[Edaily Reporter KIM JI-WAN ] On the 23rd, the domestic pharmaceutical and life sciences sectors showed mixed trends. The life sciences sector rose 0.64%. Of the 92 stocks in the sector, 53 rose, 8 remained unchanged, and 31 fell, with gainers outnumbering losers. The pharmaceutical sector fell 0.45%. Out of a total of 161 stocks, 81 rose, 20 remained unchanged, and 60 fell. Although the number of stocks that rose exceeded those that fell, the sector index closed lower.

Amid this, PROTEINA CO., LTD. drew attention for the potential of a partnership with a global AI company as the value of its proprietary experimental data gained prominence in the AI-driven new drug development market. Ingenia Therapeutics saw its technological competitiveness re-emerged as MSD conducts four global Phase 3 clinical trials for the ophthalmic drug candidate “IGT-427 (MK-8748).” DongKook Pharmaceutical Co.,Ltd. is pursuing entry into 13 countries in Central and South America, following its prostate hyperplasia treatment “Uresco Tablets,” which recorded a 76.3% market share in the market for combination drugs with the same active ingredient.

PROTEINA CO., LTD.: “Data Competition”

in

AI-Driven New Drug Development Comes to the Forefront

#PROTEINA CO., LTD. showed strong performance, buoyed by securities industry analysis suggesting that the importance of experimental data may grow in

the artificial intelligence

(AI)

-driven new drug development market

. This is interpreted as reflecting expectations that, as global big pharma companies expand their collaborations with AI firms, the value of companies possessing their own experimental data and research capabilities may be reevaluated.

According to KG Zeroin MP Doctor, PROTEINA CO., LTD. closed at 47,100 won, up 7,150 won (17.90%) from the previous day.

In a report titled “Pharmaceuticals/Biotech—The Era of AI-Driven New Drug Development: Data Is Key,” published today, Daol Investment & Securities analyzed that the focus of competition in AI-driven new drug development is shifting from simple algorithm performance to the ability to secure and utilize high-quality experimental data. The firm maintained its “Overweight” investment rating for the pharmaceutical and biotech sectors.

PROTEINA CO., LTD. was also cited as one of the domestic companies likely to benefit from this shift. The company is expanding its new drug development capabilities by collaborating with external AI firms based on its own experimental data.

Recently, global pharmaceutical companies have been rapidly increasing their collaborations with AI firms. On the 16th, Novo Nordisk decided to partner with Anthropic and utilize AI to analyze drug candidates and experimental data. The company also plans to pilot Anthropic’s Claude Science in its research and development (R&D) process.

Bristol-Myers Squibb (BMS) is rolling out the Anthropic AI platform company-wide, while Merck (MSD) has begun expanding its use of Google Cloud and Agent AI. Roche and Eli Lilly are partnering with NVIDIA to advance AI-based drug discovery and laboratory automation.

In particular, Eli Lilly is working with NVIDIA on a joint investment of up to $1 billion to build research facilities that bridge AI analysis and hands-on experimentation.

Daol Investment & Securities believes this trend is reshaping the competitive landscape of AI-driven drug discovery. While the focus used to be on how quickly AI could analyze vast amounts of data to identify promising candidate compounds, the firm explains that going forward, the key competitive advantage will lie in an iterative process: validating hypotheses proposed by AI through actual experiments and then feeding the resulting data back into the AI for further training.

Ultimately, the analysis suggests that companies with their own research facilities and experimental capabilities are likely to gain an advantage in the AI-driven drug development process. This is because, unlike publicly available data, actual experimental results accumulated within a company are difficult for external parties to obtain.

In particular, the analysis suggests that even experimental data from failed attempts in the drug development process can be valued as a new asset. This is because information on why a specific candidate compound was ineffective under certain conditions or failed in specific experiments can also be utilized by AI to design the next candidate compound or experimental conditions.

