[Edaily Reporter KIM SUNG-JIN ] On the 21st, in the pharmaceutical and biotech sector, #SkyLabs stood out the most, hitting the daily price limit after a nine-trading-day downtrend. SkyLabs is a digital healthcare company that manufactures ring-type blood pressure monitors; this surge is believed to be driven by attention from local media as the company pursues approval from the U.S. Food and Drug Administration (FDA). HLB PHARMACEUTICAL(047920), which is awaiting the FDA’s decision on its new bile duct drug, also showed strong gains.

#Orum Therapeutics, Inc., whose new drug development collaboration with Bristol-Myers Squibb (BMS) was terminated, saw its stock price fall consecutively. Analysts attribute this to the ongoing fallout following BMS’s announcement that it was halting development of “ORM-6151” (BMS project name BMS-986497), a treatment for acute myeloid leukemia (AML).

Hits Daily Price Limit

After 9 Consecutive Trading Days of Declines… Named Best HealthTech Company by Time

According to KG Zeroin MP Doctor, #SkyLabs closed at the daily price limit of 25,250 won, up 29.89% (5,810 won) from the previous trading day. The stock price rose rapidly, breaking through the 22,000 won mark immediately upon the market opening, and hit the daily price limit as early as around 10:50 a.m.

Sky Labs, which listed on KOSDAQ on the 4th, made a strong debut by closing at 23,500 won on its first trading day—a 135% increase from its initial public offering price. On the second trading day, the stock hit the daily price limit and closed at 30,550 won. However, after struggling for nine consecutive trading days from the 8th to the 18th, the stock managed to rebound today by hitting the daily price limit again.

SkyLabs’ strong stock performance today is attributed to expectations of its entry into the U.S. market. Domestically, the company has already completed distribution to approximately 2,000 hospitals and clinics nationwide, and overseas sales are also growing rapidly. Of the approximately 5 billion won in revenue generated in the first half of this year, overseas sales totaled 2.6 billion won, accounting for 52% of the total. SkyLabs has currently finalized discussions with the FDA regarding the design of clinical trials and aims to enter the U.S. market upon receiving approval by the end of 2027.

On the same day, SkyLabs announced that it had been selected for the “World’s Top HealthTech Companies of 2026” list published by the U.S. newsweekly *TIME*. It was the only Korean company to be named in the “Medical Devices and Wearables” category.

SkyLabs is the company that commercialized the “Cart BPI Pro,” a ring-shaped, cuffless blood pressure monitor capable of continuously monitoring blood pressure for 24 hours without disrupting sleep or daily life. While blood pressure data has traditionally relied on single measurements taken at specific points in time, this ring-type blood pressure monitor enables the continuous, long-term tracking of blood pressure changes during daily activities and sleep. It is drawing particular attention for its ability to monitor vital signs while reducing the burden on the elderly.

Lee Byung-hwan, CEO of SkyLabs, stated, “This selection is highly significant as it signifies that the competitiveness of wearable medical device technology developed in Korea has been recognized in the global market,” adding, “Going forward, we will expand into the global medical device and medical data markets based on technology that enables the continuous generation and utilization of clinically reliable vital sign data, including blood pressure.”

HLB INC.’s New Bile Duct Cancer Drug in Final Stages of FDA Review

HLB PHARMACEUTICAL(047920) The stock price also rose sharply

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showing strong momentum. According to KG Zeroin MP Doctor

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HLB PHARMACEUTICAL’s stock price closed at 7,650 won, up 23.19% (1,440 won) from the previous day. The upward momentum in HLB PHARMACEUTICAL’s stock price is believed to stem from expectations of FDA approval for a new bile duct cancer drug currently under development by its U.S. subsidiary, Eleva Therapeutics ( HLB INC.(028300) ).

HLB INC. announced today that the U.S. brand name “LYRFIGTU” for lirafugratinib, an FGFR2-targeted anticancer drug, has been conditionally accepted by the U.S. Food and Drug Administration (FDA). Lirafugratinib is currently undergoing FDA Priority Review as a second-line treatment for patients with advanced or metastatic cholangiocarcinoma (CCA) harboring FGFR2 fusions or rearrangements, and the FDA’s target date for approval is the 25th of this month.

Lirapugratinib is an irreversible inhibitor that highly selectively targets FGFR2 within the FGFR family. According to the company, it is designed to reduce side effects caused by off-target inhibition, which has been cited as a limitation of existing FGFR inhibitors. In particular, it is characterized by its selective binding to FGFR2, resulting in sustained inhibitory effects.

Elevate Therapeutics began full-scale development of a new drug for cholangiocarcinoma in December 2024 after signing an agreement with U.S.-based Relay Therapeutics (Relay) to license a candidate compound for the treatment of the disease. This compound was designated as a Breakthrough Therapy by the FDA in 2023 and garnered attention in March of this year when it was granted Priority Review status by the FDA.

HLB PHARMACEUTICAL is a company within the HLB INC. Group that engages in the manufacturing and sales of pharmaceuticals, as well as contract manufacturing (CMO) operations. Although there is no direct link to the anticipated FDA approval of lirapugratinib, industry observers suggest that if the FDA approves the drug, HLB PHARMACEUTICAL—the group’s manufacturing arm—could benefit. However, an HLB INC. official drew a line, stating, “Nothing has been finalized yet regarding the production of the product.”

Aftermath

of BMS’s Technology Return… Orum Therapeutics, Inc.’s Stock Price Halved in Three Days

#Orum Therapeutics

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Inc. continued to feel the fallout from BMS’s decision to halt development of the blood cancer candidate “ORM-6151” and return the rights. On this day, Orum Therapeutics, Inc.’s stock price recorded a drop that brought it close to the daily price limit. Compared to the previous trading day, the stock price fell 29.28% (10,950 won) to 26,450 won. Considering that the stock price was in the 50,000-won range before BMS’s announcement of the technology return on the 16th, the stock price has effectively been cut in half in just three trading days.

“ORM-6151,” a blood cancer drug candidate that BMS had been developing, was licensed from Orum Therapeutics, Inc. in 2023. Looking at the contract structure at the time, it was a major deal with a total transaction value of $180 million (approximately 248.4 billion won). Orum Therapeutics, Inc. received $100 million of this amount as an upfront payment, which was non-refundable. With the suspension of development, the company has lost its right to receive up to $80 million in milestone payments tied to specific development stages.

“ORM-6151,” whose development has now been halted, is a candidate drug utilizing Antibody-Drug Conjugate (DAC) technology and was, in effect, the flagship candidate representing Orum Therapeutics, Inc.’s DAC technology. DAC is a technology that combines an antibody-drug conjugate (ADC) with a target protein degrader (TPD); it is a new technology for which no company worldwide has yet achieved commercial success. While an ADC attaches a highly toxic drug to an antibody, a DAC connects a TPD—which acts as a catalyst—to the antibody, aiming for effective treatment while minimizing side effects even with small doses.

Analysts attribute the sharp, consecutive decline in Orum Therapeutics, Inc.’s stock price to the fact that the company’s next-generation candidate is also based on DAC technology. With the suspension of R&D on this candidate—which had significantly boosted the company’s valuation through its export to BMS—confidence in Orum Therapeutics, Inc.’s DAC platform technology appears to have been shaken. Orum Therapeutics, Inc. plans to proceed with clinical trials for its follow-up pipeline candidate, “ORM-1153,” as scheduled.