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Anxo Pharmaceutical Secures First Generic Drug Approvals, Aims to Rebound from BottomMar 14, 2025

Anxo Pharmaceutical’s overall performance last year fell short of expectations, with consolidated revenue totaling NT$895 million, a 4.8% decline year-on-year. The company reported a net loss attributable to the parent company of NT$57.21 million, resulting in a loss per share of NT$1.03. General Manager Lin-Chuan Yen stated that with the recent approvals of its first wave of generic drugs and the advancement of its dual strategy combining internal development with external partnerships, the company is poised for a turnaround this year and is working toward returning to profitability.

Anxo explained that last year’s underperformance was mainly due to delays in overseas licensing agreements and regulatory approvals, increased R&D investment, and adjustments to Taiwan’s National Health Insurance (NHI) drug prices. However, since last year, the company has obtained a total of 15 drug approvals domestically and internationally, including several first-to-market generics such as Anfero Film-Coated Tablets and Film-Coated Tablets. As these new products are launched and overseas licensing and regulatory processes accelerate, the company remains optimistic about its outlook for this year.

Among its new products, Anxo has developed Film-Coated Tablets in 50/850 mg and 50/500 mg dosages, designed with patent circumvention strategies. These tablets received two drug licenses from Taiwan’s Ministry of Health and Welfare (TFDA) at the end of February this year. The product is indicated for improving blood sugar control in patients with type 2 diabetes. This combination drug integrates a DPP-4 inhibitor, which promotes insulin secretion, with metformin, a widely used glucose-lowering agent. It is also the first approved generic drug in Taiwan for this specific combination therapy. Anxo has already applied for NHI reimbursement pricing. Leveraging the dual mechanisms of glycemic control and its first-to-market status, the product is well-positioned to capture early market share, not only targeting the original brand-name drug market but also competing against other combination formulations in its class.

Yen pointed out that Taiwan currently has over 2.5 million people living with type 2 diabetes. Based on NHI usage estimates, the annual consumption of combination tablets exceeds 300 million pills, representing a market worth more than NT$3 billion. Anxo’s Film-Coated Tablets are targeting a 1.5% to 5% market share this year, with plans to double their market share by 2026, making the product one of the company’s key drivers of future growth.

Looking ahead to this year, Yen stated that Anxo will continue to advance both internal and external initiatives, including expanding its drug approval portfolio at home and abroad, accelerating overseas licensing, and reactivating dormant drug licenses to drive overall business growth. Subsidiaries TAXO Pharmaceutical and AUPA Biopharm will align with the parent company’s strategy and adjust their operations accordingly. TAXO will focus on introducing new products from overseas and negotiating domestic licensing deals to enrich its product pipeline and expand its scale of operations. AUPA, responding to the parent company’s overseas business expansion, plans to invest in plant expansion this year, increasing production lines and capacity while actively acquiring new customers to build momentum for future growth.

Yen added that Anxo has plans to submit applications for 12 products for market approval this year, with eight products currently under review that are expected to receive approval within the year. In overseas markets, the company’s steady sales of existing products in Thailand and China are expected to continue contributing to revenue growth. This year, Anxo will focus on Japan as a key market, with three chronic disease drug collaboration projects nearing finalization. Both sides are currently fine-tuning the details, and a formal agreement could be reached as early as the second quarter. The company remains optimistic about its full-year outlook for 2025.

Resource: 首發學名藥證陸續到手 瑩碩營運拚谷底翻