Taheebio's Anti-Thrombotic Drug Enters Substantive FDA Review

Taheebio's anti-thrombotic oral dissolving film drug, BEQIA (TAH3311), has reached a significant milestone, officially entering the substantive review stage with the U.S. Food and Drug Administration (FDA).

The company resubmitted its New Drug Application (NDA) on June 19, 2026. Due to a federal holiday, the FDA's official receipt date was June 22. Following FDA notification on July 14, the application moved to substantive review on August 21, as no deficiencies were communicated within 60 days.

BEQIA utilizes Taheebio's TDS (Transepithelial Delivery System) technology, creating the world's first oral dissolving film for Apixaban. Apixaban, originally marketed as Eliquis by Bristol Myers Squibb and Pfizer, is a leading small molecule drug, with over 70% used to prevent thrombosis in atrial fibrillation patients. U.S. sales of Eliquis were projected at $29.2 billion in 2025.

Despite price reductions mandated by the U.S. government, Eliquis sales have surged, driven by increased prescriptions. IQVIA forecasts a 20-25% revenue growth this year, reaching $28 billion in the U.S. market.

Taheebio's BEQIA targets elderly patients with atrial fibrillation who often face swallowing difficulties. The oral dissolving film offers a convenient alternative to tablets, addressing issues like the need for water, powdering, and choking risks, thereby reducing the incidence of aspiration pneumonia. The company is actively pursuing global licensing and partnerships to expedite BEQIA's commercialization, with dozens of pharmaceutical companies from various regions already engaged in substantive discussions.

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BEQIA's entry into FDA substantive review is an important step in the product's global layout. The company will simultaneously advance global market licensing and cooperation to accelerate the product's commercialization process.