[Edaily Reporter YU JIN-HEE ] #HYUNDAI BIOSCIENCE CO., LTD.’s universal oral antiviral drug “Zefti” (CP-COV03) was unveiled at the world’s most prestigious academic forum on infectious diseases. Expectations for the commercialization of this “game-changing” new drug from Korea are rising even further as an “Integrated Trial” strategy—targeting not only dengue fever, for which there are currently no treatment options worldwide, but also fever-causing viral infectious diseases in general—was unveiled by leading global scholars.

Professor Smith, who led the White House’s COVID-19 response: “Jefty is the only alternative for symptom-based early intervention”

HYUNDAI BIOSCIENCE CO., LTD. announced on the 26th that it officially presented the development strategy and initial progress of Jefty’s integrated Phase 2/3 clinical trial (Project Name: DEN-201) for dengue fever and similar infectious diseases during an official session at “IDWeek 2026,” the annual academic conference on infectious diseases held in Washington, D.C., from the 21st to the 24th.

The presentation, personally chaired by Professor David Smith of the University of California, San Diego School of Medicine—regarded as a leading authority on the clinical development of antiviral therapies—drew significant attention from the academic community. Professor Smith is a leading virologist who has spearheaded clinical research on human immunodeficiency virus (HIV) and COVID-19. He served as the international protocol chair for the “ACTIV-2” treatment study, a U.S. government-led COVID-19 response program.

Speaking from the podium, Professor Smith emphasized, “It is extremely difficult to distinguish the cause of dengue fever and other febrile viral diseases based solely on early symptoms,” adding, “Before time is wasted on identifying a specific virus, ‘symptom-based early intervention’ must be carried out using antiviral drugs that are both safe and versatile.”

He went on to assess that “Jefti’s global clinical trial DEN-201 marks a significant milestone in demonstrating the potential of a first-in-class, host-targeted oral antiviral that works regardless of viral mutations.”

Vietnam Clinical Trial Progressing Smoothly… Initial Data Shows “Zero Serious Adverse Events”

Currently, Jefti’s Phase 2/3 clinical trial is proceeding smoothly with patient enrollment and dosing at key medical institutions—including the Hanoi National Hospital for Tropical Diseases (NHTD) and Tien Giang General Hospital (TGGH)—under the approval of the Vietnamese Ministry of Health (MOH).

The preliminary blinded pooled safety analysis results presented at the conference are highly encouraging. Not a single case of death, serious adverse event (SAE), or severe adverse reaction was reported in either the treatment group or the placebo group. Adverse reactions occurring after administration were limited to mild or moderate transient gastrointestinal symptoms, confirming an excellent tolerability and safety profile.

Local health authorities, who had previously relied solely on symptomatic treatments such as antipyretics due to the lack of available therapies, are also expressing high expectations. According to the company, Vietnamese authorities have indicated a positive stance toward expanding the scope of treatment to vulnerable populations—including children and the elderly, who have a high rate of severe disease progression—as soon as safety and efficacy are confirmed in clinical trials involving adults.

HYUNDAI BIOSCIENCE CO., LTD. plans to determine the optimal dosage early on based on the dose-specific safety and efficacy data obtained from the Phase 2 clinical trial. In the subsequent Phase 3 clinical trial, the company plans to expand beyond a single disease by adopting a “basket trial” design that groups similar flavivirus-related diseases—including dengue fever, Zika, influenza (the flu), and COVID-19—under a single framework.

The company is also accelerating efforts to establish research and development (R&D) partnerships with the U.S. government. Through its U.S. subsidiary, HYUNDAI BIOSCIENCE CO., LTD., HYUNDAI BIOSCIENCE CO., LTD. is the only Korean pharmaceutical and biotech company participating as a full member of the U.S. Medical Countermeasures Consortium (MCDC). The dengue fever clinical data presented at IDWeek represents a key asset that could lead to future national security-level collaboration projects with U.S. federal agencies.

Kim Taek-sung, CEO of HYUNDAI BIOSCIENCE CO., LTD. USA, explained, “This IDWeek presentation is deeply significant in that Professor Smith, a world-renowned scholar, has officially validated the clinical design and data value of Jefty to the global infectious disease community,” adding, “Relevant U.S. agencies are also closely monitoring the progress of this dengue clinical trial.”

He continued, “We will swiftly secure clinical evidence covering not only children and the elderly but also multiple infectious diseases to demonstrate Jefty’s unparalleled value,” and added, “We will emerge as a ‘leading global company in universal antiviral drugs’ that provides practical solutions to the global healthcare community suffering from a lack of effective treatments.”