[Edaily Reporter YU JIN-HEE ] On the 30th, as the domestic stock market experienced a downturn due to growing domestic and international uncertainties, companies in the pharmaceutical, biotech, and healthcare (hereinafter “biotech”) sectors demonstrated exceptional resilience, backed by solid earnings and tangible commercialization achievements in their pipelines. In contrast to theme stocks reliant on mere expectations, which are facing sharp correction pressures, stocks that have demonstrated concrete improvements in profitability and momentum in securing global approvals are seeing strong inflows of bargain-hunting buyers and funds seeking to hedge against earnings declines.

“HLB INC. Group” Stands Out with Full-Scale Commercialization of U.S.-Approved New Drugs and CEO-Led Responsible Management

According to KG Zeroin MP DOCTOR, four biotech companies— HLBbioStep(278650), HLB PHARMACEUTICAL(047920), Icure Pharmaceutical Incorporation(175250), and DaewonPharmaceutical(003220) —made the “Top 20 Gainers” list based on all stocks traded on the domestic stock market that day.

HLBbioStep closed at 6,140 won, surging 16.95% (890 won) from the previous day. HLB PHARMACEUTICAL, another affiliate of the same group, also settled at 10,640 won, up 11.88% (1,130 won). In addition, Icure Pharmaceutical Incorporation—which successfully returned to profitability for the first time in nine years and had its trading suspension lifted—rose 11.60% (159 won) to 1,530 won, DaewonPharmaceutical, which announced the success of Phase 3 clinical trials for its next-generation potassium-competitive acid blocker (P-CAB) drug, closed at 8,590 won, up 11.56% (890 won).

Following the U.S. Food and Drug Administration (FDA) approval of its new drug for bile duct cancer—which came after the approval of its liver cancer drug—HLB INC. launched a full-scale commercialization drive, driving up stock prices across the entire group. A key factor behind the stock price rise is the accelerated commercialization of “Ripictu,” a bile duct cancer treatment developed by its U.S. subsidiary, Eleva Therapeutics. Ripictu received FDA approval last September for the treatment of locally advanced or metastatic bile duct cancer with FGFR2 gene fusions or rearrangements.

Eleva recently participated with a dedicated booth at the European Society for Medical Oncology (ESMO 2026) conference held in Madrid, Spain, where it engaged in in-depth discussions with local healthcare professionals and global distribution partners regarding its U.S. launch strategy. Based on superior clinical data compared to existing competitive drugs, Ripictu is expected to command a 15–20% premium when insurance reimbursement pricing is determined in the U.S. This structure enables the company to secure higher profitability than existing treatments, which currently cost around $30,000 (approximately 40 million won) per month. The company has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) and is undergoing review, raising expectations for overseas market expansion.

The company’s openness to strategic partnerships with global big pharma has also stimulated investor interest. Jin Yang-gon, Chairman of HLB Group, recently revealed at an Investor Relations Day (IR Day) that while the company will maintain its direct sales system, it will flexibly consider partnerships if major global pharmaceutical companies propose sharing sales networks or expanding indications to additional cancer types.

In addition, the company’s renewed application for approval of the combination therapy of riboceranib and camrelizumab—the group’s flagship pipeline—as a first-line treatment for liver cancer is progressing smoothly. After resolving issues related to manufacturing facilities, the company has entered the FDA’s re-review process and, assuming a Class 1 classification, is on track to secure final approval by the end of the year.

The owner’s repeated share purchases have further bolstered confidence in the company. Chairman Jin, who holds a 99% personal stake, has personally demonstrated his commitment to responsible management by purchasing shares of affiliates—including HLB Therapeutics(115450), HLB innoVation(024850), and GenoFocus, Inc.(187420) —15 times in a row through the financial investment firm Epoque, in which he holds a 99% stake, and under his personal name. With major events on the horizon—including the announcement of topline results from the U.S. Phase 3 clinical trial for the treatment of neurotrophic keratitis (RGN-259) next month—the revaluation of the group’s overall stock valuations is expected to accelerate.

An HLB INC. official emphasized, “While thoroughly preparing for the successful launch of Ripictu, a new drug for cholangiocarcinoma, in the U.S. market, we will continue to demonstrate the clinical results of our follow-up pipeline, including Riboceranib, without any setbacks,” adding, “The management’s share purchases also reflect their confidence in the Group’s future growth potential.”

‘DaewonPharmaceutical’ Bets Big on P-CAB Phase 3 Clinical Trial Success and Extended-Release Formulations for Chronic Diseases

DaewonPharmaceutical’s stock price soared as news of the major clinical success of its next-generation drug for gastroesophageal reflux disease (GERD) coincided with its push into the hyperlipidemia combination therapy market. The company previously announced that its P-CAB-class drug candidate, “Padoprazan” (DW4421), successfully met the primary efficacy endpoint in a domestic Phase 3 clinical trial and fully demonstrated non-inferiority compared to existing proton pump inhibitors (PPIs).

