[Edaily Reporter YU JIN-HEE ] As the domestic securities market has recently entered a correction phase, a trend has been observed in which capital, having lost its direction, is once again flowing back into the pharmaceutical and biotech sectors. Even companies that had previously lost market trust due to various controversies, regulatory uncertainties, and allegations of exaggerated marketing—and were thus dismissed as so-called “problem children”—now appear to be stimulating investor sentiment.

According to KG Zeroin MP DOCTOR, #LEMON COMPANY LIMITED and SAM CHUN DANG PHARM CO. LTD(000250), and ROKIT HEALTHCARE Inc. Their stock prices rose 29.93% (closing price of 6,990 won), 29.82% (239,000 won), and 25.54% (60,700 won), respectively, compared to the previous day, standing out in the broader market. This sharp rise in the three companies—which had previously been the subject of market concerns—clearly demonstrated that the biotech sector can still serve as an attractive destination for capital even amid an overall market correction.

LEMON COMPANY LIMITED Hits Daily Price Limit on Earnings Turnaround, Overcoming “Sewol Ferry Phrase Controversy”

LEMON COMPANY LIMITED, a mobile healthcare data platform company, faced severe embarrassment after it was revealed that it had left an example phrase (20140416)—which evoked the date of the Sewol Ferry disaster—in the date of birth input field of patient applications at major domestic university hospitals for several years, prompting CEO Hong Byung-jin to issue an official apology. However, expectations of a financial turnaround served as a catalyst for a reversal in the stock’s performance.

The market took note of the fact that, despite being listed under the technology exemption category, Lemon Healthcare is essentially a “profitable company.” Last year, the company posted revenue of 15.9 billion won and an operating loss of 600 million won. This year, the company has forecast revenue of 24.1 billion won and an operating profit of 6.5 billion won, signaling its first operating profit since its founding. Furthermore, it has presented a roadmap to significantly expand its performance by 2027, targeting revenue of 29.6 billion won and an operating profit of 11.3 billion won.

Its technological capabilities are also robust. LEMON COMPANY LIMITED objectively demonstrated its technical prowess by receiving “A” and “A” ratings, respectively, from NICE Evaluation Information and Korea Evaluation Data in their technology assessments. The company’s “Lemon Digital Bridge” (LDB) platform organically integrates the closed electronic medical record (EMR) systems of major hospitals, establishing a customized medical MyData ecosystem that includes simplified claims processing for out-of-pocket medical insurance (Sil-Son 24). It is already stably commercialized and operational at more than 130 major general hospitals in Korea, including Seoul National University Hospital and Severance Hospital. The company plans to use the recently secured public offering funds to focus on expanding its medical artificial intelligence (AI) training data infrastructure and cloud capabilities, thereby widening its technological lead.

SAM CHUN DANG PHARM CO. LTD’s Stock Soars on U.S. FDA ‘Pre-ANDA’ Response… Regulatory Hurdles Are Just Beginning

SAM CHUN DANG PHARM CO. LTD, whose stock price had plummeted amid controversy over being designated a company with “inadequate disclosure” and disputes regarding its contract structure, saw the market react positively to news that regulatory uncertainty with the U.S. Food and Drug Administration (FDA) had eased. SAM CHUN DANG PHARM CO. LTD officially announced today that it had received a “Pre-ANDA” response from U.S. regulatory authorities regarding the development strategy and pathway for its oral semaglutide generic drug currently under development.

Securing a regulatory milestone in the race to develop oral generics containing glucagon-like peptide-1 (GLP-1)—which dominates the global obesity and diabetes treatment market—is clearly a strong positive for the capital markets.

A SAM CHUN DANG PHARM CO. LTD official stated, “With the receipt of this FDA response, the guidelines for the approval review process have become clear,” adding, “Combined with our ability to secure preemptive supply agreements in the U.S. and European markets, this has opened an opportunity to demonstrate the global value of our proprietary oral platform technology.”

