Hantai Evaluates In-House Sales for Multi-Target Cancer Drug, Plans U.S. Market Expansion

Liu Fangyu, Chairman of Hantai Biotech, announced that the company's self-developed multi-target cancer drug is currently under review by the U.S. Food and Drug Administration (FDA), and the company has already received a facility inspection notice. With the drug approval process entering a crucial stage, Hantai is not only continuing to evaluate licensing partnerships but also planning the establishment of a U.S. sales team and distribution network, leaving open the possibility of in-house product sales.

Hantai Biotech held its annual shareholders' meeting today, followed by a media briefing. The company reported that in 2025, driven by growth in sales of improved new drugs and high-barrier-to-entry generic drugs, along with the one-time upfront licensing fee recognition from the blood cancer drug Phyrago, full-year revenue reached NT$1.729 billion, a 108% year-on-year increase. Net profit attributable to the parent company was NT$750 million, up 68.6% year-on-year, with earnings per share (EPS) at NT$4.85. Both profit and EPS achieved second-highest records in company history.

Hantai stated that it has been continuously optimizing its product portfolio, transitioning step by step from high-barrier-to-entry generics to a specialty pharmaceutical company centered on improved new drugs. With multiple products launching sequentially, the company has established an operational model combining product development and commercialization capabilities. In addition to further expanding its U.S. market presence, Hantai is also advancing commercialization in China and Taiwan.

Regarding already-launched products, the blood cancer treatment drug has seen steady growth in patient usage since its October launch last year, with market penetration continuing to rise. Liu Fangyu noted that there are currently no other approved 505(b)(2) competing products in the dasatinib market, and actual patient numbers have shown a monthly increasing trend since the beginning of this year. The company is optimistic about further expanding market coverage and expects this product to become a major revenue driver.

On the progress of the highly anticipated multi-target cancer drug, Liu Fangyu stated that HND-039 is a multi-target cancer therapy applicable to several tumor indications, with renal cell carcinoma representing the largest market. The New Drug Application (NDA) remains under FDA review. In addition to ongoing discussions on the drug labeling content, the company has received an FDA inspection notice and will complete all related procedures as planned.

Regarding commercialization strategy, Liu Fangyu indicated that the company is currently evaluating both licensing partnerships and in-house sales models, and has already initiated U.S. market planning, including engaging key opinion leaders (KOLs), studying the oncology drug distribution system, and planning market access and sales team structures.

He stated that if the product obtains regulatory approval in the future, in-house sales will not be ruled out. However, if a potential partner presents favorable terms for shareholder value, such options will also be considered.

Hantai stated that it will continue to advance the development of improved new drugs, introduce external technology platforms and products, and expand international licensing collaborations and business development opportunities, aiming to file at least one new drug application or achieve a product launch annually.