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Non-fluorinated Quinolone Antibiotic

Antibiotic

Taigexyn®

Overview Superiority Marketplace Development Honor

Overview

The novel antibiotic Taigexyn® (Nemonoxacin) is TaiGen’s first approved drug. Drug-resistant bacterial infection is a global crisis, as standard treatments are becoming less and less effective against the types of infections commonly encountered in hospital or community environments. The size of the global antibiotic market is around US$1150 billion in 2017 and will likely grow as the problem of drug resistance increases. It is estimated that the size of global antibiotic market will reach USD$1686 billion in 2026 and the CAGR is 4.3%.

Taigexyn® (Nemonoxacin) was acquired under license by TaiGen 2004 from Procter & Gamble Pharmaceuticals. At the time of acquisition, the drug had completed Phase Ia clinical trial. Further development work has since been undertaken by TaiGen's clinical team, including expanding the range of possible therapeutic applications, patent protection expansion, and conducting additional clinical trials.
  • Indications in Development
  • Diabetic Foot Infection
  • Other Bacteria Infections

Superiority

  • Potent：Superior activity against MRSA, VRSA, MDRSP and PRSP
  • Broad-spectrum：Excellent activity against Gram (+), Gram (-) and atypical pathogens
  • Low Resistance：Require mutations in 3 different bacterial genes
  • Safe：Excellent safety profile, no severe FQ-related toxicity, low risk of QTc prolongation
  • Low Risk：Without risk of TB masking
  • Effective：Exceptional efficacy was shown in 3 CAP & 1 DFI trials
  • Convenient：Once-a-day prescription; Oral & IV available

Marketplace

Antibiotic resistance is one of the biggest public health challenges of our time.

Infections caused by multi-drug resistant bacteria are commonly encountered in hospital and in community.

Many widely used antibiotics are ineffective against resistant bacteria or with significant side effects. Lacking both oral and IV formulations limits their usefulness.

Development

  • Oral formulation : approved and launched in Taiwan and China.
  • Protected globally by a portfolio of patents that cover composition of matter, use and manufacturing process up to 2030.
  • Out-licensed to Zhejiang Medicine in mainland China in 2012.
  • Received QIDP (Qualified Infectious Disease Product) and Fast Track status for CAP and ABSSSI (acute bacterial skin and skin structure infections) from US FDA in 2013.
  • Partnered/licensed in 32 countries worldwide including Russia, CIS, Turkey, Mexico, Brazil and other Latin American countries.
  • Out-licensed to R-Pharm for Russia, Commonwealth Independent States and Turkey markets in 2014.
  • Out-licensed to Productos Científicos for Latin American markets in 2016.

Honor

  • 2021
  • Symbol of National Quality, IBMI
  • 2020
  • National Bio & Medicine Care Quality Award
  • 2020
  • National Innovation Excelsior Award, IBMI
  • 2019
  • National Innovation Excelsior Award, IBMI
  • 2015
  • The Innovation of the Year, BIO Taiwan
  • 2015
  • Golden Innovation Award, MOHW & MOEA
  • 2013
  • National Innovation Award, IBMI
  • 2013
  • Taipei Biotech Award for Transfer of Biotechnology
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