[Edaily Reporter Kim Seung-kwon ] On the 29th, #AriBioHoldings announced it was withdrawing the absorption merger with AriBio, a plan it had been pursuing for over two years, causing its stock to plummet to the daily lower limit in after-hours trading. In contrast, LAMEDITECH Co., Ltd.(462510)hit the daily upper limit on anticipation of the launch of its extracellular matrix (ECM) skin booster. HLB PHARMACEUTICAL(047920)HLB INC. surged more than 20% for two consecutive days on the back of the U.S. Food and Drug Administration (FDA) approval of its new bile duct cancer drug “Ripictu,” while medical artificial intelligence (AI) company VUNO, Inc.(338220)rose by more than 20% for the second day in a row following news of its expansion into China.

AriBio Holdings Hits Daily Low Following Withdrawal of Merger with AriBio

According to KG Zeroin, #AriBioHoldings (formerly Solux Co., Ltd.) closed regular trading at 3,920 won, down 1.75% from the previous trading day. However, after the market closed, the company announced the withdrawal of its absorption merger with AriBio, triggering a flood of sell orders on the Nextrade (NXT) after-market platform, causing the stock to plummet to the daily price limit.

Both companies announced that they held separate board meetings that day and signed an agreement to terminate the absorption merger contract. Consequently, all merger procedures—including the extraordinary general meeting of shareholders scheduled for January of next year, the right to demand share repurchase, and the merger effective date—have been canceled. The two companies had repeatedly postponed the schedule since signing the merger agreement in August 2024. Just a week ago, on the 22nd, they issued a corrected disclosure postponing the merger date from December 4 of this year to February 11 of next year.

The direct reason for the withdrawal is the burden of the right to demand the purchase of shares. According to the withdrawal notice, AriBio Holdings’ benchmark stock price fell significantly below the share purchase price calculated in accordance with the law. Under the recently amended merger agreement, the buyout price for AriBio Holdings shareholders was set at 10,719 won per share, which is 2.7 times the current stock price. From the shareholders’ perspective, it was more advantageous to oppose the merger and request the company to buy back their shares than to sell them on the market. The fact that the securities registration statement for the issuance of new merger shares had repeatedly been requested for amendments by the Financial Supervisory Service also acted as a burden.

A change in AriBio’s enterprise value was another factor. Last May, AriBio signed an agreement with China’s Fosun Pharmaceutical for exclusive global development and commercialization rights to “AR1001,” an oral dementia treatment candidate, valued at up to $4.7 billion. AriBio explained that, given the fluctuation in the stock’s benchmark value resulting from this additional exclusive sales rights agreement, holding an extraordinary general meeting would likely trigger a large volume of buyout requests; therefore, the merger was halted to mitigate the associated risks.

The stock price had been heavily driven by expectations for the merger. Although AriBio Holdings carried out a large-scale stock split in December 2023—allocating 14 new shares for every existing share—investor anxiety persisted as the merger was delayed due to repeated requests for corrections from the Financial Supervisory Service. Last December, the company received a notice of designation as a company with inadequate disclosures due to repeated revisions to its disclosures, and in June of this year, it changed its name from Solux Co., Ltd. to AriBio Holdings. Concerns were also high regarding the dilution of existing shareholders’ stakes, as the new shares issued through the merger were expected to amount to approximately 103% of the existing number of issued shares.

The collapse of the merger does not necessarily mean the suspension of new drug development. The global Phase 3 clinical trial for AR1001 and the contract with Fuxing Pharmaceutical will proceed separately. Moving forward, market attention is expected to shift to how AriBio will proceed with its initial public offering (IPO) and fundraising—whether through a standalone listing rather than a backdoor listing. AriBio had previously stated that, at the time of the contract with Fuxing Pharmaceutical, it was also considering the possibility of a standalone listing on the KOSPI, separate from the merger.

LAMEDITECH Co., Ltd. Hits Daily Price Limit Ahead of Launch of ECM Skin Booster ‘IoPhil’

LAMEDITECH Co., Ltd. closed at 4,035 won today, up 29.98% from the previous trading day. This marks the daily price limit. The stock price, which had remained in the 2,500-won range until mid-month, has risen by more than 50% in about two weeks.

