TAIPEI, Taiwan, December 30, 2024－TaiGen Biotechnology Company, Limited (“TaiGen”) announced today that its partner has filed the new drug application (NDA) for Taigexyn® (Nemonoxacin) capsule for the treatment of community-acquired bacterial pneumonia (CAP).

 

TaiGen announced that its partner officially submitted the New Drug Application for Taigexy® (Nemonoxacin) capsule to the Malaysia National Pharmaceutical Regulatory Agency (NPRA) on December 27th. The indicated use is for the outpatient treatment of mild community-acquired pneumonia. The estimated completion time will follow the NPRA's review process, and the actual review time and whether the drug will be approved will be subject to official notification from the regulatory authority.

 

Kuo-Lung Huang, Chairman and Chief Executive Officer of TaiGen, said, “Antibiotic resistance is a global health crisis, and new antibiotics capable of treating drug-resistant bacteria are a critical unmet medical need for healthcare systems worldwide. We look forward to Taigexyn® capsule successfully passing the market approval review and joining the pharmaceutical and healthcare system in Mainland China to combat superbugs.”.

 

According to statistics from Malaysia NPRA, pneumonia overtook ischemic heart disease for the first time in 2023 to become the leading cause of death in the country. The data shows that pneumonia-related deaths rose from 9,250 in 2014 to 18,181 in 2023, doubling in just nine years. The incidence rate also nearly doubled, from 242 per 100,000 people in 2011 to 456 per 100,000 in 2019, reflecting the growing demand for antibiotics.

 

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.

 

TaiGen Biotechnology, with a subsidiary in Beijing, China, was founded in 2001 and became listed on the Taiwan OTC Stock Market in 2014. TaiGen is a fully-integrated pharmaceutical company dedicated to the development of innovative small molecule drugs (New Chemical Entity, NCE). It has extensive experience in research topic selection, drug discovery, drug development, and regulatory approval. The company possesses the capability to conduct multi-country, multi-center clinical trials and has a track record of overseas licensing. Its flagship product, non-fluorinated quinolone antibiotic Taigexyn® (Nemonoxacin), has obtained marketing approvals in Taiwan, mainland China, and Russia. The influenza antiviral TG-1000 has completed the phase III clinical trial and filed NDA in mainland China.