[Edaily Reporter YU JIN-HEE ] As the domestic securities market has recently been realigning itself around corporate earnings and tangible clinical and commercialization achievements, the biotech sector also saw strong buying interest on the 4th, centered on companies with distinct technological capabilities and earnings momentum. Unlike thematic stocks driven solely by speculation, top-tier companies—armed with global regulatory approvals, secured exclusive supply chains, and differentiated core platform technologies—ranked among the top performers in the overall market, proving their status as market leaders.

Stock soars 135% on first day of KOSDAQ listing… SkyLabs, maker of the “world’s only ring-type blood pressure monitor”

According to KG Zeroin MP Doctor (MP DOCTOR), the three leading biotech companies that made the “Top 20 Gainers” list on the Korean stock market that day were #SkyLabs, #SAMIK PHARM. Co., LTD., and ADM Korea Inc.(187660). Each company’s stock price surged compared to the previous day: SkyLabs by 135.00% (closing price 23,500 won), SAMIK PHARM. Co., LTD. by 19.22% (6,760 won), and PenetriumBio by 14.71% (5,850 won), drawing the market’s full attention.

Experts unanimously agree that this serves as proof that companies which have obtained approvals from globally recognized institutions and demonstrated a clear cash cow tend to be recognized for their robust corporate value even amid market volatility. In fact, SkyLabs—which soared 135.00% on its first day of trading on KOSDAQ, far surpassing its initial public offering (IPO) price—saw its stock price skyrocket thanks to the commercialization of the world’s only ring-type cuffless blood pressure monitor and its steep earnings growth.

SkyLabs has gone beyond being a mere manufacturer of wearable devices to build a high-value-added healthcare platform that combines hardware with artificial intelligence (AI) algorithms to directly extract clinical-grade biometric data. Its flagship product, the “CART BP pro,” is a ring-shaped medical device that continuously monitors blood pressure for 24 hours without disrupting sleep or daily life. As of the first half of the year, the company had completed deployment to approximately 2,000 hospitals and clinics nationwide, including South Korea’s “Big 5” tertiary general hospitals: Seoul National University Hospital, Asan Medical Center, Samsung Medical Center, Severance Hospital in Sinchon, and Seoul St. Mary’s Hospital.

In the year following the launch of the CART BP Pro, the total number of prescriptions for 24-hour ambulatory blood pressure monitoring (E6547) in South Korea surged by 52.7% compared to pre-launch levels. Among these, the CART BP Pro holds an overwhelming 52.4% market share, replacing existing measurement methods while simultaneously creating new demand for health screenings.

The technical barriers to entry are also unparalleled. The technology—which uses AI to convert photoplethysmography (PPG) signals, which measure microcirculation in the fingertip, to calculate accurate blood pressure—is considered one of the most challenging in the wearable technology sector. Following the acquisition of product approval from the Ministry of Food and Drug Safety and inclusion in the National Health Insurance reimbursement list, the device was officially listed as a recommended out-of-office blood pressure monitor in the Korean Society of Hypertension’s “2026 Hypertension Clinical Practice Guidelines.”

Combined with B2B supply through DAEWOONGPHARMACEUTICAL’s robust distribution network to hospitals and clinics, as well as a model integrated with SEERS’ AI ward monitoring platform “thynC,” the company’s revenue has been doubling every year. After posting sales of 7.9 billion won last year, the company achieved a 52% share of overseas sales in the first half of this year. Following the acquisition of European Medical Device Regulation (CE-MDR) certification, it signed a supply agreement with local specialist firm IEM; global expansion is also proceeding smoothly, including collaborations with Japan’s Omron Healthcare and Otsuka Pharmaceutical, as well as efforts to secure U.S. Food and Drug Administration (FDA) approval.

Lee Byung-hwan, CEO of SkyLabs, emphasized, “We will use our KOSDAQ listing as an opportunity to accelerate our penetration of the global blood pressure monitoring market,” adding, “Based on our accumulated biometric big data, we will leap forward to become a world-class medical data production platform company encompassing pharmaceutical clinical trials and diagnostic AI.”

Secures Patent for ‘Golf Ball Dimple’ Microspheres… SAMIK PHARM. Co., LTD. Enters Regenerative Medicine Filler Market

News that SAMIK PHARM. Co., LTD. is expanding its proprietary drug delivery platform technology into the high-value-added tissue regeneration medical device sector served as a strong catalyst for its stock price. SAMIK PHARM. Co., LTD. announced today that it has completed the registration of a domestic patent (No. 10-3007858) for “Dimple-shaped Biodegradable Polymer Microspheres and Their Manufacturing Method.” This patented technology involves a manufacturing process that precisely forms microscopic indentations (dimples), resembling the surface of a golf ball, on the surface of microspheres that gradually degrade within the human body.