From this perspective, it is assessed that domestic biotech companies—including PROTEINA CO., LTD.—that possess proprietary experimental data and platforms are likely to emerge as collaboration partners for global AI companies.

However, it was also pointed out that the adoption of AI does not immediately lead to an increase in the success rate of new drug development. While AI can accelerate the speed of candidate compound screening, clinical trials to verify safety and efficacy in humans are a separate process.

Daol Investment & Securities identified HanmiPharm, Voronoi, Inc., Y-Biologics, Inc., and PROTEINA CO., LTD. as relevant companies. HanmiPharm utilizes its proprietary “Hyper-PSAR” platform, while Voronoi, Inc. conducts candidate discovery based on its own platform. Y-Biologics, Inc. and PROTEINA CO., LTD. are also advancing new drug development through collaborations with external AI companies and the use of their own experimental data.

Lee Ji-soo, an analyst at Daol Investment & Securities, stated, “In the era of AI-driven drug development, the value of data continuously accumulated through experiments will become even more important than the algorithms themselves,” adding, “Domestic companies with proprietary data and experimental capabilities will be able to secure new opportunities through research partnerships and technology transfer with AI firms.”

Ingenia Simultaneously Conducting Four Phase 3 Trials for Ophthalmic Drugs Led by MSD… Attention on Discontinuation of Competitor Drugs

#Ingenia Therapeutics (Reg. S)’s key

ophthalmic drug

candidate, IGT-427 (MK-8748), has officially entered the global

Phase 3

clinical trial stage. As U.S.-based Merck (MSD) conducts a total of four large-scale Phase 3 clinical trials targeting neovascular age-related macular degeneration (NVAMD) and diabetic macular edema (DME), attention is also focusing on Ingenia’s technological value.

Ingenia closed at 24,500 won, up 1,050 won (4.48%) from the previous day.

According to industry sources, MSD, having initiated two Phase 3 clinical trials of MK-8748 for NVAMD in the first half of this year, is now also proceeding with two Phase 3 trials for DME. This means a total of four late-stage clinical trials are being conducted simultaneously for a single candidate compound.

MK-8748 is a bispecific antibody designed to simultaneously activate the vascular endothelial cell receptor “TIE2” and inhibit vascular endothelial growth factor (VEGF). It is characterized by its ability to target both abnormal blood vessel formation and vascular instability.

In October 2022, Ingenia licensed IGT-427—which was then in the preclinical stage—to EyeBio, a UK-based biotech company specializing in ophthalmic diseases. At the time, the total value of the deal was reported to exceed 1 trillion won. Subsequently, when MSD acquired EyeBio in July 2024, responsibility for the candidate’s development was transferred to MSD. Global clinical trials are currently underway under the development code “MK-8748.”

The market views the discontinuation of competing pipelines as a factor that further enhances MK-8748’s prominence.

Roche’s “RG6351,” which was being developed using the same direct TIE2 activation mechanism, reportedly reached the Phase 2 clinical trial stage but had its development halted last July. Astellas’ “ASP4021” is also understood to have effectively halted development. Consequently, MK-8748 is widely regarded as virtually the only remaining retinal disease candidate based on the direct TIE2 activation mechanism that has advanced to a large-scale Phase 3 clinical trial.

It is also noteworthy that MSD is investing substantial funds in MK-8748. Industry estimates suggest that the costs for the four Phase 3 clinical trials will reach approximately 1 trillion won. Given the allocation of significant resources to late-stage clinical trials, it is interpreted that MSD is positioning this candidate as a key component of its ophthalmology pipeline.

The domestic securities industry is also taking note of MK-8748’s value.

Lee Ho-cheol and Lim Jae-hyun, analysts at Shinhan Investment Securities, stated that MSD aims to generate annual sales of over $5 billion in the ophthalmology sector by the mid-2030s, led by MK-8748 and MK-3000, and valued MK-8748 at approximately 1.1565 trillion won. The two analysts predicted that Phase 3 clinical trials for wet age-related macular degeneration and diabetic macular edema would be completed around 2028, with a U.S. marketing authorization application possible in 2029.

