[Yu Jin-hee, Edaily Reporter] The driving force behind the KOSDAQ rebound on the 28th was the pharmaceutical, biotechnology, and medical device (bio) sector, led by the HLB Group. Overcoming macroeconomic uncertainties and a prolonged period of market adjustment, frozen investor sentiment in the bio sector thawed rapidly as tangible milestones converged—including regulatory approvals from global agencies, the establishment of overseas footholds, and the validation of next-generation drug platforms. Market participants view the broad rally—which hit the daily price limit—as an important turning point signaling a return of optimism to the broader bio industry.

Historic U.S. FDA Full Approval for ‘LYRFIGTU’… 10 HLB Group Affiliates Hit Daily Limit in Tandem

According to financial data provider KG Zeroin MP DOCTOR, as many as 12 biotech companies made it onto the domestic stock market’s list of the top 15 daily gainers that day. Signaling the start of the rally, HLB Therapeutics surged 30.00% to close at its upper limit of 9,620 KRW. Following suit, 10 affiliates of the HLB Group—including HLB, HLB Life Science, HLB Panagene, and HLB Innovation—all hit their daily upper price limits, creating an extraordinary market spectacle.

Medical artificial intelligence (AI) specialist VUNO jumped 29.98% to 7,240 KRW, while BNC Korea, which presented validation data for its obesity therapy platform, also surged 29.98% to 3,425 KRW, jointly reinforcing the sector-wide momentum.

Market experts note that the biotech investment landscape, previously driven by vague thematic expectations, is shifting toward companies that demonstrate tangible business execution through clear clinical data, overseas regulatory approvals, and export contracts. HLB, VUNO, and BNC Korea each stand at a strategic crossroads, driven by distinct fundamental catalysts.

The catalyst for aggressive buying across HLB Group stocks was the U.S. Food and Drug Administration (FDA) approval of LYRFIGTU (active ingredient: lirafugratinib), a targeted therapy for cholangiocarcinoma (bile duct cancer). News of the approval, announced just before the Chuseok holiday, filtered into the first trading session after the break, triggering limit-up surges across the group’s listings.

Elevar Therapeutics, HLB’s U.S. subsidiary, announced on the 23rd (local time) that the U.S. FDA had approved LYRFIGTU as a second-line therapy for adult patients with previously treated, unresectable, locally advanced, or metastatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.

Elevar secured global commercialization rights to the drug from U.S.-based Relay Therapeutics in 2024 and plans to launch the therapy in the U.S. market during the fourth quarter of this year. Market enthusiasm was heightened because LYRFIGTU received “Full Approval” with no mandatory post-marketing confirmatory trial requirements, unlike existing competitor drugs—Incyte’s Pemazyre and Taiho Oncology’s Lytgobi—which entered the market via accelerated approval pathways. In rare cancer areas where patient recruitment and confirmatory trials are challenging, this approval removes a critical regulatory hurdle.

Clinical efficacy and safety metrics also stood out. In the Phase 1/2 clinical study that served as the basis for FDA approval, LYRFIGTU demonstrated an objective response rate (ORR) of 46% and a median duration of response (mDoR) of 11.8 months, exceeding the 30% to 40% response rates seen with earlier treatments. By selectively targeting FGFR2 and minimizing the inhibition of off-target FGFR family members, the incidence of side effects such as hyperphosphatemia was reduced to about 20%.

Significant hurdles remain. The annual incidence of newly diagnosed cholangiocarcinoma in the U.S. stands at approximately 8,000 cases, with FGFR2 fusions present in only about 15% of intrahepatic cases. Since the initial target addressable market is niche, commercial penetration will depend on competition for prescription market share against the incumbent Pemazyre (annual net sales of roughly 120 billion KRW), as well as Elevar’s execution across U.S. distribution networks and reimbursement listings.

HLB is accelerating label and territory expansions to broaden commercial potential. The company submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) this month and is conducting the global Phase 2 “ReFocus202” clinical trial across solid tumors other than cholangiocarcinoma, targeting FGFR2 alterations under a tumor-agnostic strategy.

“The full FDA approval of LYRFIGTU for cholangiocarcinoma is a beginning rather than an end,” said HLB Group Chairman Jin Yang-gon. “We will maximize therapeutic value by expanding indications across diverse solid tumor types and advancing combination regimens with pipeline candidates from global pharmaceutical leaders.”

Unlocking China’s Hainan Medical Zone…VUNO Rallies on Exclusive Commercial Contract

Leading medical AI company VUNO surged to its daily price limit after announcing overseas expansion into China, the company’s largest potential regional market. On the 28th, VUNO announced that it had signed an exclusive two-year distribution agreement with Chinese medical firm Guorun for its AI-powered cardiac arrest risk prediction system, VUNO Med-DeepCARS, in Hainan Province.

Under the agreement, the two companies will conduct a Proof of Concept (PoC) at key hospital sites within the Boao Lecheng International Medical Tourism Pilot Zone.

