[Yu Jin-hee, Edaily Reporter] As the domestic stock market enters a correction phase, excess liquidity is flowing back into the pharmaceutical and biotech sectors. Investors are even returning to companies previously labeled as “problematic” due to past controversies, regulatory uncertainties, and exaggerated marketing claims. According to KG Zeroin MP DOCTOR on July 20, Lemon Healthcare, Samchungdang Pharm, and ROKIT Healthcare made the list of the top 15 gainers in the domestic market. Their stock prices surged by 29.93% (6,990 KRW), 29.82% (239,000 KRW), and 25.54% (60,700 KRW), respectively, outperforming the broader market. The rally indicates that the biotech sector remains an attractive destination for capital despite lingering concerns about these specific companies.

Lemon Healthcare Shrugs Off “Sewol Commemoration Text” Blunder to Hit Daily Upper Limit on Turnaround Hopes

Lemon Healthcare, a provider of digital healthcare data platforms, closed at its daily upper limit of 6,990 KRW (29.93%). The company recently faced fierce backlash when it was revealed that its patient-facing mobile apps at major university hospitals had left a sample date input string matching the day of the Sewol ferry disaster (20140416) unverified for years. Although CEO Hong Byung-jin issued a formal apology to the victims’ families and the public, investor focus quickly shifted to the company’s financial turnaround prospects. Market participants note that Lemon Healthcare stands out because it actually generates profits despite being listed via the technology exception track. The company posted revenue of 15.9 billion KRW and an operating loss of 600 million KRW last year. For this year, it projects an operating profit of 6.5 billion KRW on revenue of 24.1 billion KRW, marking its first profitable year since its founding. It has set a further roadmap for 2027, targeting 29.6 billion KRW in revenue and 11.3 billion KRW in operating profit.The underlying technology remains robust. Lemon Healthcare received A and A ratings from NICE Information Service and Korea Ratings Data during its technology assessment. Its “Lemon Digital Bridge” (LDB) platform connects closed electronic medical record (EMR) systems at major hospitals, powering real-time medical data ecosystems such as the simplified indemnity insurance claims service “Silson24.” The system is operating stably across more than 130 major hospitals, including Seoul National University Hospital and Severance Hospital. The company plans to use the capital raised from its IPO to invest in AI training data infrastructure and expand its cloud capacity to widen the gap with competitors.

Samchungdang Pharm Soars on FDA Pre-ANDA Response, but Regulatory Hurdles Remain

Beginning. Samchungdang Pharm, whose stock had previously plummeted after being designated a company with non-compliant disclosures and facing scrutiny over its contract structure, rebounded sharply as regulatory uncertainties eased. The stock jumped 29.82% to close at 239,000 KRW. The surge followed the company’s announcement that it had received a Pre-ANDA (Abbreviated New Drug Application) response from the U.S. Food and Drug Administration (FDA) regarding its development strategy for an oral semaglutide generic. Securing regulatory guidance for an oral version of a glucagon-like peptide-1 (GLP-1) generic is a clear catalyst given the booming global obesity and diabetes market. A representative for Samchungdang Pharm stated, “The FDA response clarifies the regulatory path for our oral generic. Combined with our efforts to secure advance supply contracts in the U.S. and European markets, this is an opportunity to demonstrate the global value of our proprietary oral drug delivery technology, S-PASS.” However, market experts caution investors not to mistake a Pre-ANDA response for final approval. A Pre-ANDA meeting simply allows a generic developer to review its filing strategy with the FDA before making a formal submission. To secure actual marketing authorization, the company must still pass the formal ANDA review process, which involves rigorous testing for bioequivalence, product quality, and Good Manufacturing Practice (GMP) facility inspections. Given that Samchungdang was penalized by the Korea Exchange for omitting overseas performance data for its Eylea biosimilar, potential regulatory setbacks—such as a Complete Response Letter (CRL)—cannot be ruled out during the final filing stages. “Because the response document contains confidential details regarding our S-PASS platform and commercial strategy, we cannot disclose the full text,” the company official added. “Publishing isolated sentences could distort the true context.”

ROKIT Healthcare Rises on 8x Increase in U.S. Target Market, but Hair Regrowth Data Remains Unrevealed

ROKIT Healthcare, a developer of organ regeneration platforms, also joined the rally, closing 25.54% higher at 60,700 KRW on a combination of favorable U.S. policy updates and expectations for its anti-aging hair loss technology. The American Medical Association (AMA) recently updated its Current Procedural Terminology (CPT) Category III codes, officially incorporating the entire cycle of regenerative medicine—including custom 3D digital models and autologous tissue harvesting—into the formal medical billing system. This policy shift provides legal and billing support for ROKIT Healthcare’s core workflow, which combines AI image analysis, 3D bioprinting, and custom scaffold transplants for skin and cartilage regeneration. Previously, ROKIT’s addressable market in the U.S. was limited to approximately 1.5 million patients with diabetic foot ulcers (DFUs). Under the new codes, Medicare and private insurance coverage can be expanded to include skin cancer reconstruction and severe chronic wounds, increasing the company’s Serviceable Obtainable Market (SOM) eightfold to 11.95 million patients. In response, the company is investing 15 billion KRW this year in R&D and clinical expansion, while recruiting Dr. Nathan Lee as Chief Technology Officer (CTO) to accelerate commercialization. However, the company’s other major claim—a technology based on natural substances that reportedly achieves “complete hair regrowth within 4 weeks”—is drawing comparisons to past hype in the biotech sector. ROKIT has heavily marketed the technology as an epigenetic breakthrough that reverses the microenvironment of aging hair follicles. Yet, investigations reveal that the core technology is only at the provisional patent filing stage—a process used to claim a priority date rather than a granted patent—and the specific compounds and mechanisms remain entirely undisclosed. Distributing press releases claiming “complete hair regrowth” based solely on limited animal data, alongside contradictory statements from the company that label the study as both a non-medical human application test and a Phase 1 clinical trial for a new drug, poses significant compliance risks. This controversy comes at a time when the Financial Supervisory Service is tightening oversight of disclosure practices across the biotech sector. A representative for ROKIT Healthcare emphasized the regulatory progress, stating, “The change in U.S. policy confirms that organ regeneration workflows combining AI and 3D bioprinting are being recognized as standard medical procedures in the U.S. We will execute our commercialization roadmap to capture the multibillion-dollar U.S. market.”