FDA Accepts Taihe Biotech's Apixaban Oral Film BEQIA for Substantive Review, PDUFA Date Set for April 22, 2027
核心洞察
Taihe Biotech (搜索)'s antithrombotic oral film BEQIA (搜索) (TAH3311) has entered FDA substantive review, with a PDUFA review completion goal date of April 22, 2027.
BEQIA (搜索) is the world's first apixaban oral film, using Taihe's proprietary TDS transepithelial delivery platform to target the Eliquis market.
Eliquis generated $4.48 billion in global second-quarter 2026 revenue, up about 21-22% year-over-year despite Inflation Reduction Act price cuts.
Taihe Biotech (搜索) (6467), a Taiwanese developer focused on novel drug formulations, announced that its antithrombotic oral film BEQIA (搜索) (TAH3311) has been accepted by the U.S. Food and Drug Administration (搜索) for standard review, with a review completion goal date of April 22, 2027 under the Prescription Drug User Fee Act (PDUFA). The company resubmitted the New Drug Application on June 19, and because that date fell on a U.S. federal holiday, the FDA's official receipt date was June 22. An FDA notification letter dated July 14 stated that absent an incomplete-application notice within 60 days of submission, the case would enter substantive review on August 21; as of that date the company had received no such notice, confirming it had cleared the acceptance threshold.
Shares of Taihe, listed on Taiwan's emerging stock market, rose as much as 20% to an all-time high of NT$228 following the news.
An Apixaban Film Targeting the Eliquis Franchise
BEQIA (搜索)'s active ingredient is apixaban, the molecule marketed by Bristol Myers Squibb (搜索) and Pfizer as Eliquis, described in the source materials as the world's largest small-molecule drug and among the top three best-selling drugs globally. Eliquis is widely used in patients with atrial fibrillation (搜索) to reduce the risk of stroke (搜索) and systemic embolism, with more than 70% of its usage in that population.
According to IQVIA data cited by the company, Eliquis achieved U.S. sales of $29.2 billion in 2025. BMS's second-quarter 2026 results showed global quarterly revenue of $4.481 billion, up 21–22% year-over-year. The source materials attribute the counterintuitive growth to government-mandated price reductions under the Inflation Reduction Act, which cut the per-tablet price from $8–10 to $5.65 and then to $3.85, expanding access to new prescriptions. Insurance companies pay $2,772 for a full year of medication, compared with $46,700 in annual care costs that would be incurred in the event of a stroke (搜索). IQVIA projects revenue growth of 20–25% this year, with the U.S. market reaching $28 billion.
Although the FDA has approved generic tablet versions of apixaban, the source materials state that all of these competitors reached patent litigation settlements with the originator, pushing their market entry timelines to 2028 or later. Taihe is described as the only company pursuing the same active ingredient in a novel oral film formulation. A key near-term variable is whether the originator files a legal challenge within the 45-day window; if it confirms it will not, the likelihood of BEQIA (搜索) entering the market early and capturing share would increase significantly.
Formulation Rationale and TDS Platform
BEQIA (搜索) is developed on Taihe's proprietary TDS (Transepithelial Delivery System) platform for transdermal and transmucosal drug delivery. The company points to a U.S. National Institutes of Health survey indicating that the number of atrial fibrillation (搜索) patients in the U.S. reached 10.55 million in 2025, with patients aged 65 and older accounting for 75% of the total; approximately half of these elderly patients experience swallowing difficulties. Because apixaban requires lifelong administration, the oral film addresses clinical limitations of tablet forms that require water and present challenges with crushing and swallowing, while reducing choking risks and lowering the incidence of aspiration pneumonia (搜索), thereby improving medication adherence.
Beyond BEQIA (搜索), the source materials describe the TDS platform as extensible to oral films, buccal films and patches as new dosage forms, with buccal films enabling delivery through the oral mucosa. Taihe reportedly has formulation improvement programs targeting similarly blockbuster drugs, and more than two pharmaceutical companies have commissioned it for CDMO formulation design and manufacturing.
European Filing and Licensing Negotiations Advance
In parallel with the U.S. pathway, Taihe submitted a Marketing Authorization Application to the European Medicines Agency (搜索) on October 30, 2025, and received confirmation of receipt from the EMA on November 27 of the same year, formally entering the review process.
The company is pursuing a dual-track strategy of regulatory approval and licensing. Dozens of pharmaceutical companies from the U.S., Europe, Australia/New Zealand, Central and South America, and Asia have signed confidentiality agreements, with licensing negotiations ongoing. Market observers cited in the source materials suggest that as U.S. and European regulatory timelines become clearer, Taihe's bargaining position in subsequent licensing talks will strengthen.
Corporate Milestones
On the capital markets front, Taihe is advancing a transition from Taiwan's emerging stock market to a mainboard listing, with a pre-listing results presentation planned for September 16 and a formal mainboard listing expected in mid-to-late October. Institutional investors cited in the source materials note that with BEQIA (搜索) entering the final countdown for U.S. and European regulatory approval, combined with increased visibility of the company's specialized formulation platform value, Taihe's valuation is likely to be re-rated.
If BEQIA (搜索) obtains U.S. marketing approval, it would become Taihe's first drug launched in the U.S. market and provide the most direct validation of the commercial value of its platform technology. The subsequent approval timeline and licensing negotiation outcomes are identified as key indicators for monitoring the company's operational performance.