The significance of this sharp rise becomes clear when looking at the stock’s one-year performance. LAMEDITECH Co., Ltd., which went public in June 2024 at an offering price of 16,000 won, soared to 56,000 won during intraday trading on its first day of listing but subsequently entered a downward trend as its earnings fell short of the projections provided at the time of its IPO. The 52-week high is 9,300 won, and the low is 2,290 won. Although the stock hit the daily price limit (5,920 won) last March following approval from the Ministry of Food and Drug Safety for “HandyRay Glue,” a combined personal laser blood-drawing and blood glucose monitoring device, it was unable to sustain those gains.

Analysts attribute this sharp rise to market anticipation as the launch of its new ECM skin booster business draws near. LAMEDITECH Co., Ltd. plans to supply its new skin booster brand, “IO-FILL,” to hospitals and clinics in Korea next month. In December of last year, the company signed an exclusive domestic distribution agreement with Iretec Korea, a fellow ECM specialist, and in May of this year, it received approval from the Ministry of Food and Drug Safety (MFDS) to operate a human tissue bank, thereby meeting the regulatory requirements to handle human tissue-derived materials.

What sets IO-FILL apart is its manufacturing process. According to the company, it uses a patented natural composite surfactant during the decellularization stage instead of the synthetic surfactants used in existing products, thereby reducing the risk of inflammation and fibrosis caused by chemical residues.

The company is promoting a “turnkey” strategy that bundles devices and materials. The “FX-7000M,” a laser device for clinics and hospitals for which the company applied for approval from the Ministry of Food and Drug Safety (MFDS) last July, is designed to enhance the efficiency of delivering active ingredients—such as ECM—into the dermis by utilizing laser microchanneling technology, which creates microchannels in the skin.

LAMEDITECH Co., Ltd. stated, “We plan to launch the product in the domestic market in the second half of this year as soon as approval from the Ministry of Food and Drug Safety is granted,” adding, “We will expand our product portfolio with a focus on laser medical devices and ECM-based aesthetic solutions.”

Market growth potential also supports this strategy. According to securities analysts, the domestic ECM skin booster market is projected to grow rapidly, from 9.9 billion won last year to 92.5 billion won this year and 172.9 billion won next year. However, there are concerns that price competition could intensify—similar to the toxin market—as companies such as GC WellBeing, Baim Global, and HLB Life Science enter the market in quick succession, following early entrants like L&C BIO’s “Rituo” and HANS BIOMED CORPORATION’s “Cell-D’em.” For LAMEDITECH Co., Ltd., a latecomer to the market, the key question is whether its differentiation through device integration will actually translate into prescriptions.

HLB PHARMACEUTICAL Soars for Two Consecutive Days on ‘Refictu’ FDA Approval

HLB PHARMACEUTICAL closed at 12,030 won, up 25.05% from the previous trading day. Following the previous day’s price limit up (9,620 won), the stock has risen approximately 63% over two days. Trading volume exceeded 7 million shares that day, increasing to more than 200 times the volume of the previous trading day (32,890 shares).

The direct catalyst was the new drug approval for the group’s parent company, HLB INC. On the 23rd (local time), HLB INC.’s U.S. subsidiary, Eleva Therapeutics, received FDA marketing approval for “Ripicto” (active ingredient: lirapugratinib) as a second-line treatment for cholangiocarcinoma with confirmed FGFR2 fusions or rearrangements. This marks the first time a South Korean company has directly submitted a New Drug Application (NDA) for a global anti-cancer drug to the FDA and received approval. On the 28th, following the end of the Chuseok holiday, HLB INC. and 10 other listed group companies all closed at their daily price limit.

In the “ReFocus” Phase 1 and 2 trials, which served as the basis for approval, “Ripictu” recorded an objective response rate (ORR) of 45.7% and a median duration of response (mDoR) of 11.8 months. Eleva is targeting a U.S. launch in the fourth quarter and has also submitted a marketing authorization application to the European Medicines Agency (EMA) this month. Market attention is now shifting to the resubmission of the application for a new liver cancer drug. Jin Yang-gon, Chairman of HLB INC., stated, “The CMC supplement for Hangzhou Pharmaceutical has already been completed,” and announced that the company would resubmit the application as soon as the latest safety data is finalized.

