TTY Biopharm's combination oral capsule chemotherapy drug, part of the 5-FU class, has received its sixth regulatory approval. Following approvals for treating gastric cancer, pancreatic cancer, colorectal cancer, advanced non-small cell lung cancer, and bile duct cancer, the Taiwan Food and Drug Administration (TFDA) approved its use for breast cancer on the 22nd. This new approval marks the completion of TTY Biopharm’s comprehensive product line for breast cancer treatment.
The newly approved indication is for the adjuvant chemotherapy treatment of early-stage breast cancer with high recurrence risk in patients who are hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative. Currently, TTY Biopharm's portfolio in breast cancer treatment encompasses eight products across four major categories: chemotherapy, special formulation chemotherapy, hormone therapy, and targeted therapy, covering both early and advanced stages of the disease. This solidifies TTY Biopharm's position as the leading brand in Taiwan's oncology pharmaceutical sector.
TTY Biopharm stated that since 2010, they have been distributing the 5-FU class combination oral capsule chemotherapy drug from Japan. This drug, composed of tegafur, gimeracil, and oteracil, operates through different mechanisms to offer treatment convenience and improve patients’ quality of life. It has been approved for treating gastric cancer, pancreatic cancer, colorectal cancer, advanced non-small cell lung cancer, and bile duct cancer. With the recent approval for early-stage breast cancer, TTY Biopharm now targets an additional market worth an estimated NT$300 to NT$500 million annually, benefiting approximately 4,000 to 5,000 breast cancer patients each year.
General Manager Sara Hou noted that the combination oral capsule chemotherapy drug, which was first launched in Japan in 1999, has since been marketed in over 40 countries and is recognized as a standard treatment worldwide. In 2022, it was included in the Japanese Breast Cancer Society’s clinical practice guidelines for early breast cancer, and last year, it was also endorsed by the Taiwan Breast Cancer Society as part of their treatment consensus.
Sara Hou further emphasized that TTY Biopharm has long been dedicated to the field of breast cancer treatment. Their self-developed liposomal doxorubicin (Lipo-Dox), the first chemotherapy drug they created for breast cancer treatment, has been on the market since 2004, with over ten clinical trial research reports produced.
Moving forward, TTY Biopharm will continue to deepen its "three-pronged strategy": licensing and introducing new international drugs, exporting complex generic drugs, and developing new domestic drugs, thereby providing more diverse healthcare solutions for patients worldwide.
Resource (mandarin): 東洋複方口服膠囊癌藥獲第六張藥證 營運進補
