Anxo Pharmaceutical General Manager Lian-Chuan Yen stated at the investor conference on the 5th that the company’s efforts to expand global markets through alliances with domestic and international pharmaceutical partners have begun to yield results. As of this year, Anxo has obtained 10 drug approvals in Taiwan. With new products entering the market, the company aims to turn profitable in the second half of the year and plans to launch its IPO in 2025. Over the next five years, Anxo aims to secure more than 85 global drug approvals, including at least one new-formulation drug licensed worldwide.
Anxo is a research-driven company with both technological and market-oriented strengths. Over the past three years, R&D spending has averaged 35% of total expenses, reaching 37.4% last year—significantly higher than the 5% to 15% typically seen among listed peers (excluding pure new drug developers). Leveraging six proprietary formulation platform technologies, the company has achieved numerous first-to-market generic drug milestones in Taiwan and, through strategic alliances, expanded its product pipeline and international footprint. To date, Anxo has secured 21 technology licensing deals, 14 sales partnerships, and 8 co-development projects.
Yen noted that Calcium-Ease, developed in-house for treating secondary hyperparathyroidism in dialysis patients, has remained the only generic drug of its kind in Taiwan since its approval in 2014. Following the original drug’s withdrawal from the Taiwanese market last year, Anxo has supplied the product exclusively for 11 consecutive months. Acnoxin, approved earlier this year for severe acne, also became the first oral isotretinoin soft-gel capsule generic drug in Taiwan.
Beyond R&D, Anxo operates two key subsidiaries: Opah Biotech, which oversees manufacturing and is transitioning toward a CDMO model, and Taihosure Pharma, responsible for marketing, distribution, and the agency business for various international pharmaceuticals and functional health products. Together, these units form an integrated value chain spanning drug development, production, and commercialization.
Yen explained that Anxo has progressed through four stages of development since its founding—from value-based generics to complex generics, and from establishing a foundation in Taiwan to expanding abroad. After initial entries into China, Japan, South Korea, and ASEAN markets, the company advanced further in September when the U.S. FDA approved its IND application for AX251, a schizophrenia treatment, marking a formal step into new drug development and expansion into U.S. and European markets.
AX251 is a next-generation long-acting injectable reformulated from an existing oral drug using Anxo’s proprietary nano-crystal injectable platform, NanoCIP. The new formulation is designed to improve bioavailability while reducing side effects. The Phase I clinical trial is expected to begin in the first quarter of next year.
As of now, Anxo’s R&D pipeline includes 26 products for the Taiwan market (projected to obtain 46 approvals), 9 products for global markets, and 3 new-formulation drugs under the 505(b)(2) regulatory pathway. By 2030, the company expects to obtain more than 85 new global drug approvals, with at least one new-formulation drug achieving out-licensing.
Looking ahead, Yen said reforms in Taiwan’s National Health Insurance drug pricing system will strengthen pharmaceutical supply resilience and create opportunities for niche generic drugmakers. Anxo will continue focusing on complex generics and new-formulation drug development, driven by two core engines—innovative R&D and business development (BD). The company will pursue two key strategies: leveraging Taiwan-based production with overseas licensing partners to accelerate expansion in Asia-Pacific and Middle Eastern markets, and adopting co-development models that combine Anxo’s R&D capabilities with partners’ manufacturing or commercialization strengths, aiming to become a global leader in drug delivery system (DDS) technologies.
Resource: 雙引擎驅動 瑩碩未來五年目標新增85張藥證
