[Edaily Reporter KIM SAE-MI ] Cha Sang-hoon, CEO of AprilBio Co.,Ltd.(397030), who stepped down from management this year, has seized an opportunity to once again demonstrate the clinical value of the sustained-release platform “SAFA.” This comes after “APB-A1,” licensed to Lundbeck, failed to demonstrate the expected clinical efficacy in thyroid-associated ophthalmopathy (TED), while “APB-R3” (EVO301), licensed to U.S.-based Evomune, confirmed its efficacy in a Phase 2a clinical trial for atopic dermatitis.

CEO Cha is the founder who established AprilBio Co.,Ltd. in 2013. A former professor at Kangwon National University’s College of Biomedical Sciences, he built the “SAFA” platform based on research into antibodies and protein-based therapeutics. SAFA is a technology that uses antibody fragments bound to serum albumin to extend the half-life of therapeutic proteins in the body. Building on this technology, AprilBio Co.,Ltd. licensed APB-A1 to Lundbeck in 2021 for up to $448 million (537 billion won) and APB-R3 to Evomune in 2024 for up to $475 million (655 billion won). This brings the total value of its technology exports to 1.192 trillion won.

This year also marked a turning point for CEO Cha. In June, AprilBio Co.,Ltd. secured 346.8 billion won in investment from TKG Huchems and IMM, transferring management control to TKG Huchems. CEO Cha also sold 1.77 million shares he held to IMM for approximately 58.2 billion won. Subsequently, the largest shareholder changed to an IMM special purpose company (SPC), and last month, at an extraordinary general meeting of shareholders, representatives from TKG and IMM joined the board of directors, bringing to a close the 13-year era of founder-led management.

Although CEO Cha has relinquished management control, he has not left AprilBio Co.,Ltd. He has decided to remain as CEO of AprilBio Co.,Ltd. and focus his efforts on research and development, as well as platform and new drug development. It appears he is entrusting a significant portion of the company’s capital and management to external professional investors and strategic investors, while he himself, as the founder and technology leader, will concentrate on creating AprilBio Co.,Ltd.’s next growth engine.

Coincidentally, the first major challenge regarding SAFA’s clinical competitiveness arose immediately following the management restructuring. Lundbeck confirmed the biological activity of APB-A1 in the TED Phase 1b clinical trial but halted further development for that indication, citing a lack of the expected clinical efficacy. Although the company did not abandon the candidate compound itself or return the technology, this has raised questions about the clinical competitiveness of the SAFA platform.

However, development of APB-A1 itself has not been halted. Lundbeck recently reclassified Lu AG22515 in its pipeline as a “CD40L inhibitor, Neurology, Phase 1 clinical trial,” shifting its development focus toward neuroimmunological diseases. Although multiple sclerosis (MS), neuromyelitis optica spectrum disorders (NMOSD), and myasthenia gravis (MG) have been cited as potential indications, follow-up indications and the clinical timeline have not yet been finalized.

With the development of APB-A1 for TED having stalled, market attention has shifted to the clinical data for APB-R3, the company’s second technology-export asset.

On the 1st (local time), Evomune presented detailed Phase 2a clinical data for EVO301 in atopic dermatitis at the European Academy of Dermatology and Venereology (EADV 2026) conference in Vienna, Austria. The EVO301 treatment group achieved a 55% reduction in the Eczema Severity Assessment Index (EASI) at Week 12 compared to baseline, outperforming the placebo group’s 22% reduction and meeting the primary endpoint (P<0.01). The statistical significance compared to the placebo, which first appeared at Week 4, persisted through Weeks 8 and 12.

Long-term durability was also confirmed. Patients received EVO301 only twice—at Week 0 and Week 4. At Week 12, eight weeks after the last dose, the EASI-50 achievement rate was 63% compared to 23% in the placebo group, and the EASI-75 achievement rate was 29% compared to 9% in the placebo group. Based on pharmacokinetic (PK) data, Evomune also suggested the possibility of administering the drug at 8- to 12-week intervals during maintenance therapy. This is significant in that it demonstrates the long-term durability—a key strength touted by SAFA—in a human clinical trial.

However, the market reaction was lukewarm. On the 1st, the day the data was released, Evomune’s stock closed at $8.26 (approximately 11,150 won), a sharp drop of 12.71% from the previous day. AprilBio Co.,Ltd.’s closing price on the 2nd was 17,020 won, a sharp decline of 20.09% from the previous trading day. AprilBio Co.,Ltd.’s stock price had risen consecutively on the 30th of last month and the 1st of this month on anticipation of the EADV announcement, only to give up more than its gains immediately after the announcement.

Analysts note that the newly released data did not significantly exceed market expectations. Key results—including the 12-week EASI improvement rate of 55% in the treatment group versus 22% in the placebo group, the primary endpoint—had already been disclosed in the topline results released last February. The newly confirmed EASI-75 achievement rate was 29% in the EVO301 group and 9% in the placebo group.

While the fact that the effect persisted for eight weeks after the final dose with just two administrations is a strength, some point out that, based solely on efficacy metrics, there are limitations to confirming a clear differentiation from existing atopic dermatitis treatments. A biotech industry official stated, “Although we’ve confirmed a signal of efficacy, the key question is whether it is truly competitive compared to Dupixent.”

The next critical milestone is the global Phase 2b clinical trial for EVO301, which Evomune plans to initiate in the middle of next year. While this Phase 2a trial involved 70 participants and used an intravenous (IV) formulation, Evomune plans to switch to a subcutaneous (SC) formulation starting with subsequent trials and re-evaluate the dosage. The company must replicate the efficacy and long-term durability observed in the Phase 2a trial with the SC formulation and demonstrate differentiation beyond mere convenience of administration in the highly competitive atopic dermatitis market.

For CEO Cha, the success or failure of APB-R3 holds special significance. He has proven SAFA’s business development value by securing two major technology export deals. Now that he has handed over management control to external parties, CEO Cha’s remaining key role ultimately lies in “technology.” With SAFA’s clinical competitiveness in question following the setback in the development of APB-A1 for TED, all eyes are on whether APB-R3 will provide a turning point.

◇ Profile of Cha Sang-hoon, CEO of AprilBio Co.,Ltd.
△Born January 18, 1963
△Graduated from the Department of Environmental Science at Kangwon National University in 1987
△Completed a course in Microbiology at Montana State University, USA, in 1989
△ Ph.D. in Immunology, University of California, Davis (UC Davis), 1993
△1993–1994: Postdoctoral Researcher, UC Davis School of Medicine
△1995–present: Professor, College of Biomedical Sciences, Kangwon National University
△1997–1999: Immunology Advisor at Macrogen, Inc.(038290)
△ 2000–2012: CEO, iG-Therapy
△ 2006–2007: Visiting Professor of Pediatrics, National University of Singapore (NUS) School of Medicine
△ 2013–present: CEO, AprilBio Co.,Ltd.
△July 2022: AprilBio Co.,Ltd. listed on KOSDAQ under the Technology Exemption Listing Program