TAIPEI, Taiwan, August 10, 2026－TaiGen Biopharmaceuticals Holdings Ltd. (“TaiGen”) announced today that it has received notification from its South Korean partner, Boryung Biopharma, that the Investigation New Drug (IND) application for a Phase III clinical trial of the novel influenza antiviral Pixavir marboxil (BRC-201) oral capsules has been officially approved by the Ministry of Food and Drug Safety (MFDS) of South Korea. The Boryung team will officially initiate subsequent clinical trial operations to accelerate its strategic expansion into the South Korean influenza antiviral market.

In January of this year, TaiGen completed a licensing agreement with South Korea’s Boryung Biopharma, granting exclusive rights for the development and commercialization of Pixavir marboxil in South Korea. Following the rapid preparation and submission of the IND application, the approval to conduct Phase III clinical trials once again demonstrates the outstanding execution capability and regulatory efficiency of both teams.

The approved clinical trial is a multicenter, randomized, placebo-controlled, double-blind Phase III study designed to evaluate the efficacy and safety of Pixavir in adults and adolescents with acute uncomplicated influenza infection. Primary endpoints focus on the time to alleviation of influenza symptoms, while secondary endpoints include antiviral effects, clinical recovery status, and the reduction of influenza-related complications.

“Pixavir has accumulated robust Phase III unblinding data and commercial experience in the Greater China region, demonstrating both remarkable efficacy and superior safety,” stated Kuo-Lung Huang, Chairman of TaiGen. “The smooth approval of this South Korean IND marks a pivotal step in expanding Pixavir’s international footprint. We are confident in Boryung’s localized clinical execution and commercial promotion capabilities in South Korea. Both sides will collaborate closely to accelerate trial progress, aiming to deliver a more convenient and effective treatment option for local patients as soon as possible.”

Pixavir marboxil is a novel cap-dependent endonuclease inhibitor that exerts its therapeutic effect by blocking the "cap-snatching" mechanism essential for viral replication. Clinical studies demonstrate that the drug not only significantly shortens the disease duration, but also overcomes the limitations of traditional therapies requiring multi-day dosing regimens. Notably, clinical benefits were particularly pronounced in the 12–18 age group during previous studies.

In recent years, global influenza epidemics have exhibited a non-seasonal trend characterized by unseasonal outbreaks in late spring, summer, or early autumn, with transmission no longer restricted to winter and compounded by co-circulation with other respiratory pathogens, such as COVID-19 and RSV. Facing increasingly severe public health challenges, clinical demand for therapies capable of rapidly inhibiting viral replication and enhancing patient compliance has surged. Pixavir offers the distinct convenience of a single-dose oral regimen for a full course of treatment, effectively addressing the pain points of multi-day regimens and missed doses associated with traditional influenza drugs. Upon entering the South Korea market, Pixavir is expected to infect strong growth momentum into the Northeast Asian influenza antiviral landscape.