However, capital market experts warn that it is crucial to clearly distinguish that this FDA Seohan by no means signifies the final “approval” of the generic drug. This is because a Pre-ANDA is merely a procedure for preliminary consultation on the development direction and the appropriateness of submission documents prior to a full-fledged Abbreviated New Drug Application (ANDA). To actually obtain marketing authorization, the company must overcome numerous stringent regulatory hurdles during the formal ANDA review process, including verification of the drug’s bioequivalence, rigorous quality validation, and on-site inspections of global manufacturing facilities (GMP). Given that the company was previously sanctioned by the Korea Exchange for failing to disclose overseas sales performance data for its biosimilars, it cannot rule out risk factors—such as a Complete Response Letter (CRL)—that may arise during the formal approval application stage; therefore, a cautious approach is required for short-term, theme-driven investments.

A SAM CHUN DANG PHARM CO. LTD official stated, “The response document contains details on our proprietary S-PASS technology and our development and business strategies, so it is difficult to disclose the full text,” adding, “Disclosing only specific sentences could distort the overall meaning.”

ROKIT HEALTHCARE Inc. Smiled at the Positive News of an 8-Fold Expansion in the U.S. Regenerative Medicine Market, but… Faces the Challenge of ‘Non-Disclosure of Hair Regrowth Technology’

ROKIT HEALTHCARE Inc., a regenerative medicine platform company, also joined the list of stocks experiencing sharp gains as expectations for policy benefits in the U.S. merged with anticipation for new hair loss treatment technologies. The American Medical Association (AMA) recently updated its official medical procedure codes (CPT Category III) to incorporate the entire regenerative medicine process—including patient-specific digital 3D models and the harvesting of autologous heterotopic skin structures—into the mainstream healthcare system, which acted as an upward catalyst.

This shift in U.S. policy has laid the groundwork for a significant expansion of the scope of local health insurance coverage for ROKIT HEALTHCARE Inc.’s AI image analysis and 3D bioprinting-based skin and cartilage regeneration scaffold implantation technologies. Previously, the primary target market (SOM) in the U.S. was limited to approximately 1.5 million patients with severe diabetic foot ulcers (DFUs). However, with regulations now relaxed to include skin cancer reconstruction and severe chronic wounds—areas eligible for Medicare and private insurance claims—the local target market has surged more than eightfold to 11.95 million people. Riding this momentum, the company is aggressively investing 15 billion won this year to expand research and development (R&D) and clinical trials, and is accelerating commercialization by recruiting world-renowned scholar Dr. Inadan as Chief Technology Officer (CTO).

However, concerns are gradually mounting that the “natural substance technology promising full hair regrowth in just four weeks”—another key factor that sent the stock price soaring—could lead to a repeat of the Samchundang scandal. Although ROKIT HEALTHCARE Inc. has heavily promoted that its natural substance-based technology fundamentally reverses the microenvironment of aged hair follicles, it has been revealed that this core technology remains at the “provisional application” stage—intended to secure priority of the invention date rather than a formal patent—and that the specific ingredients and mechanism of action are kept strictly confidential. The company distributed a press release using the definitive term “complete hair regrowth” based solely on limited hair regrowth data from animal testing, and the fact that the company’s explanations regarding human application trials (non-drug) and Phase 1 clinical trials on the new drug track (drug) are inconsistent and contradictory—combined with the financial regulatory authorities’ ongoing push to strengthen transparency in biotech disclosures—are highly likely to result in a serious blow to the company’s credibility and create significant risk of selling pressure.

ROKIT HEALTHCARE Inc. official stated, “The shift in U.S. policy signifies that organ regeneration technology—which integrates AI and 3D bioprinting—is being recognized as an official procedure in the U.S. healthcare sector,” adding, “We will proceed with commercialization without a hitch to secure a leading position in the U.S. organ regeneration market.”