This Phase 3 trial was conducted at 22 major medical institutions in Korea, involving 328 patients with erosive gastroesophageal reflux disease (ERD). When the 20 mg and 40 mg padoprazan groups were compared with the current standard treatment, 40 mg esomeprazole, the drug demonstrated therapeutic efficacy equal to or better than the comparator in terms of the cure rate for esophageal mucosal defects. There was also no statistically significant difference in the incidence of adverse drug reactions, confirming a favorable safety profile.

Unlike existing PPIs, P-CAB formulations can be taken regardless of meal timing and take effect very quickly. The domestic P-CAB market is experiencing explosive growth, with annual outpatient prescription sales exceeding 400 billion won. DaewonPharmaceutical plans to formally apply for marketing authorization for padoprazan with the Ministry of Food and Drug Safety within the year and, concurrently, conduct a Phase 3 clinical trial for non-erosive gastroesophageal reflux disease (NERD) to expand its indications.

The company has also secured a strong cash cow in the chronic disease treatment sector. DaewonPharmaceutical recently began a full-scale push into the 55 billion won market for combined hyperlipidemia treatments with “Uptaba Extended-Release Tablets,” a new drug combining pitavastatin and fenofibrate choline. Uptava SR Tablets utilize proprietary formulation technology to reduce volume by as much as 43% compared to existing capsule formulations. A key strength is that it maximizes medication compliance for patients with chronic conditions who must swallow multiple pills daily. Additionally, by incorporating a hydrophilic choline salt, the formulation completely eliminates the restriction of taking the medication only after meals, allowing for convenient administration even on an empty stomach.

Phase 3 clinical trial results confirmed its overwhelming efficacy, showing a reduction in triglycerides of approximately 40% and an increase in beneficial high-density lipoprotein (HDL) cholesterol of 21% compared to the monotherapy group. DaewonPharmaceutical, which has dramatically reduced manufacturing costs by shifting to in-house production, plans to grow Upta-B SR into a blockbuster product by increasing its outpatient prescription sales to 13 billion won next year.

A DaewonPharmaceutical official stated, “The success of the Phase 3 trial for padoprazan has laid the groundwork for us to emerge as a key player in the rapidly growing gastrointestinal P-CAB market,” adding, “We will aim to achieve both revenue growth and profitability by leveraging our robust prescription drug (ETC) portfolio, led by UpTaba Extended-Release Tablets, which offer significantly improved convenience.”

Return to Profit After 9 Years, Stable Corporate Governance… Icure Pharmaceutical Incorporation Leaps into the Global K-Beauty

Market
Having shaken off the burden of a trading suspension that lasted about a year, Icure Pharmaceutical Incorporation’s stock price is believed to have surged on the back of its return to operating profit after nine years and its successful entry into the global beauty market. The Korea Exchange (KRX) completely resolved the risk of a prolonged trading suspension last month by deciding to maintain Icure Pharmaceutical Incorporation’s listing following a substantive review of its listing eligibility. Additionally, through a 25 billion won third-party private placement, SOLUM became the new largest shareholder; the new largest shareholder has pledged a voluntary three-year lock-up period on all held shares, ensuring management stability and transparency in corporate governance.

These improvements in the company’s fundamentals immediately translated into strong financial results. In the first half of this year, Icure Pharmaceutical Incorporation recorded standalone revenue of 69.7 billion won, achieving high growth of approximately 80% compared to the same period last year. Notably, the company succeeded in turning its operating profit positive in both its consolidated and standalone financial statements. The return to an operating profit on a standalone basis is a valuable achievement, realized for the first time in nine years.

The primary driver of this earnings turnaround is the high-margin cosmetics Original Design Manufacturing (ODM) business. As domestic and international indie beauty brands have performed well in the global market, demand for Icure Pharmaceutical Incorporation’s skincare products, patented hydrogel mask packs, and soft capsule formulations has skyrocketed. The company’s state-of-the-art production infrastructure, fully compliant with international certifications such as CGMP and ISO 22716, has directly led to a surge in large-scale orders.

The company’s technological differentiation has also been recognized on the world stage. Icure Pharmaceutical Incorporation’s self-developed “Electragon Gel Cream” was the only product from a Korean company selected as a finalist in the Skincare Formula category at the “2026 Cosmopack Asia Awards,” Asia’s largest beauty exhibition. It was highly praised for its innovation in combining dragon fruit and stem cell-derived ingredients with a complex emulsified gel system to deliver results comparable to those achieved with skin care devices.

Its export channels are also expanding rapidly. The company is steadily increasing its export share by securing major global distribution networks—such as Amway China, Russian retail giant Gold Apple, and U.S.-based Kiss New York—as direct export clients.

An Icure Pharmaceutical Incorporation official stated, “With the resumption of trading, we have completely eliminated governance risks and, driven by growth in our core business of cosmetics ODM, have reached a significant turning point by returning to profitability for the first time in nine years.” The official added, “We will solidify a stable trend of profitability through our proprietary formulation technology and diversification of overseas clients.”