TAIPEI, Taiwan, April 1, 2026－TaiGen Biopharmaceuticals Holdings Ltd. (“TaiGen”) announced today that it received notification yesterday (March 31) from its South Korean partner, Boryung Biopharma, regarding the formal submission of an Investigational New Drug (IND) application for a Phase III clinical trial of Pixavir marboxil (BRC-201) oral capsules to the South Korean regulatory authorities.

Boryung Biopharma signed a licensing agreement with TaiGen in January of this year, securing the exclusive rights to develop and commercialize Pixavir marboxil in South Korea. In just two months, the Boryung team has completed the preparation and submission of the IND, significantly accelerating the entry of this antiviral influenza drug into the South Korean market.

The planned clinical trial is a multicenter, randomized, double-blind, Phase III study using Oseltamivir as an active comparator. The study aims to evaluate the efficacy and safety of Pixavir in adults and adolescents with uncomplicated acute influenza virus infection. The primary endpoint is the time to alleviation of influenza symptoms, while secondary endpoints include antiviral effects and the incidence of influenza-related complications.

“Pixavir has demonstrated exceptional clinical data in the Greater China region, having successfully completed Phase III unblinding and achieved market approval in Mainland China. These results highlight its competitive advantages in both safety and shortening the duration of the disease,” stated Kuo-Lung Huang, Chairman of TaiGen. “This IND submission by Boryung Biopharma marks a vital milestone for Pixavir’s expansion into the Northeast Asian market. We have full confidence in Boryung’s development and marketing capabilities in South Korea and look forward to obtaining trial approval to provide a more effective and convenient treatment option for influenza patients.”

Pixavir marboxil is a cap-dependent endonuclease inhibitor that targets the "cap-snatching" mechanism essential for viral replication. According to previously announced Phase III data from Mainland China, Pixavir significantly shortens the time to symptom relief in adults and adolescents (ages 12~18). It offers the distinct convenience of a single-dose regimen for a full course of treatment, while demonstrating excellent safety and tolerability. The clinical benefits were particularly pronounced in the 12–18 age group.

Beyond the Phase III trial for adults and adolescents in South Korea, TaiGen continues to advance the comprehensive development of Pixavir. A Phase III clinical trial for a pediatric formulation targeting children under the age of 12 is currently in the recruitment stage. This study aims to confirm the efficacy and safety in the pediatric population, expanding the product line to all age groups to address the increasing threat of seasonal influenza.