[Edaily Reporter YU JIN-HEE ] On the 28th, the pharmaceutical, biotech, and medical device (bio) sectors—led by HLB Group—were the driving force behind the KOSDAQ market’s rebound. Breaking through macroeconomic uncertainty and a prolonged correction, a convergence of major tangible developments—including approvals from global regulatory agencies, the establishment of overseas bases, and the validation of next-generation drug platforms—appears to be rapidly reviving the previously frozen investment sentiment in the bio sector. The market views today’s surge of stocks hitting their daily price limit as a significant inflection point signaling that positive momentum is spreading across the entire bio sector.

“Ripictu” Secures Full U.S. FDA Approval… HLB INC.’s 10 Companies Hit Daily Price Limits in Unison

According to financial information provider KG Zeroin MP Doctor (MP DOCTOR), 12 biotech companies made it onto the list of the top 15 gainers on the domestic stock market today. Among them, HLB PHARMACEUTICAL(047920)soared to the daily price limit (30.00%) with a closing price of 9,620 won, serving as a catalyst for a remarkable scene in which 10 HLB INC. affiliates—including HLB INC.(028300), HLB Life Science(067630), HLB PANAGENE(046210), and HLB innoVation(024850)—all hit their daily price limits simultaneously.

In addition, medical AI company VUNO, Inc.(338220)rose 29.98% to 7,240 won, and BNC Korea Co, Ltd(256840) —which has demonstrated the efficacy of its new obesity treatment platform—also jumped 29.98% to 3,425 won, both settling at their daily price limits and contributing to the momentum of the biotech market.

Experts assess that the biotech investment landscape—which had previously relied on vague expectations—is shifting toward companies that have demonstrated “tangible commercialization” through concrete clinical results, approvals from global regulatory agencies, and export contracts. In particular, HLB INC., VUNO, Inc., and BNC KOREA—each with its own distinct momentum—are at an inflection point in the market, drawing significant attention to the future direction of their stock prices.

The trigger for the explosive buying spree that swept across the entire HLB INC. Group was the U.S. Food and Drug Administration (FDA) approval of “Lyrfigtu” (LYRFIGTU; generic name: lirapugratinib), a targeted anticancer drug for cholangiocarcinoma. The good news, announced just before the Chuseok holiday, was reflected on the first trading day after the holiday, sending the shares of all 10 group companies straight to their daily price limits.

Elevate Therapeutics announced on the 23rd (local time) that the U.S. Food and Drug Administration (FDA) had approved LYRFIGTU as a second-line treatment for adults with locally advanced or metastatic cholangiocarcinoma associated with fibroblast growth factor receptor 2 (FGFR2) gene fusions or rearrangements. Elevate Therapeutics is HLB Therapeutics’ U.S. subsidiary.

Ripicto is a new drug for which Eleva acquired global exclusive rights from U.S.-based Relay Therapeutics in 2024. It is set to launch in the U.S. market in the fourth quarter of this year. The market’s enthusiasm stems from the fact that, unlike existing competitors such as Insight’s “Pemazyre” or Daiho Oncology’s “Litgovi,” Ripictu received “Full Approval”—which waives the requirement for a confirmatory clinical trial—rather than Conditional Accelerated Approval. Given the nature of rare cancers, where recruiting subsequent patients and conducting confirmatory clinical trials is extremely challenging, this effectively resolves regulatory uncertainty entirely.

Its clinical efficacy and safety have also been demonstrated. In the Phase 1 and 2 clinical trials that served as the basis for FDA approval, Lipictu recorded an objective response rate (ORR) of 46% and a median duration of response (mDoR) of 11.8 months, outperforming the response rates of existing treatments, which range in the 30–40% range. By minimizing off-target FGFR inhibition and selectively targeting only FGFR2, the drug has also significantly reduced the incidence of side effects—such as hyperphosphatemia—to around 20%.

The challenges are clear. There are approximately 8,000 new cases of bile duct cancer in the U.S. annually, and FGFR2 mutations are present in only about 15% of these cases of intrahepatic bile duct cancer. Given the narrow market itself, early performance is expected to hinge on competition for prescriptions with Pemazyre—which has already secured a market foothold (with annual sales of approximately 120 billion won)—as well as Eleva’s capabilities in U.S. distribution and securing insurance coverage.

To overcome market limitations, HLB is accelerating its expansion into new territories. The company submitted a marketing authorization application to the European Medicines Agency (EMA) this month and is pursuing expansion into a tumor-agnostic anticancer drug through the global Phase 2 clinical trial “Refocus202,” which targets the genetic mutation itself in patients with non-bile duct solid tumors.

Jin Yang-gon, Chairman of HLB INC., emphasized, “The full approval of Ripicto for bile duct cancer is not the end, but a new beginning,” adding, “We will maximize its therapeutic value by expanding its indications to various solid tumors and through combination therapies with global big pharma pipelines.”

China’s Hainan Medical Special Zone Opens Its Doors… VUNO, Inc. Stages a Comeback Thanks to an Exclusive Agreement

VUNO, Inc.’s stock soared to the daily price limit after announcing its entry into China, its largest potential market. On the 28th, VUNO, Inc. announced that it had signed an exclusive sales agreement with Chinese medical technology firm Guorun for its AI-based cardiac arrest prediction device, “VUNO Med-DeepCARS,” in Hainan Province. Under the two-year agreement, the company will aggressively pursue proof-of-concept (PoC) testing at major hospitals within the “Boao-Lucheng International Medical Tourism Pilot Zone,” a special economic zone designated by the Chinese government for medical tourism.

