TaiGen Biopharmaceuticals Holdings Ltd (太景醫藥研發控股) has set its sights on the market for next-generation anti-influenza drugs with its new novel antibiotic, the company said at the BioTaiwan exhibition at the Taipei Nangang Exhibition Center in Taipei yesterday.
The company is developing an antiviral that is designed to block virus replication and transmission for influenza A and B viruses.
Influenza infections spread in two main steps, the first being the cap-snatching process, where the virus steals the caps or ends of its host’s ribonucleic acid to make copies of itself.
Once the virus has amassed enough copies of itself, it uses the neuraminidase enzyme to separate itself from the host cells to spread to other parts of the body.
The antiviral, which has yet to be named, is designed to halt the spread of influenza a step earlier than conventional treatments, which use a neuraminidase inhibitor such as Tamiflu that only works to halt the separation and spread of the virus.
The novel antibiotic mechanism is expected to yield faster recovery times by inhibiting the virus’ cap-snatching process, the company said.
The antiviral also has the advantage of having a much wider window for treatment, while Tamiflu is most effective only in the initial 48 hours after the onset of symptoms, it said.
However, TaiGen would have to compete with Xofluza (Baloxavir marboxil), an antiviral developed by Japanese pharmaceutical firm Shionogi Co, which pioneered cap-snatching inhibition.
Xofluza has gained marketing approval in Japan and is expected to be given the green light by the US Food and Drug Administration (FDA) by the end of this year.
While TaiGen’s drug would have a similar mechanism to Xofluza, the company has secured patents for it and plans to submit an investigational new drug application (IND) to the FDA next year.
“An IND approval from the FDA would pave the way for the company to conduct clinical trials in China and Taiwan, where the costs of such studies are much lower than in the US,” TaiGen vice president Richard Lu (呂理堅) said.
“We are encouraged by the progress of Xofluza and hope to add another option for influenza patients,” Lu said.
Regarding Taigexyn (nemonoxacin), the company’s newly launched antibiotic, Lu said that Chinese regulators are expected grant approval for an intravenous formulation of the drug before the end of this year, which would retail at a much higher price than the oral formulation.
TaiGen, which last year posted net income of NT$756 million (US$24.68 million), or earnings per share of NT$1.04, won accolades at this year’s Taiwan Bio Industry Awards as one of the few new drug developers to post a profit.