TSH Biopharm has announced promising developments in its efforts to expand both domestic and international markets. Recently, the company received regulatory approval for a new combination hypertension drug in Malaysia. Additionally, by the end of this year, TSH Biopharm expects to secure two more drug approvals in Taiwan: Kauliv, a biosimilar for osteoporosis treatment, and Tyrvaya, a nasal spray for dry eye syndrome. Both products have successfully completed and passed overseas inspections.

TSH Biopharm has now accumulated over ten new drug approvals both domestically and internationally. The company aims to add two more Taiwan approvals by the end of this year, including one for a biosimilar drug and one for a new drug. These two products have recently completed and passed their respective overseas inspections.

General Manager Sze-Yuan Yang explained that the biosimilar Kauliv, used for osteoporosis treatment, completed its overseas inspection in May this year and is currently undergoing continued review. The new drug, Tyrvaya nasal spray, developed in collaboration with an international partner, is the first of its kind using a novel administration route for treating dry eye syndrome. This drug completed and passed overseas packaging and formulation plant inspections in June.

In recent years, TSH Biopharm has been actively expanding in the Asian region. In June, the company received another approval in Malaysia for Amtrel, a combination hypertension drug containing both CCB and ACEi components. Research indicates that this combination can reduce cardiovascular events by 19.6% in high-risk hypertension patients. Furthermore, studies in Japan and Taiwan have shown that ACEi can effectively reduce the incidence of inhalation pneumonia, and these findings are included in the treatment guidelines of the Taiwan Stroke Association.

TSH Biopharm's hypertension drug Amtrel has gained trust in multiple Southeast Asian countries. It was launched in Thailand in 2015, received approval in Myanmar in 2022, and in June 2024, it was granted approval in Malaysia. TSH Biopharm continues to have several other drug approvals under review and inspection.

Resource (mandarin): 東生華高血壓複方新藥，獲馬來西亞藥證