[E-Daily Reporter SONG YOUNG-DOO ] Remedy and HLB INC., both making their KOSDAQ debuts, saw mixed fortunes. Remedy surged nearly double its initial public offering (IPO) price during the trading session, fueling expectations of a “first-day limit-up,” before giving back some of its gains due to profit-taking. Nevertheless, it recorded the highest rate of increase within the pharmaceutical and biotech sector, drawing significant investor attention.

In contrast, HLB INC. hit the daily price limit down as the fallout from the U.S. Food and Drug Administration’s (FDA) third Complete Response Letter (CRL) continued. LEMON COMPANY LIMITED, which listed on KOSDAQ last week, also saw its stock price plummet on the same day.

Soaring 67% Intraday Immediately After KOSDAQ Debut… Remedy Shows Strength Amid Volatility

According to KG Zeroin MP Doctor (MP DOCTOR) on the 13th, #Remedy, which made its debut on the KOSDAQ market that day, saw strong buying pressure immediately after the market opened. After starting trading at a price significantly above its initial public offering (IPO) price of 20,700 won, the stock soared to an intraday high of 34,650 won around 10 a.m.—a rise of approximately 67% from the IPO price.

Subsequently, a large volume of profit-taking selling emerged, causing the stock price to quickly give up its gains. Although the price dipped to 21,200 won during the afternoon session, buying interest at lower levels pushed the closing price to 22,000 won. Despite high volatility on its first day of listing, the company is regarded as having made a successful debut, posting the highest gain among pharmaceutical and biotech stocks.

The key factor driving the stock price higher is anticipation of winning a contract in India’s public healthcare procurement market. Remedy was the only participating company to pass the technical evaluation in a tender for portable digital X-ray systems being conducted by the government of Odisha, India. As a result, it advanced as the sole candidate to the price bidding stage—effectively the final hurdle—significantly increasing its chances of winning the contract.

Global radiology medical device companies participated in this tender and underwent a comprehensive evaluation of product performance, low-dose safety, manufacturing quality, and compliance with local technical specifications. Remedy was selected as the sole technically qualified bidder, thanks to its ultra-lightweight portable digital X-ray system and low-dose control technology.

Industry observers assess that this achievement carries significance beyond a mere state government tender. This is because India operates under a system where not only the central government but also individual state governments independently procure medical equipment, meaning a successful supply record in one region can serve as an important reference for tenders in other states.

Remedy has already supplied 1,534 portable X-ray units through the Indian central government’s National Tuberculosis Eradication Program (NTEP) and is shipping additional units this year. Securing this Odisha state tender is highly likely to have a positive impact on expanding into other state government procurement markets.

Expanded production capacity is another factor to watch. Current annual production capacity stands at 3,400 units and is scheduled to increase to 3,700 units this year, 7,000 units next year following the installation of automated equipment, and 7,700 units by 2028.

Cho Bong-ho, CEO of Remedy, stated, “Passing this technical evaluation as the sole bidder is a meaningful achievement that objectively validates our technological capabilities and product competitiveness in the global market.” He added, “Starting with Odisha, we will expand our business into the public healthcare market across India and do our utmost to improve local access to healthcare and promote public health.”

HLB INC. Stocks Continue to Plunge Following Third CRL

Meanwhile, HLB INC.(028300)closed at 25,650 won, down 29.92% (10,950 won) from the previous trading day. Selling pressure spread across the entire HLB INC. Group, with affiliate HLB PHARMACEUTICAL(047920)closing at 6,230 won, down 27.30% (2,340 won), and HLB Life Science(067630)closing at 1,640 won, down 26.46% (590 won).

The sharp drop in stock prices was triggered by the FDA’s third Complete Response Letter (CRL) regarding the combination therapy of the new liver cancer drug Riboceranib and Camrelizumab. The stock hit the daily price limit down for two consecutive trading days.

This CRL was not due to issues with the clinical efficacy or safety of riboceranib, but rather stemmed from findings identified during a Current Good Manufacturing Practice (cGMP) inspection of the manufacturing facility of China’s Hengrui Pharmaceuticals, which was included in the New Drug Application (NDA). The FDA notified the company that it cannot approve the application until the findings at the manufacturing facility are resolved and compliance with cGMP standards is confirmed. The CRL also stated that an additional Pre-Approval Inspection (PAI) may be conducted if necessary.

HLB INC. explained that since this inspection was a general cGMP inspection targeting the Hangzhou Pharmaceutical manufacturing facility—rather than a PAI for approval review—neither Eleva nor HLB INC. were informed in advance of the inspection or the issuance of Form 483. The company has officially requested Form 483, supplementary materials, and an estimated timeline for completion of corrective actions from Hangzhou Pharmaceutical.

The company emphasized that this CRL pertains to manufacturing facility issues unrelated to clinical results. Kim Dong-geon, CEO of Eleva, stated, “This CRL did not include any findings regarding clinical efficacy or safety data, nor did it require additional clinical trials,” adding, “Since the main requests for corrective action relate to the cGMP inspection of the manufacturing facility, we will consult closely with the FDA and Hangzhou Pharmaceutical to confirm the necessary procedures and proceed with a resubmission as soon as possible.”

Nevertheless, the market appears to be reacting more strongly to the fact that this is the third CRL. This is because repeated approval delays have caused investor fatigue to mount, and the timeline for resubmission and the timing of final approval have once again become uncertain.

Profit-taking after a short-term surge... LEMON COMPANY LIMITED also plunges 29%

In addition to HLB INC., #LemonHealthcare also saw a sharp decline, approaching the daily price limit. Lemon Healthcare closed at 6,980 won, down 28.78% (2,820 won) from the previous trading day.

LEMON COMPANY LIMITED hit the daily upper price limit on the 7th, its first day of trading on KOSDAQ, rising to 12,220 won, and drew market attention the following day by surging to 14,540 won during intraday trading. However, profit-taking selling pressure continued afterward, causing the stock to decline for five consecutive trading days, and it had given back most of its gains by the end of the day.

Market observers attribute the increased volatility to a combination of profit-taking following the initial sharp rise and a general decline in investor sentiment across the biotech sector.

However, the company maintains that there are no specific negative factors behind this sharp drop in its stock price. In a phone interview with Edaily, LEMON COMPANY LIMITED President Im Chi-kyu stated, “There have been no specific issues so far, and while the company is analyzing the causes of the stock price decline, our business is proceeding as planned.”

LEMON COMPANY LIMITED is a medical data platform company that connects hospital medical information systems with insurance companies. It operates “Claim God,” a simplified claims service for out-of-pocket medical insurance, and “Silson24,” the government’s out-of-pocket medical insurance claims service. Last year, the company recorded revenue of 15.9 billion won and an operating loss of 600 million won; this year, it aims to return to profitability with revenue of 24.1 billion won and an operating profit of 6.5 billion won. The company is expanding its medical MyData business by operating its platform at approximately 130 major hospitals, including Seoul National University Hospital, Asan Medical Center, and Severance Hospital.