The research team maximized reactivity with fibroblasts—which induce the body’s own collagen production in skin tissue—by modifying the surface structure. In in vitro comparative tests using actual human skin fibroblasts, the collagen production level of the dimple-shaped microparticles was 110–121% that of the untreated group, demonstrating up to 21% higher efficacy.

This technology is the culmination of the precision control expertise embodied in “UniSphero,” SAMIK PHARM. Co., LTD.’s proprietary long-acting injectable platform. By utilizing limonene as a dimple-forming inducer and combining it with microporous membrane control technology, the company has stably achieved uniform particle sizes (43–71 μm) and a consistent particle size distribution (0.8–1.1). It has also secured versatility, enabling broad application to major biodegradable polymers such as PLLA, PLGA, and PCL.

Taking this patent acquisition as a starting point, SAMIK PHARM. Co., LTD. is aggressively expanding its business portfolio—which had been limited to the drug delivery system sector—into the next-generation regenerative medical device market, including high-margin aesthetic and tissue-regenerative fillers. The company recently amended its articles of incorporation to formally add the manufacture and sale of medical devices to its business objectives and has begun full-scale commercialization procedures, including preclinical trials and quality certification.

SAMIK PHARM. Co., LTD. emphasized, “Dimpled microparticles are a core technology that has demonstrated outstanding potential as a tissue-regenerative material through differentiated surface modification technology,” adding, “Based on the Unispero platform, we will systematically develop a pipeline of high-performance medical devices, such as tissue-repair fillers, and cultivate them as the company’s future core growth engines.”

U.S. FDA Phase 2a Approval… PenetriumBio Rally

PenetriumBio’s corporate value has been reevaluated after its innovative mechanism for controlling the tumor microenvironment in patients with intractable cancers received official recognition from U.S. regulatory authorities. PenetriumBio announced today that it received approval from the FDA for an Investigational New Drug (IND) application for a Phase 2a clinical trial of “Penetrium,” the world’s first anticancer drug candidate designed to overcome pseudo-resistance, in patients with advanced solid tumors. This is a multicenter clinical trial designed to demonstrate the safety and tumor-suppressing efficacy of combining Penitrium with existing standard anticancer drugs in patients with advanced solid tumors who have not responded to or have developed resistance to standard-of-care (SoC) treatments.

This approval has drawn extraordinary attention from the global biotech industry, as it fundamentally overturns the mechanism of cancer resistance that has dominated the field of cancer treatment for the past 80 years. Until now, the medical community has defined the phenomenon of reduced efficacy with repeated administration of anticancer drugs as “true resistance” caused by mutations in the cancer cells themselves, and has adhered to approaches such as increasing drug doses or prescribing alternative, more toxic anticancer drugs. However, a significant portion of actual clinical failures stems not from cancer cell mutations but from “pseudo-resistance,” in which drugs are prevented from reaching their targets by barriers in the tumor microenvironment.

When anticancer drugs are administered, cancer-associated fibroblasts (CAFs) and tumor-associated macrophages (TAMs) become overactivated, causing the extracellular matrix (ECM) to fibrose and harden, and leading to a sharp rise in interstitial fluid pressure (IFP). Since anticancer drugs cannot penetrate this physical barrier, they become diluted to sub-lethal concentrations—far below the concentration required for cell death—resulting in treatment failure.

Penitrium simultaneously regulates CAFs and TAMs within the tumor microenvironment to soften the stiffened matrix and reduce abnormal tumor pressure. This restores a physical pathway, allowing co-administered anticancer drugs to penetrate deep into the tumor at their intended cytotoxic concentrations.

The FDA’s approval of a combination protocol involving the re-administration of previously ineffective anticancer drugs is a decision that acknowledges the scientific validity of the “therapeutic response recovery” mechanism, which revives drug responsiveness. It can simultaneously target metastatic tumors that share the same stromal barrier as the primary tumor, and based on existing human safety data, it possesses the scalability to skip Phase 1 clinical trials and proceed directly to Phase 2 when expanding indications to other solid tumors.

Jo Won-dong, Chairman of PenetriumBio, stated, “This FDA approval signifies that we have overcome the limitations of cancer treatment—which has long mistaken pseudo-resistance for cellular mutations—and that our new drug, which controls the stromal barrier, has confidently reached the global standard for validation.” He added, “We will successfully complete multicenter clinical trials with leading U.S. cancer research institutions to provide an innovative breakthrough for patients with intractable cancers worldwide.”