TAIPEI, Taiwan, October 18, 2026－TaiGen Biopharmaceuticals Holdings Ltd. (“TaiGen”) announced today that its commercial partners, Newsun Pharmaceutical JSC and Fideschem Inc., have officially submitted the New Drug Applications (NDAs) for both the oral capsule and intravenous infusion formulations of Taigexyn® (Nemonoxacin) for the treatment of community-acquied pneumonia (CAP) to the Drug Administration of Vietnam (DAV), and the applications have been formally accepted for review.

The review timeline will follow the DAV’s regulatory procedures; the actual duration of the review and whether the drug will receive marketing approval remain subject to official determination and notification from the regulatory authority.

Mr. Kuo-Lung Huang, Chairman of TaiGen Biopharmaceuticals, stated, "As an innovative therapy available in both oral and intravenous formulations, Taigexyn® possesses market exclusivity in Vietnam with no direct competitors in its class. Looking ahead, upon obtaining marketing authorization, being incorporated into national treatment guidelines, and securing health insurance coverage, Taigexyn® is poised to provide a breakthrough solution for Vietnam’s severe antimicrobial-resistant infections and respiratory diseases, demonstrating tremendous market expansion potential."

According to the World Health Organization (WHO), Vietnam recorded 270,000 deaths related to antimicrobial resistance (AMR) between 2020 and 2023, making it one of the countries most severely affected by AMR worldwide and the second highest in AMR-related mortality in the Western Pacific region. The situation has become increasingly acute, placing a heavy burden on the public healthcare system. Vietnam represents a US$ 1 billion annual antibiotic market, ranking as the world’s 11th largest antibiotic consumption market.

Furthermore, respiratory infections pose one of the most formidable clinical challenges in Vietnam. According to treatment guidelines from the Vietnam Respiratory Association (VNRA), community-acquired pneumonia (CAP) is the country’s most common infectious disease, accounting for 12% of all pneumonia cases. Pneumonia ranks as Vietnam’s 2nd most prevalent disease after hypertension, with an incidence of 561 cases per 100,000 population, serving as a major contributor to patient mortality and healthcare burdens. Driven by the escalating threat of antimicrobial resistance and high treatment demand for CAP, there is a critical unmet medical need for innovative antibiotic treatments.

About Taigexyn® (Nemonoxacin)
Taigexyn® is a novel non-fluorinated quinolone available in both oral and intravenous formulations. TaiGen has completed multi-national and multi-center trials of both forms. Clinical data showed it is active against drug-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and quinolone-resistant MRSA as well as quinolone-resistant Streptococcus pneumonia. Its structural design makes it less likely to develop resistance, making it suitable for first-line treatment.