TaiGen Biopharmaceuticals announced that it has officially submitted a New Drug Application (NDA) for its oral antibiotic Taigexyn (Nemonoxacin) capsules to Malaysia's National Pharmaceutical Regulatory Agency (NPRA) through its local partner.

The application, submitted on the 27th to the NPRA under the Malaysian Ministry of Health, seeks approval for the use of Taigexyn capsules to treat mild community-acquired pneumonia in outpatient settings. The timeline for review and approval will follow NPRA’s standard procedures, with the final decision subject to official notification by the regulatory authority.

Kuo-Lung Huang, Chairman and CEO of TaiGen Biopharmaceuticals, emphasized that bacterial resistance to antibiotics is a global health crisis. New antibiotics capable of combating resistant bacteria address a critical unmet medical need within healthcare systems worldwide. He expressed hope that Taigexyn will successfully pass the regulatory review process and join Malaysia's healthcare system in the fight against superbugs.

According to NPRA statistics, pneumonia became the leading cause of death in Malaysia in 2023, surpassing ischemic heart disease. The number of pneumonia-related deaths in Malaysia rose from 9,250 in 2014 to 18,181 in 2023, doubling over nine years. Furthermore, research shows that the incidence of pneumonia in Malaysia increased from 242 cases per 100,000 people in 2011 to 456 cases per 100,000 people in 2019, nearly doubling during that period. This data highlights the urgent demand for effective treatment options, such as antibiotics, in the region.

Resource: 太景*-KY抗生素新藥，遞交馬來西亞上市許可申請