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Shanghai Ark Biopharmaceutical Co.

PharmaDeviceNews Shanghai Ark Biopharmaceutical Co.
ArkBio’s FDA-authorized Phase 2 trial of ziresovir will test whether the experimental oral RSV antiviral can shorten oxygen dependence and speed recovery in severely ill hospitalized infants. Representative image.
Pharma & Biotech

FDA clears Shanghai Ark Biopharmaceutical’s ziresovir Phase 2 trial in critically ill infants with RSV

Shanghai Ark Biopharmaceutical Co., Ltd. ((ArkBio) has received authorization from the U.S. Food and Drug Administration (FDA) to conduct a Phase 2 trial of ziresovir, an oral antiviral being developed for infants with severe respiratory syncytial virus infection, including patients requiring treatment in a pediatric intensive care unit. The planned multicenter, randomized, double-blind and placebo-controlled

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ArkBio’s completion of Phase I dosing for AK0406 moves the investigational long-acting influenza prophylaxis candidate into extended safety, pharmacokinetic and immunogenicity follow-up. Representative image.
Pharma & Biotech

What does ArkBio’s AK0406 dosing milestone mean for long-acting influenza prevention?

ArkBio has dosed all Phase I cohorts of AK0406, moving the long-acting influenza prophylaxis candidate into six-month safety follow-up.

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Pharma & Biotech

ArkBio pushes AK0406 into first-in-human testing, but can a long-acting flu antiviral carve out real clinical space?

ArkBio has begun Phase I testing of AK0406 in Australia. Read why this long-acting influenza candidate matters and what risks still need proving.

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