[Song Young Doo, Edaily Reporter] The Korean biotech sector saw sharply diverging performances on July 13, with newly listed Remedi emerging as the day’s standout performer, while HLB extended its selloff following another setback from the U.S. Food and Drug Administration (FDA). Lemon Healthcare, which debuted on the KOSDAQ last week, also suffered a steep decline after its recent rally.

Remedi Jumps 67% Intraday on India Tender Expectations

According to KG Zeroin’s MP DOCTOR, Remedi, which made its KOSDAQ debut on Monday, attracted strong buying interest immediately after the market opened. The stock climbed to an intraday high of 34,650 KRW, up approximately 67% from its IPO price of 20,700 KRW.

Profit-taking later erased much of the early gains, with the stock falling as low as KRW 21,200 during afternoon trading before closing at KRW 22,000. Despite the volatility, Remedi still posted one of the strongest gains among pharmaceutical and biotech stocks, marking a successful market debut.

The rally was driven by expectations surrounding a major public healthcare procurement project in India.

Remedi announced that it was the only company to pass the technical evaluation in a tender launched by the government of Odisha, India, for portable digital X-ray systems. The company has effectively become the sole participant advancing to the final price-bidding stage, significantly improving its chances of securing the contract.

The tender evaluated product performance, low-dose radiation safety, manufacturing quality, and compliance with local technical specifications. Remedi’s ultra-lightweight portable digital X-ray system and low-radiation technology enabled it to become the only technically qualified bidder.

Industry observers believe this achievement holds significance beyond a single state-level project. Since India’s healthcare procurement system is managed independently by each state government, success in Odisha could strengthen Remedi’s position in future tenders across other Indian states.

Remedi has already supplied 1,534 portable X-ray systems under India’s National Tuberculosis Elimination Program (NTEP) and delivered additional units this year. Winning the Odisha project could further enhance its competitiveness in future government procurement projects.

Expanding production capacity also remains a key growth driver. Annual manufacturing capacity is expected to increase from the current 3,400 units to 3,700 units this year, before expanding to 7,000 units in 2027 and 7,700 units in 2028 following investments in automation.

Cho Bong-ho, Chief Executive Officer (CEO) of Remedi Co., Ltd. (Remedi), said, “Being the only company to pass the technical evaluation demonstrates that our technology and product competitiveness have been objectively recognized in the global market. Starting with Odisha, we will continue to expand our presence across India’s public healthcare market while contributing to better medical accessibility and public health.”

Third CRL Sends HLB Group Stocks Plummeting

In contrast, HLB plunged 29.92% to KRW 25,650, marking its second consecutive limit-down session.

Affiliate HLB Pharmaceutical fell 27.30% to KRW 6,230, while HLB Life Science dropped 26.46% to KRW 1,640, highlighting widespread selling pressure across the HLB group.

The sell-off followed the FDA’s issuance of a third Complete Response Letter (CRL) regarding the New Drug Application (NDA) for the combination therapy of Rivoceranib and Camrelizumab for liver cancer.

According to the company, the CRL was not related to the efficacy or safety of Rivoceranib itself. Instead, it stemmed from observations made during a routine current Good Manufacturing Practice (cGMP) inspection at a manufacturing facility operated by Jiangsu Hengrui Pharma, which is listed in the NDA.

The FDA stated that approval cannot be granted until the manufacturing issues are resolved and cGMP compliance is confirmed. The agency also indicated that an additional Pre-Approval Inspection (PAI) may be required before approval.

HLB explained that the inspection was a routine cGMP inspection rather than a PAI conducted specifically for the NDA review. As a result, neither Elevar Therapeutics nor HLB had prior knowledge of the inspection or the issuance of FDA Form 483. The company has requested Form 483, Hengrui’s corrective action plan, and the expected completion schedule.

Kim Dong-gun, CEO of Elevar Therapeutics, said, “The CRL contains no concerns regarding clinical efficacy or safety and does not require additional clinical trials. Since the primary issue relates to cGMP observations at the manufacturing facility, we will work closely with both the FDA and Hengrui to confirm the necessary procedures and resubmit the application as quickly as possible.”

Nevertheless, investors focused more on the fact that this marks the third regulatory delay, raising uncertainty about the approval timeline despite the absence of clinical issues.

Lemon Healthcare Falls Nearly 29% Following Sharp IPO Rally

Lemon Healthcare also posted a steep decline, falling 28.78% to KRW 6,980, just shy of the daily price limit.

The company surged to KRW 12,220 on its KOSDAQ debut on July 7 and reached an intraday high of KRW 14,540 the following day. However, profit-taking quickly set in, and the stock has now declined for five consecutive trading sessions, erasing most of its post-listing gains.

Market participants attributed the decline to aggressive profit-taking following the sharp rally, combined with weaker investor sentiment across the broader biotech sector.

The company, however, stated that there were no business-related issues behind the decline in its share price.

Lim Chi-gyu, President of Lemon Healthcare, told Edaily, “There are currently no material issues affecting the company. We are also reviewing the reasons behind the stock’s decline, but our business continues to proceed as planned.”

Lemon Healthcare operates a healthcare data platform that connects hospitals with insurers. Its services include CheongguuiSin, a simplified private health insurance claims platform, and Silson24, a government-supported insurance claims application.

The company generated 15.9 billion KRW in revenue last year while posting an operating loss of 600 million KRW. It expects to achieve 24.1 billion KRW in revenue and 6.5 billion KRW in operating profit this year. Its healthcare data platform is currently deployed at more than 130 major hospitals, including Seoul National University Hospital, Severance Hospital, and Asan Medical Center, as the company expands its medical data ecosystem.