The Boao-Lucheng Pilot Zone operates a special system that allows hospitals within the zone to prioritize the prescription of medical devices approved overseas before they receive formal approval in mainland China. VUNO, Inc. plans to complete administrative registration within six months and proactively secure local clinical data and prescription records to significantly shorten the approval period with the China National Medical Products Administration (NMPA) for mainland China.

In addition, its AI-powered fundus image diagnostic assistance solution, “VUNOMed Fundus AI,” has completed integration with China BioVision’s chronic disease management platform and is currently pursuing a supply contract with public medical institutions in Jiangsu Province. This two-track strategy—targeting China’s primary care sector, where there is a shortage of ophthalmologists—has been well received.

However, behind this rebound to the daily price limit lie the structural risks VUNO, Inc. faces and the harsh reality of a rights offering. Since CEO Lee Ye-ha’s return to the helm, VUNO, Inc. has divested non-core businesses and concentrated its management resources on DeepCAS. As a result, DeepCAS’s revenue in the first half of this year reached 10.4 billion won, accounting for 85.8% of total revenue, indicating a deepening reliance on a single product.

Following the end of its evaluation deferral period last March, DeepCAS is currently undergoing a new medical technology evaluation by the National Evidence-based Healthcare Research Institute (NECA). Although DeepCAS has been deployed at 154 tertiary general hospitals nationwide, if it fails to pass the evaluation—even in the unlikely event—prescriptions for non-covered services will be suspended, causing more than 85% of revenue to vanish overnight. This is a critical factor that could trigger a substantive review of the company’s eligibility for listing. The company’s expansion into the U.S. market has also hit a snag, as it received a non-compliance determination during the FDA 510(k) review last April and is currently preparing to resubmit its application within the year.

Financial burdens stemming from accumulated losses also persist. VUNO, Inc., which posted a net loss of 9.4 billion won in the first half of the year, carried out a 31.4 billion won rights offering. Since 20 billion won must be allocated to repaying perpetual convertible bonds (CBs), the funds available for research and development and regulatory approvals are limited. If CEO Lee, the largest shareholder, subscribes to only about 7% of the offering, his stake will be diluted to the 11% range, increasing the burden of defending management control.

A source in the medical AI industry noted, “While entering China’s special economic zones is an excellent breakthrough, VUNO, Inc.’s fate ultimately hinges on passing the New Medical Technology Evaluation in the fourth quarter and the success or failure of its renewed attempt to gain FDA approval,” adding, “The company must establish a profitable business model within the ‘golden window’ secured by the 31.4 billion won raised through the rights offering.”

30% Weight Loss in Animals… BNC KOREA Reports “Results” for Triple-Action Obesity Drug

BNC KOREA’s stock price shot straight to the daily upper limit following the release of preclinical results for a triple-action, long-acting obesity treatment candidate it is jointly developing with ProAppTech. News that the data surpassed the efficacy of “Wegovy” and “Mounjaro”—which currently dominate the global pharmaceutical market—spurred buying interest.

According to BNC KOREA, by combining AI-based protein sequence design with a site-specific conjugation platform technology, the company administered the candidate compound to diet-induced obese (DIO) mice for six weeks and confirmed a body weight reduction of up to approximately 30%. Under the same test conditions, this result significantly outperformed the weight loss rate (23%) recorded by Novo Nordisk’s Wegovy (semaglutide), which served as the control group.

This candidate compound works by simultaneously activating three receptors: glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), and glucagon (GCG). It maximized weight loss efficiency not only by suppressing appetite and promoting insulin secretion but also by increasing energy expenditure itself.

It also demonstrated outstanding performance in suppressing the yo-yo effect after discontinuation. The weight regain rate—the percentage of participants who regained weight after stopping the drug—was only 27.3%, significantly lower than the 47.4% rate observed for Wegovy and Mounjaro (tirzepatide). This suggests that the weight loss effect can persist for a long time even after discontinuing the drug.

The half-life in the body has also been dramatically extended. In mouse experiments simulating the human albumin recirculation environment (human FcRn transgenic mice), the candidate compound’s half-life was approximately 41 hours—more than five times longer than that of Wegovy (approximately 7 hours) under the same conditions. This is seen as opening the door to the development of next-generation formulations that could be administered once or twice a month, moving beyond the current once-weekly dosing schedule.

However, some market observers are cautioning against excessive optimism regarding the initial animal study data. This is because securing a safety margin for triple-action peptide agents—which can cause increased heart rate or gastrointestinal toxicity—is challenging, and it is common for nonclinical results in rodents not to be directly replicated in human clinical trials.

Based on these results, BNC KOREA plans to finalize the lead compound, establish a nonclinical safety and pharmacokinetic (PK) package, and simultaneously pursue technology licensing (L/O) with global pharmaceutical companies and file an Investigational New Drug (IND) application.

Choi Wan-kyu, CEO of BNC KOREA, stated, “We have confirmed not only the excellent weight-loss efficacy of the co-developed candidate compound but also its potential for success as a monthly sustained-release formulation at the preclinical stage,” adding, “Through thorough follow-up validation, we will develop it into a next-generation obesity treatment drug with global competitiveness.”