Building on its experience with the technology transfer of IGT-427, Ingenia is also expanding the global development of its follow-on candidates.

“IGT-303,” a treatment for kidney disease, entered Phase 1/2a clinical trials in Australia last November after completing preclinical studies. The company plans to pursue a global technology transfer next year after securing clinical data.

“IGT-532,” a trispecific antibody anticancer drug that simultaneously targets immune responses and tumor blood vessels, is also under development in the preclinical stage.

An Ingenia official stated, “The company is demonstrating its technological competitiveness as four candidate compounds it discovered have entered large-scale global Phase 3 clinical trials led by MSD,” adding, “We also plan to secure meaningful data from IGT-303, which is currently undergoing our own Phase 2a clinical trials in South Korea, Australia, and New Zealand, and to begin full-scale technology transfer negotiations with global pharmaceutical companies next year.” The official added, “We will accelerate R&D on our follow-up pipeline targeting cardiovascular diseases and solid tumors to expand our competitiveness in the global market.”

DongKook Pharmaceutical Co.,Ltd.’s ‘Uresco’ Captures 76% of the Combination Drug Market… Targeting 13 Countries in Central and South America

DongKook Pharmaceutical Co.,Ltd.’s improved new drug for benign prostatic hyperplasia, “Uresco Tablets,” has taken the lead in the dutasteride-tadalafil combination drug market, recording a market share of over 70%. Following confirmation of its therapeutic efficacy compared to single-ingredient drugs through a domestic Phase 3 clinical trial, the company is accelerating its overseas business expansion by pursuing entry into 13 countries in Central and South America.

On the back of this news, DongKook Pharmaceutical Co.,Ltd.’s stock closed at 21,550 won, up 1,050 won (5.12%) from the previous day.

DongKook Pharmaceutical Co.,Ltd. announced today that, based on data from the pharmaceutical market research firm UBIST from last June, Uresco Tablets recorded a 76.3% market share in the dutasteride-tadalafil combination drug market. This is the highest level among combination drugs with the same ingredients launched around the same time.

Uresco Tablets are a combination improved new drug that combines 0.5 mg of dutasteride and 5 mg of tadalafil into a single tablet. It is the world’s first combination drug to combine these two ingredients.

Dutasteride works by reducing prostate size to inhibit the progression of benign prostatic hyperplasia (BPH). Tadalafil is used to improve voiding symptoms—such as a weak urine stream or a sensation of incomplete emptying—as well as storage symptoms like frequent urination and nocturia. A key feature of Uresco Tablets is that they allow patients to take two drugs with different mechanisms of action in a single dose.

The therapeutic efficacy of the combination drug was also confirmed in clinical trials. The results of Phase 3 clinical trials conducted at various medical institutions in Korea were published in the international academic journal *BJU International*.

In this study, Uresco Tablets demonstrated superior efficacy compared to treatment with each individual component, and their safety was assessed as acceptable. DongKook Pharmaceutical Co.,Ltd. explained that this suggests the drug can simultaneously improve urinary symptoms and provide long-term management of prostate size and disease progression.

Having established a prescription base in the domestic market, DongKook Pharmaceutical Co.,Ltd. is now expanding into overseas markets.

The company recently signed a technology transfer and supply agreement for Yuresco tablets with the Spanish pharmaceutical company FAES FARMA. The agreement covers 13 countries in Central and South America, including Mexico, Colombia, Ecuador, Peru, and Chile. The company’s strategy is to expand its overseas sales territories based on the clinical data and market experience gained in the domestic prescription market.

An official from DongKook Pharmaceutical Co.,Ltd. stated, “Since benign prostatic hyperplasia requires long-term management, factors such as prostate size, the risk of disease progression, the patient’s age, and quality of life must be considered alongside current symptoms.” The official added, “As treatment goals vary from patient to patient, we expect Yuresco Tablets to play a role in broadening treatment options.”