The Boao Lecheng Pilot Zone operates under a special administrative framework that allows medical devices and therapies approved outside of China to be used in designated hospitals prior to formal national regulatory clearance. VUNO aims to complete hospital administrative registrations within six months, using this pathway to collect local real-world clinical data and commercial usage records to expedite formal approval from the National Medical Products Administration (NMPA) across mainland China.

Concurrently, VUNO’s AI fundus analysis software, VUNO Med-Fundus AI, has been integrated with the chronic disease management platform of its Chinese partner, BioVision, and the company is pursuing commercial supply agreements with public medical centers in Yangzhou, Jiangsu Province. This dual-track strategy aims to tap into China’s primary healthcare institutions, where ophthalmic specialists are scarce.

However, behind the rally to the upper limit lie unresolved structural risks and the reality of a substantial rights offering. Following CEO Lee Ye-ha’s return to the executive suite, VUNO divested non-core assets to focus resources on DeepCARS. As a result, DeepCARS’ first-half revenue reached 10.4 billion KRW, accounting for 85.8% of the company’s total first-half revenue of 12.2 billion KRW, signaling a high reliance on a single product.

DeepCARS’s domestic evaluation deferral period ended in March, and the device is currently undergoing a New Health Technology Assessment by the National Evidence-based Healthcare Collaborating Agency (NECA). Although it is deployed across 154 general hospitals, failure to pass the assessment would halt non-reimbursed clinical use and wipe out over 85% of the company’s revenue, creating a major business continuity risk that could trigger reviews of its listing eligibility. Meanwhile, the company’s expansion into the U.S. has been delayed after receiving an NSE (Not Substantially Equivalent) determination under the FDA’s 510(k) pathway in April; preparations for resubmission are scheduled for later this year.

Financial pressures from accumulated deficits persist. Having posted a net loss of 9.4 billion KRW in the first half, VUNO completed a 31.4 billion KRW rights offering with existing shareholders, followed by a public offering of forfeited shares. As 20 billion KRW is earmarked to retire perpetual convertible bonds (CB), the remaining capital for R&D and regulatory milestones is severely constrained. CEO Lee’s planned commitment to subscribe to roughly 7% of his allocated shares could dilute his equity stake to around 11%, adding to governance pressures.

“Entry into China’s pilot medical zone is a significant breakthrough, but VUNO’s ultimate operational trajectory depends on passing Korea’s New Health Technology Assessment and successfully clearing the FDA resubmission in the fourth quarter,” commented a source in the medical AI industry. “The company must secure core operational cash flows within the runway provided by the 31.4 billion KRW capital raise.”

Achieving Up to 30% Weight Reduction in Animal Models…BNC Korea Advances Triple-Agonist Obesity Pipeline

BNC Korea hit the upper limit following the release of non-clinical data for its long-acting triple-agonist obesity therapy candidate, co-developed with ProAppTec. Speculative and institutional buying converged after the study suggested efficacy surpassing existing market standards Wegovy and Mounjaro.

According to BNC Korea, repeated six-week administration of the candidate—engineered using AI-assisted peptide design and site-specific conjugation platform technology—achieved up to approximately 30% body weight reduction in diet-induced obesity (DIO) mice. Under identical experimental conditions, the control group treated with Novo Nordisk’s Wegovy (semaglutide) recorded weight loss of up to 23%.

The candidate acts simultaneously on three metabolic receptor targets: glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), and glucagon (GCG). By concurrently suppressing appetite, stimulating insulin secretion, and increasing energy expenditure, the agent aims to maximize overall weight loss efficiency.

The candidate also demonstrated suppression of weight regain following treatment cessation. The post-treatment weight recovery rate was 27.3%, significantly lower than the 47.4% observed in the Wegovy and Mounjaro (tirzepatide) arms. The developers interpret this as non-clinical evidence that weight-loss benefits may persist longer after stopping drug administration.

The in vivo half-life was also extended. In human FcRn transgenic mice that model human albumin recycling dynamics, the candidate’s terminal half-life reached approximately 41 hours—roughly five times longer than Wegovy’s seven hours under equivalent conditions. This profile opens up the technical possibility of transitioning from once-weekly to once-monthly dosing regimens.

Market analysts advise maintaining a balanced perspective regarding early preclinical animal data. Triple-agonist peptide candidates present complex safety considerations, including increased heart rate and gastrointestinal tolerability, and pharmacodynamic findings in rodents often face hurdles when translated to human subjects.

BNC Korea plans to finalize the selection of its lead candidate based on these findings and compile nonclinical safety, pharmacokinetic (PK), and chemistry, manufacturing, and controls (CMC) dossiers to pursue global licensing-out (L/O) agreements and investigational new drug (IND) applications simultaneously.

“These results validate both the potent weight-reduction efficacy of our co-developed triple-agonist candidate and its therapeutic potential as an extended-interval sustained-release agent at the preclinical stage,” said Choi Wan-gyu, CEO of BNC Korea. “Through rigorous subsequent non-clinical evaluations, we will advance this program into a globally competitive next-generation obesity therapeutic.”