HLB PHARMACEUTICAL’s stock price has fluctuated significantly over the past year in response to group-related events. Although the 52-week high was 24,250 won, the group’s stocks plummeted last July after the new liver cancer drug received its third Complete Response Letter (CRL), with the price dropping to a low of 6,000 won. This month, however, the stock began a rebound, rising by over 18% on the 21st on the back of optimism surrounding a long-acting injectable dementia treatment, and is now up approximately 94% compared to its closing price on the 18th (6,210 won).

Core business performance is improving. HLB PHARMACEUTICAL posted its best-ever half-year results in the first half of this year, with consolidated revenue of 127.9 billion won—a 56.8% increase year-over-year. Prescription drugs (ETC) such as RosuDuo, Tinzar, and Citrosin saw double-digit growth, and the company’s ranking in outpatient prescriptions rose from 48th to 42nd. However, operating profit amounted to only about 1 billion won.

The company’s medium- to long-term growth driver is its proprietary long-acting injectable platform, “SMEB.” While the company has expanded its pipeline to include treatments for dementia, Parkinson’s disease, thrombosis, and obesity, critics point out that many of these remain in the preclinical stage, highlighting the need for tangible results. Given that the price-to-earnings ratio (PER) exceeds 100 times, investors must also consider valuation concerns separate from the group’s overall momentum.

An HLB PHARMACEUTICAL official stated, “The company’s performance was driven by a combination of its subsidiaries’ results and growth in its existing pharmaceutical business,” adding that the company plans to continue improving profitability through in-house production at its new plant in Hyangnam.

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VUNO, Inc. Soars for Second Straight Day on Exclusive Sales Agreement for DeepCas in Hainan, China

VUNO, Inc. closed at 8,320 won, up 21.99% from the previous trading day. Following a 22.44% gain the day before, this marks the second consecutive day of gains in the 20% range.

The news driving the stock price was the company’s entry into the Chinese market. On the 28th, VUNO, Inc. announced that it had signed a two-year exclusive sales agreement with Guorun, a Chinese medical technology company, for “VunoMed DeepCAS,” an AI-based cardiac arrest prediction medical device, in Hainan Province. The two companies will conduct a proof of concept (PoC) at major hospitals within the Boao Lucheng International Medical Tourism Pilot Zone. This pilot zone is a special economic zone where drugs and medical devices approved overseas can be used in mainland China prior to local approval, potentially serving as a shortcut to reduce the time required for local market entry. In Jiangsu Province, the company is pursuing a contract with BioVision, a local chronic disease management platform provider, to introduce the fundus imaging AI “FundusAI.”

The stock price has faced a turbulent year. Although the 52-week high was 30,350 won, the price fell to a low of 4,235 won as DeepCas’s FDA approval was delayed due to requests for supplementary multiethnic data, followed by a rights offering and workforce restructuring. The closing price today remains more than 70% below the peak.

Earnings are also in a transitional phase. Last year’s revenue rose 35% to 34.8 billion won, but revenue for the first half of this year fell 27.6% year-over-year to 12.2 billion won, and the operating loss widened to 8.3 billion won. This is due to restrictions on new hospital adoptions as Deepcas entered the New Medical Technology Evaluation process. Since Deepcas sales account for 86% of the total at 10.4 billion won, the evaluation results—expected in the fourth quarter—are likely to be a turning point for the future stock price.

Meanwhile, HanmiPharm announced after the market closed today that it had received notice from U.S.-based Genentech regarding the termination of the technology transfer agreement and the return of rights for the oral targeted anticancer drug “Belvarapenib” (HM95573). HanmiPharm had licensed this compound to Genentech in September 2016 for a total of $910 million (approximately 1 trillion won at the time), consisting of an upfront payment of $80 million plus milestone payments of up to $830 million; the company is now regaining the rights to the compound after about 10 years. The termination will take effect on December 27, 90 days after the date of notification, and the $80 million upfront payment already received will not be returned. A HanmiPharm official stated, “This is a contractual termination procedure regarding a matter that Genentech had already officially announced it was discontinuing development on several years ago, and it was an expected outcome.”