Chinese-based Joincare Pharmaceutical has met the primary endpoint in a Phase III trial of its partnered flu candidate TG-1000.
Taiwan-based TaiGen Biotechnology Company announced its Chinese partner’s success in the Phase III trial of TG-1000 in shortening time to recovery.
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The primary endpoint of the study, the time to alleviation of all influenza symptoms of the TG-1000 group was 60.9 hours, statistically shorter than the placebo group of 87.9 hours. There were no safety concerns observed in the study.
Secondary endpoints, including antiviral efficacy, clinical symptom alleviation, and influenza-related complications, are still undergoing analysis.
The Phase III trial was a multi-centre, randomised, double-blinded study to evaluate the efficacy and safety of TG-1000 compared with a placebo in adult and adolescent patients with uncomplicated acute influenza infection. The study enrolled 752 participants, most of whom were influenza virus A infected.
CEO of TaiGen, Kuo-Lung Huang said: “The positive outcome of TG-1000 Phase III trial represents another opportunity for an innovative drug to enter clinical use. TaiGen holds a cautiously optimistic attitude.”
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By GlobalDataTaiGen signed an exclusive licensing agreement with Joincare Pharmaceutical to develop and commercialise TG-1000 in China in March 2023.
TaiGen will continue to advance development in Europe, the US, and other Asian countries. Joincare Pharmaceutical will be looking to file a new drug application (NDA) for TG-1000 in mainland China in the second half of 2024.
TG-1000 is a novel pan-influenza antiviral, which interrupts viral replication and transmission via a cap-snatching mechanism to demonstrate broad-spectrum activity against influenza-A, influenza-B, avian flu H7N9, and Tamiflu-resistant viruses.
Influenza landscape
Each year, there are approximately 1 billion cases of seasonal influenza worldwide, with 3-5 million severe illnesses and up to 650,000 deaths. In the US, about 8% of the population contracts influenza each season, resulting in approximately $10.4bn in indirect medical costs annually.
In the vaccine field, Moderna is leading with way with messenger RNA (mRNA) flu vaccines, with a candidate in Phase III trials. There are currently 11 different pipeline mRNA flu vaccines in Phase II and III clinical trials.
