug discovery should be expanded to include not only companies designing candidate compounds but also those supplying experimental materials and data and increasing the likelihood of clinical success. Since Lunit Inc. is also expanding into these areas through its SCOPE business, the analyst believes it is worth paying attention to the potential for a revaluation of its business value in 2027.

Attention is also focused on whether this collaboration will serve as a catalyst for a rebound for domestic medical AI companies, which surged during the 2023 AI boom but subsequently underperformed due to pressures to prove profitability. Stocks included in related exchange-traded funds (ETFs) are also drawing attention. The KIWOOM Medical AI ETF includes Lunit Inc., VUNO, Inc., NEUROPHET Inc., and SEERS, while the UNICORN Generative AI Small-Cap Active ETF includes Lunit Inc. and VUNO, Inc.

Seo Beom-seok, CEO of Lunit Inc., stated, “It is highly significant that Summit, a leader in the development of next-generation immuno-oncology drugs, is utilizing Lunit Inc.’s AI technology for its ibonesimab research,” adding, “We will continue to expand the potential applications of AI pathology technology in the global new drug development sector.”

VUNO, Inc.: DeepCAS Evaluation and U.S. Resubmission Mark a Turning Point

VUNO, Inc.(338220)closed at 7,680 won, up 1,770 won (29.95%) from the previous trading day. Key points to watch this year and early next year are the evaluation of “VunoMed DeepCAS” as a new medical technology and the resubmission of its application for approval to the U.S. Food and Drug Administration (FDA).

DeepCAS is an AI medical device that analyzes blood pressure, pulse, respiration, and body temperature in general ward patients to alert healthcare providers to the risk of cardiac arrest within 24 hours. It is the first AI medical device in Korea to be designated as an “advance-entry medical technology” and has been used in clinical settings on a non-reimbursed basis under a moratorium on the New Medical Technology Evaluation.

The National Evidence-based Healthcare Research Institute (NECA) held a New Medical Technology Evaluation Committee meeting on the 23rd. As that day marked the first trading day following the committee meeting, anticipation regarding the evaluation results may have contributed to the rise in the stock price. A NECA official stated, “The committee meets monthly, and this month’s meeting was held on the 23rd,” but regarding the results, added, “We cannot disclose them until they are published on our website.” Industry observers expect the evaluation results to be communicated to the company in mid-November.

If the evaluation is passed, the technology will move beyond temporary use and be officially recognized as a new medical technology. The company expects that as uncertainty surrounding continued use diminishes, adoption by new hospitals will increase. A VUNO, Inc. official stated, “Since the evaluation deferral is a temporary measure, we expect that once the technology can be used officially, institutions that had hesitated to adopt it due to uncertainty will begin using it more widely.”

However, passing the new medical technology evaluation does not automatically mean coverage under the national health insurance system. The product must undergo separate procedures, including an evaluation by the Health Insurance Review and Assessment Service (HIRA). “Following the new medical technology evaluation, the product will undergo an evaluation by HIRA as part of the reimbursement process. We expect this procedure to take place next year,” VUNO, Inc. explained.

In the U.S. market, the company is preparing to resubmit DeepCAS for FDA approval. Last April, DeepCAS received a “insufficient evidence of equivalence” determination during the FDA’s 510(k) premarket notification review. A VUNO, Inc. official stated, “The key milestones for this year and early next year are the evaluation of DeepCAS as a new medical technology and the resubmission of the application to the U.S. FDA,” adding, “We aim to resubmit the application to the FDA by the end of this year.”

NEUROPHET Inc. Takes a Breather on Big Pharma Contracts

#NEUROPHET Inc. closed at 6,540 won, up 900 won (15.96%) from the previous trading day. NEUROPHET Inc. is also riding the wave of increasing utilization of medical AI in global new drug development.

The company is pursuing a business that uses brain imaging analysis technology to support patient evaluation prior to the administration of Alzheimer’s disease treatments and to monitor side effects during treatment, as well as providing imaging analysis (ICL·Imaging Core Lab) services for clinical research to pharmaceutical and biotech companies.

Commenting on the day’s stock price rise, a representative of NEUROPHET Inc. stated, “This is interpreted as the result of improved investor sentiment across the medical AI sector following the announcement of the AI biomarker research collaboration between Lunit Inc. and U.S.-based Summit, as well as the resulting upward momentum.” The representative added, “It appears that interest in related companies has expanded as the potential for utilizing medical AI technology in the new drug development processes of global pharmaceutical companies has come to the fore.”

The key to future business expansion lies in converting technology validation with global pharmaceutical companies into commercialization agreements. NEUROPHET Inc. has been collaborating with Lilly and Roche and has set a goal of securing commercialization agreements within the year. However, related discussions appear to be taking longer than initially anticipated.

NEUROPHET Inc. official stated, “We are continuing discussions with global Big Pharma companies to secure commercialization agreements,” but added, “Since global pharmaceutical companies’ technology validation and commercialization review procedures are rigorous and require detailed negotiations, the schedule is somewhat behind initial expectations.”

The spokesperson further elaborated, “We are steadily continuing discussions between the two companies and proceeding with the relevant procedures, with the goal of signing a commercialization agreement as soon as possible.”

NEUROPHET Inc.’s supply to U.S. medical institutions is also on the rise. “Neurofit Aqua AD Plus,” which received FDA approval this year, signed a supply agreement with Elevate Clinic in the U.S. last August. The company is currently in discussions with other North American medical institutions regarding additional supply.

Next year, a key variable will be the extent to which these supply discussions and collaborations with big pharma translate into actual contracts and revenue. The expansion of prescriptions for Alzheimer’s disease treatments, such as Lecembi, is also cited as a factor that will increase demand for image analysis. NEUROPHET Inc. official stated, “Demand for our main products is gradually increasing in line with the expansion of Lecembi prescriptions,” adding, “We expect the growth in product supply and revenue to continue.”